What interventions protect patients from falling?

Falls in care facilities and hospitals are common events that cause considerable morbidity and mortality for older people. This is an update of a review first published in 2010 and updated in 2012.

To assess the effects of interventions designed to reduce the incidence of falls in older people in care facilities and hospitals.

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (August 2017); Cochrane Central Register of Controlled Trials (2017, Issue 8); and MEDLINE, Embase, CINAHL and trial registers to August 2017.

Randomised controlled trials of interventions for preventing falls in older people in residential or nursing care facilities, or hospitals.

One review author screened abstracts; two review authors screened full‐text articles for inclusion. Two review authors independently performed study selection, 'Risk of bias' assessment and data extraction. We calculated rate ratios (RaR) with 95% confidence intervals (CIs) for rate of falls and risk ratios (RRs) and 95% CIs for outcomes such as risk of falling (number of people falling). We pooled results where appropriate. We used GRADE to assess the quality of evidence.

Thirty‐five new trials (77,869 participants) were included in this update. Overall, we included 95 trials (138,164 participants), 71 (40,374 participants; mean age 84 years; 75% women) in care facilities and 24 (97,790 participants; mean age 78 years; 52% women) in hospitals. The majority of trials were at high risk of bias in one or more domains, mostly relating to lack of blinding. With few exceptions, the quality of evidence for individual interventions in either setting was generally rated as low or very low. Risk of fracture and adverse events were generally poorly reported and, where reported, the evidence was very low‐quality, which means that we are uncertain of the estimates. Only the falls outcomes for the main comparisons are reported here.

Care facilities

Seventeen trials compared exercise with control (typically usual care alone). We are uncertain of the effect of exercise on rate of falls (RaR 0.93, 95% CI 0.72 to 1.20; 2002 participants, 10 studies; I² = 76%; very low‐quality evidence). Exercise may make little or no difference to the risk of falling (RR 1.02, 95% CI 0.88 to 1.18; 2090 participants, 10 studies; I² = 23%; low‐quality evidence).

There is low‐quality evidence that general medication review (tested in 12 trials) may make little or no difference to the rate of falls (RaR 0.93, 95% CI 0.64 to 1.35; 2409 participants, 6 studies; I² = 93%) or the risk of falling (RR 0.93, 95% CI 0.80 to 1.09; 5139 participants, 6 studies; I² = 48%).

There is moderate‐quality evidence that vitamin D supplementation (4512 participants, 4 studies) probably reduces the rate of falls (RaR 0.72, 95% CI 0.55 to 0.95; I² = 62%), but probably makes little or no difference to the risk of falling (RR 0.92, 95% CI 0.76 to 1.12; I² = 42%). The population included in these studies had low vitamin D levels.

Multifactorial interventions were tested in 13 trials. We are uncertain of the effect of multifactorial interventions on the rate of falls (RaR 0.88, 95% CI 0.66 to 1.18; 3439 participants, 10 studies; I² = 84%; very low‐quality evidence). They may make little or no difference to the risk of falling (RR 0.92, 95% CI 0.81 to 1.05; 3153 participants, 9 studies; I² = 42%; low‐quality evidence).

Hospitals

Three trials tested the effect of additional physiotherapy (supervised exercises) in rehabilitation wards (subacute setting). The very low‐quality evidence means we are uncertain of the effect of additional physiotherapy on the rate of falls (RaR 0.59, 95% CI 0.26 to 1.34; 215 participants, 2 studies; I² = 0%), or whether it reduces the risk of falling (RR 0.36, 95% CI 0.14 to 0.93; 83 participants, 2 studies; I² = 0%).

We are uncertain of the effects of bed and chair sensor alarms in hospitals, tested in two trials (28,649 participants) on rate of falls (RaR 0.60, 95% CI 0.27 to 1.34; I² = 0%; very low‐quality evidence) or risk of falling (RR 0.93, 95% CI 0.38 to 2.24; I² = 0%; very low‐quality evidence).

Multifactorial interventions in hospitals may reduce rate of falls in hospitals (RaR 0.80, 95% CI 0.64 to 1.01; 44,664 participants, 5 studies; I² = 52%). A subgroup analysis by setting suggests the reduction may be more likely in a subacute setting (RaR 0.67, 95% CI 0.54 to 0.83; 3747 participants, 2 studies; I² = 0%; low‐quality evidence). We are uncertain of the effect of multifactorial interventions on the risk of falling (RR 0.82, 95% CI 0.62 to 1.09; 39,889 participants; 3 studies; I² = 0%; very low‐quality evidence).

In care facilities: we are uncertain of the effect of exercise on rate of falls and it may make little or no difference to the risk of falling. General medication review may make little or no difference to the rate of falls or risk of falling. Vitamin D supplementation probably reduces the rate of falls but not risk of falling. We are uncertain of the effect of multifactorial interventions on the rate of falls; they may make little or no difference to the risk of falling.

In hospitals: we are uncertain of the effect of additional physiotherapy on the rate of falls or whether it reduces the risk of falling. We are uncertain of the effect of providing bed sensor alarms on the rate of falls or risk of falling. Multifactorial interventions may reduce rate of falls, although subgroup analysis suggests this may apply mostly to a subacute setting; we are uncertain of the effect of these interventions on risk of falling.

Interventions for preventing falls in older people in care facilities and hospitals

Review question
How effective are interventions designed to reduce falls in older people in care facilities and hospitals?

Background
Falls by older people in care facilities, such as nursing homes, and hospitals are common events that may cause loss of independence, injuries, and sometimes death as a result of injury. Effective interventions to prevent falls are therefore important. Many types of interventions are in use. These include exercise, medication interventions that include vitamin D supplementation and reviews of the drugs that people are taking, environment or assistive technologies including bed or chair alarms or the use of special (low/low) beds, social environment interventions that target staff members and changes in the organisational system, and knowledge interventions. A special type of intervention is the multifactorial intervention, where the selection of single interventions such as exercise and vitamin D supplementation is based on an assessment of a person's risk factors for falling. Falls are reported in two ways in our review. One outcome is rate of falls, which is the number of falls. The other outcome is risk of falling, which is the number of people who had one or more falls.

Search date

We searched the healthcare literature for reports of randomised controlled trials relevant to this review up to August 2017.

Study characteristics
This review included 95 randomised controlled trials involving 138,164 participants. Seventy‐one trials (40,374 participants) were in care facilities, and 24 (97,790 participants) in hospitals. On average, participants were 84 years old in care facilities and 78 years old in hospitals. In care facilities, 75% were women and in hospitals, 52% were women.

Quality of the evidence
The majority of trials were at high risk of bias, mostly relating to lack of blinding. With few exceptions, the quality of evidence for individual interventions in either setting was generally rated as low or very low. Risk of fracture and adverse events were generally poorly reported and, where reported, the evidence was very low quality, which means that we are uncertain of the estimates.

Key results

There was evidence, often from single studies, for a wide range of interventions used for preventing falls in both settings. However, in the following we summarise only the falls outcomes for four key interventions in care facilities and three key interventions in hospitals.

Care facilities We are uncertain of the effect of exercise on the rate of falls (very low‐quality evidence) and it may make little or no difference to the risk of falling (low‐quality evidence). General medication review may make little or no difference to the rate of falls (low‐quality evidence) or the risk of falling (low‐quality evidence). Prescription of vitamin D probably reduces the rate of falls (moderate‐quality evidence) but probably makes little or no difference to the risk of falling (moderate‐quality evidence). The population included in these studies appeared to have low vitamin D levels.

We are uncertain of the effect of multifactorial interventions on the rate of falls (very low‐quality evidence). They may make little or no difference to the risk of falling (low‐quality evidence).

Hospitals We are uncertain whether physiotherapy aimed specifically at reducing falls in addition to usual rehabilitation in the ward has an effect on the rate of falls or reduces the risk of falling (very low‐quality evidence). We are uncertain of the effect of bed alarms on the rate of falls or risk of falling (very low‐quality evidence).

Multifactorial interventions may reduce the rate of falls, although this is more likely in a rehabilitation or geriatric ward setting (low‐quality evidence). We are uncertain of the effect of these interventions on risk of falling.

Studies of falls in nursing facilities show considerable variation in falls incidence rates but a “middle of the road” figure provided in a review of incidence rates is 1.7 falls per person‐year, compared with 0.65 falls per person‐year for older people living in the community (Rubenstein 2006). In a study conducted in 40 Canadian residential care facilities, 62% of participants fell over a one‐year period, with a falls rate of 2.51 falls per person per year (Kennedy 2015). It should be noted, however, that routine recording of falls incidents in standard reporting systems is likely to under‐estimate the incidence of falls (Hill 2010; Sutton 1994). In a prospective one‐year study in 528 nursing homes in Bavaria, Germany, about 75% of falls occurred in the residents' rooms or in bathrooms; 41% occurred during transfers and 36% when walking (Becker 2012). The fall rate was higher in men (2.8 falls per person year) than women (1.49 falls per person year), and falls were less common in people requiring the lowest and highest levels of care. Lord 2003 also found that fall rates were lower in frailer people who were unable to rise from a chair or stand unaided. In this group, increased age, male sex, higher care classifications, incontinence, psychoactive medication use, previous falls and slow reaction times were associated with increased falls. Systematic reviews have shown that in nursing homes, falls history, walking aid use, moderate disability, cognitive impairment, wandering, Parkinson's disease, dizziness, use of sedatives, antipsychotics, antidepressants and total number of medications used are associated with an increased risk of falling (Deandrea 2013; Muir 2012). In residents with dementia, age, use of psychotropic drugs, fair or poor general health, gait impairment and trunk restraint use are associated with an increased number of falls (Kropelin 2013).

In hospital settings, a falls incidence of 5.71 falls per 1000 bed days has been found in 16 US general medical surgical and speciality units (Shorr 2012), 6.45 falls per 1000 bed days in 24 Australian medical and surgical wards (Barker 2016), 10.9 falls per 1000 bed days in eight Australian rehabilitation/geriatric units (Hill 2015) and 17.1 falls per 1000 bed days in psychogeriatric wards (Nyberg 1997). In elderly care wards in an UK district general hospital in 2004, the reported rate was as high as 18.0 falls per 1000 bed days (Healey 2004). A similar rate has been reported in some high‐risk wards in Australia (Barker 2016).

Systematic reviews have shown that risk factors for falls in hospital inpatients are falls history, age, cognitive impairment, sedative and antidepressant use, gait instability, agitated confusion and urinary incontinence (Deandrea 2013; Oliver 2004). For older patients in rehabilitation hospital settings, risk factors include carpet flooring, vertigo, being an amputee, confusion, cognitive impairment, stroke, sleep disturbance, anticonvulsants, tranquillisers, antihypertensive medications, previous falls and need for transfer assistance (Vieira 2011).

There is considerable mortality and morbidity associated with falls in care facilities and hospitals. A study in 24 Australian medical and surgical wards reported a fall injury rate of 2.36 per 1000 bed days (Barker 2016). A study in both these settings reported an incidence of 533 per 1000 person years for all injuries, 20 per 1000 person years for hip fracture, and 270 per 1000 person years for head injuries, for which 13% (14/107) required medical attention (Nurmi 2002). Overall, men were 1.5 times more likely to be injured than women. Older people who sustain a hip fracture while in hospital have been shown to have poor outcomes compared with people sustaining similar fractures in the community (Murray 2007). Falls have been reported to be the most common cause of death from an external cause in residents of care facilities (Ibrahim 2015).

The majority of falls are caused by complex combinations of factors operating at the time of each fall event. Interventions may target risk factors in participants or target staff and clinicians with the aim of improving clinical practice or the organisation of care. In some studies, single interventions have been evaluated while in others, interventions with more than one component have been evaluated. Delivery of multiple‐component interventions may be based on individual assessment of risk (a multifactorial intervention) or the same components are provided to all participants (a multiple intervention). A taxonomy has been developed to describe and classify types of intervention (Lamb 2007; Lamb 2011). Key intervention categories include exercise, medication (drug target) interventions which include interventions targeting vitamin D and medication reviews, environment or assistive technologies including bed/chair alarms or the use of low/low beds, social environment interventions which target staff members and changes in the organisational system, knowledge interventions and multifactorial interventions.

The majority of randomised controlled trials considered within this review provide a comparison with ‘usual care’ in the care facilities and hospitals involved. Typically, 'usual care' will include standard practices for managing commonly known, potentially modifiable, risk factors for falls and, moreover, the components of usual care will vary both over time and between settings.

A systematic review is required to summarise evidence of the impact of purposeful interventions designed to prevent falls, in addition to the unknown impact of routine (and probably variable) care in care facilities and hospitals. Despite routine activities attempting to reduce falls, falls are common in these settings and they result in considerable mortality and morbidity. Results will inform healthcare professionals, researchers, policy makers, informal care givers and consumers. This review is an update of a Cochrane Review first published in 2010 (Cameron 2010), and previously updated in 2012 (Cameron 2012).

To assess the effects of interventions designed to reduce the incidence of falls in older people in care facilities and hospitals.

Types of studies

We considered for inclusion all randomised trials, including quasi‐randomised trials (for example, alternation), cluster‐randomised trials and trials in which treatment allocation was inadequately concealed.

Types of participants

We included trials of interventions to prevent falls in older people, of either sex, in care facilities or hospitals. We considered trials for inclusion if the majority of participants were over 65 years or the mean age was over 65 years, and the majority were living in care facilities or were patients in hospital. We excluded trials conducted in places of residence that do not provide residential health‐related care or rehabilitative services, for example retirement villages or sheltered housing. Trials with participants resident in the community and in care facilities were included either in this review or in the Cochrane Review of interventions for preventing falls in older people living in the community (Gillespie 2012), depending on the proportion of participants in each setting. Inclusion in either review was determined by discussion between the authors of both reviews. Trials recording falls in both settings may be included in both reviews.

We subdivided care facilities based on level of care provided. We defined high‐level care facilities as "establishments that are primarily engaged in providing inpatient nursing and rehabilitative services for long‐term care patients. The care is generally provided for an extended period of time to individuals requiring nursing care. These establishments have a permanent core staff of registered or licensed practical nurses that, along with other staff, provide nursing care in combination with personal care" (OECD 2011). We defined intermediate‐care facilities as "institutions which provide health‐related care and services to individuals who do not require the degree of care which hospitals or skilled nursing facilities provide, but because of their physical or mental condition require care and services above the level of room and board" (NLM 2012). Some facilities provided both these levels of care. For cluster‐randomised trials, the classification of the level of care was based on the description of the facility. For individually‐randomised trials where the level of care provided by the facility was clearly described, this description informed the classification. Where the inclusion/exclusion criteria of a trial selected patients who required high or intermediate level of care from a mixed‐care facility, the classification was based upon the care needs of the individual participants.

For trials in hospitals, participants included staff or in‐patients. We excluded interventions that took place in emergency departments, outpatient departments or where hospital services were provided in community settings. We subdivided hospitals into those providing acute, and those providing subacute care. We defined subacute care as "medical and skilled nursing services provided to patients who are not in an acute phase of an illness but who require a level of care higher than that provided in a long‐term care setting" (NLM 2012).

Studies recruiting participants post‐stroke were excluded as interventions to prevent falls in this population are reviewed in a separate Cochrane Review Interventions for preventing falls in people after stroke (Verheyden 2013).

Types of interventions

Any intervention designed to reduce falls in older people compared with any other intervention, usual care or placebo. We grouped interventions using the fall‐prevention classification system (taxonomy) developed by the Prevention of Falls Network Europe (ProFaNE) (Lamb 2011). Interventions have been grouped by combination (single, multiple, or multifactorial), and then by the type of intervention (descriptors). Full details are available in the ProFaNE taxonomy manual (Lamb 2007). The possible intervention descriptors are: exercises, medication (drug target, i.e. withdrawal, dose reduction or increase, substitution, provision), surgery, management of urinary incontinence, fluid or nutrition therapy, psychological interventions, environment/assistive technology, social environment, interventions to increase knowledge, other interventions.

Types of outcome measures

We included only trials that reported raw data or statistics relating to rate or number of falls, or number of participants sustaining at least one fall during follow‐up (fallers). Trials that reported only those participants who had more than one fall were included. Trials that reported only specific types of fall (e.g. injurious falls) were not included. Trials that focused on intermediate outcomes such as improved balance or strength, and did not report falls or falling as an outcome, were excluded.

Primary outcomes
  • Rate of falls (falls per unit of person time that falls were monitored)

  • Number of fallers (risk of falling)

Secondary outcomes
  • Number of participants sustaining fall‐related fractures

  • Complications of the interventions

  • Economic outcomes

Electronic searches

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to 3 August 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (2017, Issue 8), MEDLINE (including Epub Ahead of Print, In‐Process & Other Non‐Indexed Citations, Ovid MEDLINE Daily, Ovid MEDLINE and Versions) (1946 to 3 August 2017), Embase (1980 to 2017 Week 31), and CINAHL (1982 to 3 August 2017). We also searched ongoing trial registers via the World Health Organization's ICTRP Search Portal (3 August 2017) and ClinicalTrials.gov (3 August 2017). We did not apply any language restrictions.

For this update, the search results were limited from 2012 onwards. The search update process was run in two stages: the first search was run in February 2016 and a second top‐up search was run in August 2017. Details of the search strategies used for previous versions of the review are given in Cameron 2012.

In MEDLINE (OvidSP), subject‐specific search terms were combined with the sensitivity‐ and precision‐maximising version of the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE (Lefebvre 2011). We modified this strategy for use in CENTRAL, Embase, and CINAHL (seeAppendix 1 for all strategies).

Searching other resources

We also checked reference lists of articles and further trials were identified by contact with researchers in the field. For the first version of this review, we identified trials in care facilities and hospitals included in Gillespie 2003.

Data collection and analysis were carried out according to methods stated in the published protocol (Cameron 2005), and subsequently amended to concur with updated methods in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011a) as described in Differences between protocol and review. Data collection and analysis were carried out according to methods stated in the published protocol (Cameron 2005), which were based on the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011a).

Selection of studies

From the title, abstract, or descriptors, one review author screened all abstracts to identify potentially relevant trials for full review. Two review authors screened potentially relevant abstracts. From the full text, two review authors independently assessed potentially eligible trials for inclusion and resolved disagreement by discussion, or by adjudication with a third review author. Full‐text review was undertaken using Covidence. Disagreement was resolved by discussion and consensus or third party adjudication when necessary. We contacted trial authors for additional information if necessary to assess eligibility.

Data extraction and management

Pairs of review authors independently extracted data using a pre‐tested data extraction form for studies included to 2012. For this update,again pairs of review authors independently extracted data from the identified studies using Covidence. Multiple reports from the same study were linked as a single study in Covidence and evidence from all reports were reviewed in undertaking data extraction. Where data were unclear authors were contacted whenever possible for clarification. Disagreement was resolved by discussion and consensus or third party adjudication when necessary.

Assessment of risk of bias in included studies

Pairs of review authors independently assessed risk of bias for each included study based on recommendations in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011b). Assessors were not blinded to author and source institution. Review authors did not assess their own trials. Disagreement was resolved by consensus, or by third party adjudication.

We assessed risk of bias for the following domains: sequence generation (selection bias); allocation concealment (selection bias); blinding of participants and personnel (performance bias); blinding of outcome assessment (detection bias), incomplete outcome data (attrition bias), and selective reporting (reporting bias). Since all the outcomes collected in our review are susceptible to the same risk of bias, we have not assessed outcomes for risk of detection bias or completeness of outcome data separately. Additionally, we assessed bias in the recall of falls due to less reliable methods of ascertainment (Hannan 2010), and bias resulting from major imbalances in key baseline characteristics (e.g. age, gender, previous falls, medical status, dependency, cognitive function). Assessors rated the risk of bias as low, high or unclear for each domain.

We established additional criteria within currently existing domains for assessing the additional risks of bias associated with cluster randomisation (Section 16.3.2; Higgins 2011b). Thus 'recruitment bias' was considered as a component of selection bias under allocation concealment; 'baseline imbalance' resulting from small numbers of clusters was considered in bias resulting from major imbalances in key characteristics; risk of bias resulting from 'loss of clusters' was considered under incomplete outcome data; and 'incorrect analysis' that failed to take into account the effect of clustering and that could not be satisfactorily remedied was considered under selective outcome reporting. We did not assess the risk of bias relating to the 'comparability with individually‐randomised trials' as a separate item as it is impossible to establish suitable criteria for an individual trial out of context. The potential for differences in effects between cluster‐ and individually‐randomised trials was considered in our assessment of the quality of the evidence and in our Discussion.

Our criteria for 'Risk of bias' assessments are shown in Appendix 2.

Measures of treatment effect

We have reported the treatment effect for rate of falls as a rate ratio (RaR) and 95% confidence interval (CI). For number of fallers and number of participants sustaining fall‐related fractures we have reported a risk ratio (RR) and 95% CI. We used results reported at discharge from hospital for trials that continued to monitor falls after discharge.

Rate of falls

The rate of falls is the total number of falls per unit of person time that falls were monitored (e.g. falls per person year). The rate ratio compares the rate of falls in any two groups during each trial.

We used a rate ratio (for example, incidence rate ratio or hazard ratio for all falls) and 95% CI if these were reported in the paper. If both adjusted and unadjusted rate ratios were reported, we used the unadjusted estimate, unless the adjustment was for clustering. If a rate ratio was not reported but appropriate raw data were available, we used Excel to calculate a rate ratio and 95% CI. We used the reported rate of falls (falls per person year) in each group and the total number of falls for participants contributing data, or we calculated the rate of falls in each group from the total number of falls and the actual total length of time falls were monitored (person years) for participants contributing data. In cases where data were only available for people who had completed the study, or where the trial authors had stated there were no losses to follow‐up, we assumed that these participants had been followed up for the maximum possible period. Where there were no falls in one arm of a study, and a low total number of falls and/or participants (e.g. Beck 2016; Cadore 2014), the rate of falls cannot be determined. Such data were therefore not pooled, however the omission of these data from the pooled analysis is considered unlikely to change any estimate of effect.

Risk of falling

For number of fallers, a dichotomous outcome, we used a risk ratio as the treatment effect. The risk ratio compares the number of people who fell once or more (fallers) in the intervention and control arms of each trial.

We used a reported estimate of risk (hazard ratio for first fall, risk ratio (relative risk), or odds ratio) and 95% CI if available. If both adjusted and unadjusted estimates were reported we used the unadjusted estimate, unless the adjustment was for clustering. If an odds ratio was reported, or there was no effect estimate and 95% CI, and appropriate data were available, we calculated a risk ratio and 95% CI using the csi command in Stata or in Review Manager. For the calculations, we used the number of participants contributing data in each group if this was known; if not reported, we used the number randomised to each group.

Secondary outcomes

For the number of participants sustaining one or more fall‐related fractures, we used a risk ratio as described in 'Risk of falling' above.

Unit of analysis issues

For trials that were cluster randomised, for example by care facility or ward, we performed adjustments for clustering (Higgins 2011c), if this was not done in the published report. We used intra‐cluster correlation coefficients reported by Dyer 2004 (falls per person year 0.100, number of residents falling 0.071, and residents sustaining a fracture 0.026).

For trials with multiple intervention groups, we either combined the groups or included only one pair‐wise comparison (intervention versus control) in any analysis in order to avoid the same group of participants being included twice.

For trials that excluded the intervention period from the falls outcomes, we did not pool the outcomes data with other studies.

Dealing with missing data

Only the available data were used in the analyses; we did not impute missing data.

Assessment of heterogeneity

We assessed heterogeneity within a pooled group of trials using a combination of visual inspection of the graph along with consideration of the Chi² test (with statistical significance set at P < 0.10), and the I² statistic (Higgins 2003). We based our interpretation of the I² results on that suggested by Higgins 2011a: 0% to 40% might not be important; 30% to 60% may represent moderate heterogeneity; 50% to 90% may represent substantial heterogeneity; and 75% to 100% may represent very substantial ('considerable') heterogeneity.

Assessment of reporting biases

To explore the possibility of publication and other reporting biases, we constructed funnel plots for analyses that contained more than 10 studies.

Data synthesis

We classified interventions into those taking place in care facilities and those taking place in hospitals, and pooled these separately because participant characteristics and the environment warrants different types of interventions in the different settings, possibly implemented by people with different skill mixes.

Within these categories, we grouped the results of trials with comparable interventions and participant characteristics, and compiled forest plots using the generic inverse variance method in Review Manager. This method enabled pooling of the adjusted and unadjusted treatment effect estimates (rate ratios or risk ratios) that were reported in the paper, or we calculated from data presented in the paper (seeMeasures of treatment effect). Where the total number of patients, rather than admissions, could not be determined, we did not pool these data with other studies. Where the reported trial outcomes did not include falls during the intervention period, we did not pool these data with those of other trials.

Where appropriate, we pooled results of comparable studies using both fixed‐effect and random‐effects models. We chose the model to report by careful consideration of the extent of heterogeneity and whether it can be explained by factors such as the number and size of included studies, or the level of care provided. We used 95% CIs throughout. We considered, on a case by case basis, not pooling data where there was considerable heterogeneity (I² statistic value of greater than 75%) that could not be explained by the diversity of methodological or clinical features among trials. Where it was inappropriate to pool data, we still presented trial data in the analyses or tables for illustrative purposes and reported these in the text.

Subgroup analysis and investigation of heterogeneity

We minimised heterogeneity as much as possible by grouping trials as described previously (using ProFaNE categories of interventions). We categorised broad interventions further by grouping subtypes of interventions according to ProFaNE (e.g. for exercise interventions). We explored heterogeneity by carrying out subgroup analyses based on level of care and level of cognition at enrolment in care facilities and hospitals where possible. We subdivided the care facilities into high, intermediate or mixed levels of care. The levels of care of the facilities reflect the levels of dependence of the participants. In hospitals, the level of care was subdivided by acute versus subacute or mixed levels of care. We also carried out subgroup analyses by stratification of intervention types according to ProFaNE (e.g. for exercise types, medication target interventions), and type of fracture. Subgroup analyses based upon the individual components of the multifactorial interventions was precluded by the study design and reporting. Data were inadequate for conducting a subgroup analysis by level of frailty of the participants in trials of exercise in care facilities.

We grouped trials by level of cognition into those that included only participants with cognitive impairment versus those with no cognitive impairment, or a mixed sample at enrolment.

We used the random‐effects model to pool data in all subgroup analyses testing for subgroup differences due to the high risk of false‐positive results when comparing subgroups in a fixed‐effect model (Higgins 2011d). We used the test for subgroup differences available in Review Manager to determine whether there was evidence for a difference in treatment effect between subgroups.

Sensitivity analysis

Where there was substantial statistical heterogeneity we carried out a post‐hoc sensitivity analysis to explore the effect of removing trials from the analysis if visual inspection of the graph showed poorly overlapping confidence intervals. Where there was considered to be significant statistical heterogeneity for rate of falls but not risk of falling, sensitivity analyses were carried out to determine the likely effects of using random‐effects versus fixed‐effect meta‐analyses for the risk of falling (e.g. for exercise versus usual care in care facilities and multifactorial interventions in care facilities). We conducted post‐hoc sensitivity analyses for exercise in care facilities, excluding trials with 20 participants or less in each arm of the trial to explore the possibility of small‐trial effects, due to the observed asymmetry in the Funnel plots. We conducted a sensitivity analysis for exercise compared to usual care in care facilities including Cadore 2014, which had zero falls in the intervention arm, using one fall in the intervention arm to examine the likely effect of omitting this trial from the analysis. We also conducted a sensitivity analysis excluding one trial with a known non‐normal distribution of falls in the intervention arm from the analysis of general medication review in care facilities for the rate of falls outcomes.

Sensitivity analyses according to study quality were not possible as most studies were at potential risk of bias.

Economic issues

We have noted the results from any economic evaluations (cost‐effectiveness analysis, cost‐utility analysis) incorporated in included studies. We also extracted from each trial reporting a cost analysis, cost description or analytic model, the type of resource use reported (e.g. delivering the intervention, hospital admissions, medication use) and the cost of the items for each group.

Assessing the quality of the evidence and 'Summary of findings' tables

For each comparison, we used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the quality of the body of evidence (Schünemann 2011) for each outcome listed in Types of outcome measures. For all comparisons where there were two or more trials, GRADE assessment was performed independently by two review authors and disagreement was resolved by discussion, or by adjudication with a third review author. We adopted a different approach for single trial comparisons, where we started with the assumption that the quality of evidence was likely to be very low. This reflected assumptions of downgrading at a minimum for serious risk of bias (typically performance and detection bias), for serious indirectness (trial being conducted was a single trial or setting), and for serious imprecision (failure to meet the 200 to 300 events optimal size criteria) (Guyatt 2011). Where these assumptions did not hold, we performed GRADE assessment as above. The quality rating 'high' is reserved for a body of evidence based on randomised controlled trials. We ‘downgraded’ the quality rating to 'moderate', 'low' or 'very low' depending on the presence and extent of five factors: study limitations, inconsistency of effect, imprecision, indirectness or publication bias. We used the GRADE approach to assess quality of evidence related to the primary and secondary outcomes listed in the Types of outcome measures. We prepared a 'Summary of findings' table for each of the main categories of interventions, for listed outcomes.

We selected the following comparisons for presentation in 'Summary of findings' tables as these are the most common falls prevention activities considered and applied in clinical settings. In care facilities: exercise, vitamin D supplementation, medication review and multifactorial interventions; in hospitals: exercise, bed alarms and multifactorial interventions.

Results of the search

For this update we screened a total of 3989 records from the following databases: Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (0 records); CENTRAL (127), MEDLINE (1104), Embase (1211), CINAHL (314) the WHO ICTRP (450) and Clinicaltrials.gov (783). We also found 29 potentially eligible studies from other sources. After removal of 503 duplicates, 3515 citations were screened for inclusion.

Screening of the search update identified a total of 413 records for potential inclusion, for which full‐text reports were obtained. Thirty‐five new trials were included in this update, 27 new ongoing trials identified and seven new studies await classification. In addition, a new subgroup analysis (Stenvall 2012) from the Stenvall 2007 trial and a cost‐effectiveness analysis (Haines 2013) of Haines 2011 have been added. A flow diagram summarising the study selection process is shown in Figure 1.

What interventions protect patients from falling?

Overall, there are now 95 included trials, 105 excluded studies, eight studies awaiting classification and 31 ongoing trials.

Due to the review size, not all links to references have been inserted in the text but can be viewed in Table 8.

Included studies

Thirty‐five additional trials have been included in this update, 28 trials in care facilities and seven in hospitals (seeTable 8). This review now contains 95 trials with 138,164 participants. Details of individual trials are provided in the Characteristics of included studies, and are briefly outlined below.

Design

Participants were individually randomised in 53 studies, whereas 42 studies used a cluster‐randomised design (seeTable 8).

Settings

The included trials were carried out in 23 countries (seeTable 8).

Of the 71 studies (40,374 participants) in care facilities, 17 were in high‐level care facilities, 17 were in intermediate‐level care facilities and 37 were in facilities with mixed levels of care, or combinations of facilities that included both high and intermediate levels of care. Of the 24 studies (97,790 participants) in hospital settings, 10 were in an acute hospital setting, 12 were in subacute settings, and 2 were in both acute and subacute care settings (seeTable 8).

Van Gaal 2011a and Van Gaal 2011b have been included as two separate trials although reported in the same paper as the participants were randomised separately in two settings (nursing homes and hospitals) and results are reported by setting.

Interventions

Using ProFaNE taxonomy, all studies were categorised by intervention and grouped by combination (single, multiple, or multifactorial) (seeAppendix 3). The first column of Appendix 3 shows the intervention classification (single, multiple, or multifactorial) and setting type (care facility or hospital). The components of included 'Exercises' interventions, 'Environmental/assistive technology' and 'Medication (drug target)' interventions are shown in Appendix 4, Appendix 5 and Appendix 6 respectively.

In care facilities, 54 trials tested the effect of a single intervention only, three trials tested both single and multiple interventions (Huang 2016; Imaoka 2016; Sambrook 2012), one trial tested a multiple intervention only (Schnelle 2003), and 13 trials tested a multifactorial intervention. In hospitals, 18 trials tested the effect of a single intervention and six tested a multifactorial intervention.

Seven studies tested the effect of two interventions (Faber 2006; Haines 2011; Huang 2016; Nowalk 2001; Sambrook 2012; Saravanakumar 2014; Tuunainen 2013), and one tested three interventions (Imaoka 2016) in comparison with usual care. Donald 2000 was a 2 x 2 factorial study of supervised exercises and flooring types that has been classified as two single interventions.

In general, included studies compared an active falls prevention intervention with a control group comprising 'usual care', that typically would have included standard falls prevention activities. Often, however, standard practice in terms of falls prevention activities was not clearly described. Additional descriptions of the control groups provided for individual trials are provided in the Characteristics of included studies table, the 'Summary of findings' tables available for some comparisons, and the analyses headings and/or footnotes. A general description of the control arms for the main intervention categories is also given below.

In care facilities, 17 trials of exercise provided a comparison with usual care, defined as no exercise, no change in previous lifestyle or exercise type or level unlikely to change physical performance and nine trials provided a comparison of two different exercise programmes (see Table 9). Trials of medication target interventions in care facilities more often provided a comparison with placebo (see Table 10). Trials of vitamin D supplementation in care facilities provided estimates of effect compared with usual care or placebo. In hospitals, multifactorial interventions were generally compared with a control group consisting of standard falls prevention activities. Whether or not the control arm included some of the multifactorial intervention components was not always clearly reported. Additional detail is provided in the description of individual studies in the results text and within the Characteristics of included studies table.

Description of interventions in studies of exercise interventions in care facilities

TrialInterventionControlComment
Buckinx 2014Whole body vibration exercise programmeUsual care: no change to lifestyle 
Buettner 2002Supervised group exercisesUsual care 
Cadore 2014Multicomponent exercises. Twice‐weekly, 40‐minute durationUsual care: “mobility” exercises (30 minutes per day at least 4 days per week), small active and passive movements applied as stretches in a rhythmic fashion 
Choi 2005Tai ChiUsual care: routine activities, without participation in any regular exercise classes 
da Silva Borges 2014Ballroom dancingUsual care: agreed not to engage in any regular physical activity 
Faber 2006
  • A functional balance, strength and mobility programme

Usual care: no change usual pattern of activityBoth comparisons of interventions vs usual care considered under exercise vs usual care. Comparisons of interventions arms considered under comparisons of different exercise categories.
Fu 2015Wii balance training (1 hour 3 x week)Different exercise: Balance training (Otago) (1 hour, 3 x week) 
Imaoka 2016Reduced exercise ‐ individualised exercise only.Different exercise: groups plus individualised exercises (described by study authors as usual care) 
Irez 2011Combination exercises: PilatesUsual care: no Pilates, instructed not to change current activity levels 
Kerse 2008Activity programmeUsual care 
Kovacs 2012Multimodal exercise – Otago Exercise programmeDifferent exercise: Osteoporosis exercise programme, includes balance and strengthening exercises 
Kovacs 2013Multimodal exercise – Otago Exercise programmeUsual care: social activities such as board games, listening to music 
Mulrow 1994Tailored exercisesUsual care: friendly visit, usually involved reading to participant, avoided physical activity 
Nowalk 2001
  • Supervised exercise

  • Tai Chi


Plus control (basic enhanced programme)
Usual care: basic enhanced programme including falls‐prevention programme with 3 education sessions and a walking programmeResults for interventions vs usual care as reported by study authors presented in Analysis 1.2 as data not suitable for calculation of RaR or RR.
Rosendahl 2008Functional exercise programmeUsual care: Seated activities, including watching films, reading, singing 
Sakamoto 2006Single leg practice 1 min / leg, 3 x dailyUsual care: no details 
Saravanakumar 2014
  • Tai Chi

  • Flexibility (yoga)

Different exercise: "staying active": includes games, group activities, a gym with bike and activities such as walking and gardeningAll comparisons presented under comparisons of different exercise categories.
Schoenfelder 2000Ankle‐strengthening exerciseUsual care: little information 
Serra‐Rexach 2011Training sessions + usual care physiotherapyDifferent exercise: usual care physiotherapy (40 to 45 minutes/day 5 x weekly)‐ stretches, aerobic exercise such as walking (though low intensity) 
Shimada 2004Gait exercises + usual exercisesDifferent exercise: physiotherapy for pain, stretches, low‐ and high‐intensity resistance training, gait training, stairs, lower limb function 
Sihvonen 2004Balance training (visual feedback)Usual care: little information 
Sitja Rabert 2015Whole body vibration + exercise static and dynamic balance and strength exercise)Different exercise: same exercise programme done on land 
Toulotte 2003Supervised exercisesUsual care: continued daily routine 
Tuunainen 2013
  • Group strength training: Progressive resistance, supervised group training, 1 hour, 2x weekly

  • Balance and strength training

Different exercise: self‐administered training (1 hour, 2 x weekly): Stretching, crouching and rising administered by nurses written instructions from physiotherapistAll comparisons presented under comparisons of different exercise categories.
Yokoi 2015Group supervised seated stick exercises 25 minutes, 2 x weekly (included daily house‐keeping and hobbies for both exercise and control group)Usual care: activities of daily living and 10‐minute group stretching exercises continued. No other exercises were conducted. 

Description of interventions in the medication review trials

StudyMedication reviewControlComment
Crotty 2004aAdditional pharmacistUsual care 
Crotty 2004bAdditional pharmacistUsual care 
Frankenthal 2014Medication reviewNo interventional recommendations made by pharmacist to chief physician 
Garcia Gollarte 2014Physician education on drug use in older people, plus medication review in 10%No intervention or information about an educational interventionFalls data excludes the intervention period; not suitable for pooling
Houghton 2014Multiprofessional medication reviewUsual care (support from the NHS) 
Juola 2015Nursing education to reduce medication useUsual care 
Lapane 2011Clinical informatics tool for medication review: providing reports to pharmacists and nursing staff to assist identifying residents at risk for delirium and falls. Reports generated within 24 hours of admission, used during monthly medication review and at time of Minimum Data Set reporting or when falls or delirium triggered resident assessment protocols.Usual care (includes monthly medication review by pharmacist) 
Patterson 2010Pharmacist review of psychoactive medicationsUsual care 
Peyro Saint Paul 2013Ceasing medication to avoid hyponatraemiaUsual careUnusual study, not pooled with others
Potter 2016DeprescribingMedication review without deprescribing 
Streim 2012Deprescribing antidepressantsContinue taking antidepressantsData not suitable for pooling.
Zermansky 2006Medication review by pharmacistUsual care 

Outcomes

The source of data used for calculating outcomes for each trial for generic inverse variance analysis is shown in Appendix 7. Seventeen trials met our inclusion criteria but did not report data that could be included in pooled analyses. Reported results from these trials are presented in the text or additional tables. Raw data for rate of falls and number of fallers when reported or when they could be calculated are shown in Appendix 8. Twenty‐four trials reported data on fractures suitable for use in pooled analyses, other reported fractures data is presented in the text. Twenty‐nine trials clearly reported data on adverse events, but in many of these it was not clear if adverse‐event data were recorded systematically; for the majority of trials, this outcome was not reported.

Excluded studies

Overall there were 105 excluded studies (seeCharacteristics of excluded studies for details). Of the 51 newly excluded studies (see Figure 1): five were excluded as they were not randomised; five were conducted in the wrong population (e.g. including participants post stroke); 10 were conducted in the wrong setting (in most of these, the majority of participants were living in the community); two studies of flooring interventions were excluded as the intent was to reduce fall injuries, rather than falls (Drahota 2013; {"type":"clinical-trial","attrs":{"text":"NCT01618786","term_id":"NCT01618786"}}NCT01618786); 22 studies were excluded as they measured falls as a potential adverse outcome of the intervention; two did not report falls outcomes; one study was excluded as it reported a specific type of falls only (Sahota 2014); three trials were discontinued and one had invalid falls data (DeSure 2013).

Of the 54 studies excluded in the previous version of this review: 21 trials were excluded because the intervention they tested was not designed to reduce falls, rather falls were measured as a potential adverse outcome of an intervention with a different aim; in 11 trials the majority of participants were living in the community; eight excluded trials did not provide sufficient data on falls or fallers; seven included participants post stroke and seven were not randomised (Cameron 2012). Of note is that four trials that had been excluded in Cameron 2012 because they included participants with post‐stroke hemiplegia, have now either been retracted (Sato 2000; Sato 2005a; Sato 2005b; see Retraction Watch) or, for Sato 2011, likely to be retracted in future because of serious concerns about research misconduct as revealed in Bolland 2016.

Ongoing studies

We are aware of 31 ongoing studies, 14 set in care facilities and 17 in hospitals (seeCharacteristics of ongoing studies for details). The ongoing studies in care facilities include five exercise trials in care facilities (two of whole body vibration), one trial of a multiple intervention of exercise and nutrition, one of nutrition, three of medication review, one of vitamin D supplementation, three of service model changes, and one of a telesurveillance system; two trials are likely to have been completed, one of whole body vibration (JPRN‐UMIN000000555) and one of vitamin D supplementation (JPRN‐UMIN000008361). The ongoing studies in hospitals include three trials of medication review, four of exercise, one of an education intervention, five social environment interventions including one of student training, one psychological intervention, one of a sensor technology, one educational intervention, and one multifactorial intervention; five trials are likely to be completed, three of medication review (ISRCTN42003273; {"type":"clinical-trial","attrs":{"text":"NCT01876095","term_id":"NCT01876095"}}NCT01876095; {"type":"clinical-trial","attrs":{"text":"NCT02570945","term_id":"NCT02570945"}}NCT02570945), one of exercise (Hassett 2016), and one of telesurveillance ({"type":"clinical-trial","attrs":{"text":"NCT01561872","term_id":"NCT01561872"}}NCT01561872).

Details of 'Risk of bias' assessment for nine items for each trial are shown in the Characteristics of included studies. Summary results for these items are shown in Figure 2, Figure 3 and Table 11.

Summary of 'Risk of bias' assessment of included studies

Risk of BiasLowHighUnclear
Sequence generation (selection bias)69% (66/95)2% (2/95)28% (27/95)
Allocation (selection bias)45% (43/95)15% (14/95)40% (38/95)
Blinding of participants and personnel (performance bias)7% (7/95)91% (86/95)2% (2/95)
Blinding of outcome assessors (detection bias)11% (10/95)68% (65/95)21% (20/95)
Incomplete outcome data (attrition bias)63% (60/95)27% (26/95)9% (9/95)
Selective reporting (reporting bias)53% (50/95)8% (8/95)39% (37/95)
Method of ascertaining falls47% (45/95)28% (27/95)24% (23/95)
Baseline imbalance54% (51/95)27% (26/95)19% (18/95)
Other bias92% (87/95)2% (2/95)6% (6/95)

The majority of included studies were considered at high risk of bias for at least one domain. In particular, there was a high risk of performance bias for the majority of studies due to lack of blinding. Only three trials were considered at low risk of bias for all or the majority of domains (Bischoff 2003; Broe 2007; Flicker 2005), these all examined vitamin D supplementation in comparison with placebo. However, for many other types of interventions, blinding was generally not feasible (e.g. exercise, bed alarms). The risk of bias was often unclear, in particular for risk of selection bias due to allocation concealment. Potential bias varied within comparison groups and it is difficult to judge whether any bias would result in an over‐ or under‐estimation of treatment effect.

Allocation

Under half of included studies (39 in all) were considered at low risk of selection bias; this often reflected lack of clarity on the methods for allocation concealment. We assessed risk of bias in sequence generation as low in 66 trials, high in two trials that described inappropriate methods (Michalek 2014; Wald 2011), and unclear in the remaining 27 trials, usually because of a lack of reporting of methods. We judged methods for concealment of allocation prior to group assignment to carry low risk of bias in 43 trials, high in 14 trials and to be unclear in the remaining 38 trials, again typically due to lack of reporting. Barker 2016, a cluster‐randomised trial, is an example of a trial at high risk of selection bias due to lack of allocation concealment: although the initial cluster allocation was concealed, the subsequent recruitment of participants into the study (i.e. admission to the ward) was not.

Blinding

Blinding of participants and personnel was uncommon and indeed blinding of these was not feasible for many intervention types (e.g. exercise, multifactorial interventions). In all, 86 trials were at high risk of performance bias, with just seven trials being at low risk and the remaining two trials being judged at unclear risk of bias.

The likelihood of detection bias in relation to the ascertainment of falls by outcome assessors was also high in 65 trials, generally as falls were ascertained by staff who were not blinded (e.g. Barker 2016). Risk of bias was low in 10 trials, most commonly in vitamin D trials where administration of a placebo was possible (e.g. Flicker 2005) and unclear in 20 trials.

Incomplete outcome data

The risk of attrition bias due to incomplete outcome data was assessed as high in 26 trials (the high risk of attrition in some trials is likely to be related to longer periods of follow‐up; e.g. 12 months for Juola 2015 and 16 months for Kennedy 2015). Risk of bias was low in 61 trials, where there was no loss to follow‐up (this occurred more frequently in a hospital setting: e.g. Barker 2016; Hill 2015) or losses were balanced between groups (e.g. Cadore 2014; Kerse 2008). Risk of bias was unclear in eight trials, which generally reflected unclear reporting (e.g. Van de Ven 2014).

Selective reporting

Reporting bias was judged as unclear in 37 trials, generally as no protocol was identified (e.g. Healey 2004), and low risk in 50 trials where results were reported according to the protocol (e.g. Potter 2016), or all expected falls outcomes were reported (e.g. Law 2006). Eight trials were at high risk, usually where outcomes mentioned in the protocol or methods were not reported (e.g. Ang 2011).

Other potential sources of bias

The method of ascertaining falls was judged to be at a low risk of bias for 45 trials, at high risk of bias for 27 trials, generally where falls were poorly defined (e.g. Healey 2004), and at unclear risk for 23 trials when methods were not reported (e.g. Sakamoto 2006). The risk of bias relating to imbalance in baseline characteristics was considered to be low in 51 trials, high in 26 trials, and unclear in 18 trials. Risk of baseline imbalance usually occurred in small trials (e.g. Buckinx 2014) or cluster‐randomised trials (e.g. Becker 2003; Choi 2005; Van Gaal 2011a; Van Gaal 2011b; Whitney 2017). Two trials were considered to be a high risk of other bias, this was due to the author being employed by the company producing the intervention (Clifton 2009), or the individual randomisation being to one of two clusters, hence the trial was not truly individually randomised (Michalek 2014). There was a low risk of other bias in 87 trials and unclear risk in six trials due to unusual study design (stepped‐wedge trial in Aizen 2015; Hill 2015; and including a non‐randomised patient preference arm in Streim 2012) or ongoing falls prevention activities (Aizen 2015; Ang 2011; Barker 2016; Cumming 2008).

Cluster‐randomised trials

There were a large number of included cluster‐randomised trials (44%, 42/95), many of which had a large number of participants (e.g. Barker 2016; Shorr 2012). Risk of bias particular to cluster‐randomised trials were considered within other domains (seeAssessment of risk of bias in included studies). However, it is worth noting that some of these trials contained a small number of clusters and hence were more prone to baseline imbalance (e.g. Choi 2005; Van Gaal 2011a; Van Gaal 2011b), and in some cases prediction of allocation concealment (e.g. Choi 2005; Koh 2009). Loss of whole clusters could also lead to a high risk of attrition bias (e.g. Cox 2008).

See: Table 1; Table 2; Table 3; Table 4; Table 5; Table 6; Table 7

Summary of findings: Exercise compared with usual care in care facilities

Exercise compared with usual care for falls prevention in care facilities
Population and setting: older (≥ 65 years) residents of care facilities
Intervention: exercise
Comparison: usual care
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed risk
Usual care
Corresponding risk
Exercise
Rate of falls
Length of follow‐up: 3 to 12 months
Low‐risk population1RaR 0.93
(0.72 to 1.20)
2002
(10 studies)
+ooo
VERY LOW7
These results were heterogeneous: subgroup analysis by type of exercise did not explain the heterogeneity.
Four additional trials (N = 130) with data not suitable for pooling reported a reduction in the rate of falls.
1000 per 1000 py930 (720 to 1200) per 1000 py
High‐risk population2
3500 per 1000 py3255 (2520 to 4200) per 1000 py
Risk of falling
Length of follow‐up: 3 to 12 months
Low‐risk population3RR 1.02
(0.88 to 1.18)
2090
(10 studies)
++oo
LOW8
1 additional trial (2 comparisons, N = 110) reported no significant difference in the risk of falling.
250 per 1000255 (220 to 295) per 1000
Moderate‐risk population4
500 per 1000510 (440 to 590) per 1000
High‐risk population5
700 per 1000714 (616 to 826) per 1000
Risk of fracture
Length of follow‐up: 6 months
Average risk population6RR 0.88
(0.25 to 3.14)
183
1 study
+ooo
VERY LOW9
This outcome poorly reported.
42 per 100037 (11 to 132) per 1000
Adverse events
Length of follow‐up: 4 to 12 months
See commentSee commentNot estimable.1032
(4 studies)
+oooVERY LOW

10

1 serious adverse event reported (death due to a ruptured abdominal aortic aneurysm one week after the follow‐up tests, association could not definitely be ruled out) in 1 trial (183 participants).Three trials reported no differences in adverse events:
  • 1 trial (639 participants) reporting aches and pains, P = 0.75

  • 1 trial (194 participants) reported no statistical difference in severe soreness (10 exercise versus 11 control), severe bruises (2 versus 1), severe fatigue (4 versus 1)

  • 1 trial reported no adverse events

*Illustrative risks for the control group were derived from all or subgroups of trials in care facilities reporting the outcome. The exact basis for the assumed risk for each outcome is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; py: person years; RaR: Rate Ratio; RR: Risk Ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings: General medication review compared with usual care in care facilities

General medication review compared with usual care for falls prevention in care facilities
Population and setting: older (≥ 65 years) residents of care facilities
Intervention: general medication review (NB: the primary aim of all medication review is to reduce psychoactive medications)
Comparison: usual care
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Usual careGeneral medication review
Rate of falls
Length of follow‐up: 6 to 12 months
Low‐risk population1RaR 0.93
(0.64 to 1.35)
2409
(6 studies)
++oo
LOW7
The approaches taken in the six pooled studies were:
  • medication review meeting involving clinical pharmacist, pharmacy technician, care home staff and GP(s)

  • medication review with recommendations to chief physician based on STOPP/START criteria

  • nurse education on harmful medications in older people

  • monthly reviews of psychoactive medications

  • medication review and deprescribing

  • GP record + consultation with patient and care


2 additional RCTs found no strong evidence for an effect on the rate of falls (1 RCT of education of physicians on drug use in older people (716 participants, falls only reported following the intervention period); 1 trial of antidepressant deprescribing (36 participants randomised)).
1000 per 1000 py930 (640 to 1350)per 1000 py
High‐risk population2
3500 per 1000 py3255 (2240 to 4725)per 1000 py
Risk of falling
Length of follow‐up: 6 to 12 months
Low‐risk population3RR 0.93
(0.80 to 1.09)
5139
(6 studies)
++oo
LOW8
The approaches taken in the six studies were:
  • pharmacist transition coordinator for patients discharged from hospital to nursing care facilities for the first time

  • a pharmacist‐led outreach programme (audit + feedback + education of staff regarding medications and falls risk)

  • nurse education on harmful medications in older people

  • GRAM software for decision support for prescribing practices

  • GP and a geriatrician / pharmacologist independently identifying deprescribing targets using a list of potentially inappropriate medicines vs medication review without deprescribing

  • review of GP record + consultation with patient and carer


1 additional RCT of education of physicians on drug use in older people (716 participants) found no strong evidence for an effect on the risk of falling following the intervention period.
250 per 1000233 (200 to 273) per 1000
Moderate‐risk population4
500 per 1000465 (400 to 545) per 1000
High‐risk population5
700 per 1000651 (560 to 763) per 1000
Risk of fracture
Length of follow‐up: 12 months
Average risk population6RR 1.60
(0.28 to 9.16)
93
(1 trial)
+ooo
VERY LOW9
Intervention was GP and a geriatrician/pharmacologist independently identifying deprescribing targets using a list of potentially inappropriate medicines vs medication review without deprescribing.
42 per 100067 (12 to 614) per 1000
Adverse events
Length of follow‐up: 12 months
Average risk population10RR 1.07
(0.23 to 5.01)
93
(1 trial)
+ooo
VERY LOW9
Serious vascular events in both trial arms and significant withdrawal reactions in 2 intervention participants (Potter 2016).
60 per 100064 (14 to 301)
per 1000
**Illustrative risks for the control group were derived from all or subgroups of trials in care facilities reporting the outcome. The exact basis for the assumed risk for each outcome is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; py: person years; RaR: Rate Ratio; RR: Risk Ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings: Vitamin D supplementation in care facilities

Vitamin D supplementation compared with no vitamin D supplementation for falls prevention in care facilities
Population and setting: older (≥ 65 years) residents of care facilities1
Intervention: vitamin D supplementation (vitamin D or vitamin D + calcium)
Comparison: usual care (or calcium supplementation)
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
ControlVitamin D
Rate of falls
Length of follow‐up: 3 to 24 months
Low‐risk population2RaR 0.72
(0.55 to 0.95)
4512
(4 studies)
+++o
MODERATE8
Studies included two studies of vitamin D3 + calcium versus calcium, and 2 studies of vitamin D2 versus usual care or placebo.
1000 per 1000 py720 (550 to 950)per 1000 py
High‐risk population3
3500 per 1000 py2520 (1925 to 3325)per 1000 py
Risk of falling
Length of follow‐up: 3 to 24 months
Low‐risk population4RR 0.92
(0.76 to 1.12)
4512
(4 studies)
+++o
MODERATE9
Studies included two studies of vitamin D3 + calcium versus calcium, and 2 studies of vitamin D2 versus usual care or placebo.
250 per 1000230 (190 to 280)per 1000
Moderate‐risk population5
500 per 1000460 (380 to 515)per 1000
High‐risk population6
700 per 1000644 (532 to 784)per 1000
Risk of fracture
Length of follow‐up: 3 to 24 months
Average risk population7RR 1.09
(0.58 to 2.03)
4464
(3 studies)
+ooo
VERY LOW10
These studies represent only a subset of studies evaluating the effect of vitamin D on fractures. Included studies were two studies of vitamin D3 + calcium versus calcium, and 1 study of vitamin D2 versus usual care.
42 per 100046 (24 to 85) per 1000
Adverse events
Length of follow‐up: 3 to 24 months
ND12ND12RR 4.84
(0.24 to 98.90)
747
(2 studies)
+ooo
VERY LOW11
No serious events reported. Studies tested supplementation with 800 IU oral cholecalciferol (vitamin D3) and 1000 IU oral ergocalciferol (vitamin D2) daily.
Data derived from just 2 cases of increased constipation in the intervention arm in 1 study (N = 122). No adverse events recorded in the other study (N = 625)
*Illustrative risks for the control group were derived from all or subgroups of trials in care facilities reporting the outcome. The exact basis for the assumed risk for each outcome is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; ND: not done; py: person years; RaR: Rate Ratio; RR: Risk Ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings: Multifactorial interventions compared with usual care in care facilities

Multifactorial interventions compared with usual care for falls prevention in care facilities
Population and setting: older (≥ 65 years) residents of care facilities
Intervention: multifactorial interventions (two or more categories of intervention given based on individual risk profile)
Comparison: usual care (without intervention)1
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
ControlVitamin D
Rate of falls
Length of follow‐up: 6 to 12 months
Low‐risk population2RaR 0.88 (0.66 to 1.18)3439
(10 studies)
+ooo
VERY LOW8
One additional study (31 participants) of exercise plus nutritional support reported zero falls in the intervention arm and two in the control arm.
1000 per 1000 py720 (550 to 950)per 1000 py
High‐risk population3
3500 per 1000 py2520 (1925 to 3325)per 1000 py
Risk of falling
Length of follow‐up: 6 to 12 months
Low‐risk population4RR 0.92 (0.81 to 1.05)3153
(9 studies)
++oo
LOW9
One additional study (482 participants) reported a reduction in the proportion of recurrent fallers (difference 19%, 95% CI 2% to 36%: P = 0.03).
250 per 1000230 (190 to 280)per 1000
Moderate‐risk population5
500 per 1000460 (380 to 515)per 1000
High‐risk population6
700 per 1000644 (532 to 784)per 1000
Risk of fracture
Length of follow‐up: 6 to 12 months
Average risk population7RR 0.79 (0.30 to 2.07)2160
(5 studies)
+ooo
VERY LOW10
 
42 per 100034 (13 to 87) per 1000
Adverse events
Length of follow‐up: 11 weeks to 12 months
See commentSee commentNot estimable.312
(3 studies)
+ooo
VERY LOW11
One trial reported a case of a fall in the intervention arm; two studies reported no adverse events.
*Illustrative risks for the control group were derived from all or subgroups of trials in care facilities reporting the outcome. The exact basis for the assumed risk for each outcome is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; py: person years; RaR: Rate Ratio; RR: Risk Ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings: Additional exercise plus physiotherapy compared with usual physiotherapy in hospitals

Additional exercise plus physiotherapy compared with usual physiotherapy for falls prevention in hospitals
Population and setting: older (≥ 65 years) patients in hospital settings
Intervention: additional exercise plus physiotherapy
Comparison: usual physiotherapy
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Usual physiotherapyAdditional Exercise
Rate of falls
Length of follow‐up: inpatient stay (mean 29 days) or 2 weeks
Low‐risk population1RaR 0.59 (0.26 to 1.34)215
(2 studies)
+ooo
VERY LOW7
One study compared additional exercises versus conventional physiotherapy alone, and 1 study tested additional group standing balance circuit classes
1300 per 1000 py767 (338 to 1742) per 1000 py
Moderate‐risk population2
3500 per 1000 py2065 (910 to 4690) per 1000 py
High‐risk population3
6000 per 1000 py3540 (1560 to 8040) per 1000 py
Risk of falling
Length of follow‐up: inpatient stay (mean 29 days) or 8 weeks
Low‐risk population4RR 0.36
(0.14 to 0.93)
83
(2 studies)
+ooo
VERY LOW8
One study compared additional exercises versus conventional physiotherapy alone, and 1 study tested additional daily physiotherapy sessions
30 per 100011 (4 to 28) per 1000
Moderate‐risk population5
150 per 100054 (21 to 140) per 1000
High‐risk population6
340 per 1000122 (48 to 316) per 1000
Risk of fractureSee commentSee commentSee comment  No data available
Adverse events
Length of follow‐up: 2 weeks
0 events0 eventsNot estimable161
(1 study)
+ooo
VERY LOW9
One study reported no adverse events, two studies did not report this outcome
*Illustrative risks for the control group were derived from all or subgroups of trials in hospitals reporting the outcome. The exact basis for the assumed risk for each outcome is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; py: person years; RaR: Rate Ratio; RR: Risk Ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings: Bed alarms compared with usual care in hospitals

Bed alarms compared with usual care for falls prevention in hospitals
Population and setting: older (≥ 65 years) patients in hospital settings
Intervention: bed alarms
Comparison: usual care
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Usual careBed alarms
Rate of falls
Length of follow‐up: inpatient stay (mean 19 days; not known)
Low‐risk population1RaR 0.60
(0.27 to 1.34)
28,649
(2 studies)
++oo
VERY LOW7
One cluster‐randomised study tested education and support on using bed/chair alarms; and one study tested sensor alarms fitted to patients' upper leg at rest time.
A third study (n = 70) reported no difference in the number of falls (data not suitable for pooling).
1300 per 1000 py780 (351 to 1742)per 1000 py
Moderate‐risk population2
3500 per 1000 py2100 (945 to 4690) per 1000 py
High‐risk population3
6000 per 1000 py3600 (1620 to 8040) per 1000 py
Risk of falling
Length of follow‐up: inpatient stay (mean 19 days; not known)
Low‐risk population4RR 0.93
(0.38 to 2.24)
28,649
(2 studies)
+ooo
VERY LOW8
One cluster‐randomised study tested education and support on using bed/chair alarms; and one study tested sensor alarms fitted to patients' upper leg at rest time
30 per 100028 (11 to 67) per 1000
Moderate‐risk population5
150 per 1000140 (57 to 336) per 1000
High‐risk population6
340 per 1000316 (129 to 762) per 1000
Risk of fractureSee commentSee commentSee comment  No data available.
Adverse events
Length of follow‐up: inpatient stay (mean 19 days; not known)
0 events0 eventsNot estimable.27,742
(2 studies)
+ooo
VERY LOW9
2 trials reported that there were no adverse events
*Illustrative risks for the control group were derived from all or subgroups of trials in hospitals reporting the outcome. The exact basis for the assumed risk for each outcome is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; py: person years; RaR: Rate Ratio; RR: Risk Ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings: Multifactorial interventions compared with usual care in hospitals

Multifactorial interventions compared with usual care for falls prevention in hospitals
Population and setting: older (≥ 65 years) patients in hospital settings
Intervention: multifactorial interventions (two or more categories of intervention given based on individual risk profile)
Comparison: usual care 1
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Usual careMultifactorial
Rate of falls
Length of follow‐up: inpatient stay (median 4 days to mean 30 days)
Low‐risk population2RaR 0.80
(0.64 to 1.01)
44,664
(5 studies)
++oo
LOW9
The 5 studies tested compared different multifactorial interventions versus usual care in acute, subacute or mixed care settings.
  • 1 study (acute care) tested risk assessment and up to 6 interventions for high‐risk patients, plus staff education

  • 1 study (acute and subacute care) tested risk assessment, staff and patient education, drug review, environmental modifications and exercise

  • 1 study (subacute care) tested risk assessment and targeted interventions (exercise, educational sessions from OT, hip protectors)

  • 1 study (acute and subacute care) tested risk factor screening and targeted care plan in at‐risk patients

  • 1 study (subacute care) tested a multimedia falls education with follow‐up for patients plus staff education and feedback.


See footnote13 for comment on a post‐hoc subgroup analysis by setting.
1300 per 1000 py1040 (832 to 1313) per 1000 py
Moderate‐risk population3
3500 per 1000 py2,800 (2240 to 3535) per 1000 py
High‐risk population4
6000 per 1000 py4800 (3840 to 6060) per 1000 py
Risk of falling
Length of follow‐up: inpatient stay (median 4 days to mean 30 days)
Low‐risk population5RR 0.82
(0.62 to 1.09)
39,889
(3 studies)
+oooVERY LOW

10

The 3 studies tested compared different multifactorial interventions versus usual care in acute, subacute or mixed care settings.
  • 1 study (acute care) tested risk assessment and up to 6 interventions for high‐risk patients, plus staff education

  • 1 study (acute and subacute care) tested risk assessment, staff and patient education, drug review, environmental modifications and exercise

  • 1 study (subacute care) tested risk assessment and targeted interventions (exercise, educational sessions from OT, hip protectors)


One additional study analysed fallers by the number of admissions, and found a reduction in the risk of falling (adjusted OR 0.55, 95% CI 0.38 to 0.81).
30 per 100025 (19 to 33) per 1000
Moderate‐risk population6
150 per 1000123 (93 to 164) per 1000
High‐risk population7
340 per 1000279 (211 to 371) per 1000
Risk of fracture
Length of follow‐up: inpatient stay (mean in acute wards 8 days to mean 30 days)
Average risk population8RR 0.76
(0.14 to 4.10)
4615
(2 studies)
+ooo
VERY LOW11
The 2 studies pooled tested compared different multifactorial interventions versus usual care in subacute or mixed care settings.
  • 1 study (acute and subacute care) tested risk assessment, staff and patient education, drug review, environmental modifications and exercise

  • 1 study (subacute care) tested risk assessment and targeted interventions (exercise, educational sessions from OT, hip protectors)


Two additional studies reported no difference in extremely low risk of fracture (1 study Intervention: 11/17698, 0.06% vs Control: 13/17566, 0.07%) or number of fractures (Intervention 4/1402 0.3% vs 6/1719, 0.3%).
18 per 100014 (3 to 74) per 1000
Adverse events
Length of follow‐up: inpatient stay
0 events0 eventsNot estimable.39,763
(4 studies)
+ooo
VERY LOW12
4 trials reported that there were no adverse events.
*Illustrative risks for the control group were derived from all or subgroups of trials in hospitals reporting the outcome. The exact basis for the assumed risk for each outcome is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; MultiF: multifactorial; OR: Odds Ratio; OT: Occupational Therapist py: person years; RaR: Rate Ratio; RR: Risk Ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

We present results by setting (care facilities or hospitals), combination (single, multiple, or multifactorial) and intervention type (categorised according to ProFaNE, Lamb 2011) in Appendix 3.

Care facilities: single interventions

Single interventions consist of one major category of intervention only and are delivered to all participants in the group.

Exercise

Twenty‐five trials (2848 participants) investigated exercise as a single intervention (seeTable 9), four trials (986 participants) were cluster randomised (Choi 2005; Kerse 2008; Rosendahl 2008; Yokoi 2015), and the remaining 22 trials (1862 participants) were individually randomised. However, many of these trials were small (median 60 participants, range 16 to 682; seeTable 8). The types of exercise are shown in Table 9. The control arm of the different trials also varied. Four trials included three arms (Faber 2006; Nowalk 2001; Saravanakumar 2014; Tuunainen 2013). One was a cross‐over trial (Toulotte 2003). The trials are categorised below, both according to the ProFaNE exercise category (see Appendix 4) and the comparator arm of the trial. A summary of the evidence from exercise versus usual care for falls prevention in care facilities is provided in Table 1.

Only two trials reported on the impact of exercise interventions on fractures (Rosendahl 2008, Sitja Rabert 2015). Nine trials reported on adverse events, while 16 trials did not report adverse‐event data.

In seven trials, the reported data were incomplete and not suitable for pooling with other studies (Buettner 2002; Cadore 2014; da Silva Borges 2014; Imaoka 2016; Nowalk 2001; Serra‐Rexach 2011; Toulotte 2003); seeAnalysis 1.2 and Analysis 4.2). Falls data from Imaoka 2016 excluded the intervention period and thus are not presented in the forest plot.

Analysis

Comparison 1 Care facilities: Exercise vs usual care, Outcome 2 Rate of falls and number of fallers: trials with incomplete data.

Rate of falls and number of fallers: trials with incomplete data
StudyInterventionComparatorParticipants (N)Study findings (NR = not reported)
Buettner 2002Exercise: Supervised group exercises, combination exercises.Usual care27Rate of falls: Falls were reduced but the treatment effect estimate and confidence interval were not reported in the published study or research monograph.
Risk of falling: NR
Cadore 2014Exercise: Multicomponent exercise programme including gait/balance and strength/resistance trainingUsual care including mobility exercises24Rate of falls: Over 12 weeks there were no falls in the multicomponent arm in comparison to a rate of falls of 0.8 falls per patient per month in the mobility exercises arm of the study (P < 0.001). Participants were aged > 85 years.
Risk of falling: NR
da Silva Borges 2014Exercise: Ballroom dancing (3D exercises; EG)No regular physical activity (CG)59Rate of falls: The authors reported " fewer falls in the EG post‐test compared to the CG post‐test (p<0.0001)."
Risk of falling: NR
Nowalk 2001Exercise: 1. "Fit NB Free" Individually tailored combination exercises.
2. "Living and Learning/Tai Chi"
Usual routine activities110Rate of falls: NR
Risk of falling: No significant difference in risk of falling (time to first fall) between either intervention group and the usual care group (P = 0.29).
Toulotte 2003Exercise: Supervised exercises, combination exercises.Usual care20Rate of falls: The authors reported that falls were reduced but a falls rate could not be determined from the published data.
Risk of falling: NR

Analysis

Comparison 4 Care facilities: Comparisons of different exercise programs (see Appendix 4 for details), Outcome 2 Rate of falls and number of fallers: trials with incomplete data.

Rate of falls and number of fallers: trials with incomplete data
StudyInterventionComparatorParticipants (N)Study findings
Imaoka 2016Exercise: Additional group exercise (described by author as "Usual care": combination group exercises plus individualised exercise)Individualised exercise (described by author as "reduced exercise")39Rate of falls: Not reported
Risk of falling: No strong evidence for a reduction in the risk of falling in the post‐intervention period with additional group exercise (RR 0.48, 95% CI 0.17 to 1.3). The falls data are not presented in the forest plot as they exclude the intervention period.
Serra‐Rexach 2011Exercise: Training sessions (combination exercises) plus usual care physiotherapyUsual care physiotherapy (40‐45 min / day 5 x weekly)40Rate of falls: "The mean number of falls per participant recorded over the study period was 1.2 fewer in the intervention group than in the control group (95% CI = 0.0–3.0, P =.03)."
Risk of falling: not reported

Exercise versus usual care

Seventeen trials (2406 participants) compared an exercise intervention with usual care, defined as no exercise, no change in previous lifestyle or exercise type or level unlikely to change physical performance (e.g. seated flexibility exercise programme). Four trials (986 participants) of exercise in comparison with usual care were cluster randomised (Choi 2005; Kerse 2008; Rosendahl 2008; Yokoi 2015), the remaining 13 trials (1420 participants) were individually randomised. Faber 2006, included two exercise intervention arms, we combined the results from the two intervention groups in these analyses. As there is considerable clinical heterogeneity within these studies, we undertook analyses to explore heterogeneity, which are reported below.

Rate of falls

Ten trials (2002 participants) reporting on the impact of exercise in comparison with usual care in care facilities on the rate of falls had considerable statistical heterogeneity (I² = 76%, heterogeneity P < 0.0001). Nevertheless, as these trials were considered clinically similar in terms of the intervention, comparator, patient group and outcomes, these trials were pooled with a random effects meta‐analysis (Analysis 1.1: Rate ratio (RaR) = 0.93, 95% confidence interval (CI) 0.72 to 1.20). We are uncertain whether exercise reduces the rate of falls in care facilities as the quality of the evidence was assessed as very low (Table 1).

Analysis

Comparison 1 Care facilities: Exercise vs usual care, Outcome 1 Rate of falls.

In a subgroup analysis by broad types of exercise, there was no evidence of a difference between subgroups (Analysis 2.1: test for subgroup differences P = 1.00).

Analysis

Comparison 2 Care facilities: Exercises vs usual care (grouped by type of exercise), Outcome 1 Rate of falls.

To explore further the heterogeneity in these findings, we carried out a post‐hoc subgroup analysis by level of care (high or intermediate levels of care, or mixed levels). There was evidence of a difference between these subgroups that partially explained the heterogeneity (Analysis 3.1: test for subgroup differences Chi² = 6.39, I² = 69%, 2 df, P = 0.04). In studies of facilities providing mixed levels of care, the heterogeneity was no longer evident (I² = 0%, P = 0.41) and there was no evidence of an effect (Analysis 3.1.3 RaR: 1.08, 95% CI 0.92 to 1.28, 3 trials, 477 participants: I² = 0%). However, heterogeneity remained considerable for trials in a high or intermediate level of care (I² = 78%, P = 0.001).

Analysis

Comparison 3 Care facilities: Exercise vs usual care (grouped by level of care), Outcome 1 Rate of falls.

Four additional trials (130 participants) reported outcomes on rate of falls with data not suitable for pooling (Analysis 1.2); all reported a reduction in falls.

Risk of falling

Pooled data from 10 trials (2090 participants) indicated exercise may make little or no difference to the risk of falling (risk ratio (RR) with random‐effects RR 1.02, 95% CI 0.88 to 1.18: I² = 23%; Analysis 1.3; low‐quality evidence, Table 1).

Analysis

Comparison 1 Care facilities: Exercise vs usual care, Outcome 3 Number of fallers.

There were no subgroup differences in post‐hoc analyses for number of fallers between different levels of care (Analysis 3.2; test for subgroup differences P = 0.56) or types of exercise (Analysis 2.2; test for subgroup differences P = 0.71).

Analysis

Comparison 2 Care facilities: Exercises vs usual care (grouped by type of exercise), Outcome 2 Number of fallers.

Analysis

Comparison 3 Care facilities: Exercise vs usual care (grouped by level of care), Outcome 2 Number of fallers.

Faber 2006 carried out a post‐hoc subgroup analysis and found that the intervention in frail participants may increase risk of falling (hazard ratio (HR) 2.95, 95% CI 1.64 to 5.32; 115 participants), while in the pre‐frail subgroup there was no strong evidence for a reduction in the risk of falling (HR 0.62, 95% CI 0.29 to 1.33; 105 participants) (test for subgroup difference P ≤ 0.10). Other trials did not provide data suitable for a post‐hoc subgroup analysis of the effectiveness of the intervention according to the frailty of the participants.

Nowalk 2001 (N = 110) reported that there was no significant difference in the risk of falling between "Fit NB Free" individually‐tailored combination exercises, or the "Living and Learning/Tai Chi" in comparison with usual routine activities; data were not suitable for pooling (Analysis 1.2).

Risk of fracture

One trial of functional exercises (Rosendahl 2008, 183 participants) found no strong evidence for a reduction in the risk of hip fracture (Analysis 1.4.1: RR 0.16, 95% CI 0.01 to 2.81; 3 fractures) or total fractures (Analysis 1.4.2: RR 0.88, 95% CI 0.25 to 3.14; 10 fractures). We are uncertain whether exercise reduces the risk of fracture as the quality of the evidence was assessed as very low (Table 1).

Analysis

Comparison 1 Care facilities: Exercise vs usual care, Outcome 4 Number of people sustaining a fracture.

Adverse events

Two trials (833 participants) of exercise compared with usual care reported the rates of adverse event outcomes including aches, pains, fatigue, soreness and bruises. Kerse 2008 (639 participants) reported no differences in the level of adverse outcomes on negative binomial regression adjusted for clustering (aches and pains at six months exercise 46.7, 95% CI 39.3 to 54.9 versus usual care 51.1, 95% CI 43.8 to 58.4, P = 0.75). Mulrow 1994 (194 participants) found no difference in the proportion of participants reporting severe soreness (Analysis 1.7.1: RR 0.91, 95% CI 0.40 to 2.04), severe bruises (Analysis 1.7.2: RR 2.00, 95% CI 0.18 to 21.69) or severe fatigue (Analysis 1.7.3: RR 4.00, 95% CI 0.46 to 35.14); there were no injuries during the therapy sessions. One trial (16 participants) reported that there were no adverse events (Schoenfelder 2000). One trial (183 participants) reported a death due to a ruptured abdominal aortic aneurysm one week after the follow‐up tests of the exercise intervention for which association could not definitely be excluded by geriatric review (Rosendahl 2008). We are uncertain of the effects of exercise on adverse events as the quality of the evidence has been assessed as very low; Table 1).

Analysis

Comparison 1 Care facilities: Exercise vs usual care, Outcome 7 Adverse events: aches and pains.

Sensitivity analysis

As a sensitivity analysis, the pooled analysis of rate of falls was conducted with a fixed‐effect model. This made little difference to the estimate of effect (RaR 1.01, 95% CI 0.91 to 1.13). The pooled analysis of the risk of falling with a fixed‐effect model also made little difference to the estimate of effect (RR 1.04, 95% CI 0.92 to 1.18). We also conducted a sensitivity analysis including Cadore 2014, which had zero falls in the intervention arm, calculated using one fall in lieu of zero in this arm. This had little impact on the effect estimate (RaR 0.85, 95% CI 0.63 to 1.13; I² = 81%).

To further explore the heterogeneity in the results, outcomes for all trials excluding two trials (Schoenfelder 2000; Sihvonen 2004) with 20 participants or less in each arm of the trial were pooled (this chosen threshold was arbitrary but considered indicative of 'very small' trials). This did not reduce the heterogeneity for rate of falls (Analysis 1.5: I² = 70%), or change the overall pooled estimate of rate of falls (Analysis 1.5: RaR 0.91, 95% CI 0.72 to 1.15) or risk of falling (Analysis 1.6: RR 1.04, 95% CI 0.89 to 1.21; I² = 25%).

Analysis

Comparison 1 Care facilities: Exercise vs usual care, Outcome 5 Rate of falls, excluding studies with ≤20 participants in each arm.

Analysis

Comparison 1 Care facilities: Exercise vs usual care, Outcome 6 Number of fallers, excluding studies with ≤20 participants in each arm.

Funnel plots testing for publication bias

We constructed funnel plots of trials of exercise versus usual care for both the rate of falls and risk of falling outcomes. The funnel plots appeared asymmetrical for both rate of falls and risk of falling (Figure 4 and Figure 5), which may indicate publication bias or lower methodological quality leading to spuriously inflated effects in the smaller trials. In addition to the trials included in the funnel plots, there were four other trials reporting a reduction in the rate of falls.

What interventions protect patients from falling?

Funnel plot of comparison: 1 Care facilities: Exercise vs usual care (grouped by level of care), outcome: 1.2 Number of fallers. NB One additional trial with data not suitable for pooling reported no significant reduction in the risk of falling.

Comparisons of different exercise categories

Nine trials (584 participants) provided 12 comparisons of two different exercise programmes (Faber 2006; Fu 2015; Imaoka 2016; Kovacs 2012; Saravanakumar 2014; Shimada 2004; Serra‐Rexach 2011; Sitja Rabert 2015; Tuunainen 2013). All trials were individually randomised. Seven trials (nine comparisons; 505 participants) had data suitable for pooling (Faber 2006; Fu 2015; Kovacs 2012; Saravanakumar 2014; Shimada 2004; Sitja Rabert 2015; Tuunainen 2013). Two trials provided data on the effectiveness of additional balance exercises (Shimada 2004; Tuunainen 2013). All other comparisons included only single trials; the quality of evidence was considered very low for these comparisons.

Rate of falls

Five trials (Faber 2006; Fu 2015; Saravanakumar 2014; Shimada 2004; Tuunainen 2013; 305 participants) with data suitable for analysis reported the effect of nine comparisons of different exercise programmes on the rate of falls (Analysis 4.1). For eight of these comparisons there was only a single trial with less than 200 participants; the quality of the evidence was considered very low so the relative effectiveness of these exercise programmes on reducing the rate of falls remains uncertain.

Analysis

Comparison 4 Care facilities: Comparisons of different exercise programs (see Appendix 4 for details), Outcome 1 Rate of falls.

Pooled data from two trials (Shimada 2004; Tuunainen 2013) of additional balance exercises indicated a reduction in the rate of falls (Analysis 4.1.1: RaR 0.62, 95% CI 0.40 to 0.96; I² = 0%; 56 participants; 86 falls). We are uncertain of the effect of additional balance exercise on falls as the quality of the evidence has been assessed as very low (downgraded two levels due to serious risk of bias, and one level for imprecision).

Serra‐Rexach 2011 (40 participants) compared training sessions of a combination of exercises in addition to usual physiotherapy and reported fewer falls in the intervention group (Analysis 4.2).

Risk of falling

Six trials (Faber 2006; Imaoka 2016; Kovacs 2012; Shimada 2004; Sitja Rabert 2015; Tuunainen 2013; 327 participants) reported the effect of seven comparisons of different exercise categories on the risk of falling (Analysis 4.3). Six comparisons contained only a single trial and the quality of evidence for these comparisons was considered very low; the relative effectiveness of these exercise programmes on reducing the risk of falling remains uncertain.

Analysis

Comparison 4 Care facilities: Comparisons of different exercise programs (see Appendix 4 for details), Outcome 3 Number of fallers.

Pooled data from two trials (Shimada 2004; Tuunainen 2013) of additional balance exercises did not show evidence of a strong effect on reducing the risk of falling Analysis 4.3.1 (RR 0.79, 95% CI 0.43 to 1.45; I² = 0%; 56 participants; 24 fallers). We are uncertain of the effect of additional balance exercise on falls as the quality of the evidence has been assessed as very low (downgraded two levels for risk of bias, and one level for imprecision).

In Imaoka 2016, there was no strong evidence for a reduction in the risk of falling in the post‐intervention period with additional group exercise (RR 0.48, 95% CI 0.17 to 1.3).

Risk of fracture

Sitja Rabert 2015 (159 participants) compared exercise performed on a whole body vibration platform to the same land based exercises and reported one fracture in the intervention group and none in the control group (Analysis 4.4: RR 2.89, 95% CI 0.12 to 69.07; 1 fracture). We are uncertain whether or not whole body vibration reduces the risk of fracture.

Analysis

Comparison 4 Care facilities: Comparisons of different exercise programs (see Appendix 4 for details), Outcome 4 Number of people sustaining a fracture.

Adverse events

Four trials (269 participants) comparing alternative exercise programmes reported on adverse events; no serious adverse events were reported. Saravanakumar 2014 (29 participants) reported an instance of a non‐injurious fall during a yoga intervention. Sitja Rabert 2015 (159 participants) comparing exercise on a whole body vibration platform with land‐based exercise reported that "statistical results showed no differences between groups (P=0.430)" and that "ten percent of participants in the exercise group and 16.3% in the whole body vibration plus exercise group presented a possible or probable relation of causality with the intervention, but this difference was not statistically significant (P =0.450)." The most commonly reported adverse events were pain (18%) and soreness (13%) but these data were not reported according to group allocation. Serra‐Rexach 2011 (40 participants), testing additional physiotherapy, reported a case of transient lumbalgia. Lastly, Kovacs 2012 (41 participants), which compared a multimodel exercise programme based on Otago plus osteoporosis exercises with osteoporosis exercises, reported that there were no adverse events.

Medication (drug target) interventions

Medication review

Twelve studies (7366 participants) examined the effect of medication review interventions in care facilities on falls (Crotty 2004a; Crotty 2004b; Frankenthal 2014; Garcia Gollarte 2014; Juola 2015; Frankenthal 2014; Houghton 2014; Lapane 2011; Patterson 2010; Potter 2016; Streim 2012; Zermansky 2006). Seven trials (4536 participants) were individually randomised (Crotty 2004a; Frankenthal 2014; Frankenthal 2014; Lapane 2011; Potter 2016; Streim 2012; Zermansky 2006), and five trials (2830 participants) were cluster randomised (Crotty 2004b; Garcia Gollarte 2014; Juola 2015; Houghton 2014; Patterson 2010). Two studies (1054 participants) did not report falls data suitable for pooling (Garcia Gollarte 2014; Streim 2012). The primary aim of all medication review is generally to reduce psychoactive medications. Therefore, all trials were considered clinically similar except for one study of medication review for hyponatraemia (Peyro Saint Paul 2013). Further details of the interventions and comparisons are provided in Table 10. A summary of the evidence for general medication review for falls prevention in care facilities is provided in Table 2.

Rate of falls

Six trials (2409 participants) reporting data on the rate of falls in trials of general medication review were considered clinically appropriate to pool, despite considerable statistical heterogeneity. General medication review may make little or no difference to the rate of falls (Analysis 5.1.1: RaR 0.93, 95% CI 0.64 to 1.35, 6 trials, 2409 participants; I² = 93%; low‐quality evidence). Subgroup analyses by level of care were not conducted as all trials were conducted in mixed settings.

Analysis

Comparison 5 Care facilities: Medication review vs usual care, Outcome 1 Rate of falls.

Garcia Gollarte 2014 (716 participants) conducted a cluster‐randomised trial of education of physicians on drug use in older people, plus medication review with feedback in 10% of patients. Data from this study were not pooled as falls during the six‐month intervention period were not reported. Over the three months following the intervention, after adjustment for clustering, the rate of falls (RaR 0.74, 95% CI 0.49 to 1.13) did not provide strong evidence for an effect.

A post‐hoc sensitivity analyses was conducted excluding Potter 2016 (93 participants), in which 3 participants in the intervention group had more than 30 falls. The heterogeneity in this analysis remained high (Analysis 5.4: I² = 87%) and there was no strong evidence of a reduction in the rate of falls.

Analysis

Comparison 5 Care facilities: Medication review vs usual care, Outcome 4 Rate of falls post‐hoc sensitivity analysis (excluding Potter 2016).

One additional small trial examined medication review to avoid hyponatraemia (Peyro Saint Paul 2013; Analysis 5.1.2: nine participants), we are uncertain whether medication review reduces falls in adults with chronic moderate hyponatraemia (serum sodium level 123 mEq/L to 134 mEq/L).

Streim 2012 conducted a trial that included both randomised and a non‐randomised patient‐preference arm. The randomised arms of the trial (36 participants), examined deprescribing of antidepressants. The authors reported that "the discontinuation and continuation groups exhibited similar non‐significant increases in the odds of fall per week with an increase in odds of falls of 1.38 per week (95% CI 4.07 to 0.47); Z=0.59; p=0.55) in the discontinuation group and 1.50 per week (95% CI 0.55 to 4.07); Z=0.80; p=0.43) in the continuation group. The similarity in odds ratios corresponds to discontinuation only reducing the odds ratio of falls relative to the continuation ratio by approximately 10% (ratio of ORs=0.92 (95% CI=(0.21, 4.01); Z=0.11; p=0.91)."

Risk of falling

Pooled data from six clinically similar trials (5139 participants) reporting falls risk data indicated that general medication review may make little or no difference to the risk of falling (Analysis 5.2.1: RR 0.93, 95% CI 0.80 to 1.09; 5139 participants: I² = 48%). The quality of the evidence was considered low (downgraded one level for risk of bias and one level for inconsistency).

Analysis

Comparison 5 Care facilities: Medication review vs usual care, Outcome 2 Number of fallers.

In Garcia Gollarte 2014 (716 participants), after adjustment for clustering, the risk of falling (RR 0.86, 95% CI 0.59 to 1.26) did not provide strong evidence for an effect over the three months following the intervention.

We are uncertain of whether medication review reduces falls in adults with chronic moderate hyponatraemia (Analysis 5.2.2: RR 0.42, 95% CI 0.07 to 2.59: 1 trial; 9 participants).

Risk of fracture

Potter 2016 (93 participants) reported the effect of medication review on the risk of fracture (Analysis 5.3: RR 1.60, 95%CI 0.28 to 9.16; 5 fractures), we are uncertain of the effect of medication review on risk of fracture as the quality of the evidence has been assessed as very low.

Analysis

Comparison 5 Care facilities: Medication review vs usual care, Outcome 3 Number of people sustaining a fracture.

Subgroup analysis by cognitive status

Juola 2015 provided data for subgroups according to cognitive status. After adjustment for clustering, the rate of falls was reduced for those with an Mini Mental State Examination (MMSE) greater than 15 (RaR 0.23, 95% CI 0.12 to 0.44; 49 participants) or an MMSE of 10‐15 (RaR 0.27, 95%CI 0.17 to 0.44; 45 participants) but not for those with an MMSE <10 (RaR 1.27, 95% CI 0.95 to 1.69; 95 participants).

Adverse events

Two studies (102 participants) reported on adverse events; the remaining 10 studies did not clearly report on adverse events related to the intervention.

In a study of deprescribing (Potter 2016; 93 participants), serious vascular events occurred in three control participants and one intervention participant, and two intervention participants experienced significant adverse medicine withdrawal reactions (symptomatic rapid atrial fibrillation and agitation) (Analysis 5.5.1: RR 1.07, 95%CI 0.23 to 5.01; 1 trial).

Analysis

Comparison 5 Care facilities: Medication review vs usual care, Outcome 5 Serious adverse events.

Peyro Saint Paul 2013 (nine participants) reported one serious adverse event (a major gastrointestinal bleed) related to discontinuing a proton‐pump inhibitor in the intervention arm.

We are uncertain of the effects of medication review on adverse events as the quality of the evidence has been assessed as very low (Table 2).

Vitamin D supplementation

Eight studies (9278 participants) examined vitamin D supplementation administered in some form (Bischoff 2003; Broe 2007; Chapuy 2002; Flicker 2005; Grieger 2009; Imaoka 2016; Kennedy 2015; Law 2006). Six trials (5561 participants) were individually randomised (Bischoff 2003; Broe 2007; Chapuy 2002; Flicker 2005; Grieger 2009; Imaoka 2016) and two trials (3717 participants) were cluster randomised (Kennedy 2015; Law 2006). Four trials (4512 participants) tested the effect of vitamin D supplementation on falls (Bischoff 2003; Broe 2007; Flicker 2005; Law 2006), one trial (583 participants) tested the effect of vitamin D and calcium supplementation (Chapuy 2002), two trials (166 participants) tested multivitamin supplementation that included vitamin D plus calcium (Grieger 2009; Imaoka 2016), and one trial (4017 participants) tested an educational intervention aimed at increasing prescription of adequate levels of vitamin D, calcium and osteoporosis medications (Kennedy 2015). Seven of the eight studies reported serum vitamin D levels at baseline (Bischoff 2003; Broe 2007; Chapuy 2002; Flicker 2005; Grieger 2009; Imaoka 2016; Law 2006). Vitamin D levels were low or very low in these studies enrolling residents of care facilities. Baseline vitamin D levels for one trial (Kennedy 2015) were not reported. A summary of the evidence for vitamin D supplementation for falls prevention in care facilities is provided in Table 3.

For the specific comparison of multivitamin supplementation including vitamin D and calcium versus placebo (Grieger 2009; Imaoka 2016), the quality of the evidence was considered very low.

Rate of falls

Pooled data from four trials (4512 participants) indicated that vitamin D supplementation probably reduces the rate of falls (Analysis 6.1.1: RaR 0.72, 95% CI 0.55 to 0.95; I² = 62%: moderate‐quality evidence). The type of vitamin D administered is indicated in the footnotes.

Analysis

Comparison 6 Care facilities: Vitamin D supplementation vs no vitamin D supplementation, Outcome 1 Rate of falls.

We are uncertain whether multivitamin supplementation including vitamin D and calcium reduces the rate of falls as the quality of the evidence is very low (Analysis 6.1.2: RaR 0.38, 95% CI 0.20 to 0.71; 91 participants; 1 study).

An education intervention aimed at increasing the prescription of vitamin D, calcium and osteoporosis medication (Kennedy 2015) may make little or no difference to the rate of falls (Analysis 6.1.3: RaR 1.03, 95% CI 0.85 to 1.25; 4017 participants; 1 study; low‐quality evidence, downgraded two levels due to risk of bias).

Risk of falling

Pooled data from four trials (4512 participants) indicated that vitamin D supplementation probably makes little or no difference to the risk of falling (Analysis 6.2.1: RR 0.92, 95% CI 0.76 to 1.12; I² = 42%; moderate‐quality evidence, downgraded one level for risk of bias).

Analysis

Comparison 6 Care facilities: Vitamin D supplementation vs no vitamin D supplementation, Outcome 2 Number of fallers.

Vitamin D plus calcium supplementation (Chapuy 2002), probably makes little or no difference to the risk of falling (Analysis 6.2.2: RR 1.03, 95% CI 0.90 to 1.18; 583 participants; 1 study; moderate‐quality evidence downgraded one level for risk of bias).

We are uncertain whether multivitamin supplementation including vitamin D and calcium reduces the risk of falling (Analysis 6.2.3: RR 0.82, 95% CI 0.40 to 1.66; 91 participants; 1 study). Imaoka 2016 (75 participants), conducted a four‐arm trial which found no strong evidence for an effect of daily nutritional supplementation including 900 IU vitamin D (including 400 IU vitamin D3 and 200mg calcium in a multivitamin supplement) in comparison with usual care over the six months following the three‐month intervention period (RR 0.58, 95%CI 0.20 to 1.68, N = 34). Outcomes data were not pooled with other studies as they excluded the intervention period; falls are for six months post‐intervention.

An education intervention aimed at increasing the prescription of vitamin D, calcium and osteoporosis medication (Kennedy 2015) may make little difference or no difference to the risk of falling (Analysis 6.2.4: RR 1.05, 95% CI 0.90 to 1.23; 4017 participants; 1 study; low‐quality evidence, downgraded two levels for risk of bias).

Risk of fracture

Pooled data from three trials of vitamin D supplementation showed little effect on fall related fractures (Analysis 6.3.1: RR 1.09, 95% CI 0.58 to 2.03; I² = 63%; 4464 participants; 178 fractures: very low‐quality evidence). Different trials reported different types of fractures; the type of fractures are shown in the footnotes to the analysis. We are uncertain whether vitamin D supplementation reduces the risk of fall related fractures as the evidence has been assessed as very low.

Analysis

Comparison 6 Care facilities: Vitamin D supplementation vs no vitamin D supplementation, Outcome 3 Number of people sustaining a fracture.

We are uncertain whether vitamin D plus calcium supplementation reduces the risk of fall related fractures (Analysis 6.3.2: RR 0.62, 95% CI 0.36 to 1.07; 583 participants; 48 hip fractures; very low‐quality evidence, downgraded one level for risk of bias, one level for imprecision and one level as this review only includes a subset of the trials available reporting the effects of this intervention on fractures).

An education intervention aimed at increasing the prescription of vitamin D, calcium and osteoporosis medication (Kennedy 2015; 4017 participants) reported that 1.5% of falls in control participants and 1.6% of falls in intervention participants resulted in a fracture, the study was not powered to detect a difference in fall‐related fractures, we are uncertain of the effects of this intervention on fractures (very low‐quality evidence, downgraded two levels for risk of bias and two levels for imprecision).

Adverse events

Four trials (1365 participants) reported adverse‐event data.

Two of four trials (747 participants) of vitamin D supplementation reported on adverse events (Bischoff 2003, Flicker 2005); no serious adverse events were reported. Bischoff 2003 reported two cases of increased constipation in the intervention arm and no cases of hypercalcaemia (Analysis 6.4.1: constipation RR 4.84, 95%CI 0.24 to 98.80; 122 participants). Flicker 2005 reported that there were no adverse events. We are uncertain of the effects of Vitamin D supplementation (up to 1000 IU daily) on adverse events as the quality of the evidence has been assessed as very low (Table 3).

Analysis

Comparison 6 Care facilities: Vitamin D supplementation vs no vitamin D supplementation, Outcome 4 Adverse events.

One trial of vitamin D and calcium supplementation (800 IU of vitamin D3 + 1200 mg calcium carbonate daily) reported a similar rate of gastrointestinal disorders in each arm of the study and three cases of hypercalcaemia in the intervention arm, we are uncertain of the effects on adverse events (Chapuy 2002; Analysis 6.4.2; gastrointestinal adverse events RR 0.82, 95% CI 0.45 to 1.48; 583 participants; very low‐quality, downgraded one level for risk of bias and two levels for imprecision).

Grieger 2009, which tested multivitamin supplementation including vitamin D and calcium, reported there were no serious adverse events; the three adverse events reported were in the control arm of the trial (rash/vertigo, behavioural issues, indigestion), we are uncertain of the effects on adverse events (Analysis 6.4.2: RR 0.13, 95% CI 0.01 to 2.41; 91 participants, 40 events; very low‐quality evidence).

Environment/assistive technology

In a cross‐over trial, Clifton 2009 (43 participants) tested a wireless position‐monitoring device and found no strong evidence for a reduction in the rate of falls (Analysis 7.1: RaR 0.65, 95% CI 0.33 to 1.27; no adjustments for cross‐over design made in the analysis). There were no serious adverse events. We are uncertain whether or not wireless position monitoring has an effect on the rate of falls in care facilities (very low‐quality evidence).

Analysis

Comparison 7 Care facilities: Environmental interventions vs usual care, Outcome 1 Rate of falls.

Social environment

Seven cluster‐randomised trials examined service change interventions in care facilities (13,127 participants in six trials Cox 2008; Chenoweth 2009; Meyer 2009; Van de Ven 2014; Van Gaal 2011a; Ward 2010, plus 982 facility beds in Colon‐Emeric 2013). These included three trials of staff training interventions (Colon‐Emeric 2013; and 7029 participants from Cox 2008 and Van Gaal 2011a) and four of a service model change (6098 participants; Chenoweth 2009; Meyer 2009; Van de Ven 2014; Ward 2010). These interventions target staff or caregivers and changes in the organisational system in which an intervention is delivered, rather than targeting patients directly. The rate of falls for these interventions were not pooled due to high clinical and statistical heterogeneity (test for subgroup differences: P = 0.0001, I² = 85.6%). Two studies (6516 participants) reported data on risk of fracture (Meyer 2009, Ward 2010). No studies reported on adverse events. Although there were only single trials for the comparisons within this category, the generally larger size of these trials meant that optimal information size criteria may be met and GRADE assessments were conducted by two review authors.

Staff training

Cox 2008 (5637 participants) studied a half day education programme about fall and fracture prevention for managers, nurses and health care assistants, given by specialist osteoporosis nurses. There was no strong evidence for a reduction in the rate of falls, we are uncertain of the effects as the quality of the evidence was assessed as very low (Analysis 8.1.1: RaR 1.19, 95% CI 0.92 to 1.53; very low‐quality evidence, downgraded two levels for risk of bias and one level for imprecision). The intervention may make little or no difference to the rate of fracture (reported incidence rate ratio (IRR) for all fractures: IRR 0.94, 95% CI 0.71 to 1.26; for hip fractures: IRR 0.86, 95% CI 0.63 to 1.18; low‐quality evidence downgraded two levels for risk of bias).

Analysis

Comparison 8 Care facilities: Social environment vs usual care, Outcome 1 Rate of falls.

The intervention in Van Gaal 2011a (392 participants) consisted of education to implement a patient‐safety programme directed at falls, urinary tract infection, and pressure ulcers based on available guidelines. There was no strong evidence for a reduction in rate of falls, we are uncertain of the effects on the rate of falls (Analysis 8.1.2: RaR 0.63, 95% CI 0.34 to 1.16; very low‐quality evidence, downgraded two levels for risk of bias, one level for indirectness and one level for imprecision).

Colon‐Emeric 2013 (number of resident participants not reported, 497 staff participants, 982 facility beds) conducted a pilot cluster‐randomised trial testing a programme to improve staff connections, communication, and problem solving compared to usual care during implementation of a falls quality improvement programme. There was no strong evidence for an effect on the change in falls rate from baseline to post intervention periods between the two arms of the study, we are uncertain of the effects in reducing falls (RaR of change in falls rate 0.81, 95% CI 0.55 to 1.20; very low‐quality evidence, downgraded one level for each of risk of bias, indirectness and imprecision).

Service model change

Meyer 2009 (1125 participants) found that use of a falls risk‐assessment tool in comparison with nurses' judgement alone probably makes little or no difference to the rate of falls or risk of falling (Analysis 8.1.3: RaR 0.96, 95% CI 0.84 to 1.10; Analysis 8.2: RR 0.99, 95% CI 0.85 to 1.16; both outcomes moderate‐quality evidence, downgraded one level for risk of bias). We are uncertain whether or not this intervention reduces the risk of fracture as the quality of the evidence was assessed as very low (Analysis 8.3.1: RR 0.96, 95% CI 0.57 to 1.63; 77 fractures in total; downgraded one level for risk of bias and two levels for imprecision).

Analysis

Comparison 8 Care facilities: Social environment vs usual care, Outcome 2 Number of fallers.

Analysis

Comparison 8 Care facilities: Social environment vs usual care, Outcome 3 Number of people sustaining a fracture.

Two studies examined dementia care mapping, but data from Chenoweth 2009 were not suitable for pooling. Chenoweth 2009 (289 participants) reported that "... at follow‐up there were fewer falls with dementia‐care mapping than in usual care (p=0·02) and more falls in person‐centred care than in usual care (p=0·03)." Van de Ven 2014 (293 participants) delivered a four‐month dementia care mapping intervention twice during the 12‐month follow‐up period after baseline. The rate of falls at study endpoint was greater in the intervention arm of the study (Analysis 8.1.4: RaR 1.84, 95% CI 1.40 to 2.42). We are uncertain of the effects of dementia care mapping on the rate of falls as the quality of the evidence has been assessed as very low (downgraded two levels for risk of bias, one level for inconsistency and one level for imprecision).

Ward 2010 (5391 participants) employed a practice nurse to encourage the adoption of best practice strategies and reported "0.13 fewer falls per 100 beds per month; 95% CI, −0.36 to 0.10; P = 0.259" for the intervention period. There was no difference in risk of hip fracture between intervention and control groups during the 17 months of intervention (Analysis 8.3.2; RR 0.95, 95% CI 0.63 to 1.44; 215 hip fractures). We are uncertain of the effects of this intervention on fractures as the quality of the evidence has been assessed as very low (downgraded two levels for risk of bias, and two levels for imprecision).

Psychological interventions

Two studies (163 participants) examined the impact of psychological interventions on falls (Huang 2016; Van het Reve 2014). Both trials were individually randomised, Huang 2016 is a three‐arm trial for which falls excluded the intervention period; findings are also discussed under "Care facilities: multiple interventions". Neither trial reported data on the risk of fracture or adverse events.

In Van het Reve 2014 (114 participants) a computer‐based cognitive training programme focused on improving attention was combined with strength and balance training, and compared with strength and balance training alone. The intervention showed no strong evidence for an effect on falls rates (Analysis 9.1: RaR 1.22, 95% CI 0.78 to 1.92), risk of falling during the intervention period (Analysis 9.2.2; RR 1.35, 95% CI 0.23 to 7.88) or over 12 months post‐intervention (RR 1.38, 95% CI 0.76 to 2.51; data not shown).

Analysis

Comparison 9 Care facilities: Psychological interventions vs control, Outcome 1 Rate of falls.

Analysis

Comparison 9 Care facilities: Psychological interventions vs control, Outcome 2 Number of fallers.

In a three‐arm study, Huang 2016 tested the effects of a cognitive‐behavioural intervention conducted by a trained facilitator in comparison with usual care in 49 participants. Over the three months following the intervention, there were 1.67 falls per person year in the usual care arm of the study (10 falls in seven fallers), but no falls in the cognitive‐behavioural intervention arm. Data were not pooled as falls excluded the intervention period.

The quality of the evidence for both the rate and risk of falling was considered very low (downgraded one level for risk of bias, inconsistency and indirectness and two levels for imprecision), so we are uncertain of the effectiveness of psychological interventions in reducing falls.

Other single interventions

Three trials (564 participants) examined other single interventions of lavender olfactory stimulation (Sakamoto 2012), sunlight exposure (Sambrook 2012), and multisensory stimulation in a Snoezelen room (Klages 2011); two trials (169 participants) were individually randomised (Sakamoto 2012; Klages 2011) and one (Sambrook 2012; 395 participants) was cluster randomised. The quality of the evidence was considered very low for all of these single‐trial comparisons.

For one year, Sakamoto 2012 (145 participants) tested the effect of lavender olfactory stimulation by applying lavender patches or placebo patches to clothing near the neck daily. This intervention did not show strong evidence for a reduction in the rate of falls (Analysis 10.1: RaR 0.57, 95% CI 0.32 to 1.01) or risk of falling (Analysis 10.2: RR 0.67, 95% CI 0.40 to 1.12). The authors reported that there were no adverse events. We are uncertain of the effectiveness of lavender olfactory stimulation as the quality of the evidence is very low.

Analysis

Comparison 10 Care facilities: Other single interventions vs control, Outcome 1 Rate of falls.

Analysis

Comparison 10 Care facilities: Other single interventions vs control, Outcome 2 Number of fallers.

In Sambrook 2012 (395 participants), a trial of increased sunlight exposure had low adherence to the sunlight intervention (Durvasula 2012). We are uncertain of the effects on falls as the quality of the evidence has been assessed as very low for all outcomes (downgraded one level for each of risk of bias, indirectness and imprecision; Analysis 10.1.2: RaR 1.05, 95% CI 0.71 to 1.56; Analysis 10.2.2: RR 1.09, 95% CI 0.88 to 1.36; Analysis 10.3: risk of fracture: RR 1.07, 95% CI 0.53 to 2.17, total 32 fractures). The authors reported no difference in the incidence rates of new skin cancers between arms of the trial and one fall on the way to a sunlight session. Adverse‐event data for this three‐arm trial are also reported below under Multiple interventions.

Analysis

Comparison 10 Care facilities: Other single interventions vs control, Outcome 3 Number of people sustaining a fracture.

Klages 2011 (24 participants) compared the effect of multisensory stimulation in a Snoezelen room with control activities in people with dementia and reported, without providing data, that the "Group membership did not alter falls frequency". Adverse‐event data were not reported. We are uncertain of the effectiveness of multisensory stimulation as the quality of the evidence is very low.

Care facilities: multiple interventions

In multiple interventions, the same combination of single categories of intervention was delivered to all participants in the group. Three trials (652 participants) examined multiple interventions in care facilities (Sambrook 2012; Schnelle 2003; Huang 2016). One trial (412 participants) was cluster randomised (Sambrook 2012) and two trials (240 participants) were individually randomised. The quality of the evidence was considered very low for the single trial comparisons of exercise plus management of urinary incontinence and fluid therapy with usual care (Schnelle 2003), and cognitive‐behavioural therapy to address fear of falling with an exercise programme versus usual care (Huang 2016).

In Schnelle 2003 (190 participants), participants engaged in supervised exercises and were offered fluids and regular toileting. There was no strong evidence for an effect in reducing the rate of falls (Analysis 11.1.1: RaR 0.62, 95% CI 0.38 to 1.01), risk of falling (Analysis 11.2.1: RR 0.62, 95% CI 0.36 to 1.05) or risk of fracture (Analysis 11.3.1: RR 4.26, 95% CI 0.48 to 37.55; total five fractures). Adverse events were not reported. We are uncertain of the effectiveness of this intervention as the quality of the evidence is very low.

Analysis

Comparison 11 Care facilities: Multiple interventions vs usual care, Outcome 1 Rate of falls.

Analysis

Comparison 11 Care facilities: Multiple interventions vs usual care, Outcome 2 Number of fallers.

Analysis

Comparison 11 Care facilities: Multiple interventions vs usual care, Outcome 3 Number of people sustaining a fracture.

One intervention group in Sambrook 2012 (412 participants), which was based in Australia, tested the effect of increased sunlight exposure plus calcium supplementation, with low adherence to the sunlight intervention (Durvasula 2012). We are uncertain of the effects on falls as the quality of the evidence has been assessed as very low for all outcomes (downgraded one level for each of risk of bias, indirectness and imprecision; Analysis 11.1.2: RaR 1.03, 95% CI 0.85 to 1.25; Analysis 11.2.2: RR 0.96, 95% CI 0.77 to 1.19; Analysis 11.3.2: risk of fracture RR 0.78, 95% CI 0.36 to 1.67; total 31 fractures). The authors reported no significant difference in the incidence rates of new skin cancers between arms of the trial (18 new cancers total) and an increase in the adjusted all‐cause mortality in the calcium‐treated group compared with the UV alone group (HR 1.23 versus 0.76, P = 0.03; 40 deaths; adjusted for age, sex and season). There was a lack of evidence for a strong effect on increased death rates from myocardial infarction (age‐adjusted HR 3.83, 95% CI 0.97 to 15.27, P = 0.06; sex‐adjusted HR 4.17, 95% CI 0.69 to 25.16, P = 0.12; the authors reported that they did not record cardiovascular events prospectively). We are uncertain of the effects on adverse events as the quality of the evidence is very low (downgraded one level for each of risk of bias, indirectness and imprecision).

In a three‐arm trial, Huang 2016 studied an intervention which combined cognitive‐behavioural therapy to address fear of falling with an exercise programme in comparison with usual care in 50 participants. In the three months following the eight‐week intervention the authors reported a reduction in falls in both the combined intervention and the cognitive‐behavioural intervention arm alone (reported Kruskal‐Wallis P < 0.001). There were 1.67 falls per person year in the usual care arm of the study (10 falls in seven fallers), and no falls in the cognitive behavioural plus exercise intervention arm; data were not pooled as falls excluded the intervention period. Adverse events were not reported. We are uncertain of cognitive‐behavioural therapy combined with an exercise programme as the quality of the evidence is very low.

Care facilities: multifactorial interventions

In multifactorial interventions, two or more categories of intervention are given, and these are linked to each individual's risk profile. An initial assessment is usually carried out by one or more health professionals and an intervention is then provided or recommendations given or referrals made for further action. A summary of the evidence for multifactorial interventions in comparison with usual care in care facilities is provided in Table 4.

Thirteen trials (4226 participants) in care facilities studied multifactorial interventions (Beck 2016; Becker 2003; Dyer 2004; Jensen 2002; Kerse 2004; McMurdo 2000; Neyens 2009; Ray 1997; Rubenstein 1990; Salvà 2016; Shaw 2003; Walker 2015; Whitney 2017). Eleven trials were cluster‐randomised trials (Beck 2016; Becker 2003; Dyer 2004; Jensen 2002; Kerse 2004; McMurdo 2000; Neyens 2009; Ray 1997; Salvà 2016; Walker 2015; Whitney 2017; 3470 participants), and two were individually randomised (Rubenstein 1990; Shaw 2003; 756 participants). Whitney 2017 was also a cross‐over trial. None of these trials were sufficiently similar to allow analysis of subgroups of specific combinations of interventions. Two studies did not report data suitable for use in the quantitative analysis (Beck 2016; Ray 1997). Three studies (2160 participants) reported data on hip fractures (Becker 2003; Jensen 2002; Shaw 2003), and one reported total fractures (Salvà 2016). Three studies (312 participants) reported adverse‐event data (Beck 2016; McMurdo 2000; Whitney 2017).

Rate of falls

Despite statistical heterogeneity between the trials for the rate of falls, trials were considered clinically similar enough for pooling to be meaningful. Pooled data from 10 trials (3439 participants) for rate of falls did not demonstrate strong evidence for a reduction in falls (Analysis 12.1: RaR random effects 0.88, 95% CI 0.66 to 1.18: I² = 84%). Beck 2016 (31 participants) reported falls outcomes in a cluster‐randomised trial of an exercise programme plus nutritional support. There were zero falls in the intervention arm and two in the control arm over an 11‐week period. Overall, we are uncertain of the effects of multifactorial interventions on the rate of falls in care facilities as the quality of evidence has been assessed as very low (Table 4).

Analysis

Comparison 12 Care facilities: Multifactorial interventions vs usual care, Outcome 1 Rate of falls.

Risk of falling

Pooled data from nine trials (3153 participants) for risk of falling (Analysis 12.2: RR random effects 0.92, 95% CI 0.81 to 1.05: I² = 42%) did not demonstrate strong evidence for a reduction in falls. Ray 1997 (482 participants) only recorded the number of people having two or more falls during follow‐up (recurrent fallers) and reported a reduction in the proportion of recurrent fallers (difference 19%, 95% CI 2% to 36%: P = 0.03). Overall, multifactorial interventions in care facilities may make little or no difference to the risk of falling (low‐quality evidence; Table 4).

Analysis

Comparison 12 Care facilities: Multifactorial interventions vs usual care, Outcome 2 Number of fallers.

Risk of fracture

Pooled results for five studies (2160 participants) reporting risk of fracture did not show strong evidence for an effect (Analysis 12.3: RR 0.79, 95% CI 0.30 to 2.07: I² = 44%; 76 fractures). Data from three of the five trials (1695 participants) were for hip fracture (Becker 2003; Jensen 2002; Salvà 2016) and two trials (465 participants) reported total fractures (Shaw 2003; Whitney 2017). Two trials (1255 participants) included hip protectors as an intervention (Becker 2003; Shaw 2003). We are uncertain of the effects of multifactorial interventions on the risk of fracture as the quality of evidence has been assessed as very low (Table 4).

Analysis

Comparison 12 Care facilities: Multifactorial interventions vs usual care, Outcome 3 Number of people sustaining a fracture.

Adverse events

Three studies (312 participants) reported adverse‐event data. One trial reported an instance of a fall in the intervention arm (Whitney 2017), two studies reported that there were no adverse events (Beck 2016; McMurdo 2000). We are uncertain of the effects of multifactorial interventions on adverse events as the quality of evidence has been assessed as very low (Table 4).

Subgroup analyses exploring heterogeneity

To explore the heterogeneity in these results, we carried out post‐hoc subgroup analysis by levels of care (high or intermediate or mixed levels of care). The test for subgroup differences showed a difference between subgroups for both the rate of falls (Analysis 13.1: P = 0.005, I² = 81%) and risk of falling (Analysis 13.2: P = 0.03, I² = 72%). Within care facilities providing either high or intermediate levels of care, statistical heterogeneity was not important and pooled data showed a reduction in both the rate of falls (Analysis 13.1.1: high‐level care: RaR 0.59, 95% CI 0.44 to 0.79; I² = 8%, P = 0.30; Analysis 13.1.2: intermediate‐level care: RaR 0.64, 95% CI 0.50 to 0.83; I² = 33%, P = 0.23), and the risk of falling (Analysis 13.2.1: high level care: RR 0.75, 95% CI 0.57 to 0.98; Analysis 13.2.2: intermediate level care: RR 0.75, 95% CI 0.60 to 0.94; I² = 0%, P = 0.44). However, heterogeneity remained high in studies of mixed levels of care (Analysis 13.1.3: RaR 1.23, 95% CI 0.85 to 1.77; I² = 77%, P = 0.001; Analysis 13.2.3: RR 1.01, 95% CI 0.88 to 1.15; I² = 24%, P = 0.26).

Analysis

Comparison 13 Care facilities: Multifactorial interventions vs usual care (grouped by level of care), Outcome 1 Rate of falls.

Analysis

Comparison 13 Care facilities: Multifactorial interventions vs usual care (grouped by level of care), Outcome 2 Number of fallers.

We also carried out a subgroup analysis comparing trials recruiting people with cognitive impairment versus trials with participants with no cognitive impairment (based on inclusion/exclusion criteria) or a mixed sample. Two trials recruited residents with cognitive impairment only (Neyens 2009; Shaw 2003). In addition, two trials (Becker 2003; Jensen 2002) carried out pre‐planned subgroup analyses by levels of cognition, which are reported in Rapp 2008 and Jensen 2003, respectively. Cognitive impairment was defined differently in all four studies (see footnotes to Analysis 14.1 and Analysis 14.2). There was no evidence of subgroup differences between those with higher or mixed levels of cognition and those with lower cognition for both rate of falls (Analysis 14.1: test for subgroup differences P = 0.97, I² = 0%) and risk of falling (Analysis 14.2: test for subgroup differences P = 0.41, I² = 0%).

Analysis

Comparison 14 Care facilities: Multifactorial interventions vs usual care (grouped by level of cognition), Outcome 1 Rate of falls.

Analysis

Comparison 14 Care facilities: Multifactorial interventions vs usual care (grouped by level of cognition), Outcome 2 Number of fallers.

Subgroup analysis based upon the individual components of the interventions was precluded by the study design.

Sensitivity analysis

Considering statistical heterogeneity in the rate of falls, meta‐analyses with a random‐effects model was considered the most appropriate. However, there was only moderate heterogeneity in the risk of falling data, therefore trials were pooled using the fixed‐effect model as a sensitivity analysis. Pooled data from 10 trials (3439 participants) using a fixed‐effect model for rate of falls showed an RaR 0.87, 95% CI 0.79 to 0.97 (compare with Analysis 12.1: I² = 84%) and from nine trials (3153 participants) for risk of falling showed an RR 0.92, 95% CI 0.84 to 1.00 (compare with Analysis 12.2: I² = 42%).

Funnel plots testing for publication bias

A funnel plot of trials of multifactorial interventions in care facilities was conducted for the outcome of rate of falls (Figure 6). There was no obvious asymmetry on visual inspection.

Hospitals: single interventions

Exercise

Three individually‐randomised trials (244 participants) tested the effect of additional physiotherapy in rehabilitation wards (Donald 2000; Jarvis 2007; Treacy 2015). One study tested additional strengthening exercises (Donald 2000), one additional balance training (Treacy 2015), and one additional physiotherapy (Jarvis 2007). A summary of the evidence for exercise for falls prevention in hospitals is provided in Table 5. No data on the risk of fractures were reported. One trial (161 participants) reported that there were no adverse events (Treacy 2015), two studies did not report adverse‐event data.

Pooled data did not provide evidence for a reduction in rate of falls (Analysis 15.1: RaR 0.59, 95% CI 0.26 to 1.34; 215 participants, 2 trials; I² = 0%; very low‐quality evidence). Pooled data from two trials (83 participants) showed a reduction in the risk of falling (Analysis 15.2: RR 0.36, 95% CI 0.14 to 0.93: I² = 0%: very low‐quality evidence). We are uncertain whether additional exercise reduces the rate or risk of falling or has adverse events as the evidence has been assessed as very low.

Analysis

Comparison 15 Hospitals: Additional exercises vs usual physiotherapy, Outcome 1 Rate of falls.

Analysis

Comparison 15 Hospitals: Additional exercises vs usual physiotherapy, Outcome 2 Number of fallers.

Medication (drug target) interventions

Two trials (319 participants) examined medication target interventions, one examined medication review (Michalek 2014), and the other vitamin D supplementation (Burleigh 2007). These comparisons were from single trials only and the quality of evidence was considered very low.

Multiprofessional medication review

Michalek 2014 (114 participants) conducted a quasi cluster‐randomised trial that examined the effect of review of suitability of medications for aged patients in comparison with usual care. After adjustment for clustering there was no strong evidence for an effect on the rate of falls (Analysis 16.1: RaR 0.14, 95% CI 0.00 to 6.63) or risk of falling (Analysis 16.2: RR 0.18, 95% CI 0.01 to 3.47). Adverse‐event data were not reported. We are uncertain of the effectiveness of medication review in hospitals as the quality of the evidence is very low.

Analysis

Comparison 16 Hospitals: Medication review vs usual care, Outcome 1 Rate of falls.

Analysis

Comparison 16 Hospitals: Medication review vs usual care, Outcome 2 Number of fallers.

Vitamin D supplementation

Burleigh 2007 (205 participants) conducted an individually‐randomised trial that investigated whether 800 IU of vitamin D plus 1200 mg of calcium supplements reduced falls compared with 1200 mg calcium supplements alone in participants with a median length of stay of 30 days. There was no strong evidence for an effect on risk of falling (Analysis 17.1: RR 0.82, 95% CI 0.59 to 1.14) or fractures (Analysis 17.2: RR 0.34, 95% CI 0.04 to 3.05; total four fractures). The rates of gastrointestinal complaints were similar between the arms of the trial (Analysis 17.3: RR 1.37, 95% CI 0.32 to 5.98). We are uncertain of the effectiveness of vitamin D supplementation in hospitals as the quality of the evidence is very low.

Analysis

Comparison 17 Hospitals: Vitamin D supplements vs no vitamin D supplements, Outcome 1 Number of fallers.

Analysis

Comparison 17 Hospitals: Vitamin D supplements vs no vitamin D supplements, Outcome 2 Number of people sustaining a fracture.

Analysis

Comparison 17 Hospitals: Vitamin D supplements vs no vitamin D supplements, Outcome 3 Adverse events.

Environment/assistive technology interventions

Six trials (39,127 participants) examined environment or assistive technology interventions, two trials (11,153 participants) were of furnishing adaptations (Donald 2000; Haines 2010), and four (27,974 participants) were of communication aids (Mayo 1994; Shorr 2012; Tideiksaar 1993; Wolf 2013). Four trials (356 participants) were individually randomised (Donald 2000; Mayo 1994; Tideiksaar 1993; Wolf 2013), and two (38, 771 participants) were cluster randomised (Haines 2010; Shorr 2012). Donald 2000 was a 2 x 2 factorial design. The quality of the evidence was considered very low for the single trial comparisons of carpet in comparison with vinyl floors (Donald 2000) and identification bracelets for high‐risk fallers (Mayo 1994).

Furnishing/adaptations

Donald 2000, in a factorial design with 54 participants, found that carpeted floors compared with existing vinyl floors in subacute hospital wards resulted in an increase in rate of falls (Analysis 18.1.1: RaR 14.73, 95% CI 1.88 to 115.35) and no strong evidence for an increase in the risk of falling (Analysis 18.2.1: RR 8.33, 95% CI 0.95 to 73.37). We are uncertain of the impact of carpeting on falls as the quality of the evidence is very low.

Analysis

Comparison 18 Hospitals: Environmental interventions vs usual care, Outcome 1 Rate of falls.

Analysis

Comparison 18 Hospitals: Environmental interventions vs usual care, Outcome 2 Number of fallers.

In a cluster‐randomised trial, Haines 2010 (11,099 participants) examined an intervention which consisted of providing one low‐low bed per 12 existing beds in acute and subacute wards. There was no strong evidence of an effect on the rate of falls; we are uncertain of the effectiveness of low‐low beds as the quality of the evidence is considered very low (Analysis 18.1.2: RaR 1.39, 95% CI 0.22 to 8.78; very low‐quality evidence downgraded two levels for risk of bias, one level for indirectness and two levels for imprecision).

Neither trial reported adverse event or fracture data.

Communication aids

Identification bracelet for high‐risk fallers

Mayo 1994 (134 participants) studied the effect of wearing a blue identification bracelet on falls in high‐risk patients in a subacute hospital setting. They found no reduction in rate of falls (Analysis 18.1.3: RaR 1.15, 95% CI 0.72 to 1.84) or risk of falling (Analysis 18.2.2: RR 1.34, 95% CI 0.76 to 2.36). In this study, there was no reduction in risk of falling in the subgroup with a Short Portable Mental Status Questionnaire (SPMSQ) score < 9 (low cognition) or the subgroup with SPMSQ score ≥ 9 (high cognition). Adverse events were not reported. We are uncertain of the effectiveness of identification bracelets for reducing falls in hospitals as the quality of the evidence is very low.

Bed exit alarms

Three trials (28,717 participants) examined bed exit alarms in hospital (Shorr 2012; Tideiksaar 1993; Wolf 2013). One large trial (Shorr 2012) was cluster randomised. A summary of the evidence for bed exit alarms for falls prevention in hospitals is provided in Table 6. Shorr 2012 (27,672 participants) examined an educational intervention to support clinical judgement on the use of bed or chair exit alarms. Wolf 2013 (98 participants) enrolled patients with an increased risk of falling that required assistance with mobilisation during rest time. Pooled data from these two studies did not show a strong reduction in the rate of falls (Analysis 18.1.4: RaR 0.60, 95% CI 0.27 to 1.34: very low‐quality evidence) or risk of falling (Analysis 18.2.3: RR 0.93, 95% CI 0.38 to 2.24: very low‐quality evidence). We are uncertain whether bed exit alarms reduce the rate of falls or risk of falling as the quality of the evidence has been assessed as very low

Tideiksaar 1993 (70 participants) studied bed exit alarms for preventing falls in hospital. During the nine‐month evaluation period, "There was no significant difference in the number of bed‐falls between the two groups (p = 1.00)."

Two trials of bed alarms (27,742 participants) indicated that there were no adverse events (Shorr 2012; Tideiksaar 1993); we are uncertain of the effects of bed alarms on adverse events as the quality of the evidence has been assessed as very low (Table 6).

Social environment

Social environment interventions target staff members and changes in the organisational system, rather than targeting patients directly. Six trials (9074 participants) examined service model change interventions (Dykes 2010; Koh 2009; Mador 2004; Stenvall 2007; Van Gaal 2011b; Wald 2011). Three trials (8587 participants) were cluster randomised (Dykes 2010; Koh 2009; Van Gaal 2011b), and three (487 participants) were individually randomised (Mador 2004; Stenvall 2007; Wald 2011). Studies were not pooled as they were considered to examine clinically heterogenous interventions. One study reported data on risk of fracture (Stenvall 2007). None of the studies reported adverse‐event data. We are uncertain of the effects of all social environment interventions in hospitals as the quality of the evidence was assessed as very low.

Service model change

Two studies examined implementation of guidelines in acute care settings in hospitals. Koh 2009 (1122 participants) compared multifaceted fall‐prevention guideline implementation with routine dissemination. There was no strong evidence for an effect on the rate of falls (Analysis 19.1.1: RaR 1.82, 95% CI 0.23 to 14.55; very low‐quality evidence, downgraded two levels for risk of bias, one level for indirectness and two levels for imprecision). Van Gaal 2011b (2201 participants) studied the implementation of three guidelines (falls, urinary tract infection, pressure ulcers) targeting nursing staff in comparison with usual care. There was no strong evidence for an effect on the rate of falls (Analysis 19.1.2: RaR 0.67, 95% CI 0.17 to 2.59; very low‐quality evidence, downgraded two levels for risk of bias, and two levels for imprecision). We are uncertain of the effects of guideline implementation on falls as the quality of the evidence is considered very low.

Analysis

Comparison 19 Hospitals: Social environment vs control, Outcome 1 Rate of falls.

Dykes 2010 (5264 participants) tested the effect of a computer‐based fall‐prevention tool kit in comparison with usual care. There was no strong evidence for an effect on the rate of falls (Analysis 19.1.3: RaR 0.55, 95% CI 0.02 to 16.29) or risk of falling (Analysis 19.2.1 RR 0.91, 95% CI 0.06 to 14.21). We are uncertain of the effectiveness of this intervention (very low‐quality evidence, downgraded two levels for risk of bias, and two levels for imprecision).

Analysis

Comparison 19 Hospitals: Social environment vs control, Outcome 2 Number of fallers.

Wald 2011 (217 participants) compared providing care in an acute ward for the elderly with care in general medical wards to usual care. There was no strong evidence for an effect on the rate of falls (Analysis 19.1.4: RaR 0.72, 95% CI 0.10 to 5.10).

Mador 2004 (71 participants) examined a new behavioural advisory service for people with confusion in comparison with usual care. There was no strong evidence for an effect on the risk of falling (Analysis 19.2.2: RR 2.44, 95% CI 0.85 to 7.02).

Stenvall 2007 (199 participants) compared post‐operative care in a ward providing a comprehensive ortho‐geriatric service with usual care in an orthopaedic ward following surgery for hip fracture. This intervention achieved a reduction in the rate of falls (Analysis 19.1.5: RaR 0.38, 95% CI 0.19 to 0.74) and the risk of falling (Analysis 19.2.3: RR 0.41, 95% CI 0.20 to 0.83) at discharge. There were four new fractures in the control group but none in the intervention group (Analysis 19.3.1: RR 0.11, 95% CI 0.01 to 1.52). These findings also applied to the subgroup analysis of patients with dementia (64 participants), i.e. the rate of falls and risk of falling was reduced (RaR 0.07, 95% CI 0.01 to 0.57; RR 0.12, 95% CI 0.02 to 0.85).

Analysis

Comparison 19 Hospitals: Social environment vs control, Outcome 3 Number of people sustaining a fracture.

Knowledge interventions

Two trials (3028 participants) examined knowledge interventions in hospitals in individually‐randomised trials. Neither trial reported data on the risk of fracture. Haines 2011 reported that there were no adverse events from interaction with the education materials; Ang 2011 did not report on adverse events.

Ang 2011 (1822 participants), testing an educational session by a trained research nurse targeting individual fall risk factors in patients at high risk of falling in an acute setting and achieved a reduction in risk of falling (Analysis 20.2: RR 0.29, 95% CI 0.11 to 0.74); however, we are uncertain of the effects of this intervention as the quality of the evidence has been assessed as very low (downgraded two levels for risk of bias, one level for indirectness and one level for imprecision).

Analysis

Comparison 20 Hospitals: Knowledge/education interventions vs usual care, Outcome 2 Number of fallers.

Haines 2011 (1206 participants) evaluated two forms of multimedia patient education compared with usual care in a mixture of acute and subacute wards. One intervention consisted of written and video‐based materials plus one‐on‐one bedside follow‐up from a physiotherapist (complete programme) and the other intervention group received educational materials only. Neither intervention showed strong evidence of a reduction in the rate of falls (Analysis 20.1.1 complete programme RaR 0.83, 95%CI 0.54 to 1.27; very low‐quality evidence, downgraded one level for indirectness, one level for inconsistency and one level for imprecision; Analysis 20.1.2 educational materials only RaR 0.91, 95%CI 0.62 to 1.35; low‐quality evidence, downgraded one level for indirectness and one level for imprecision) or risk of falling (Analysis 20.2.2 complete programme RR 0.74, 95%CI 0.48 to 1.14; very low‐quality evidence, downgraded one level for indirectness, one level for inconsistency and one level for imprecision; Analysis 20.2.3 educational materials only RR 0.84, 95% CI 0.56 to 1.27; low‐quality evidence, downgraded one level for indirectness and one level for imprecision). In a post‐hoc subgroup analysis, in participants who were cognitively intact the authors reported that falls were less frequent in those receiving the complete programme, compared with those in the materials only group (adjusted hazard ratio (HR) for rate of falls 0.51, 95% CI 0.28 to 0.93; risk of falling 0.65, 95% CI 0.36 to 1.18; 626 participants) and the control group (adjusted HR for rate of falls 0.43, 95% CI 0.24 to 0.78; risk of falling 0.51, 95%CI 0.28 to 0.94; 590 participants) (test for subgroup differences P < 0.05). There was a higher risk of injurious falls in those with cognitive impairment with the complete programme (7.49 falls per 1000 patient days compared with 2.89 falls per 1000 patient days in the control group; 192 participants). We are uncertain of the effects of the complete educational programme with follow‐up on falls (very low‐quality evidence) but providing educational materials only may make little or no difference to the rate of falls or risk of falling (low‐quality evidence).

Analysis

Comparison 20 Hospitals: Knowledge/education interventions vs usual care, Outcome 1 Rate of falls.

Other single interventions

No included studies examined other single interventions in a hospital setting.

Hospitals: multiple interventions

No included studies examined multiple interventions in a hospital setting.

Hospitals: multifactorial interventions

Six trials (45,416 participants) tested the effect of multifactorial interventions in comparison with usual care in a hospital setting (Aizen 2015; Barker 2016; Cumming 2008; Haines 2004; Healey 2004; Hill 2015). Five trials (44,790 participants) were cluster randomised (Aizen 2015; Barker 2016; Cumming 2008; Healey 2004; Hill 2015), and one (626 participants) was individually randomised (Haines 2004). Two trials used a stepped‐wedge design (Aizen 2015; Hill 2015). The categories of interventions for each trial are shown in Appendix 3 and further details are provided in the Characteristics of included studies. A summary of the evidence for multifactorial interventions for falls prevention in hospitals is provided in Table 7. Two studies (4625 participants) reported data on risk of fracture (Cumming 2008; Haines 2004). Four of six trials (39,763 participants) reported on adverse events (Aizen 2015; Barker 2016; Haines 2004; Hill 2015). We have shown whether the settings were acute or subacute in the footnotes of the analyses. Given most of these trials were large with important differences such as in the setting and in the format and delivery of their multifactorial intervention, we present some details of the individual trials first before reporting the pooled analyses.

Aizen 2015 (752 participants) conducted a two‐stage (stepped‐wedge) cluster randomised trial in five geriatric rehabilitation wards. The multifactorial intervention included medical, behavioural, cognitive and environmental modifications with additional orientation guidance and mobility restriction for moderate‐risk patients and permanent personal supervision for high‐risk patients. The usual care arm included any activities undertaken by the participants recommended or administered by their treating team. The authors reported that "No significant difference was found in fall rates during follow‐up between intervention and control wards". The findings of this study were not pooled as some aspects of the study methodology and data collection could not be confirmed.

Barker 2016 (35,264 participants, 46,245 admissions) investigated a “6‐PACK” intervention in comparison with usual care (which included standard falls prevention activities) with a cluster‐randomised trial in 24 acute medical or surgical wards and found no change in rate of falls or risk of falling. There was no evidence of effect on the rate of injurious falls (RaR 0.96, 95% CI 0.72 to 1.27). Data were determined based on admissions, some patients were admitted more than once.

Cumming 2008 (3999 participants) examined an intervention in both acute and subacute wards in which a nurse and physiotherapist each worked for 25 hours per week for three months in all intervention wards. No trial interventions were delivered in the usual care arm. This trial also found no change in the rate of falls or risk of falling. The review authors consider both Barker 2016 and Cumming 2008 to be well‐conducted trials. The interventions they studied would be regarded as sound falls prevention practice including use of falls risk‐assessment tools and supervision for patients at risk but no effect on falls was observed.

The multidisciplinary intervention in Haines 2004 (626 participants) took place in three subacute wards. The programme included a falls risk alert card with an information brochure, exercise, education programme, and hip protectors, in addition to usual care. In the control arm, patients received usual care but none of the interventions from the falls prevention programme; the study staff completed the risk assessment and generated recommendations but none of these recommendations were instituted. The authors reported that the difference in falls between the two groups was "most obvious after 45 days of observation", suggesting that this programme benefited people staying longer in hospital but it could also be explained by long staying frequent fallers in the control group.

Healey 2004 (1654 participants) examined a risk‐factor reduction care plan for patients with a history of falls in a cluster‐randomised trial in eight acute and subacute wards. Interventions included assessment and interventions targeted at eyesight, medications, blood pressure management, mobility, urine testing, bed rail use, bed height, footwear, ward positioning, environmental causes and call bells. In the usual care arm, the care plan was not introduced and no changes to practice or environment relevant to falls prevention were made during the study.

Hill 2015 conducted a stepped‐wedge cluster‐randomised controlled trial in eight hospital rehabilitation and geriatric wards (3121 participants, 3606 admissions), which tested the effect of an individualised multimedia education intervention (also tested in Haines 2011) provided to eligible patients with basic cognition, and staff, aiming to educate patients about falls prevention strategies and to motivate engagement in falls‐prevention strategies (ProFaNE categories of social environment and knowledge). Usual care included patient’s screening, assessment and implementation of individualised falls‐prevention strategies, ongoing staff training and environmental strategies. There was a reduction in the rate of falls (Analysis 21.1: RaR 0.60, 95% CI 0.42 to 0.94). There was also a reduction in the rate of injurious falls (adjusted RaR 0.65, 95% CI 0.42 to 0.88; data analysed by number of admissions rather than participants).

Analysis

Comparison 21 Hospitals: Multifactorial interventions vs usual care, Outcome 1 Rate of falls.

In a pre‐specified subgroup analysis, Hill 2015 reported that the rate of falls was reduced in people without significant cognitive impairment who received the educational intervention (MMSE > 23/30; adjusted RaR 0.53, 95%CI 0.36 to 0.77, P < 0.001; 1930 participants), but there was no strong evidence for an effect in the subgroup of patients who were cognitively impaired (who did not receive the patient intervention, but may have benefited from the staff training intervention component; adjusted RaR 0.65, 95% CI 0.40 to 1.05; 1676 participants).

Rate of falls

Pooled results from five trials (44,664 participants) of multifactorial interventions showed a borderline reduction in the rate of falls, with a reduction overall of 20%; the 95% confidence intervals indicated this estimate of effect may range as high as a reduction of 36% or result in an increase in falls rates of 1%; (Analysis 21.1: RaR random‐effects 0.80, 95% CI 0.64 to 1.01; 5 trials: I² = 52%; low‐quality evidence, downgraded one level for risk of bias and one level for imprecision; Table 7). These findings were further explored in a subgroup analysis by setting (see below).

Risk of falling

Pooled data from three trials (39,889 participants) of the five trials pooled for the rate of falls outcome were generally consistent with the effect estimate for the rate of falls with a reduction in the risk of falling that did not reach statistical significance (Analysis 21.2: RR random‐effects 0.82, 95% CI 0.62 to 1.09; 3 trials: I² = 0%; very low‐quality evidence; Table 7). Notably Hill 2015 reported a reduction in the risk of falling (adjusted odds ratio (OR) 0.55, 95% CI 0.38 to 0.81) in a subacute setting; however, these data were analysed by number of admissions, rather than participants, so these data were not pooled. The choice of model for the pooled analysis did not affect the estimate of effect as the statistical heterogeneity was 0%. We are uncertain of the effects of multifactorial interventions on risk of falling in hospitals (very low‐quality evidence).

Analysis

Comparison 21 Hospitals: Multifactorial interventions vs usual care, Outcome 2 Number of fallers.

Risk of fracture

Two trials (4625 participants; Cumming 2008; Haines 2004) reported fracture data suitable for pooling. There was no strong evidence for a reduction in the number of people sustaining a fracture (Analysis 21.3: RR 0.76, 95% CI 0.14 to 4.10: I² = 0%; nine fractures; very low‐quality evidence; Table 7).

Analysis

Comparison 21 Hospitals: Multifactorial interventions vs usual care, Outcome 3 Number of people sustaining a fracture.

In Barker 2016, there were very few fractures in an acute setting, with 11 (0.06%) people experiencing a fall‐related fracture in the intervention arm and 13 (0.07%) in the control arm. In Hill 2015, there were six fractures in the control group (three hip fractures) and four in the intervention group (not hip) in a subacute setting; these data represent number of fractures and admissions rather than patients. The data from these two studies are not pooled; however, the results are consistent with the pooled estimate showing no strong effect on the risk of fracture.

We are uncertain whether multifactorial interventions reduce the risk of fracture as the quality of the evidence has been assessed as very low.

Adverse events

No adverse events were reported in the four trials (39,763 participants; Aizen 2015; Barker 2016; Haines 2004; Hill 2015) that reported this outcome. We are uncertain of the effects of multifactorial interventions on adverse events as the quality of the evidence has been assessed as very low (Table 7).

Subgroup analysis by type of care (acute, subacute or mixed settings)

A post‐hoc subgroup analysis was conducted for multifactorial interventions conducted in hospitals for acute care settings, subacute settings or mixed (both subacute and acute) settings. The test for subgroup differences indicated a possible difference between the settings (types of care) for rate of falls (Analysis 22.1, P = 0.04). Pooled data indicate a reduction in the falls rate in trials conducted in the subacute setting (Analysis 22.1.3: RaR 0.67, 95% CI 0.54 to 0.83), but not in the acute (Analysis 22.1.1: RaR 1.04, 95% CI 0.79 to 1.37) or mixed settings (Analysis 22.1.2: RaR 0.88, 95% CI 0.61 to 1.27). There were no differences between subgroups for pooled data by setting for risk of falling (Analysis 22.2, test for subgroup differences P = 0.75) or risk of fracture (Analysis 22.3, test for subgroup differences P = 0.56). One additional study reporting data for the risk of falling and fracture that were not pooled was conducted in a subacute setting (Hill 2015).

Analysis

Comparison 22 Hospitals: Multifactorial interventions vs usual care (grouped by type of care), Outcome 1 Rate of falls.

Analysis

Comparison 22 Hospitals: Multifactorial interventions vs usual care (grouped by type of care), Outcome 2 Number of fallers.

Analysis

Comparison 22 Hospitals: Multifactorial interventions vs usual care (grouped by type of care), Outcome 3 Number of people sustaining a fracture.

Multifactorial interventions including targeted patient education may reduce the rate of falls in a subacute setting (low‐quality evidence, downgraded one level for risk of bias and one level for inconsistency due to some uncertainty in the subgroup analysis).

Studies in participants with cognitive impairment

Eleven trials reported findings specifically for patients with dementia or cognitive impairment.

Care facilities

In care facilities, Juola 2015 (227 participants) included 93% of participants with a dementia diagnosis in a trial of nurse education on harmful medications. The intervention showed a reduction in the rate of falls in those with an MMSE score of 10 or greater, but no strong evidence of an effect in those with an MMSE of less than 10. In a trial of a multifactorial intervention (Whitney 2017; 191 participants), 97% of participants were cognitively impaired but the intervention did not show any strong evidence for an effect on the rate of falls or risk of falling.The effects of combination exercise, a multimodal exercise programme, a behaviour advisory service for people with confusion, dementia care mapping, and multisensory stimulation in a Snoezelen room have been examined in people with dementia in several studies (Chenoweth 2009; Klages 2011; Kovacs 2013; Mador 2004; Toulotte 2003; Van de Ven 2014). However, these interventions were tested in single small studies or the studies did not report data suitable for further analysis.Chenoweth 2009 and Buettner 2002 reported costs associated with interventions for participants with dementia in care facilities.

Hospitals

In hospitals, a knowledge‐based intervention that did not show strong evidence for a reduction in the rate of falls overall showed a reduction in falls in those who were cognitively intact, but not in those with cognitive impairment in a post‐hoc analysis (Haines 2011). When the intervention was applied as a multifactorial intervention, only delivered to those with basic cognition, a reduction in both the rate of falls and risk of falling was observed (Hill 2015). In an acute hospital setting, Stenvall 2007 found that a multifactorial intervention including comprehensive geriatric assessment and rehabilitation for people with femoral neck fractures reduced falls in a subgroup with dementia, however the number of participants was low and the evidence assessed as very low quality, so we are uncertain of the effectiveness of this intervention.

Economic evaluations

The 11 studies reporting economic outcomes (nine in care facilities and two in a hospital setting) are summarised in Appendix 10. Only one study (Haines 2013), reported an economic evaluation in terms of the cost to prevent falls.

In a subgroup of hospital inpatients who were cognitively intact, a falls patient education programme in a hospital setting had a cost of AUD 294 to prevent one fall and AUD 526 to prevent one faller (Haines 2013).

This review now includes 95 trials (138,164 participants) of which 71 trials (40,374 participants; mean age 84 years; 75% women) were in care facilities and 24 trials (97,790 participants; mean age 78 years; 52% women) were in hospitals. Despite the addition of 35 trials (77,869 participants) to the previous review, many of the results from the pooled analyses remain inconsistent and inconclusive. Although 24 trials reported data on fractures suitable for use in the analyses, all fracture data were very low‐quality evidence and thus we are uncertain of the effects of any intervention on risk of fracture. Twenty‐nine trials clearly reported data on adverse events, although in several it was to report an absence of adverse events. There were very few serious adverse events and minor complications, where reported, were usually similar in the intervention and control groups. Overall, we are uncertain of the effects on adverse events as the quality of the evidence has been assessed as very low.

Care facilities

Exercise

Twenty‐five trials in care facilities investigated exercise as a single intervention. Despite the large number of trials, many were small (< 100 participants). Only two trials reported the effects of exercise on risk of fracture and nine on adverse events.

Seventeen trials compared an exercise intervention with usual care. A summary of the evidence for exercise in comparison with usual care in care facilities is provided in Table 1. Funnel plots of the pooled trials (10 trials each for rate of falls and risk of falling; plus positive findings in an additional four trials reporting rate of falls that could not be pooled) indicated potential publication bias for this comparison.

In the 10 trials of exercise compared with usual care that were pooled reporting rate of falls, there was considerable heterogeneity in the results, which was only partially explained by a subgroup analysis grouping trials according to level of nursing care provided. We are uncertain whether exercise had an effect on the rate of falls in care facilities as the quality of the evidence has been assessed as very low. Subgroup analyses by type of exercise did not explain the heterogeneity.

There was less statistical heterogeneity in the data on risk of falling for trials of exercise compared with usual care. Pooled data indicated exercise may make little or no difference to the risk of falling (low‐quality evidence).

There was limited evidence for exercise types other than gait, balance and functional training or trials testing a combination of exercise categories in comparison with usual care. Whilst three trials tested Tai Chi programmes (which have been demonstrated to be effective at reducing the risk of falling in a community setting), data were not suitable for pooling.

We are uncertain of the impact of exercise on the risk of fracture or adverse events (very low‐quality evidence).

Nine trials provided 12 comparisons of two different exercise programmes. Comparisons of different types of exercise were all considered of very low quality so we are uncertain of the relative effectiveness of different types of exercise.

While no clear effect on reduction in falls from exercise was identified within the current review, either overall or by subgroups according to level of care or type of exercise, there was a high degree of heterogeneity between the studies. The range of different types of exercise, populations and settings investigated plus the small size of many trials has resulted in only limited evidence being available for any particular combination of these factors. Importantly, the limited evidence does not represent convincing evidence of a lack of effect and the possibility of some types, intensity or duration of exercise being effective for specific populations remains.

Medication (drug target)

Medication review

Twelve studies examined medication review in care facilities. One study reported on the risk of fracture. Two studies reported instances of adverse events.

A summary of the evidence for general medication review in care facilities is provided in Table 2. Pooled results from five trials of general medication review indicated that this intervention may make little or no difference to the rate of falls or risk of falling (low‐quality evidence). We are uncertain of the effect of general medication review on risk of fracture or adverse events as the quality of the evidence has been assessed as very low.

Vitamin D supplementation

Eight trials examined vitamin D interventions in care facilities. Five trials examined the effect of vitamin D supplementation, two trials investigated the effect of daily multivitamin supplementation which included vitamin D and calcium and one tested an education intervention aimed at increasing prescription of adequate levels of vitamin D, calcium and osteoporosis medications. Only three trials reported data on the risk of fracture and five on adverse events.

A summary of the evidence for vitamin D supplementation in care facilities is provided in Table 3. Vitamin D supplementation probably reduces the rate of falls (moderate‐quality evidence) but vitamin D supplementation (with or without calcium) probably makes little or no difference to the risk of falling (moderate‐quality evidence). The 28% reduction in falls rate observed (RaR 0.72, 95% CI 0.55 to 0.95) is substantial. Average serum vitamin D levels at baseline were reported to be low or very low in seven of eight studies (including the five studies of vitamin D with or without calcium supplementation), indicating that these results are applicable to residents of care facilities with low vitamin D levels. Based on other studies, the reduction in the rate of falls may be related to improvement in muscle function (De Spiegeleer 2018).

We are uncertain of the effect of vitamin D supplementation (up to 1000 IU daily) on the risk of fall‐related fractures or adverse events as the quality of the evidence has been assessed as very low. These studies represent only a subset of the studies evaluating the effect of vitamin D on fractures.

We are uncertain whether multivitamin supplementation including vitamin D and calcium reduces the rate or risk of falling based on two studies as the quality of the evidence is very low.

One study of an education intervention aimed at increasing the prescription of vitamin D, calcium and osteoporosis medication may make little or no difference to the rate of falls or risk of falling (low‐quality evidence).

Environment/assistive technology

There were no large trials of this type in care facilities. We are uncertain of the effect on rate of falls of wireless position monitoring in care facilities (very low‐quality evidence).

Social environment

Seven trials in care facilities targeted staff training or implemented service model changes. Two studies reported data on the risk of fracture and no studies reported adverse‐event data. None of the interventions showed strong evidence for a reduction in falls. These interventions included staff education on fall and fracture prevention, a project nurse facilitating best‐practice falls injury prevention strategies, guideline implementation (falls, urinary tract infection, and pressure ulcers), dementia care mapping, a risk‐assessment tool versus nurses' judgement and a programme to improve staff connections, communication, and problem‐solving. Results were inconsistent in two trials of dementia care mapping. Use of a falls risk‐assessment tool in comparison with nurses' judgement alone probably makes little or no difference to the rate of falls or risk of falling (moderate‐quality evidence). We are uncertain of the effect on falls of a half‐day education programme about fall and fracture prevention for staff (very low‐quality evidence). We are uncertain of the impact of the other social environment interventions on falls.

Knowledge/education

There were no trials of knowledge interventions in care facilities.

Psychological interventions

Two studies in care facilities evaluated the effect of psychological interventions on falls. Neither trial reported data on the risk of fracture and adverse‐event data were not reported.

One trial examined a cognitive‐behavioural intervention with a focus on falls‐risk reduction, the other examined a computer‐based cognitive training programme focused on improving attention combined with strength and balance training, compared with strength and balance training alone. We are uncertain of the effects of psychological interventions on rate of falls or risk of falling as the quality of the evidence is very low.

Other single interventions

Three trials (564 participants) examined other single interventions. We are uncertain whether lavender olfactory stimulation, multisensory stimulation in a Snoezelen room or sunlight exposure reduces falls as the quality of the evidence has been assessed as very low.

Multiple interventions

An intervention for incontinent residents in high‐level nursing care facilities that included exercise, offering regular fluids and toileting, showed no strong evidence for an effect and we are uncertain of the effectiveness as the quality of the evidence is very low (Schnelle 2003).

Increased sunlight exposure plus calcium supplementation had low adherence to sunlight exposure; we are uncertain of the effects on falls or adverse events as the quality of the evidence is very low (Sambrook 2012). There was no difference in the incidence rates of new skin cancers, but an increase in the adjusted all‐cause mortality in the calcium‐treated group compared with the UV alone group (hazard ratio (HR) 1.23 versus 0.76, P = 0.03). Despite documented concerns about increased risk of cardiovascular events, in particular myocardial infarction, with calcium supplementation (Bolland 2010), there was a lack of evidence for a strong effect on increased death rates from myocardial infarction, so the biological reason for the observed increase in all‐cause mortality is uncertain. We are uncertain of the effects on adverse events as the quality of evidence is very low.

Multifactorial interventions

In multifactorial interventions, two or more categories of intervention are given, and these are linked to each individual's risk profile. An initial assessment is usually carried out by one or more health professionals and an intervention is then provided or recommendations given or referrals made for further action. All trials compared a multifactorial intervention with 'usual care', which in many cases included some falls‐prevention activities. These standard care practices may have changed over time; however, the degree to which the comparator arm does or does not include components of the intervention activities is not clear enough to base any additional analysis on. A summary of the evidence for multifactorial interventions in comparison with usual care in care facilities is provided in Table 4.

This review included 13 multifactorial trials in care facilities. Five studies reported data on risk of fractures. One study reported an instance of a fall as an adverse event, two studies reported that there were no adverse events, and the remaining studies did not report on adverse events. The interpretation of pooled data from multifactorial interventions is problematic because of variation in components between trials, and variation of combinations of components delivered to individuals in the trials.

Pooled results did not show strong evidence for a reduction in the risk of falling or risk of fracture; however, there was considerable statistical heterogeneity. Multifactorial interventions may make little or no difference to the risk of falling in care facilities (low‐quality evidence). We are uncertain of the effects of multifactorial interventions in care facilities on the rate of falls or risk of fractures as the quality of evidence has been assessed as very low. A post‐hoc subgroup analysis based on high, intermediate or mixed levels of nursing care showed a statistical difference between subgroups, with a reduction in falls in high‐ and intermediate‐level care facilities, but not in studies or facilities with a mixed level of care. As there is no clear external evidence that could explain these subgroup results, and the finding is not completely consistent across studies, the finding is not considered credible (Guyatt 2011a), and no conclusion based on these subgroups is made. Subgroup analysis by level of cognition did not explain the heterogeneity.

Hospitals

Exercise

Three trials in hospitals (244 participants) investigated exercise as a single intervention. Two of these were small, including less than 60 participants. Only one trial reported on adverse events.

The three trials tested the effect of additional physiotherapy in rehabilitation wards (Table 5); however, we are uncertain of the effect of this intervention on rate of falls or whether it reduces risk of falling as the quality of the evidence has been assessed as very low. There were no data available on fractures and the one study reporting on adverse events found none.

Medication (drug target)

Medication review

In hospitals, we are uncertain of the effects of medication review on either rate of falls or risk of falling; this was tested in only one trial (very low‐quality evidence).

Vitamin D supplementation

One trial in an acute geriatric unit found no strong evidence of an effect of vitamin D supplementation on risk of falling, despite the low levels of vitamin D at baseline. The median length of stay was only 30 days. We are uncertain of the effects of vitamin D in hospitals on rate of falls or risk of falling, rate of fracture or adverse events as the quality of the evidence has been assessed as very low.

Environment/assistive technology

Six trials in hospitals investigated environment/assistive technology interventions.

Pooled data from two trials (28,649 participants) were available on the use of bed alarms in hospitals (Table 6). The larger trial, which was a cluster‐randomised trial with 28,551 participants, of bed/chair alarms was an education intervention to support judgement on their use. We are uncertain of the effects of bed alarms on the rate of falls, risk of falling or adverse events as the quality of the evidence has been assessed as very low.

We are uncertain whether carpet flooring, tested in one small trial, increases the rate of falls and risk of falling compared with vinyl flooring (very low‐quality evidence). We are uncertain of the effects on rate of falls or risk of falling of using identification bracelets for patients at high risk.

A large trial of the use of one low‐low bed per 12 existing beds in hospitals had no effect on rate of falls. However, large confidence intervals indicate a lack of precision in the estimate and we are uncertain of the effect of providing low‐low beds on the rate of falls (very low‐quality evidence).

Social environment

Six trials in hospitals targeted staff training or implemented service model changes. One trial in a hospital setting reported data on the risk of fracture. No studies reported adverse‐event data. Trials tested a comprehensive post‐operative ortho‐geriatric service in a geriatric ward for patients with proximal femoral fracture surgery compared with usual care in an orthopaedic ward, guideline implementation, fall‐prevention toolkit software, a new acute care service for elderly patients, and a new behavioural advisory service for people with confusion. We are uncertain of the effects of these interventions on falls as the quality of the evidence has been assessed as very low.

Knowledge/education

Two trials examined knowledge interventions in hospitals. Neither trial reported data on the risk of fracture and one study reported that there were no adverse events.

We are uncertain of the effects of an educational session based on identified risk factors and usual fall‐prevention care in acute medical wards as the quality of the evidence was assessed as very low.

In a mixture of acute and subacute wards, a trial providing patients with educational materials alone and educational materials with professional follow‐up did not show strong evidence for a reduction in the rate of falls (Haines 2011). Providing patients with educational materials alone may make little or no difference to the rate of falls or risk of falling (low‐quality evidence).

In a post‐hoc subgroup analysis, educational materials with professional follow‐up showed a reduction in falls in participants with no cognitive impairment in comparison with usual care. There is moderate credibility for this post‐hoc subgroup analysis (Guyatt 2011a); however, we are uncertain of the effectiveness of this intervention in reducing the rate of falls as the quality of the evidence has been assessed as very low. Due to the contrast between the effectiveness of providing this intervention as a single intervention and its effectiveness when provided as a multifactorial intervention targeted at cognitively intact participants (Hill 2015; which further supports the credibility of the result found in the subgroup analysis within Haines 2011), no conclusion on the effectiveness of this intervention when delivered as a single intervention is made as this is likely to result in difficulty in interpretation.

Psychological interventions

There were no trials of psychological interventions in hospitals.

Other single interventions

There were no trials of other single interventions in hospitals.

Multiple interventions

There were no trials of multiple interventions in hospitals.

Multifactorial interventions

In multifactorial interventions, two or more categories of intervention are given, and these are linked to each individual's risk profile. An initial assessment is usually carried out by one or more health professionals and an intervention is then provided or recommendations given or referrals made for further action. All trials included a comparison with 'usual care' that in many cases included some falls prevention activities. These standard care practices may have changed over time; however, the degree to which the comparator arm does or does not include components of the intervention activities was not clear enough to explore this.

This review included six multifactorial trials in hospitals. Five trials provided data suitable for pooling for the rate of falls, three for the risk of falling. Two studies reported data on risk of fractures. Four studies reported adverse‐event data, there were no adverse events.

The evidence for multifactorial interventions in hospitals is summarised in Table 7. Pooled results showed a borderline reduction in the rate of falls with a point estimate of a reduction of 20%; the 95% confidence intervals indicated this estimate of effect may range as high as a reduction of 36% or result in an increase in falls rates of 1% (Analysis 21.1: RaR random effects 0.80, 95% CI 0.64 to 1.01; 5 trials: I² = 52%); however, there was moderate heterogeneity. The interpretation of pooled data from multifactorial interventions is problematic because of variation in components between trials, and variation of combinations of components delivered to individuals in the trials. A subgroup analysis based on the setting demonstrated a likely significant difference between subgroups. Pooled data from two trials in a subacute setting showed that multifactorial interventions, both included targeted patient education, may reduce the rate of falls (RaR 0.67, 95%CI 0.54 to 0.83; low‐quality evidence).

Pooled results on the risk of falling included only three of the five trials that were pooled for the rates of falls, but the overall effect estimate was generally consistent with the rate of falls, giving a point estimate of a 18% reduction in the risk of falling, with wider 95% confidence intervals indicating this may range between a 38% reduction and a 9% increase (Analysis 21.2: RR random‐effects 0.82, 95% CI 0.62 to 1.09; 3 trials: I² = 0%). This did not achieve statistical significance, but one of the additional trials that was not pooled also reported a reduction in the risk of falling based on admissions in a subacute setting (Hill 2015; 3121 participants). No difference between subgroups by setting was observed. We are uncertain of the effects on risk of falling as the quality of the evidence was assessed as very low.

We are uncertain of the effect of multifactorial interventions on the risk of fracture or adverse events as the quality of the evidence has been assessed as very low.

Subgroup analyses by level of care partly explained the heterogeneity, but due to variations in study design there is some uncertainty if findings are due to the setting or other factors, including the specific combination of interventions provided. Multifactorial interventions that include targeted patient education may reduce the rate of falls in a subacute setting (low‐quality evidence).

A cost‐effectiveness analysis from one trial of multifactorial interventions is to be published (Hill 2014 protocol for Hill 2015).

Studies in participants with cognitive impairment

There is limited evidence for interventions to reduce falls in people with cognitive impairment where these people are a clearly defined group. Although only 11 trials reported findings specifically for patients with dementia or cognitive impairment, many participants in care facilities trials, including those testing interventions that probably or may reduce falls (e.g. vitamin D supplementation), had cognitive impairment.

Economic evaluations

A cost‐effectiveness analysis of a patient education programme reduced falls in a subgroup of hospital patients who were cognitively intact (Haines 2011). In this subgroup the intervention, which consisted of written and video‐based materials plus one‐on‐one bedside follow‐up from a trained health professional, cost AUD 294 to prevent one fall and AUD 526 to prevent one person falling (2008 dollars; reported in Haines 2013).

No conclusions can be drawn from the other 10 trials reporting economic outcomes.

Although we have included 95 trials in this review, these have tested a very wide variety of interventions, sometimes with different comparators rather than control or usual care, in various types of facility. Approximately three quarters of included trials were conducted in care facilities, however many of these were small.

In this review, we have reported results from care facilities and hospitals separately to improve applicability of the interventions to each setting. Careful consideration of the context of effective interventions is required. As Becker 2010 points out, the type of care provided in care facilities differs between countries and healthcare systems. Also, consideration needs to be taken of cultural and organisational contexts when generalising the results from this review. Unfortunately, the level of care and case mix in each facility in this review was often not clearly defined. In addition there is striking variability in type, targeting, intensity and duration of the falls prevention programmes that were studied. Reports of trials in hospitals are also unlikely to adequately describe the complex interaction that is likely to occur between the intervention and the usual falls‐prevention practices occurring within hospitals.

Twenty‐five trials of exercise in care facilities were included, 17 of which tested exercise with usual care. However, many of these were small and whilst there were a number of trials examining balance, gait or functional training exercise programmes, there were few trials on flexibility, strength/resistance training and 3D exercise (including Tai Chi). There were several comparisons of different exercise programs; however, there was generally only one small trial for each comparison so the data were too few to be informative.

The quality of available evidence for vitamin D supplementation was reasonable (moderate‐quality evidence). However, there were few studies of vitamin D supplementation taken in the form of a multivitamin. Trials of environmental/assistive technologies and social environment (e.g. staff training, service model changes) generally studied clinically different interventions, precluding pooling of trial results. Whilst there was a very large trial of bed alarms conducted in hospitals, this trial was of education, training and support for their use and there were no trials of bed alarms in care facilities. Medication review is generally aimed at reducing psychoactive medications. There were a number of trials of medication review in care facilities considered clinically similar enough to justify pooling. However, there was a large degree of inconsistency in the trial findings.

The interpretation of the multifactorial interventions is complex because of the variation in components, duration and intensity of the intervention, and how the interventions were implemented. The study design does not allow evaluation of individual components of the interventions in either care facilities or hospitals.

Only one trial specifically assessed the benefit of using a validated falls risk‐assessment tool in comparison with clinical judgement in a care facility (Meyer 2009) and none did in hospital, although this approach is widely used in both settings. Some multifactorial trials (e.g. Barker 2016) used validated falls risk‐assessment tools to determine the application of appropriate interventions, but the effects of the falls risk‐assessment tool cannot be separated from that of the interventions. This lack of evidence calls into question the wide use of these tools internationally and further trials examining the effectiveness of the tools are warranted.

Few trials have incorporated interventions relating to the circumstances of falls, e.g. assistance with toileting, rather than targeting individual risk factors, as in the continuous quality improvement model used to develop a falls‐prevention programme in Lohse 2012.

The comparator in many trials is 'usual care'. Frequently, what falls‐prevention activities are included as a component of usual care is not clearly reported. This hinders interpretation of how 'usual' care may change over time and any potentially useful subgroup analyses based on this.

In terms of outcomes, 30 of the included trials did not report usable data for calculating rate of falls and 36 trials for risk of falling (seeAppendix 7). Many studies reporting data suitable for pooling reported data for one but not both of these outcomes. This may explain some of the inconsistency between the findings. Even fewer studies reported the impact of the interventions on fractures or adverse events. Within those studies that did report on adverse events, it was often unclear if these data were recorded systematically. Studies that reported data on fractures reported outcomes for different types of fractures (e.g. hip fractures only versus total fractures). Other studies not eligible for inclusion in this review may provide additional evidence for the impact of the interventions on fractures. In particular, whilst a larger proportion of included studies reported data on the risk of fracture following vitamin D supplementation, it is important to consider that these trials represent only a subset of the studies evaluating the effect of vitamin D on fractures available. In addition, some trials of interventions that may increase falls during the intervention period (exercise, medication review) only reported falls during the post‐intervention period. Other studies report only a subset of falls (e.g. bedside falls in Sahota 2014), and therefore do not meet the inclusion criteria for this review. Many cluster‐randomised trials did not adjust for clustering, therefore this was performed post‐hoc by the review authors (as indicated by a "c" in Appendix 7, for details see Unit of analysis issues).

Vitamin D supplementation in care facilities reduced the rate of falls but not the risk of falling. This discrepancy might be explained by differential effects on multiple fallers (i.e. those falling more than once over the study period). However, too few of these trials reported data on multiple fallers to enable meaningful analysis of this outcome.

Only Haines 2011 included a cost‐effectiveness evaluation of their hospital patient education programme in terms of falls prevented to inform the value for money for the intervention tested. An economic evaluation of the intervention tested in Hill 2015 is still to be published.

Many of the interventions studied would be difficult to sustain in usual clinical practice due to competing factors in the clinical environment. In aged‐care settings, vitamin D supplementation is relatively cheap, and once it commences as part of a person’s regular medication regimen it can be continued indefinitely. In hospital settings, educating staff and patients regarding falls prevention would be regarded as good clinical practice and is sustainable in the long term provided the necessary resources are available.

There is scope for realigning clinical practice with less emphasis on use of scales to assess falls risk (because there is no convincing research evidence of their effectiveness) and encouraging clinical staff to focus on factors that may be more effective, for example educating patients and families about falls and how to avoid them.

This review containing 95 trials (138,164 participants) does not provide robust evidence regarding effective interventions for reducing falls in the settings considered. We assessed the quality of the evidence using the GRADE approach which considers the risk of bias, inconsistency, indirectness, imprecision and other biases (including publication bias) for the evidence for each outcome of the main comparisons. The GRADE assessments are reported in Table 1 to Table 7 and the findings are cross‐referenced in the relevant results sections. The GRADE quality of evidence for many outcomes was low or very low. This largely reflects the risk of bias in the individual studies and also the significant heterogeneity and imprecision in many of the pooled study estimates.

Despite the addition of 35 trials in this update, this has generally not improved the robustness of the results compared with the previous version of this review (Cameron 2012). Although there are now a number of trials conducted for some interventions types (e.g. exercise, medication review and vitamin D supplementation in care facilities and multifactorial interventions in hospitals), the overall quality of the evidence was low to very low for all outcomes and comparisons except for rate and risk of falling for vitamin D supplementation, and use of a falls risk‐assessment tool, all in care facilities. There was also evidence indicating potential publication bias in trials of exercise conducted in care facilities.

Studies in this review varied widely in their risk of bias (seeTable 11). The majority of included studies all contained some risk of bias. The included studies illustrated the wider problems of variation in the methods of ascertaining, recording, analysing, and reporting falls described in Hauer 2006. Many trials have used a single approach for ascertaining the number of falls, the limitations of this have been demonstrated in a study of falls data derived from a large hospital based randomised controlled trial (Hill 2010). For some aspects of study design, minimisation of bias is difficult. For example, it is not possible to blind participants and treatment providers for exercise, bed alarms and other types of interventions. Falls were generally recorded by nursing or care home staff who were frequently not blinded to the intervention. In addition, not all studies met the contemporary standards of the extended CONSORT statement (Schulz 2010), including the extensions for cluster‐randomised trials (Campbell 2004), non‐pharmacological trials (Boutron 2008), and pragmatic randomised trials (Zwarenstein 2008), so reporting was unclear in many instances, particularly for allocation concealment or selective outcome reporting when no protocol could be identified.

There is a potential for differences between individually‐ and cluster‐randomised trials. This review included a large proportion of cluster‐randomised trials (44%). Within this review, in general trials were more likely to be cluster randomised or not depending on the intervention being investigated and the setting. Thus, whilst five of six trials of multifactorial interventions in hospitals (enrolling 99% of participants), and 85% of those conducted in care facilities (82% of participants) were cluster randomised, in contrast for trials of exercise in care facilities, 88% of trials with 65% of participants were individually randomised. Similarly, for trials of vitamin D supplementation in care facilities, 75% of trials (with 60% of participants) were individually randomised. Although it has been reported that contamination, or 'herd effects' in individually‐randomised trials conducted in facilities may result in decreasing the estimate of effect (Hahn 2005), this is considered unlikely to have had a major impact on the estimates of effect or conclusions for this review. The reasons for this according to the major categories of intervention are described below.

For trials of exercise in care facilities, the estimates of effect of the three cluster‐randomised trials that contributed to pooling (Kerse 2008; Rosendahl 2008; Yokoi 2015), did not appear to differ to the range of estimates for the individually‐randomised trials. For vitamin D in care facilities, as the single cluster‐randomised trial contributing to the pooled result (Law 2006) had a smaller estimate of effect compared to the individually‐randomised trials, this indicates that contamination of the control group was unlikely to have played a role in the estimate of effect, which increases the confidence in the effect estimate. For medication review in care facilities, there was a more even balance of individually‐ and cluster‐randomised trials; 58% of trials (62% of participants) were individually randomised. The estimates of effect from the trials were inconsistent within both the cluster‐ and individually‐randomised trials, thus the high inconsistency of findings between trials for this intervention cannot be explained by the type of randomisation used. Two cluster‐randomised trials contributed only 18% of the participants for the evidence for multifactorial interventions in care facilities, the estimates of effect in these two trials were similar to that for the pooled overall effect estimates. All trials of additional exercise in care facilities were individually randomised. In trials of bed exit alarms in hospitals, only two trials contributed to pooled data; 96% of participants were enrolled in one trial that was cluster randomised, thus consideration of the findings of trials that were individually in comparison with cluster randomised is uninformative. Similarly, comparisons of individually‐ and cluster‐randomised trials within multifactorial interventions in hospitals are not feasible given 99% of participants were enrolled in cluster‐randomised trials.

There was significant unexplained heterogeneity in the findings for the rate of falls for several comparisons (exercise, medication review and multifactorial in care facilities), which limited the confidence in the results (seeTable 1, Table 2 and Table 4), and was reflected in the generally low quality of evidence. The heterogeneity may be due to variations in intervention components, duration, intensity and settings as well as variations in the populations.

The evidence for some ProFaNE categories of interventions contained a degree of indirectness, where the intervention was a recommendation for, or education on, use of the intervention, rather than implementing the intervention for all participants (e.g. Kennedy 2015 for vitamin D, Shorr 2012 for bed alarms). In addition, where evidence was from a single trial or setting, it was likely to be considered to have a degree of limited applicability, or indirectness to other settings, (e.g. Sambrook 2012 which examined sunlight exposure in Australia).

There was also imprecision in some estimates, where the number and size of trials was small (seeTable 5) or in particular for the risk of fracture where few trials reported this outcome and events were infrequent (e.g. vitamin D Table 3).

There was some evidence for likely publication bias for trials in exercise, where the included studies appeared to include a disproportionate number of small studies with positive findings (seeFigure 4, Figure 5) .

We attempted to minimise publication bias in the review by searching multiple databases, and drew on the handsearch results published in the Cochrane Library in the Cochrane Central Register of Controlled Trials (CENTRAL). We also contacted authors of studies identified in trials registers that were completed, but for which full reports had not been identified, studies where only conference abstracts were identified, and many studies where it was unclear whether or not they met the inclusion criteria. We placed no foreign language restrictions in our search strategy; two studies were published in languages other than English (Peyro Saint Paul 2013; Salvà 2016), correspondence with authors provided information on study methods and results. However, despite these efforts, evidence of likely publication bias in trials of exercise conducted in care facilities remained.

Although the majority of screening of search citations for potentially eligible studies in this update was performed by only one author, we suggest this was not a source of bias given that the screening was over‐inclusive with the onus being given to obtaining full‐text reports for all potentially eligible studies. We observe also that where screening was undertaken by two review authors, the progression to full‐text review was reduced.

Five newly published studies that were identified in the top‐up search in August 2017 await classification (Dever 2016; Hewitt 2014; Raymond 2017; Van der Linden 2017; Wylie 2017). This was a pragmatic decision taken in view of the delay that would have resulted from their likely inclusion and after consideration of the potential impact of these trials on review findings. We concluded that our decision to postpone the inclusion of these five trials was not an important source of bias.

Whilst we strictly applied a priori inclusion and exclusion criteria to the selection of studies for this review, which should minimise bias, this does result in the inclusion of a subset of the available evidence and this applies in particular to risk of fracture outcome. All included studies were required to present data on the overall rate of falls or risk of falling, those reporting only a subset of falls (e.g. injurious falls, bedside falls) were excluded. We also excluded 22 trials reporting falls as adverse effects, although in some instances the intervention might plausibly have reduced falls. For a more comprehensive systematic review of the effect of vitamin D supplementation on fractures, see Avenell 2014.

For single‐trial comparisons, we took a different approach to GRADE assessment where a single rater checked whether the trial findings for each outcome met pre‐specified criteria for downgrading the evidence. The criteria were established before this alternative assessment took place. For 26 single‐trial comparisons these criteria were met. For 18 comparisons in 16 trials these criteria did not apply, generally because of a large trial size, and GRADE assessment was conducted in duplicate. For these assessments, in two trials (three outcomes), the quality of the evidence was considered moderate (Chapuy 2002; Meyer 2009), and in three trials (five outcomes) the quality of the evidence was considered low (Cox 2008; Haines 2011; Kennedy 2015); for all other comparisons and outcomes the quality of the evidence was considered very low.

There are potential biases within the data included in the review in terms of non‐normal distribution of falls rates in the included studies (as seen in Potter 2016), missing data including the loss of clusters within some trials, selective outcome reporting (seeTable 11), decisions regarding pooling of studies where there is high heterogeneity and selection of models used for meta‐analyses where there is heterogeneity for one falls outcome, but not another (e.g. high heterogeneity for rate of falls but not risk of falling). The potential biases due to these factors are captured by the GRADE assessments of the overall quality of evidence (Table 1 to Table 7). There are also potential biases in decisions to conduct post‐hoc subgroup and sensitivity analyses (e.g. Analysis 5.4; seeSubgroup analysis and investigation of heterogeneity and Sensitivity analysis). This has been taken into account in conducting GRADE assessments (e.g. confidence in the credibility of subgroup analysis is considered in the inconsistency rating for the subgroup analysis by setting for multifactorial interventions in hospitals), making cautious interpretations of the findings (e.g. considering findings based on subgroup analysis by setting for multifactorial interventions in care facilities of low credibility) and transparently reporting these analyses under Differences between protocol and review.

We explored the possibility of publication bias by constructing funnel plots of trials of exercise in care facilities and multifactorial interventions in care facilities (Figure 4, Figure 5, Figure 6). There was some asymmetry in the falls outcomes for trials of exercise in care facilities indicating potential publication bias.

Using the generic inverse variance method in this review enabled us to pool results as reported by trial authors with our own calculated from raw data, and results adjusted for clustering.

The ProFaNE falls prevention taxonomy enabled us to pool similar interventions in the analyses using a systematic approach. However, classification of some interventions according to this taxonomy was unclear and required judgement in some cases. We consulted with the ProFaNE authors when necessary.

We searched for other systematic reviews of falls prevention initiatives in care facilities and hospitals published since 2012 within our search described in Appendix 1. We compared our review results with the Cochrane Review 'Interventions for preventing falls in older people living in the community' (Gillespie 2012), and identified six other systematic reviews incorporating meta‐analyses (Chan 2015; Le Blanc 2015; Sherrington 2017; Silva 2013; Stubbs 2015; Vlaeyen 2015).

Comparison with trials in community‐living older people

In contrast to the findings in this review for residents of care facilities and hospital inpatients, the evidence is clear that falls can be prevented using exercise in older people living in the community (Gillespie 2012). The effectiveness of group‐based and home‐based exercise programmes and Tai Chi in particular is well established in the community setting. There is the potential for falls to be reduced in care facilities using the same multiple‐component exercise programmes, but despite 25 trials in this review testing exercise programmes in care facilities, the results were inconsistent. Only three trials examined exercises in hospitals; the quality of the evidence was considered very low.

Vitamin D supplementation may reduce falls in community‐living people with lower vitamin D levels (Gillespie 2012). This is consistent with the finding in this review that vitamin D is effective in reducing falls in care facilities as most residents have low vitamin D levels (Pilz 2012). 

The effects of multifactorial approaches are inconsistent between trials and settings. In the community setting, multifactorial interventions, including falls‐risk assessment, reduced the rate of falls but not the risk of falling (Gillespie 2012). Similarly, multifactorial interventions overall may make little or no difference to the risk of falling in care facilities. However, findings on the rate of falls were inconsistent. In hospitals, multifactorial interventions (that include targeted patient education) may reduce the rate of falls in a subacute hospital setting.

There is some evidence that falls prevention strategies in the community can be cost saving (Gillespie 2012), but there were no economic evaluations conducted within the care facilities and only one in hospital trials (Haines 2011) to provide information on value for money for effective interventions.

Supplementary review

Nyman 2011 conducted a supplementary review of the 41 trials included in Cameron 2010 with specific reference to people’s recruitment, retention in the trial, and adherence to intervention components. Adherence was high for individually‐targeted and group‐based exercise (72% to 89%) and for medication interventions (68% to 88%). The authors reported that adherence was related to treatment effectiveness in three studies testing medication and multifactorial interventions in care facilities. They estimated that by 12 months, on average, only a third of care‐facility residents are likely to be adhering to falls prevention interventions. The current review was not able to comment on adherence or retention. Nyman 2011 provides an important perspective giving context to interpretation of the research.

Exercise

Chan 2015 conducted a systematic review of exercise interventions for older adults with cognitive impairment, only three of seven trials in a pooled analysis enrolled participants living in a care setting. Two of these studies were included in this review (Toulotte 2003 and Rosendahl 2008), but Chan 2015 included unpublished subgroup data for Rosendahl 2008, and Rolland 2007 and was excluded from this review as falls were monitored as adverse events.

Sherrington 2017 conducted a systematic review and meta‐analysis of exercise interventions to prevent falls in older adults. This review included 14 RCTs (15 comparisons) of exercise interventions in care settings and found no significant effect on the rate of falls. These authors observed possible asymmetry in the funnel plot, which was not statistically significant on Egger's test. Three of the trials included in Sherrington 2017 were excluded from this review (DeSure 2013; Resnick 2002; Rolland 2007; seeCharacteristics of excluded studies). Two of the trials included in the pooled estimate in Sherrington 2017 were considered as multiple interventions under the ProFaNE classification system in this review (Huang 2016, ; seeAppendix 3). Data reported for one study were considered not suitable for pooling in this review (Toulotte 2003). All other trials were included.

Silva 2013 included 12 studies of exercise in care facilities. This review pooled studies of exercise as a single intervention with studies of exercise as a component of a multifactorial intervention. The authors found a significant reduction in the risk of falling (RR 0.71, 95% CI 0.64 to 0.92, I² = 72%). There was no significant effect on the risk of fracture (RR 0.57, 95% CI 0.21 to 1.57). All of the included trials were included in our review.

Lee 2017 included 21 studies of exercise in care facilities, 15 with exercise as a single intervention, six with exercise combined with one or more interventions. Data were pooled from studies comparing exercise with other interventions, usual care or placebo. In the current review, comparisons of alternate exercise programs were not pooled with trials of exercise in comparison with usual care (for details see Table 9). Three of the trials included in Lee 2017 were excluded from this review (DeSure 2013; Lord 2003b; Wolf 2003); two of these were considered to be conducted in a community setting. Data from one trial were not pooled in our review as there were zero falls in the intervention arm (Cadore 2014); this study has a weighting of 0.4% in the meta‐analysis in Lee 2017. Pooled data of trials of exercise as a single intervention in Lee 2017 found no difference in the rate of falls or risk of falling, consistent with the findings of our review.

The current review found inconsistent effects for exercise in care facilities and is broadly consistent with Silva 2013 and Sherrington 2017 although pooling combinations differed. Our review contrasts with Chan 2015 as Chan 2015 pooled trials across both community and care facility settings and much of the impact observed in their meta‐analysis may have been from trials conducted in the community.

Vitamin D supplementation

A systematic review conducted for the US Preventative Services Task Force (Le Blanc 2015), examining trials conducted in both institutionalised or community settings, found that vitamin D significantly reduced the number of falls per person but did not significantly reduce the risk of falling, consistent with the findings in care facilities in this review. The authors reported that sensitivity analysis based on institutionalised status "resulted in similar estimates". The two included studies conducted in institutionalised settings are included in this Cochrane Review. The authors concluded that "Treatment of vitamin D deficiency in asymptomatic persons might reduce mortality risk in institutionalised elderly persons and risk for falls but not fractures."

Bolland 2014 pooled outcomes from six randomised trials conducted in care facilities or hospitals and found no significant reduction in falls with vitamin D supplementation with or without calcium supplementation (RR 0.96, 95% CI 0.88 to 1.05). The authors concluded that supplementation with vitamin D does not reduce risk of falling by a 'clinically relevant' threshold of 15% or more and that future trials are unlikely to alter this conclusion. One study included as institutional in the Bolland 2014 review was excluded from this review as 51% of participants were residing in the community (Graafmans 1996); all other studies were included in this review. This Cochrane Review has analysed studies conducted in care facilities or hospitals separately and found that whilst vitamin D supplementation did not reduce the risk of falling, it did reduce the rate of falls in care facilities. Our analysis included data on the rate of falls in care facilities from the same four studies pooled for the risk of falling and whilst there was heterogeneity for the pooled rate of falls outcome (I² = 62%), it was lower than observed in Bolland 2014 when pooling studies in either setting (I² = 92%).

Other recent systematic reviews

Vlaeyen 2015 included 13 randomised controlled trials of fall‐prevention programmes conducted in nursing homes. The authors found no significant effect of the interventions overall on the number of falls (10 studies) or risk of falling (six studies). They reported that multifactorial interventions significantly reduced the number of falls (four studies) and the number of recurrent fallers (four studies), but not the risk of falling (four studies). They reported that staff training and education had a significant harmful effect on the number of falls (two studies). All trials were included in our review.

Stubbs 2015 conducted an umbrella review of meta‐analyses in care facilities and hospitals and concluded that there was consistent evidence that multifactorial interventions reduce falls in care facilities and hospitals and reported that there was consistent evidence that exercise and vitamin D reduces falls in care facilities, based on the inclusion of nine individual meta‐analyses including Cameron 2012, Bolland 2014 and Sherrington 2011 (Sherrington 2017 is discussed above). Other meta‐analyses included in Stubbs 2015 and published since 2012 were Choi 2012, Guo 2014 and Santesso 2014. Choi 2012 pooled three studies conducted in care settings, all of which were included in this review: a vitamin D trial (Broe 2007), a multifactorial trial (Neyens 2009), and Rapp 2008, which is included as a subgroup analysis of Becker 2003 in our review. Guo 2014 conducted an 'exploratory meta‐analysis' examining fall‐prevention interventions for those with or without cognitive impairment in institutionalised and non‐institutionalised settings. Eight trials included in Guo 2014 were not considered for our review as they had been assessed as being conducted in the community setting: all eight trials were considered in Gillespie 2012, seven of which were included (Conroy 2010, Davison 2005, Haines 2009, Hendriks 2008, Latham 2003, Lightbody 2002, Lord 2005) and one of which was excluded because falls were reported as adverse events (Vogler 2009). Santesso 2014 conducted a meta‐analysis of hip protectors; as we consider hip protectors are intended to reduce fractures rather than falls, this intervention is not included in our review.

Implications for practice

We found evidence of effectiveness for some fall‐prevention interventions in care facilities and hospitals, although for many the quality of the evidence was considered low or very low. For all interventions, we are uncertain of their effects on fractures and on adverse events as the quality of the evidence for both outcomes was assessed as very low. For each setting, the summary is structured by the main categories of interventions evaluated in at least one setting in the review: exercise, medication (medication review; vitamin D supplementation); psychological interventions, environment/assistive technology, social environment, interventions to increase knowledge, other interventions, multiple interventions and multifactorial interventions. There was a lack of evidence on surgery, management of urinary incontinence, or fluid or nutrition therapy in both settings.

  • Exercise

    • We are uncertain of the effect of exercise on the rate of falls as the quality of the evidence was assessed as very low. Exercise may make little or no difference to the risk of falling (low‐quality evidence; Table 1).

  • Medication

    • General medication review may make little or no difference to the rate of falls or risk of falling (low‐quality evidence); Table 2.

    • The prescription of vitamin D in care facilities probably reduces rate of falls (moderate‐quality evidence), but prescription of vitamin D (with or without calcium) probably makes little or no difference to the risk of falling (moderate‐quality evidence); Table 3.

    • An education intervention aimed at increasing the prescription of vitamin D, calcium and osteoporosis medication may make little or no difference to the rate of falls or risk of falling (low‐quality evidence).

  • Environment/assistive technology

    • There is a general lack of evidence on these interventions in care facilities.

    • We are uncertain of the effect on rate of falls of wireless position monitoring in care facilities (very low‐quality evidence).

  • Social environment

    • Use of a falls risk‐assessment tool in comparison with nurses' judgement alone probably makes little or no difference to the rate of falls or risk of falling (moderate‐quality evidence).

    • We are uncertain of the effects on falls of a half‐day education programme about fall and fracture prevention for staff given by specialist osteoporosis nurses in care facilities (very low‐quality evidence).

    • We are uncertain of the effects on falls of other interventions targeting staff and the organisation of care on falls, including guideline implementation and dementia care mapping (very low‐quality evidence).

  • Knowledge/education

    • There is a lack of evidence on these interventions in care facilities.

  • Psychological interventions

    • We are uncertain of the effects on falls of a cognitive‐behavioural intervention with a focus on falls risk reduction (very low‐quality evidence).

    • We are uncertain of the effects on falls of a computer‐based cognitive training programme focused on improving attention (very low‐quality evidence).

  • Other single interventions

    • We are uncertain whether lavender olfactory stimulation, multisensory stimulation in a Snoezelen room or sunlight exposure reduces falls (very low‐quality evidence).

  • Multiple interventions

    • We are uncertain about the effect on falls of a multiple intervention for incontinent residents that included exercise, offering regular fluids and toileting (very low‐quality evidence).

    • We are uncertain about the effect on falls of a multiple intervention comprising increased sunlight exposure plus calcium supplementation (very low‐quality evidence).

  • Multifactorial

    • We are uncertain of the effects of multifactorial interventions on the rate of falls (very low‐quality evidence). Multifactorial interventions may make little or no difference to the risk of falling (low‐quality evidence); Table 4.

  • Exercise.

    • We are uncertain whether providing additional physiotherapy in subacute wards has an effect on the rate of falls or whether it reduces the risk of falling (very low‐quality evidence); Table 5.

  • Medication

    • We are uncertain of the effect of medication review on either rate of falls or risk of falling (very low‐quality evidence).

    • We are uncertain of the effect of vitamin D supplementation on either rate of falls or risk of falling (very low‐quality evidence).

  • Environment/assistive technology

    • We are uncertain of the effect of bed sensor alarms on the rate of falls or risk of falling (very low‐quality evidence); Table 6.

    • We are uncertain whether carpet flooring, tested in one small trial, increases the rate of falls and risk of falling compared with vinyl flooring (very low‐quality evidence).

    • We are uncertain of the effects on rate of falls or risk of falling of using identification bracelets for patients at high risk of falling (very low‐quality evidence).

    • We are uncertain of the effect of providing low‐low beds on the rate of falls (very low‐quality evidence).

  • Social environment

    • We are uncertain of the effects of interventions targeting staff and the organisation of care (including guideline implementation) on rate of falls or risk of falling (very low‐quality evidence).

  • Knowledge or education

    • We are uncertain of the effects on falls of an educational session based on identified risk factors and usual fall‐prevention care in acute medical wards (very low‐quality evidence).

    • Providing patients with educational materials alone may make little or no difference to the rate of falls or risk of falling (low‐quality evidence).

  • Psychological interventions

    • There is a lack of evidence on these interventions in hospitals.

  • Other single interventions

    • There is a lack of evidence on whether or not falls risk‐assessment tools and associated interventions reduce falls.

  • Multiple interventions

    • There is a lack of evidence on these interventions in hospitals.

  • Multifactorial intervention

    • Multifactorial interventions may reduce the rate of falls, although subgroup analysis suggest this may apply mostly to a subacute setting (low‐quality evidence). We are uncertain of the effects of multifactorial interventions on the risk of falling (very low‐quality evidence); Table 7.

Implications for research

Further research, primarily randomised controlled trials, is warranted to help inform decisions in this key area. We suggest the following guide to help discussions on future priorities.

  • Further research into supervised exercise programmes in both settings. There is a particular need for larger trials in care facilities and trials that clearly describe the care needs of the participants.

  • Further research to strengthen the evidence for multifactorial interventions in both settings. Of note is that there are some substantial individual trials that have shown an important effect in reducing the rate of falls. A key feature of these multifactorial interventions is the individualised nature of the interventions delivered. This implies that further research with emphasis on an individualised, standardised approach to delivery of interventions with consistent description and application within further trials is warranted, including as a clear description of existing falls prevention practices in the control arm of any trials and the interaction of the intervention arm of the trial with usual care. A mixed methods approach may be necessary to achieve this.

  • Further trials of patient‐directed interventions, especially in care facilities; for example, with a psychological and educational focus.

  • Trials with interventions incorporating approaches based on the circumstances of falls in addition to individual risk factors, e.g. regular assisted toileting in both care facilities and hospitals (Lohse 2012; Schnelle 2003).

  • Further trials testing the routine use of validated falls risk‐assessment tools.

  • Further research is required testing interventions targeting staff, and changes to the organisational system in which an intervention is delivered or the introduction of new healthcare models.

  • In care facilities, additional trials on medication review, vitamin D plus calcium supplementation, environmental/assistive technologies and social environment interventions are required. There should be an emphasis on large trials.

  • In hospitals, more trials of additional exercise, social environment and knowledge interventions are needed.

  • Further research focusing on participants with dementia.

Other aspects, including research methods, that need to be adopted in all future studies are as follows.

  • Classification of the components of the fall‐prevention intervention using the taxonomy developed by the Prevention of Falls Network Europe (ProFaNE) (Lamb 2007; Lamb 2011). This will produce consistency between trials allowing for more effective pooling of data.

  • Consideration is needed of the nature of 'usual care' and its potential interaction with the intervention group.

  • For multifactorial trials, clear descriptions are needed of the components and the proportion of the participants receiving the different interventions.

  • Falls data should be collated by a researcher blind to group allocation.

  • Fall events should be reported by group as total number of falls, fallers, and people sustaining a fall‐related fracture or brain injury; rate of falls (falls per person year or per 1000 patient days); multiple fallers and number in each analysis.

  • Results should be analysed using appropriate, pre‐specified methodology (e.g. negative binomial regression, survival analysis) (Robertson 2005). Group comparisons should be expressed as incidence rate ratios and risk ratios with 95% confidence intervals.

  • Authors of trials not excluding people with cognitive impairment should plan to report the results by level of cognitive impairment to indicate whether degree of impairment is an effect modifier.

  • Design and reporting of trials should meet the contemporary standards of the extended CONSORT statement including those relating to randomised sequence generation and allocation concealment prior to randomisation (Schulz 2010). Pragmatic trials and those testing non‐pharmacological interventions should incorporate the requirements defined in Zwarenstein 2008 and Boutron 2008.

  • Clear description of usual care in the control arms of trials and discussion of the interaction of the intervention with this is needed.

  • Design and reporting of cluster randomised trials should follow contemporary guidance (Campbell 2004) including the reporting of intra‐class correlation coefficients.

  • Where factorial designs are employed, data for each treatment cell should be reported to allow interpretation of possible interactions between different intervention components (McAlister 2003).

  • There is a clear need for further research clearly reporting on the cognitive status of the included participants and including those with cognitive impairment.

  • Economic evaluations should be conducted alongside randomised controlled trials to establish the cost‐effectiveness of each intervention being tested. This involves measuring health‐related quality of life as an outcome, defining the perspective and timeframe for costs, collecting data on healthcare use, costing healthcare resources, calculating cost‐effectiveness ratios (if the intervention is effective in reducing falls), and evaluating uncertainty. Guidelines for carrying out and reporting economic evaluations in falls prevention trials have been published (Davis 2011).

Summary

According to the Cochrane Handbook for Systematic Reviews of Interventions (1), systematic reviews summarize the results of controlled healthcare trials to provide a high level of evidence on the effectiveness of healthcare interventions. This evidence is then used to enlighten judgments about the evidence and to inform practice recommendations. While fall prevention in hospitals has been studied for several decades, much of the evidence has been inconclusive. Our team read this review with great interest hoping that it would inform practice recommendations (2).

Unfortunately, this most recent fall prevention systematic review is again inconclusive and furthermore adds to the confusion related to the benefits of fall prevention interventions in hospital settings. However, the reported limitations relate to inaccurate assumptions and errors in calculations made by the systematic review authors, rather than the quality of the studies and associated evidence. For example, in relation to our team’s study, Cameron et al reported the following: "Dykes 2010 (5264 participants) tested the effect of a computer‐based fall prevention tool kit in comparison with usual care. There was no strong evidence for an effect on the rate of falls (Analysis 19.1.3: RaR 0.55, 95%CI 0.02 to 16.29) or risk of falling (Analysis 19.2.1 RR 0.91, 95% CI 0.06 to 14.21)." To calculate the confidence interval for rate of falls, Cameron et al used a formula that did not consider the effect of matching in their analyses. As noted by Imai (2009), matching greatly reduces the standard error in cluster‐randomised experiments (3). Based on our data, the RaR 0.55 has 95% CI 0.36 to 0.83 and the p‐value for that test that pRaR=1 was p =.005 (this is the same p‐value for the test that the rate difference = 0 as published in our results paper (4)). In addition, Cameron et al incorrectly reported the relative risk of falling for patients in our study as .91, rather than .61 (see Table 3 of our results paper [(34/2755)/(51/2509) = .61]). Perhaps this was a typographical error or a miscalculation but given the difference in results found by the systematic review authors compared to those reported by our team in Journal of the American Medical Association (4), Cameron and colleagues should have contacted us to clarify their results, rather than risk including inaccurate data in their systematic review and meta‐analysis. The inaccurate assumptions and miscalculations associated with our clinical trial call into question the rigor and accuracy of Cameron et al’s systematic review since the authors calculated rate ratios, risk ratios, and 95% confidence intervals for many of the included studies and therefore they may have made similar errors in other calculations that they made for other studies they evaluated.

The inaccurate assumptions and calculation errors in this systematic review further perpetuate the myth that patient falls in hospitals are not preventable. It is our hope that Cochrane will refine its systematic review methodology to include a process for systematic review authors to check their assumptions with study authors to ensure that accurate results are reported that can be used to enlighten judgments and to inform practice recommendations. Cochrane reviews carry substantial weight; they should have high methodological standards.

1. Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.0 (updated July 2019). Cochrane, 2019. Available from www.training.cochrane.org/handbook.

2. Cameron ID, Dyer SM, Panagoda CE, Murray GR, Hill KD, Cumming RG, Kerse N. Interventions for preventing falls in older people in care facilities and hospitals. Cochrane Database of Systematic Reviews 2018, Issue 9. Art. No.: {"type":"entrez-nucleotide","attrs":{"text":"CD005465","term_id":"30322203","term_text":"CD005465"}}CD005465. DOI: 10.1002/14651858.CD005465.pub4.

3. Imai K, King G, and Nall, C. The essential role of pair matching in cluster‐randomized experiments, with application to the Mexican universal health insurance evaluation. Statistical Science 2009;24(1):29‐53.

4. Dykes PC, Carroll DL, Hurley A, Lipsitz S, Benoit A, Chang F, et al. Fall prevention in acute care hospitals: A randomized trial. JAMA 2010;304(17):1912‐8

Reply

Thank you for your feedback. We agree that Cochrane reviews hold to a high standard for evidence quality to inform formal recommendations. The authors of this review share your frustration that the evidence is, on the whole, insufficient to be certain of the effects of the various and often complex interventions used for falls prevention in the settings covered in our review.

Cochrane reviews are undertaken using standard methods that need to be applied to all studies. For cluster randomised trials, these methods also involve adjustment for clustering. The approach taken in our review is detailed in the methods section under Unit of analysis issues. Of note is that these methods do not include consideration of matching of clusters in the results.

Your trial, Dykes 2010, was added to the review in the previous 2012 update. We can confirm that the analysis of the trial was done in an appropriate manner that was consistent with all other cluster randomised trials within the review. As the results for number of fallers was not reported as an adjusted risk ratio for falling within the trial report, adjustment was necessary and performed. The adjustment for clustering requires rounding to whole numbers of participants for determination of the risk ratio, and thus the reported 0.91 rather than 0.61 is not an error but a consequence of rounding following adjustment for a relatively small number of clusters (8 clusters, adjusted values intervention 1/58 versus control 1/53; RR 0.91). For all versions of this review, the authors have approached trial investigators for missing data and clarification where necessary; your trial report was considered sufficiently reported not to need this action.

We hope this explanation will restore your faith in our review.

Contributors

Feedback from: Patricia C Dykes1,2, Jason S Adelman3, Michael Bogaisky4, Ann C Hurley1, David W Bates1,2 and Stuart R Lipsitz1,2. (1Center for Patient Safety, Research and Practice, Brigham and Women’s Hospital, Boston, MA; 2Harvard Medical School, Boston, MA; 3Columbia University Irving Medical Center/New York‐Presbyterian, New York, NY; 4Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY)
Reply from: Suzanne Dyer and Ian Cameron (review authors)
Editors: Cathie Sherrington (Feedback Editor; Cochrane Bone, Joint and Muscle Trauma Group) and Helen Handoll (Co‐ordinating Editor, Cochrane Bone, Joint and Muscle Trauma Group)

DateEventDescription
27 January 2020AmendedFeedback and response added

Protocol first published: Issue 3, 2005
Review first published: Issue 1, 2010

DateEventDescription
7 September 2018AmendedNIHR acknowledgement added
10 August 2018New search has been performedFor this update, the following changes were made.
  • Search updated to August 2017.

  • 35 new trials added.

  • The classification of social environment interventions has been reconsidered. Stenvall 2007 has been reclassified as a social environment intervention (previously multifactorial). Koh 2009 and Van Gaal 2011b are still classified within the social environment ProFaNE category but considered as organisational service model change rather than staff training.

  • Trials on medication review in care facilities reclassified according to medication target, rather than according to the type of health professional performing the review.

  • Additional subgroup analysis by level of care conducted for multifactorial interventions in hospitals.

  • Background section revised and citations updated.

  • Risk of bias conducted for additional items for previously included trials according to current Cochrane guidelines.

  • Overall quality of evidence for main comparisons assessed according to GRADE.

  • Exercise interventions are reported according to the ProFaNE exercise category and the comparator arm of the trial.

10 August 2018New citation required and conclusions have changedNew evidence, the reclassification of some intervention categories and the implementation of new methods, including assessment of the quality of the evidence using GRADE, has resulted in some changed conclusions.
Changes made to authorship, including addition of new authors.
27 February 2013Feedback has been incorporatedChanges relate to two pieces of feedback, received 19 December 2013 and 12 February 2013. Two Summary [of feedback] and Reply entries were added to the Feedback section. There were no changes to the review in relation to the second piece of feedback. Changes in relation to the first piece included:1. Appendix 6 was revised and Appendices 7 and 8 were deleted. 2. A new Appendix 7, containing raw data, was added.

3. Sections of the review (principally, the 'Description of studies') were revised to reflect these changes.

9 November 2012New search has been performedFor this update, published in Issue 12, 2012, the following changes were made:1. Search updated to March 2012 2. Twenty additional trials (35,270 participants) included in this update

3. One previously included trial recruiting people post stroke (Barreca 2004) excluded, as no longer within the scope of this version of the review


4. Kerse 2008 reclassified as an exercise intervention (formerly multifactorial) 5. Additional trials testing multifactorial interventions with results for subgroups with and without cognitive impairment

6. Evidence relating to additional interventions, these include: patient education in hospital (Ang 2011; Haines 2011), dementia care mapping (Chenoweth 2009), motion sensors (Clifton 2009), decision‐support software (Dykes 2010; Lapane 2011), multivitamin supplementation (Grieger 2009), low‐low beds (Haines 2010), multisensory stimulation (Klages 2011), guideline implementation (Koh 2009; Van Gaal 2011a; Van Gaal 2011b), a fall risk assessment tool (Meyer 2009), increased sunlight exposure (Sambrook 2012), lavender oil stimulation (Sakamoto 2012), an acute care service for elderly people (Wald 2011)


7. One newly included trial included a cost‐effectiveness analysis (Chenoweth 2009)
8. Background section revised and citations updated 9. 'Risk of bias' item relating to 'Allocation concealment' split into two: 'Sequence generation' and 'Allocation concealment' and applied to all included studies

10. Subgroup analyses revised

9 November 2012New citation required and conclusions have changed1. In response to the external referee's comments, the title of this review has been changed to reflect the fact that facilities which do not include nursing care are also included in this review.
2. Change in conclusion for multifactorial interventions in care facilities from no evidence of effect to a suggestion of possible benefits. Evidence from one trial for the effectiveness of an educational session targeting identified risk factors in acute hospital setting.
30 November 2009AmendedCorrection of two minor errors
23 September 2009AmendedThe published review 'Interventions for preventing falls in elderly people' (Gillespie 2003) is not being updated. Due to its size and complexity it was split into two reviews: 'Interventions for preventing falls in older people living in the community' and 'Interventions for preventing falls in older people in nursing care facilities and hospitals'
1 April 2009AmendedConverted to new review format

The authors would like to acknowledge the considerable contributions of Leslie Gillespie and Clare Robertson to earlier versions of the review, and Clare Robertson for support on data management and statistical calculations. The authors would like to thank Lindsey Elstub and Joanne Elliott for their support at the editorial base.

We thank the following for their useful and constructive comments on this version of the review: Dr Joanne Elliott, Dr Helen Handoll, Prof Finbarr Martin, and Prof Cameron Swift.

We thank the following for their useful and constructive comments on earlier versions of the protocol and/or review: Assoc Prof Jacqueline Close, Dr Simon Gates, Dr Helen Handoll, Prof Peter Herbison, Prof Finbarr Martin, Prof Cathie Sherrington, and Dr Janet Wale. We are grateful to Prof Sarah Lamb, Prof Clemens Becker and Dr Klaus Pfeiffer for their assistance with use of the ProFaNE taxonomy, and to Prof Peter Herbison for his advice on statistical issues in previous versions of the review. We are also grateful to Prof William Gillespie and Dr Mohit Arora for assistance in assessing the risk of bias for some previously included studies and Dr Mohit Arora for screening trial registry records in the top‐up search. We thank Geraldine Wallbank of the George Institute for Global Health, Sydney for her assistance in completing Appendix 7 for previously included studies.

This project was supported by the National Institute for Health Research (NIHR) via Cochrane Infrastructure funding to the Cochrane Bone, Joint and Muscle Trauma Group. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, the NIHR, the National Health Service (NHS) or the Department of Health. Funding for immediate open access was received from the NIHR Cochrane review gold open access scheme.

Edited (no change to conclusions)

Care facilities: Exercise vs usual care

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls102002Rate ratio (Random, 95% CI)0.93 [0.72, 1.20]
2 Rate of falls and number of fallers: trials with incomplete data  Other dataNo numeric data
3 Number of fallers102090Risk Ratio (Random, 95% CI)1.02 [0.88, 1.18]
4 Number of people sustaining a fracture1 Risk Ratio (Fixed, 95% CI)Subtotals only
4.1 Hip fractures1183Risk Ratio (Fixed, 95% CI)0.16 [0.01, 2.81]
4.2 All fractures1183Risk Ratio (Fixed, 95% CI)0.88 [0.25, 3.14]
5 Rate of falls, excluding studies with ≤20 participants in each arm81959Rate ratio (Random, 95% CI)0.91 [0.72, 1.15]
6 Number of fallers, excluding studies with ≤20 participants in each arm9 Risk Ratio (Random, 95% CI)1.04 [0.89, 1.21]
7 Adverse events: aches and pains1582Risk Ratio (M‐H, Fixed, 95% CI)1.23 [0.61, 2.48]
7.1 Severe soreness1194Risk Ratio (M‐H, Fixed, 95% CI)0.91 [0.40, 2.04]
7.2 Severe bruises1194Risk Ratio (M‐H, Fixed, 95% CI)2.0 [0.18, 21.69]
7.3 Severe fatigue1194Risk Ratio (M‐H, Fixed, 95% CI)4.0 [0.46, 35.14]

Care facilities: Exercises vs usual care (grouped by type of exercise)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls10 Rate Ratio (Random, 95% CI)Subtotals only
1.1 Gait, balance, functional training41347Rate Ratio (Random, 95% CI)0.96 [0.69, 1.33]
1.2 Whole body vibration162Rate Ratio (Random, 95% CI)0.96 [0.58, 1.60]
1.3 Combination of exercise categories (see Appendix 4 for categories in each trial)6683Rate Ratio (Random, 95% CI)0.94 [0.60, 1.47]
2 Number of fallers10 Risk Ratio (Random, 95% CI)Subtotals only
2.1 Gait, balance, and functional training51452Risk Ratio (Random, 95% CI)1.02 [0.80, 1.31]
2.2 3D (Tai Chi)159Risk Ratio (Random, 95% CI)0.60 [0.19, 1.87]
2.3 Whole body vibration vs usual care162Risk Ratio (Random, 95% CI)0.88 [0.54, 1.43]
2.4 Combination of exercise categories (see Appendix 4 for categories in each trial)4607Risk Ratio (Random, 95% CI)1.07 [0.88, 1.29]

Care facilities: Exercise vs usual care (grouped by level of care)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls10 Rate ratio (Random, 95% CI)Subtotals only
1.1 High level nursing care facilities2210Rate ratio (Random, 95% CI)1.79 [0.89, 3.60]
1.2 Intermediate level care facilities51315Rate ratio (Random, 95% CI)0.70 [0.47, 1.04]
1.3 Facilities providing mixed levels of care3477Rate ratio (Random, 95% CI)1.08 [0.92, 1.28]
2 Number of fallers102090Risk Ratio (Random, 95% CI)1.02 [0.88, 1.18]
2.1 High level nursing care facilities1194Risk Ratio (Random, 95% CI)1.16 [0.83, 1.62]
2.2 Intermediate level care facilities61419Risk Ratio (Random, 95% CI)0.94 [0.75, 1.17]
2.3 Mixed level care facilities3477Risk Ratio (Random, 95% CI)1.05 [0.76, 1.47]

Care facilities: Comparisons of different exercise programs (see Appendix 4 for details)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls5 Rate Ratio (Fixed, 95% CI)Subtotals only
1.1 Additional gait, balance, functional training256Rate Ratio (Fixed, 95% CI)0.62 [0.40, 0.96]
1.2 Strength/resistance vs self‐training134Rate Ratio (Fixed, 95% CI)0.74 [0.50, 1.10]
1.3 Balance and strength vs self‐training132Rate Ratio (Fixed, 95% CI)0.48 [0.30, 0.77]
1.4 Flexibility (Yoga) vs 'Staying active' program120Rate Ratio (Fixed, 95% CI)0.47 [0.24, 0.91]
1.5 3D (Tai Chi) vs 'Staying active' program120Rate Ratio (Fixed, 95% CI)0.52 [0.28, 0.98]
1.6 Flexibility (Yoga) vs 3D (Tai Chi)118Rate Ratio (Fixed, 95% CI)1.11 [0.51, 2.37]
1.7 3D exercises ("In balance") vs Functional balance, strength & mobility1142Rate Ratio (Fixed, 95% CI)0.73 [0.60, 0.89]
1.8 Wii balance board vs Otago balance program160Rate Ratio (Fixed, 95% CI)0.35 [0.19, 0.63]
2 Rate of falls and number of fallers: trials with incomplete data  Other dataNo numeric data
3 Number of fallers5 Risk Ratio (Fixed, 95% CI)Subtotals only
3.1 Additional gait, balance, and functional training256Risk Ratio (Fixed, 95% CI)0.79 [0.43, 1.45]
3.2 Strength/resistance vs self‐training134Risk Ratio (Fixed, 95% CI)0.56 [0.30, 1.03]
3.3 Balance and strength vs self‐training132Risk Ratio (Fixed, 95% CI)0.55 [0.29, 1.05]
3.4 Additional whole body vibration1159Risk Ratio (Fixed, 95% CI)1.28 [0.71, 2.31]
3.5 3D exercises ("In balance") vs Functional balance, strength & mobility1142Risk Ratio (Fixed, 95% CI)0.92 [0.70, 1.21]
3.6 Comparison of combination exercise programmes141Risk Ratio (Fixed, 95% CI)0.54 [0.29, 1.01]
4 Number of people sustaining a fracture1 Risk Ratio (Fixed, 95% CI)Totals not selected
4.1 Total fractures1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]

Care facilities: Medication review vs usual care

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls7 Rate ratio (Random, 95% CI)Subtotals only
1.1 General medication reviews vs usual care62409Rate ratio (Random, 95% CI)0.93 [0.64, 1.35]
1.2 Medication review for hyponatraemia19Rate ratio (Random, 95% CI)0.63 [0.16, 2.49]
2 Number of fallers7 Risk Ratio (Random, 95% CI)Subtotals only
2.1 General medication review vs usual care65139Risk Ratio (Random, 95% CI)0.93 [0.80, 1.09]
2.2 Medication review for hyponatraemia19Risk Ratio (Random, 95% CI)0.42 [0.07, 2.59]
3 Number of people sustaining a fracture1 Risk Ratio (Fixed, 95% CI)Totals not selected
3.1 General medication review vs usual care1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
4 Rate of falls post‐hoc sensitivity analysis (excluding Potter 2016)5 Rate ratio (Random, 95% CI)Subtotals only
4.1 General medication reviews vs usual care5 Rate ratio (Random, 95% CI)0.82 [0.60, 1.11]
5 Serious adverse events1 Risk Ratio (M‐H, Fixed, 95% CI)Totals not selected
5.1 General medication review vs usual care1 Risk Ratio (M‐H, Fixed, 95% CI)0.0 [0.0, 0.0]

Care facilities: Vitamin D supplementation vs no vitamin D supplementation

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls6 Rate ratio (Random, 95% CI)Subtotals only
1.1 Additional Vitamin D supplementation44512Rate ratio (Random, 95% CI)0.72 [0.55, 0.95]
1.2 Multivitamins (including vitamin D3 + calcium) vs placebo191Rate ratio (Random, 95% CI)0.38 [0.20, 0.71]
1.3 Education on Vitamin D + calcium + osteoporosis medications vs usual care14017Rate ratio (Random, 95% CI)1.03 [0.85, 1.25]
2 Number of fallers7 Risk Ratio (Random, 95% CI)Subtotals only
2.1 Vitamin D supplementation44512Risk Ratio (Random, 95% CI)0.92 [0.76, 1.12]
2.2 Vitamin D + calcium supplementation vs placebo1583Risk Ratio (Random, 95% CI)1.03 [0.90, 1.18]
2.3 Multivitamins (including vitamin D3 + calcium) vs usual care or placebo191Risk Ratio (Random, 95% CI)0.82 [0.40, 1.66]
2.4 Education on Vitamin D + calcium + osteoporosis medications vs usual care14017Risk Ratio (Random, 95% CI)1.05 [0.90, 1.23]
3 Number of people sustaining a fracture4 Risk Ratio (Random, 95% CI)Subtotals only
3.1 Vitamin D supplementation34464Risk Ratio (Random, 95% CI)1.09 [0.58, 2.03]
3.2 Vitamin D3 + calcium vs placebo1583Risk Ratio (Random, 95% CI)0.62 [0.36, 1.07]
4 Adverse events4 Risk Ratio (M‐H, Fixed, 95% CI)Totals not selected
4.1 Multivitamins (including vitamin D3 + calcium) vs usual care or placebo1 Risk Ratio (M‐H, Fixed, 95% CI)0.0 [0.0, 0.0]
4.2 Vitamin D + calcium supplementation1 Risk Ratio (M‐H, Fixed, 95% CI)0.0 [0.0, 0.0]
4.3 Vitamin D supplementation2 Risk Ratio (M‐H, Fixed, 95% CI)0.0 [0.0, 0.0]

Care facilities: Environmental interventions vs usual care

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls1 Rate Ratio (Fixed, 95% CI)Totals not selected
1.1 Wireless position‐monitoring patch vs usual care1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]

Care facilities: Social environment vs usual care

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls4 Rate Ratio (Fixed, 95% CI)Totals not selected
1.1 Staff education on fracture prevention vs usual care1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
1.2 Guideline implementation programme vs control1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
1.3 Risk assessment tool vs nurses' judgement1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
1.4 Dementia care mapping vs usual care1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
2 Number of fallers1 Risk Ratio (Fixed, 95% CI)Totals not selected
2.1 Risk assessment tool vs nurses' judgement1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
3 Number of people sustaining a fracture2 Risk Ratio (Fixed, 95% CI)Subtotals only
3.1 Risk assessment tool vs nurses' judgement11125Risk Ratio (Fixed, 95% CI)0.96 [0.57, 1.63]
3.2 Project nurse facilitating best‐practice falls injury prevention strategies vs usual care15391Risk Ratio (Fixed, 95% CI)0.95 [0.63, 1.44]

Care facilities: Psychological interventions vs control

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls1 Rate Ratio (Fixed, 95% CI)Totals not selected
1.1 Exercise + cognitive training vs exercise1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
2 Number of fallers1 Risk Ratio (Fixed, 95% CI)Totals not selected
2.1 Exercise + cognitive training vs exercise1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]

Care facilities: Other single interventions vs control

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls2 Rate Ratio (Fixed, 95% CI)Totals not selected
1.1 Lavender patch vs placebo1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
1.2 Sunlight exposure vs usual care1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
2 Number of fallers2 Risk Ratio (Fixed, 95% CI)Totals not selected
2.1 Lavender patch vs placebo1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
2.2 Sunlight exposure vs usual care1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
3 Number of people sustaining a fracture1 Risk Ratio (Fixed, 95% CI)Totals not selected
3.1 Sunlight exposure vs usual care1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]

Care facilities: Multiple interventions vs usual care

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls2 Rate Ratio (Fixed, 95% CI)Totals not selected
1.1 Exercise + management of urinary incontinence + fluid therapy vs usual care1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
1.2 Sunlight exposure + calcium vs usual care1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
2 Number of fallers2 Risk Ratio (Fixed, 95% CI)Totals not selected
2.1 Exercise + management of urinary incontinence + fluid therapy vs usual care1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
2.2 Sunlight exposure + calcium vs usual care1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
3 Number of people sustaining a fracture2 Risk Ratio (Fixed, 95% CI)Totals not selected
3.1 Exercise + management of urinary incontinence + fluid therapy vs usual care1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
3.2 Sunlight exposure + calcium vs usual care1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]

Care facilities: Multifactorial interventions vs usual care (grouped by level of care)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls103439Rate Ratio (Random, 95% CI)0.88 [0.66, 1.18]
1.1 High level nursing care facilities21499Rate Ratio (Random, 95% CI)0.59 [0.44, 0.79]
1.2 Intermediate level care facilities3670Rate Ratio (Random, 95% CI)0.64 [0.50, 0.83]
1.3 Mixed level care facilities51270Rate Ratio (Random, 95% CI)1.23 [0.85, 1.77]
2 Number of fallers9 Risk Ratio (Random, 95% CI)Subtotals only
2.1 High level nursing care facilities1981Risk Ratio (Random, 95% CI)0.75 [0.57, 0.98]
2.2 Intermediate level care facilities3670Risk Ratio (Random, 95% CI)0.75 [0.60, 0.94]
2.3 Mixed level care facilities51502Risk Ratio (Random, 95% CI)1.01 [0.88, 1.15]

Care facilities: Multifactorial interventions vs usual care (grouped by level of cognition)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls10 Rate ratio (Random, 95% CI)Subtotals only
1.1 Participants with cognitive impairment41199Rate ratio (Random, 95% CI)0.83 [0.49, 1.40]
1.2 Participants with no cognitive impairment or mixed sample81805Rate ratio (Random, 95% CI)0.84 [0.62, 1.13]
2 Number of fallers10 Risk Ratio (Random, 95% CI)Subtotals only
2.1 Participants with cognitive impairment4955Risk Ratio (Random, 95% CI)0.79 [0.57, 1.12]
2.2 Participants with no cognitive impairment or mixed sample81805Risk Ratio (Random, 95% CI)0.94 [0.78, 1.12]

Hospitals: Vitamin D supplements vs no vitamin D supplements

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Number of fallers1 Risk Ratio (Fixed, 95% CI)Totals not selected
1.1 Vitamin D + calcium vs calcium1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
2 Number of people sustaining a fracture1 Risk Ratio (Fixed, 95% CI)Totals not selected
2.1 Vitamin D + calcium vs calcium1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
3 Adverse events1 Risk Ratio (M‐H, Fixed, 95% CI)Totals not selected
3.1 Gastrointestinal complaints (nausea, vomiting, diarrhoea)1 Risk Ratio (M‐H, Fixed, 95% CI)0.0 [0.0, 0.0]

Hospitals: Environmental interventions vs usual care

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls5 Rate Ratio (Random, 95% CI)Subtotals only
1.1 Carpet flooring vs vinyl flooring154Rate Ratio (Random, 95% CI)14.73 [1.88, 115.35]
1.2 Low‐low beds vs usual care111099Rate Ratio (Random, 95% CI)1.39 [0.22, 8.78]
1.3 Blue identification bracelet vs usual care (no bracelet)1134Rate Ratio (Random, 95% CI)1.15 [0.72, 1.84]
1.4 Bed alarms vs usual care228649Rate Ratio (Random, 95% CI)0.60 [0.27, 1.34]
2 Number of fallers4 Risk Ratio (Fixed, 95% CI)Subtotals only
2.1 Carpet flooring vs vinyl flooring154Risk Ratio (Fixed, 95% CI)8.33 [0.95, 73.37]
2.2 Blue identification bracelet vs usual care (no bracelet)1134Risk Ratio (Fixed, 95% CI)1.34 [0.76, 2.36]
2.3 Bed alarms vs usual care228649Risk Ratio (Fixed, 95% CI)0.93 [0.38, 2.24]

Hospitals: Social environment vs control

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls5 Rate Ratio (Fixed, 95% CI)Totals not selected
1.1 Organisational service model change (fall prevention guideline implementation)1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
1.2 Organisation service model change (falls prevention, incontinence and ulcer guideline implementation)1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
1.3 Organisational service model change (fall prevention toolkit software)1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
1.4 Acute care service for elderly patients vs usual care1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
1.5 Post‐operative orthogeriatric service after hip fracture1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
2 Number of fallers3 Risk Ratio (Fixed, 95% CI)Totals not selected
2.1 Fall prevention tool kit software vs usual care1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
2.2 Behaviour advisory service vs usual care1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
2.3 Post‐operative orthogeriatric service after hip fracture1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
3 Number of people sustaining a fracture1 Risk Ratio (Fixed, 95% CI)Totals not selected
3.1 Post‐operative orthogeriatric service after hip fracture1 Risk Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]

Hospitals: Knowledge/education interventions vs usual care

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls1 Rate Ratio (Fixed, 95% CI)Totals not selected
1.1 Educational materials + health professional follow‐up vs usual care1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
1.2 Educational materials only vs usual care1 Rate Ratio (Fixed, 95% CI)0.0 [0.0, 0.0]
2 Number of fallers2 Risk Ratio (Random, 95% CI)Totals not selected
2.1 Individualised educational session vs usual care1 Risk Ratio (Random, 95% CI)0.0 [0.0, 0.0]
2.2 Educational materials + health professional follow‐up vs usual care1 Risk Ratio (Random, 95% CI)0.0 [0.0, 0.0]
2.3 Educational materials only vs usual care1 Risk Ratio (Random, 95% CI)0.0 [0.0, 0.0]

Hospitals: Multifactorial interventions vs usual care (grouped by type of care)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Rate of falls544664Rate Ratio (Random, 95% CI)0.80 [0.64, 1.01]
1.1 Acute level of care135264Rate Ratio (Random, 95% CI)1.04 [0.79, 1.37]
1.2 Subacute or acute (mixed) levels of care25653Rate Ratio (Random, 95% CI)0.88 [0.61, 1.27]
1.3 Subacute level of care23747Rate Ratio (Random, 95% CI)0.67 [0.54, 0.83]
2 Number of fallers3 Risk Ratio (Random, 95% CI)0.82 [0.62, 1.09]
2.1 Acute level care1 Risk Ratio (Random, 95% CI)0.99 [0.33, 3.00]
2.2 Subacute or acute (mixed) levels of care1 Risk Ratio (Random, 95% CI)1.04 [0.48, 2.28]
2.3 Subacute level of care1 Risk Ratio (Random, 95% CI)0.78 [0.57, 1.07]
3 Number of people sustaining a fracture2 Risk Ratio (Fixed, 95% CI)0.76 [0.14, 4.10]
3.1 Subacute or acute (mixed) levels of care1 Risk Ratio (Fixed, 95% CI)0.32 [0.01, 8.95]
3.2 Subacute level of care1 Risk Ratio (Fixed, 95% CI)1.02 [0.14, 7.24]

Aizen 2015

MethodsStepped‐wedge, cluster‐randomised controlled trial.
ParticipantsSetting: hospital, subacute, 5 geriatric rehabilitation wards, Israel.N = 508 participants; 5 clustersSample: 52% womenAge (years): mean 83.2

Baseline characteristics

Individualised fall prevention programme
  • N: 200

  • Age ‐ mean (SD) : 84.6 (5.6)

  • Female ‐ N (%): 92 (46.0)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: N


Usual care
  • N: 308

  • Age ‐ mean (SD) : 84.1 (7.7)

  • Female ‐ N (%): 173 (56.1)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: N


Inclusion criteria: Over 65 years; admitted to rehabilitation ward
Exclusion criteria: Restricted to bed; refused to participate
Pretreatment differences: Phase 1: Longer stay in the control group patients (P < 0.001); higher percentage of females in the control group (P = 0.03)
Interventions
  • Individualised fall prevention programme. Falls risk assessment and management: including medical interventions, environmental modifications, equipment modifications, cognitive and behavioural treatment, family guidance. Mobility restrictions and optimising location on weekly assessment. Environmental modifications unclear.

  • Usual care. Any activities undertaken by the participants recommended or administered by their treating team

Outcomes
Duration of the studyPeriod of inpatient admission
NotesOutcomes of phase one used only. Outcomes data for phase one and two only reported separately, attempts to contact authors unsuccessful. Excluded from pooling as group allocation of clusters unclear.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information for judgement.
Allocation concealment (selection bias)High riskAllocation not concealed as consent only required for those receiving the intervention.
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding not possible
Blinding of outcome assessment (detection bias)
All outcomes
High riskSenior nursing staff in control wards were aware of the study because the researchers were collecting study data. Researchers were not blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition balanced across groups and missing outcomes not great enough to have a clinically relevant impact on observed effect size.
Selective reporting (reporting bias)Unclear riskProtocol not available
Method of ascertaining fallsLow riskQuote: "from notes in medical records themselves, and by asking a senior nurse each day about any falls on the ward in the past 24 h."
Quote: "Information on falls was collected by the researchers from incident reports filed in patients’ medical records,"
Baseline imbalanceHigh riskLonger length of stay in control group at baseline suggests greater dependency in this group at baseline and not adjusted for in analysis
Other biasUnclear riskQuote: "some falls prevention activities were already occurring in control (and intervention) wards before the start of our study. These activities continued during the study period, making it more difficult to show any effect of our interventions."
Impact of other falls intervention approaches unclear. Stepped‐wedge trial but only data from phase 1 used as falls data not reported for both phases in combination.

Ang 2011

MethodsRCT (individually randomised)
ParticipantsSetting: acute care hospital, Singapore N = 1822 participants Sample: newly admitted patients from 8 medical wards (50% women) Age (years): mean (SD) intervention group 70.3 (14.2), control group 69.7 (14.7)

Inclusion criteria: aged ≥ 21; Hendrich II Fall Risk Model score ≥ 5


Exclusion criteria: admitted before start of study; fallen prior to falls risk assessment
Interventions
  • Education + usual care: participants received one educational session (no more than 30 minutes) based on identified risk factors. Designed to increase awareness of risk of falling during hospitalisation and teach risk‐reduction strategies. Relatives of confused participants received the educational session

  • Control: usual care and including usual fall‐prevention interventions

Outcomes
Duration of the study8 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Allocation of the participants to control or intervention groups was determined using block randomisation with the aid of a computer program and stratified by ward to ensure an even mix in the ward."
Allocation concealment (selection bias)Low riskQuote: "Sealed, opaque, serially numbered envelopes were produced from the randomizations sequence separately for each stratum."
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskQuote: "The research investigator scanned the electronic hospital occurrence report (eHOR) daily during weekday for entries of fall incidences reported by the nurses from the wards and ascertained if the entries were on participants involved in the study."
Nursing staff recording falls described as blind to group allocation. Not clear if the research investigator was blind to group allocation
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: all data analysed according to ITT.
Selective reporting (reporting bias)High riskJudgement comment: methods mention incidence of falls but only data on risk of falling reported.
Method of ascertaining fallsHigh riskJudgement comment: falls not clearly defined.
Baseline imbalanceLow riskNo important differences at baseline.
Other biasUnclear riskUnclear impact of standard falls prevention activities.

Barker 2016

MethodsCluster‐randomised controlled trial
ParticipantsSetting: 24 acute medical and surgical wards from 6 hospitals, AustraliaN = 31,411 unique participants, including 3853 admitted to both intervention and control wards at different times; 24 clusters.Sample: 48.5% womenAge (years): median 67 (interquartile range 51‐79)

Baseline characteristics:


6‐PACK programme
  • N: 22,670 admissions; 17,698 participants

  • Age Median (IQR): 68 (51‐80)

  • Female N (%): 11,476 (50.6)

  • Medical status defined? ‐ Y/N : Y (3+ comorbidities 21.2%)

  • Falls risk defined?‐ Y/N: N

  • Dependency defined? ‐ Y/N: No

  • Cognitive status defined? ‐ Y/N: Y


Usual care
  • N: 23,575 admissions; 17,566 participants

  • Age Median (IQR): 67 (51‐79)

  • Female N (%): 11,424 (48.5)

  • Medical status defined? ‐ Y/N : Y (3+ comorbidities 25.3%)

  • Falls risk defined?‐ Y/N: N

  • Dependency defined? ‐ Y/N: N

  • Cognitive status defined? ‐ Y/N: Y


Inclusion criteria: Wards: where fall‐related injuries have been identified as a problem, acute medical or surgical wards; average patient length of stay <10 days; wards to have one or less low‐low beds to each six standard beds on medical wards and one or less low‐low beds to each, 29 standard beds on surgical wards; a fall risk assessment and/or prevention strategy checklist is not already included in the daily patient care plan documentation. Wards that have a fall risk assessment and/or prevention strategy checklist included on admission documentation but do not have a policy that this must be updated daily will not be excluded from participating in the study.
Exclusion criteria: No patient level exclusion criteria.
Pretreatment differences: Nil
Interventions
  • 6‐PACK programme comprising a 9 item falls risk assessment tool and delivery of one or more of six interventions to high risk patients: 1) Placement of a ‘falls alert' sign above the patient’s bed. 2) Supervision of patients while in the bathroom. 3) Use of a low‐low bed. 4) Ensuring that the patient’s walking aid is within reach at all times. 5) Establishment of a toileting regimen. 6) Use of a bed/chair alarm when the patient is positioned in the bed/chair. Staff education integral to implementation.Nurses were asked to update the fall risk tool for each of their patients each shift and to apply a falls alert sign and one or more of the remaining 6‐PACK interventions to patients classified as being at high risk

  • Usual care. Any standard hospital practice provided by wards as part of existing hospital policy relating to fall prevention, which may have included some components of the 6‐PACK programme and other interventions such as non‐slip socks, constant patient observers, and falls alert wrist bands.

Outcomes
  • Rate of falls

  • Number of fallers (number of unique fallers provided by author correspondence)

  • Number of injurious falls

  • Fracture falls (number of unique patients with fractures provided by author correspondence)

  • Multiple falls

  • Adverse events

Duration of the study12 months intervention period plus 3 month pre‐randomisation baseline period
NotesACTRN12611000332921
"The use of all 6‐PACK programme components (fall risk tool and six interventions) was threefold higher on intervention wards than on control wards (incidence rate ratio 3.05, 95% confidence interval 2.14 to 4.34; P<0.001)."
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "used the RALLOC command in Stata to develop the randomisation schedule, using a random sequence in blocks of two generated by the study statistician."
Judgement comment: random sequence allocation done.
Allocation concealment (selection bias)High riskQuote: "Concealment of allocation was ensured, as the schedule was accessible only by the study statistician, who was not involved in ward recruitment or data collection."
Judgement comment: although allocation sequence initially concealed, subjects were enrolled after cluster randomisation, and sequence would have been known at this time.
Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "It will not be feasible to blind ward nurses or patients to the intervention."
Judgement comment: not done.
Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote: "Blinding of the assessors collecting the fall and falls prevention practice data was also not possible. Assessors blinded to group allocation did the secondary coding of characteristics of falls and injuries, and the primary assessor completed the coding. A statistician blinded to group allocation (RW) did the data analysis."
Judgement comment: not done.
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: no loss to follow‐up
Selective reporting (reporting bias)Low riskJudgement comment: all falls outcomes reported as per trial registry record.
Method of ascertaining fallsLow riskQuote: "by daily auditing of patient medical records and verbal report of the nurse unit managers. These data will then be triangulated with hospital incident reporting and administrative patient episode datasets. Concurrent to this will be hospital‐wide education and reminders of the fall definition and incident reporting best practice, facilitated by use of an existing training package. 23 Patient"
Judgement comment: multiple methods of concurrent recording of falls data used.
Baseline imbalanceLow riskQuote: "Characteristics of admitted patients and length of stay were similar for intervention and control groups and across baseline and randomised controlled trial periods"
Judgement comment: no imbalance across groups.
Other biasUnclear riskUnclear impact of any ongoing falls prevention activities.

Beck 2016

MethodsRCT (cluster randomised), nursing home subgroup data.
ParticipantsSetting: 3 residential care homes, high‐level care, DenmarkN = 31 participants; 3 clusters.Sample: 65% womenAge (years): mean 88

Baseline Characteristics


Multidisciplinary nutritional support
  • N: 9 nursing home

  • Age Range: 88.1 (9.6)

  • Sex (% female): 6 (67)

  • Medical status defined?: N

  • Falls risk defined?: N

  • Dependency defined? (ADL problem, No. social services for home help, nursing): Y


Control
  • N: 22 nursing home

  • Age Range: 87.8 (7.0)

  • Sex (% female): 14 (64)

  • Medical status defined?: N

  • Falls risk defined?: N

  • Dependency defined? (ADL problem, No. social services for home help, nursing): Y


Inclusion criteria: 65+ years, at nursing home or receiving home care (assistance with meals) with 2 points according to Eating Validation Scheme (EVS) completed by nursing staff caregivers (would benefit from intervention) able to completed planned tests
Exclusion criteria: not able or willing to give informed consent
Pretreatment differences: living in a nursing home: intervention 16%, control 55% (P < 0.001); 30‐seconds chair‐stand modified, mean (SD) 4.9 (3.3) intervention, 2.5 (2.7) control (P = 0.004); cognitive problem 56% intervention versus 78% control (P = 0.03)
Interventions
  • Multidisciplinary nutritional support. Nutrition co‐ordinator involvement, multidisciplinary project group meetings, plan of action in the municipality care register system, Exercise, nutritional support, support for dysphagia and eating problems as indicated by EVS screening. 30 to 45 minutes moderate‐intensity exercise sessions including strength and balance training twice a week, oral training supplements after exercise, weekly assessment of weight, individual dietetics treatment plan and regular reviews by dietician, multidisciplinary meeting weekly to evaluate and adjust individual treatment plans, OT involvement if indicated. Health professional involvement: Nutrition co‐ordinator, physiotherapist twice weekly, dietician performs initial interview, then regular consultations and phone or group follow‐up, occupational therapist to consults with patients who suffer from eating dependency or chewing and swallowing problems and initiate interventions if indicated.

  • Control. Nutrition co‐ordinator involvement plus standard interventions from physiotherapist, registered dietician and occupational therapist requested through the municipality’s normal assessment and referral system will be maintained.

Outcomes
Duration of the study11 weeks
NotesA trial of nutritional support using a structured and multidisciplinary approach, focusing on nutritional risk factors, in undernourished older adults in both home care and nursing home settings, with results reported separately.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskJudgement comment: sequence generation by drawing a lot for an opaque envelope.
Allocation concealment (selection bias)High riskJudgement comment: randomisation by researcher not involved in the study (2016 p200). Author correspondence quote: "participants were invited by means of the staff who did not know about the result of the group allocation". and "we did not include new admissions". However: "Due to the limited knowledge about the benefit of nutritional support among home‐care clients, the aim was to randomly assign 2 of the 3 home‐care clusters to the intervention group", this is likely to enable the randomisation sequence to be predicted, concealment not possible for the final cluster.
Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "The researchers for this study included the research assistants (AGC, BSH, SD‐S, and TKSM) and the primary investigator (AB), who were not blinded for the intervention."
Judgement comment: blinding not done.
Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote: "The researchers for this study included the research assistants (AGC, BSH, SD‐S, and TKSM) and the primary investigator (AB), who were not blinded for the intervention. Before starting the analysis the primary investigator (AB) was reblinded for participants’ group assignment."
Judgement comment: not done, falls data collected by unblinded research nurse. Although primary investigator "reblinded" before analysis no details were reported on the method for this and it is considered likely to include a risk of residual unblinding.
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: author correspondence clarified data and indicated one withdrawal, no other loss to follow‐up.
Selective reporting (reporting bias)Low riskJudgement comment: trial protocol available and falls outcomes consistently reported.
Method of ascertaining fallsLow riskQuote: "The information was gathered by means of data from the RAI‐NH version 2.0 and RAI‐HC version 2.0 assessments and the municipality care register system. For each participant, the same trained nurse collected"
Judgement comment: concurrent falls data collection with clear definition.
Baseline imbalanceHigh riskJudgement comment: baseline imbalance in nursing home subgroup for cognition, no adjustment performed
Other biasLow riskNone detected.

Becker 2003

MethodsRCT (cluster randomised by facility).
ParticipantsSetting: 6 long‐term care facilities (high‐level nursing care), Germany N = 981 participants; 6 clusters. Sample: 79% women Age (years): mean (SD) intervention group 83.5 (7.5), control group 84.3 (6.9)

Inclusion criteria: resident of facility. Inclusion criteria for exercise programme: able to stand while holding a chair, able to lift one foot


Exclusion criteria: none stated
Interventions
  • Fall prevention programme for staff and residents. Residents chose to participate in any combination of interventions for any length of time. Those choosing to participate in fall registration only also received environmental modification and modification of nursing care

    • Staff training on risk factors and preventive measures (60 minutes), audit and monthly feedback re falls and injuries

    • Check list of 76 environmental hazards (lighting, chair and bed height, floor surfaces, etc). Feedback to staff and administrators

    • Resident education: all received written information, offered personal consultation by study nurse or exercise instructor

    • Group exercise programme (progressive balance and resistance training) 75 minutes, 2 x per week

    • Hip protectors

  • Control: usual care, no specific program activities.

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (hip fractures)

  • Adverse events

Duration of the study12 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCluster randomisation of 6 facilities using sealed envelopes selected by an independent person. Insufficient information to permit judgement
Allocation concealment (selection bias)Unclear riskAllocation in sealed envelopes, but individuals admitted after group allocation by a person who may have been unblinded and may have had knowledge of participant characteristics
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff at facilities who recorded falls were likely to be aware of their facility's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskAll residents included in analysis.
Selective reporting (reporting bias)Low riskAll expected falls outcomes completely and thoroughly reported. Adjustment for clustering conducted
Method of ascertaining fallsLow riskFall definition provided and concurrent recording of falls
Baseline imbalanceHigh riskGreater proportion of intervention group were taking 4 or more medications
Other biasLow riskNone identified.

Bischoff 2003

MethodsRCT (individually randomised)
ParticipantsSetting: 2 hospitals with long‐stay geriatric care units, Basel, Switzerland N = 122 participants Sample: 100% women Age (years): mean (SD) intervention group 85.4 (5.9), control group 84.9 (7.7)

Inclusion criteria: female; aged ≥ 60; able to walk 3 metres


Exclusion criteria: primary hyperparathyroidism; hypercalcaemia; hypercalcuria; renal insufficiency; fracture or stroke in last 3 months
Interventions1. 800 IU oral cholecalciferol (vitamin D3) plus 1200 mg calcium daily for 12 weeks
2. Control: 1200 mg calcium daily for 12 weeks
Outcomes
  • 1. Rate of falls

  • 2. Number of people falling

  • 3. Number sustaining a fracture (hip fractures)

  • 4. Adverse events

Duration of the study12 weeks
Notes50% of participants had a baseline serum vitamin level < 30 nmol/L
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "The randomization was performed by an independent statistician."
Allocation concealment (selection bias)Low riskParticipants randomised in groups of four by an independent statistician
Blinding of participants and personnel (performance bias)
All outcomes
Low riskJudgement comment: double‐blind
Blinding of outcome assessment (detection bias)
All outcomes
Low riskPatients, nurses, and all investigators were blinded to the treatment assignment throughout the study
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: high loss to follow‐up (31% in vit D and 25% in control group); however, analysed as ITT with rate ratio accounting for days of follow‐up and balanced between groups
Selective reporting (reporting bias)Low riskJudgement comment: no study protocol identified, but data on falls, fallers, multiple falls as adjusted and adjusted outcomes reported.
Method of ascertaining fallsLow riskQuote: "Falls were recorded by the nurses on the inpatient units who had received training in the use of the fall protocol (date, time, circumstances, injuries). Falls were defined as “unintentionally coming to rest on the ground, floor, or other lower level.” Coming to rest against furniture or a wall was not counted as a fall. (24) Nurses completed the fall protocol if they observed or received a report of a fall."
Baseline imbalanceLow riskJudgement comment: characteristics and number of falls balanced at baseline
Other biasLow riskJudgement comment: none identified. Small groups randomised however given trial is double‐blinded randomisation unlikely to be predictable

Broe 2007

MethodsRCT (individually randomised)
ParticipantsSetting: 1 long‐term care facility (high‐level care), USA N = 48 participants included in review (total of 124 in the study) Sample: 73% women Age (years): mean 89 (SD 6)

Inclusion criteria: life expectancy > 6 months; able to swallow medications; resident for > 3 months


Exclusion criteria: taking glucocorticoids; anti‐seizure medications; pharmacological doses of vitamin D; calcium metabolism disorders; severe mobility restriction; fracture within previous 6 months
Interventions
  • 200 IU of vitamin D2 daily for 5 months (not included in review)

  • 400 IU of vitamin D2 daily for 5 months (not included in review)

  • 600 IU of vitamin D2 daily for 5 months (not included in review)

  • 800 IU of vitamin D2 daily for 5 months

  • Control: placebo daily for 5 months

Outcomes
  • Rate of falls

  • Number of people falling

Duration of the study5 months
NotesMean baseline serum vitamin D level for 800 IU group and control group combined was 53 nmol/L
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "... computer‐generated randomisation list."
Allocation concealment (selection bias)Low riskPharmacy conducted randomisation and supplied medication in blister packs with name and patient identification number only
Blinding of participants and personnel (performance bias)
All outcomes
Low riskJudgement comment: double‐blind
Blinding of outcome assessment (detection bias)
All outcomes
Low riskNursing staff completing incident forms blinded to treatment status because blister packs and tablets identical in appearance. Also, quote: "a programmer, not involved with this study and not aware of participant study group assignments, created the falls dataset linking the participant identification number with falls reported during the study period"
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: low loss to follow‐up and ITT analysis performed.
Selective reporting (reporting bias)Low riskJudgement comment: no protocol identified, however all expected outcomes (falls, rate of falls and fallers) reported.
Method of ascertaining fallsLow riskJudgement comment: falls concurrently recorded and clearly defined
Baseline imbalanceUnclear riskJudgement comment: few differences at baseline; however baseline cognition, medical comorbidities and function not reported
Other biasLow riskNone identified.

Buckinx 2014

MethodsRCT. Individually randomised.
ParticipantsSetting: 2 residential care facilities, intermediate‐level care, BelgiumN = 62 participantsSample: 76% womenAge (years): mean 83.2 (SD 7.9)

Baseline characteristics


Whole body vibration
  • N: 31

  • Age ‐ mean (SD): 82.2 (9.02)

  • Female N (%): 20 (64.5)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (Y/N)?: Y

  • Dependency defined (Y/N)?: Y

  • Cognitive status defined? Y/N: Y


Control
  • N: 31

  • Age ‐ mean (SD): 84.2 (6.83)

  • Female N (%): 27 (87.1)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (Y/N)?: Y

  • Dependency defined (Y/N)?: Y

  • Cognitive status defined? Y/N: Y


Inclusion criteria: residents from two nursing homes; able to remain standing; able to move with or without technical assistance
Exclusion criteria: weight greater than 150 kg; electronic implants; knee or hip prostheses; epilepsy; bleeding disorders; inflammatory abdominal disorders; high risk of thromboembolism; malignancy; unconsolidated fracture; refusal of doctor or family
Pretreatment differences: gender (more women in control group) P = 0.04; lower body mass in control group P < 0.01; lower MMSE in control group, P = 0.04
Interventions
  • Whole body vibration. Exercise programme on a sinusoidal vibration platform (Vibrosphere), standing without shoes with knees flexed, cushion placed under vibrosphere. 3 x weekly, 5 series of 15 seconds of vibrations at 30 Hz, 2mm amplitude, alternate with 30 seconds rest, total vibration time 1 minute 15 seconds, minimum 1 day between sessions. Supervised by one of 4 people, 2 physiotherapists and 2 authors.

  • Usual care. No change to lifestyle during study, no involvement in any new type of physical activity

Outcomes
  • Number of falls

  • Number of people falling

Duration of the study6 months intervention, follow‐up to 12 months.
NotesCompliance: 91.9% of exercise sessions performed.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "We performed the randomisation by blocks of four with a computer‐generated randomisation procedure."
Judgement comment: computer‐generated randomisation.
Allocation concealment (selection bias)Unclear riskQuote: "An identification number and a randomisation number were created for each participant."
Judgement comment: method of concealment of allocation sequence from those enrolling participants was unclear.
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not done. Blinding not possible.
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: not done. Nurses recorded falls, they were not blinded. Blinded assessment unlikely to include falls outcomes.
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: numbers and reasons balanced between groups.
Selective reporting (reporting bias)Low riskJudgement comment: number of falls not defined as outcome in trial registry. Trials registry indicates 3 months outcomes. Reporting of falls data appears complete although not predefined.
Method of ascertaining fallsLow riskQuote: "Nurses completed the fall record with the date, time, and circumstances of the falls."
Judgement comment: likely that falls were recorded at time of event.
Baseline imbalanceHigh riskBaseline differences in weight, gender, MMSE may impact on falls rates.
Other biasLow riskJudgement comment: none identified

Buettner 2002

MethodsRCT (individually randomised)
ParticipantsSetting: 3 nursing care facilities, USA (1 high‐level nursing facility, 1 skilled nursing facility, 1 intermediate‐level facility) N = 27 participants Sample: 44% women Age (years): mean 83.3 (range 60 to 98)

Inclusion criteria: ≥ 2 falls in past 2 months between 7.00 am to 9 am; MMSE score < 23; aged > 60; walking independently, or with 1 assistant or assistive device


Exclusion criteria: not resident for ≥ 60 days; a healing fracture; attending physiotherapy
Interventions
  • Supervised group exercises: walking group daily at 6.30 am; exercise to improve function (balance, strength, and flexibility) 3 x per week in mid afternoon; sensory air mat therapy (movement, relaxation) 2 x per week in evenings. Intervention overseen by Certified Therapeutic Recreational Specialist with assistance of staff members. The interventions were scheduled at the time of day when most falls occur and in the locations where the falls occur

Outcomes
Duration of the study2 months
NotesPublished data incomplete. Further data provided by authors could not be analysed
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo description of method of sequence generation
Allocation concealment (selection bias)Unclear riskNo description of allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff collecting falls data do not appear to have been blinded to allocation status
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskJudgement comment: insufficient detail on which patients are included in data analysis for judgement.
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified. Number of falls analysed as t‐test of absolute numbers without rate, considering pre‐test falls.
Method of ascertaining fallsHigh riskJudgement comment: falls not clearly defined
Baseline imbalanceUnclear riskJudgement comment: Baseline characteristics not reported by allocation group
Other biasLow riskJudgement comment: None detected

Burleigh 2007

MethodsRCT (individually randomised)
ParticipantsSetting: general assessment and rehabilitation wards in an acute geriatric unit, Glasgow, Scotland N = 205 participants Sample: 59% women, median serum vitamin D (25 OHD) = 22.00 nmol/L, IQR 15.00 to 30.50 at baseline. Age (years): mean (SD) intervention 82.3 (7.6), control 83.7 (7.6)

Inclusion criteria: admitted to a ward in the acute geriatric unit; aged ≥ 65


Exclusion criteria: hypercalcaemia; urolithiasis; renal dialysis; terminal illness; bed bound; reduced Glasgow Coma Score; already prescribed vitamin D and calcium; 'nil by mouth' on admission
Interventions
  • 800 IU oral cholecalciferol (vitamin D3) plus 1200 mg calcium daily until separation from the facility

  • Control: 1200 mg calcium daily until discharge or death

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (all fractures)

  • Adverse events

Duration of the studyAproximately 9 months. Median length of stay 30 days
NotesBaseline serum vitamin D (25 OHD) = median 22.00 nmol/L, IQR 15.00 to 30.50
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "... randomised using a random numbers table"
Allocation concealment (selection bias)Low riskQuote: "Randomisation was known only to the statistician and pharmacist who subsequently issued an appropriate uniquely numbered drug blister pack to each patient’s ward."
Blinding of participants and personnel (performance bias)
All outcomes
Low riskJudgement comment: double‐blind
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskStaff completing falls data may have been aware of treatment status as there was no placebo in place of vitamin D. Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: ITT analysis and losses balanced between groups
Selective reporting (reporting bias)Low riskJudgement comment: falls and fallers outcomes reported as per trial registration
Method of ascertaining fallsLow riskJudgement comment: falls defined and recorded concurrently
Baseline imbalanceHigh riskJudgement comment: 2x2 indicates significant difference in proportion with Zimmer frame between groups (P = 0.02).
Other biasLow riskJudgement comment: falls and fallers outcomes reported as per trial registration

Cadore 2014

MethodsRCT (individually randomised)
ParticipantsSetting: residential care facility, mixed‐level care, SpainN = 24 participantsSample: 70% womenAge (years): mean 91.9 (SD 4.1)

Baseline Characteristics


Multicomponent exercises
  • N : 11

  • Age Range ‐ mean (SD) (overall 91.9 +/‐ 4.1 years): 93.4 ± 3.2

  • Female (17/24 overall) n (%): 8/11

  • Medical status defined? (admission diagnosis & co‐morbidities): N

  • Falls risk defined?: Y, Dual task walking

  • Dependency defined?: Y

  • Mean no falls pre‐training: 0.77+/‐0.44

  • Cognitive status defined?: Y


Control
  • N : 13

  • Age Range ‐ mean (SD) (overall 91.9 +/‐ 4.1 years): 90.1 ± 1.1

  • Female (17/24 overall) n (%): 9/13 (69)

  • Medical status defined? (admission diagnosis & co‐morbidities): N

  • Falls risk defined?: Y, Dual task walking

  • Dependency defined?: Y

  • Mean no falls pre‐training: 0.93n+/‐0.3

  • Cognitive status defined?: Y


Inclusion criteria: nursing home residents from Pamplona, Spain; 85 years or older; frail (as per Fried's criteria): 3 or more of slowness, weakness, weight loss, exhaustion, and low physical activity
Exclusion criteria: the absence of frailty or pre‐frailty syndrome; dementia; disability (defined as a Barthel Index (BI) lower than 60 and inability to walk independently without help of another person); recent cardiac arrest; unstable coronary syndrome; active cardiac failure; cardiac block; any unstable medical condition
Pretreatment differences: baseline demographic data not reported
Interventions
  • Multicomponent exercises. Muscle power training (8–10 repetitions, 40% to 60 % of the one‐repetition maximum) combined with balance and gait retraining, including warm up and cool down periods. Twice weekly, 40 minute duration, at least 2 consecutive days between sessions

  • Control. Mobility exercises: small active and passive movements applied as a series of stretches in a rhythmic fashion to the individual joints. Such exercises are routinely encouraged in most Spanish nursing homes. 30 minutes per day at least 4 days per week

Outcomes
Duration of the study12 weeks
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "The randomisation sequence was generated by http://www.randomization.com and concealed until interventions were assigned."
Allocation concealment (selection bias)Low riskQuote: "and concealed until interventions were assigned."
Judgement comment: author correspondence. Quote: "The group allocation was concealed. A researcher with no previous contact with subjects as well as not involved with assessment and training made the allocation of subjects."
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding of participants not possible due to active involvement in intervention.
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: blinding mentioned is not for falls outcomes. Residents who were not blinded recorded falls.
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: loss to follow‐up low and balanced between groups.
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol or trials registry records identified
Method of ascertaining fallsHigh riskQuote: "Data on the incidence of falls were assessed retrospectively using questionnaires to residents."
Judgement comment: based on recall of participants.
Baseline imbalanceUnclear riskJudgement comment: baseline demographic data not reported
Other biasLow riskJudgement comment: none identified

Chapuy 2002

MethodsRCT (individually randomised)
ParticipantsSetting: 55 intermediate nursing care facilities, France N = 610 participants Sample: 100% women Age (years): mean 85.2 (SD 7.1)

Inclusion criteria: ambulatory; life expectancy > 2 years


Exclusion criteria: malabsorption; serum calcium > 2.63 mmol/L; chronic renal failure (serum creatinine >150 μmol/L), taking bone metabolism altering medications within the past year, e.g. corticosteroids, anticonvulsants or high doses of thyroxine; fluoride salts (43 months), bisphosphonates, calcitonin (41 month), calcium (4500 mg/day) and vitamin D (4100 IU/day) during the last 12 months
Interventions
  • 800 IU of vitamin D3 + 1200 mg calcium carbonate fixed combination daily

  • 800 IU of vitamin D3 + 1200 mg calcium carbonate separately daily

  • Control: placebo

Outcomes
  • Number of people falling

  • Number sustaining a fracture (hip fracture)

  • Adverse events

Duration of the study24 months
NotesDescribed as "apartment houses for elderly people" in Chapuy 2002 but provision of drugs supervised by nursing staff "to ensure compliance". Mean baseline serum vitamin D level 22 nmol/L
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information about the sequence generation process to permit judgement of 'Low risk' or 'High risk'
Allocation concealment (selection bias)Unclear riskAlthough described as multicentre, randomised, double‐masked, placebo‐controlled, the method of concealment prior to allocation is not described in sufficient detail to allow a definite judgement
Blinding of participants and personnel (performance bias)
All outcomes
Low riskJudgement comment: double‐blind
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBlinding of treatment status to outcome assessors not mentioned. Participants were asked if they had an adverse event (including falls) in last 3 months. Not clear if the person asking would have known allocation status
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskJudgement comment: loss to follow‐up over 2‐year period unclear.
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified.
Method of ascertaining fallsHigh riskFalls events poorly defined.
Baseline imbalanceLow riskJudgement comment: groups balanced at baseline
Other biasLow riskJudgement comment: none detected

Chenoweth 2009

MethodsRCT (cluster randomised by unit).
ParticipantsSetting: 15 residential dementia care units (high‐level nursing care), Sydney, Australia N = 289 residents; 15 clusters Sample: people with dementia (78% women)Age (years): mean (SD) person‐centred care group 83 (7.6), dementia‐care mapping group 84 (6.4), usual care group 83 (7.6)

Inclusion criteria (facilities): task‐focused (not person‐centred) care systems. Inclusion criteria (residents): dementia and low cognitive function; aged >60; high dependency needs; persistent need‐driven dementia compromised behaviours


Exclusion criteria (residents): serious co‐morbidities complicating or masking dementia; palliative care; unremitting pain; distressing physical symptoms; respite placement
Interventions
  • Person‐centred care: one researcher trained 2 care staff per site in allocated method of care (see 'Notes'), worked with trained staff to implement care plans, provided two site visits to give ongoing support for staff, then regular telephone contact for 4 months

  • Dementia care mapping: two researchers trained 2 care staff per site in allocated method of care (see 'Notes'), carried out "mapping" with trained staff, developed care plans with trained staff, trained staff helped colleagues implement plans, regular telephone contact from researchers for 4 months

  • Usual care: non person‐centred care that is task‐focused and concerned mostly with physical care needs

Outcomes
Duration of the study8 months
NotesPerson‐centred care emphasised social interactions at affective level based on life histories; aimed to preserve personal identity and foster meaningful relationships.
Dementia‐care mapping: "mapping" consisted of observation of each participant for 6 hours per day for 2 days to identify factors related to well‐being
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Allocation was done by the study statistician (MTK), who was unaware of the identity of sites, using an SAS20 program."
Allocation concealment (selection bias)Low riskEligible residents were selected by facility managers or directors before randomisation of sites
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Treatment allocation was masked to assessors."
Three separate research assistants collected outcome data from each cluster of five facilities. Staff of facilities instructed not to inform assessors of interventions
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: >20% loss from person‐centred care and usual care arms.
Selective reporting (reporting bias)Unclear riskJudgement comment: falls stated as outcome ‐ Incidents, quote: "and subsequent admissions to hospital were discerned from official records of incidents including residents’ falls, fractures, lacerations, bruises, medication errors, and behavioural incidents" (p320, column 1, para 2). However, falls not stated as outcome in initial trial registry record (added retrospectively)
Method of ascertaining fallsHigh riskJudgement comment: falls poorly defined and multiple sites enrolled.
Baseline imbalanceLow riskJudgement comment: differences at baseline adjusted for in analysis.
Other biasLow riskJudgement comment: none identified.

Choi 2005

MethodsRCT (cluster randomised).
ParticipantsSetting: 2 residential care facilities (intermediate‐level care), Korea N = 68 participants; 2 clusters. Sample: 75% women Age (years): mean 77.9 (range 61 to 91)

Inclusion criteria: ambulatory; age > 60; at least one fall risk factor (impaired gait, impaired balance; a fall in the last year; postural hypotension; four or more medications affecting balance)


Exclusion criteria: severe dementia; physical illness that may prevent completion of 12‐week course of exercise; involvement in any other exercise
Interventions
  • Supervised Tai Chi: 35‐minute group sessions with certified Tai Chi leader, 3 x per week for 12 weeks

Outcomes
Duration of the study3 months
NotesCluster randomised, described as quasi‐experimental design with a non‐equivalent control group.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "... two facilities with similar characteristics were selected and randomly assigned to either the experimental or control group by coin tossing." 
Allocation concealment (selection bias)High riskAfter first toss the allocation of the second facility would be known. No description of whether individual participant recruitment was undertaken after group allocation by a person who was unblinded and may have had knowledge of participant characteristics
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff at facilities who recorded falls were likely to be aware of their facility's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: loss similar between groups.
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified.
Method of ascertaining fallsHigh riskJudgement comment: falls defined but only recorded weekly.
Baseline imbalanceHigh riskJudgement comment: significant difference between groups in muscle strength and balance measures ‐ addressed for balance and strength scores by using difference scores ‐ but no adjustment apparent for falls data.
Other biasLow riskJudgement comment: assignment predicable as cluster randomised and only 2 facilities, however this accounted for under allocation concealment. No other sources of bias identified.

Clifton 2009

MethodsRCT (individually randomised)
ParticipantsSetting: 1 veterans skilled nursing facility (high‐level nursing care), Washingon state, USA N = 43 participants Sample: 5% women Age (years): mean 82.2 (SD 7.1)

Inclusion criteria: expected length of stay > 120 days; high risk of falling (Morse Scale score ≥ 50); unable to ambulate or transfer without assistance


Exclusion criteria: history of adverse reaction to medical adhesives; mechanobullous disease; skin breakdown on the legs > 10 cm; skin eruption on the legs
Interventions
  • FallSaver system: wireless position‐monitoring patch fixed to the thigh. Transmitted signal to receiver/alarm unit when angle of declination reached about 45 degrees from horizontal, indicating the individual was moving into a weight‐bearing position

Outcomes
Duration of the studyCross‐over after 60 days for second 60‐day period
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation sequence generated using a web‐based programme
Allocation concealment (selection bias)Low riskQuote: "Allocation of sequence, performed by the study coordinator, was masked until informed consent was obtained from each respective subject."
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not possible
Blinding of outcome assessment (detection bias)
All outcomes
High riskCaregivers recorded falls. Not blind to FallSaver use
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: higher loss to follow‐up in intervention arm due to discontinuing intervention.
Selective reporting (reporting bias)Low riskJudgement comment: falls outcomes reported as per trial registration
Method of ascertaining fallsLow riskJudgement comment: falls defined and recorded concurrently.
Baseline imbalanceUnclear riskJudgement comment: characteristics not reported by group allocation.
Other biasHigh riskJudgement comment: author employed by company making FallSaver devices

Colon‐Emeric 2013

MethodsRCT (cluster randomised), pilot study
ParticipantsSetting: 8 residential care facilities, 4 veterans affair, 4 community, USA.N = Not Reported (NR). 8 clusters, 982 facility beds.Sample: NRAge (years): NR

Baseline Characteristics


CONNECT & FALLS
  • N: NR. 4 facilities, average bed size 131.3. 243 staff participants.

  • Age ‐ mean (SD): NR

  • Female (%): NR

  • Medical status defined? ‐ Y/N : NR

  • Falls risk defined? ‐ Y/N : NR

  • Dependency defined? ‐ Y/N: NR

  • Cognitive status defined? ‐ Y/N: NR


FALLS only
  • N: NR. 4 facilities, average bed size 114.3. 254 staff participants.

  • Age ‐ mean (SD): NR

  • Female (%): NR

  • Medical status defined? ‐ Y/N : NR

  • Falls risk defined? ‐ Y/N : NR

  • Dependency defined? ‐ Y/N: NR

  • Cognitive status defined? ‐ Y/N: NR


Inclusion criteria: residents: aged 50 years or over; experienced one or more falls during the study period, and remained in the NH at least 72 hours after the fall. Staff: all NH employees aged 18 and older who had direct resident contact were eligible for participation. Emloyees from nursing, rehabilitation, social work, dietary services, environmental services, activities, medical services and administration.
Exclusion criteria: Staff: temporary agency staff and staff working only as needed
Pretreatment differences: more patients who fell had visual impairment in intervention nursing homes, more Caucasian staff in intervention nursing homes
Interventions
  • CONNECT followed by FALLS: CONNECT is an intervention which is a process to implement quality improvement programs, aiming to improve nursing home (NH) staff connections, communication, and problem solving. Uses storytelling, relationship mapping, mentoring, self‐monitoring, and feedback to help staff identify communication gaps and practice interaction strategies. CONNECT for 12 weeks consisting of 2 in‐class sessions plus mentoring for 2 weeks after each session; then FALLS for 12 weeks.

  • FALLS only. Falls quality improvement programme which includes group training, modules, teleconferences, academic detailing, and audit and feedback on multifactorial falls prevention (addressing orthostatic hypotension, sensory impairment, footwear, gait and assistive devices, toileting needs, environmental problems, fall‐related medications, and vitamin D). One half‐day training session followed by 11 weekly teleconferences. Case‐based self study modules. Academic detailing sessions for small groups of staff conducted twice at each nursing unit.

Outcomes
  • Rate of falls

  • Ratio of change in rate of falls

  • Adverse events

Duration of the study24 weeks intervention (12 weeks CONNECT/control plus 12 weeks FALLS), 6 months post‐intervention follow‐up.
Notes{"type":"clinical-trial","attrs":{"text":"NCT00836433","term_id":"NCT00836433"}}NCT00836433. Baseline data and N for all residents not known, confirmed by author correspondence.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskJudgement comment: sequence by random number generator.
Allocation concealment (selection bias)Unclear riskJudgement comment: person assigning treatment groups was blinded to nursing home identity, but unclear if individual participant recruitment (staff) was completed prior to assignment of the cluster.
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: unable to blind personnel.
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: as staff would have recorded falls and staff were the subject of the intervention, it is unlikely that blinding would have been possible for those recording falls data.
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: there were no missing data for fall rates.
Selective reporting (reporting bias)Low riskJudgement comment: data on falls are reported as per trial record and includes the main expected falls outcomes.
Method of ascertaining fallsLow riskQuote: "Falls were ascertained from facility fall logs, incident reports, and the Minimum Data Set; occupied bed days were calculated from daily census data that each facility provided."
Judgement comment: falls were clearly defined and likely to be recorded concurrently in facility fall logs used as the data source.
Baseline imbalanceLow riskJudgement comment: the analysis accounted for clustering and potential confounders
Other biasLow riskJudgement comment: none identified.

Cox 2008

MethodsRCT (cluster randomised by Primary Care Organisation (PCO) each containing nursing care facilities).
ParticipantsSetting: 209 care homes (high and intermediate level care), England and Wales N = 5637 participants. 29 clusters Sample: 77% women Age (years): not stated

Inclusion criteria (facilities): if local ethics and research governance procedures were swift enough to enable enrolment


Exclusion criteria (facilities): if demographic information was not provided
Interventions
  • Half day training sessions for managers, nurses and health care assistants in each PCO. Training delivered by specialist osteoporosis nurses and included information on falls and falls prevention

  • Control group received training 12 months later

Outcomes
  • Number of people falling

  • Number sustaining a fracture (all fractures, hip fractures)

Duration of the study12 months
Notes5 of 29 clusters lost to follow‐up in intervention group compared with 16 of 29 clusters in control group
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "The PCOs were stratified into two groups, larger PCOs and smaller PCOs based on the median number of care homes. Within each stratum, a single block of allocations was undertaken using a computer package to ensure equivalent numbers of PCOs in each group."
Allocation concealment (selection bias)Low riskQuote: "All PCO demographic data were forwarded to the Department of Health Science at the University of York for randomisation and allocation." "The allocation was undertaken by an independent researcher."
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: no statement re blinding. Facilities and staff (including manager reporting outcome data) knew of allocation
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff at facilities who recorded falls were likely to be aware of their facility's allocation status
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: 16% loss to follow‐up for control group
Selective reporting (reporting bias)Low riskJudgement comment: no protocol, but all expected outcomes reported (number of falls, risk of falls and fractures) and as described in methods.
Method of ascertaining fallsHigh riskJudgement comment: no fall definition reported. Fall and fracture data collected via questionnaire to each facility manager ‐ likely variability
Baseline imbalanceUnclear riskJudgement comment: baseline data on cognition, comorbidities, function not reported.
Other biasLow riskJudgement comment: none identified.

Crotty 2004a

MethodsRCT (individually randomised)
ParticipantsSetting: patients awaiting transfer from a hospital to a long‐term care facility, Australia N = 110 participants Sample: 61% women Age (years): mean 82.7 (SD 6.4)

Inclusion criteria: acute and subacute hospital patients being transferred to nursing care facility; life expectancy greater than a month


Exclusion criteria: none stated
Interventions
  • Pharmacist transition coordinator for patients transferring from hospital to a care facility for the first time: medication management transfer summaries from hospitals, timely coordinated medication reviews by accredited community pharmacists, and case conferences with physicians and pharmacists

  • Control: usual hospital discharge process

Outcomes
Duration of the study12 months. Participants followed up for 8 weeks post discharge
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "The study biostatistician provided a computer‐generated allocation sequence that used block randomization and was stratified by hospital.”
Allocation concealment (selection bias)Low riskQuote: "Randomization was coordinated by a centralized hospital pharmacy service."
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not possible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot clear whether staff recording falls were aware of existence of transfer summaries and case conferences
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: reasons for loss to follow‐up similar between groups.
Selective reporting (reporting bias)Low riskJudgement comment: falls were a secondary outcome measure.
Method of ascertaining fallsHigh riskJudgement comment: no clear definition or staff training described
Baseline imbalanceLow riskJudgement comment: no significant difference between groups at baseline
Other biasLow riskNone identified.

Crotty 2004b

MethodsRCT (cluster randomised)
Cluster randomisation of regions such that each metropolitan health area allocated to intervention or control. Facility in an intervention region selected at random and matched to a facility in a control region. Matching facilities not randomised
ParticipantsSetting: 20 residential care facilities (10 high‐ and 10 low‐level care), Adelaide, Australia N = 715 participants. 20 clusters. Sample: 84% women Age (years): mean 84.1 (SD 7.8)

Inclusion: none stated


Exclusion criteria: none stated
Interventions
  • Pharmacist outreach intervention: intervention physicians received two 30 minutes academic detailing visits from pharmacist based on evidence‐based guidelines, audit of prescribing practice (psychotropic and/or antihypertensive medication, use of aspirin or warfarin) and number of falls in previous 12 months. One nurse per facility received four 2‐hour education sessions (change management, management of the behavioural symptoms of dementia, medication management and falls prevention techniques). Pharmacist educated each facility on reducing use of psychotropic drugs

  • Usual care

Outcomes
Duration of the study7 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "All randomisation was conducted using a computer‐generated random allocation program by a person external to the project."
Allocation concealment (selection bias)High riskCluster randomisation of regions. Facility in an intervention region selected at random and matched to a facility in a control region
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: outcome was assessed blind to group allocation but intervention facilities would have been aware of intervention.
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff at facilities who recorded falls were likely to be aware of their facility's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: losses to follow‐up even between groups
Selective reporting (reporting bias)Unclear riskJudgement comment: injurious falls included as outcome measure but not reported
Method of ascertaining fallsHigh riskJudgement comment: no clear definition of falls, no staff training.
Baseline imbalanceLow riskJudgement comment: adjusted for baseline differences.
Other biasLow riskNone identified.

Cumming 2008

MethodsRCT (cluster randomised)
Cluster randomisation of 12 matched pairs of wards
ParticipantsSetting: 24 acute and subacute wards in 12 hospitals, Sydney, Australia N = 24 wards, 3999 patients. 24 clusters. Sample: 59% women Age (years): mean 79.0 (SD 12.8)

Inclusion criteria: all admitted patients


Exclusion criteria: none stated
Interventions
  • Targeted multifactorial intervention: a nurse and physiotherapist each worked for 25 hours per week for 3 months in all intervention wards. Provided risk assessment of falls, staff and patient education sessions, drug review, arranged walking aids, eyewear, modification of bedside and ward environments, increased supervision, liaison with staff about confusion and foot problems, an exercise programme, and sock alarms for selected patients (maximum of 2 per ward) who staff considered unsafe to walk unsupported

  • Usual care. No trial interventions.


NB. Continuation of existing pre‐trial falls prevention activities in control and intervention wards during the study.
Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (all fractures)

Duration of the study3 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Randomisation of each matched pair of wards was usually done during the week before the study started for that pair of wards. Randomisation involved sealed, opaque envelopes and was supervised by a study investigator ... unaware of ward characteristics."
Allocation concealment (selection bias)Low riskQuote: "We included all patients in study wards during each three month study period." "Randomisation of each matched pair of wards was usually done during the week before the study started for that pair of wards. Randomisation involved sealed, opaque envelopes and was supervised by a study investigator ... unaware of ward characteristics."
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff at the wards who recorded falls were likely to be aware of their ward's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: ITT analysis.
Selective reporting (reporting bias)Low riskJudgement comment: outcomes reported as per trial registration
Method of ascertaining fallsLow riskJudgement comment: falls clearly defined and collected concurrently.
Baseline imbalanceLow riskJudgement comment: groups well‐balanced at baseline.
Other biasUnclear riskQuote: "Another limitation is that some falls prevention activities were already occurring in control (and intervention) wards before the start of our study. These activities would have continued during the study period, making it more difficult to show any effect of our interventions."
Judgement comment: some other falls prevention activities ongoing ‐ impact of this unclear.

da Silva Borges 2014

MethodsRCT (individually randomised)
ParticipantsSetting: residential care facilities, intermediate‐level care, BrazilN = 59Sample: NRAge (years): 68

Baseline Characteristics


Ballroom dancing programme
  • N : 30

  • Age : mean (SD) : 68 (8.33)

  • Female (%): NR

  • Medical status defined? ‐Y/N : N

  • Falls risk defined? ‐Y/N: N

  • Dependency defined? ‐ Y/N: Y (all functionally autonomous)

  • Cognitive status defined? ‐ Y/N: Y


Control
  • N : 29

  • Age : mean (SD) : 67 (7.70)

  • Female (%): NR

  • Medical status defined? ‐Y/N : N

  • Falls risk defined? ‐Y/N: N

  • Dependency defined? ‐ Y/N: Y

  • Cognitive status defined? ‐ Y/N: Y


Inclusion criteria: resident of long‐stay institution in Rio de Janeiro state, Brazil, functionally autonomous in ADL, had not engaged in any regular physical activity for at least three months
Exclusion criteria: any condition that could prevent a participant from undergoing tests or interventions (such as cardiopathy, hypertension, uncontrolled asthmatic bronchitis, osteoarthritis, recent fracture, tendinitis, neurological problems and severe obesity, as well as the use of a prosthesis or medication that could cause attention disorders); cognitive impairment, especially memory function
Pretreatment differences: unclear, baseline characteristics not reported
Interventions
  • Ballroom dancing programme. Ballroom dancing with 10 minute warm‐up with flexibility exercises and low‐intensity dance movements, then higher‐intensity rhythms for 30 minutes, then 10 minutes relaxation to music. 3 x 50‐minute sessions weekly on alternate days.

  • Control. Normal daily activities. Advised not to engage in any regular physical therapy until after study period

Outcomes
  • Analysis of falls outcome

Duration of the study12 weeks
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote: "randomly allocated by simple draw"
Judgement comment: unclear how the draw was conducted and whether or not this would result in a truly random sequence.
Allocation concealment (selection bias)Unclear riskJudgement comment: allocation concealment not described.
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not possible.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskJudgement comment: it is unclear who reported the falls data.
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: to exclude patients due to falls may have a significant impact on falls data if these patients were multiple fallers or at high risk. Group allocation is not reported.
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol available.Falls data not published due to error in article.
Method of ascertaining fallsHigh riskJudgement comment: falls data were not recorded concurrently, it is unclear what type of medical records were accessed to confirm falls, this may not include records of non‐injurious falls.
Baseline imbalanceUnclear riskJudgement comment: baseline characteristics of participants not reported.
Other biasLow riskJudgement comment: none detected

Donald 2000

MethodsRCT (2 x 2 factorial design)
ParticipantsSetting: 1 elderly care rehabilitation (subacute) ward, Gloucester, UK N = 54 Sample: individuals admitted to one elderly care rehabilitation ward over an 8‐month period (81% women) Age (years): mean 83

Inclusion criteria: patients admitted for rehabilitation


Exclusion criteria: none stated
Interventions
  • Assigned to ward area with vinyl floor covering and conventional physiotherapy (functional based physiotherapy, once or twice daily)

  • As above (1) plus seated leg strengthening exercises (hip flexors and ankle dorsiflexors

  • Assigned to ward area with carpet and conventional physiotherapy

  • As above (3) plus seated leg strengthening exercises (hip flexors and ankle dorsiflexors)

Outcomes
  • Rate of falls

  • Number of people falling

Duration of the study9 months. Follow‐up of individual patients was duration of admission (mean length of stay 29 days)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskSequence generation not described. Quote: "Using randomized envelopes for each risk group, patients were assigned a floor group (carpet or vinyl) and a physiotherapy group (conventional physiotherapy or additional exercise)."
Allocation concealment (selection bias)Unclear riskRandomised achieved by randomising envelopes. Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not possible
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome assessors do not appear to have been blinded to treatment status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: high loss to follow‐up but ITT analysis for falls outcomes.
Selective reporting (reporting bias)Low riskJudgement comment: no protocol identified, but falls and fallers data reported completely.
Method of ascertaining fallsUnclear riskJudgement comment: falls clearly defined, but insufficient information on frequency of recording of falls data for judgement.
Baseline imbalanceLow riskJudgement comment: groups balanced at baseline.
Other biasLow riskJudgement comment: none identified.

Dyer 2004

MethodsRCT (cluster randomised)
ParticipantsSetting: 20 residential care homes (intermediate‐level care), UK N = 196 participants. 20 clusters. Sample: 78% women Age (years): mean (SD) intervention group 87.4 (6.9), control group 87.2 (6.9)

Inclusion criteria (facilities): ≥ 5 residents; not specializing in mental illness; without nursing services. Inclusion criteria (residents): aged ≥ 60


Exclusion criteria: temporary residents or terminal illness
Interventions
  • Multifactorial, multidisciplinary intervention: baseline assessments by physiotherapist, nurse and OT and interventions based on these.

    • Exercise: supervised gait, balance, co‐ordination and functional + strength/resistance + flexibility + general physical exercises. 3 x 40‐minute sessions per week for 3 months. Progressive exercises individually tailored and delivered by exercise assistants supported by physiotherapists. Carried out in groups or individually if residents unable to participate in groups because of frailty or cognitive impairment

    • Staff education

    • Medical review: baseline assessments screened by geriatrician. Recommendations re medication review, orthostatic hypotension, and osteoporosis prevention sent to participant's GP for GP to implement

    • Environmental modification: OT assistant visited facilities to assess and report on falls hazards, with facilities being alerted of major hazards

    • Optician and podiatry referrals based on baseline assessment

  • Usual care, no intervention.

Outcomes
  • Rate of falls

  • Number of people falling

Duration of the study12 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskAllocation sequence used computer‐generated random number tables
Allocation concealment (selection bias)Low riskQuote: "The allocation sequence was performed and kept secure by a researcher independent of the study, and blinded to baseline assessment results."
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff at the facilities who recorded falls were likely to be aware of their facility's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskLosses balanced between groups.
Selective reporting (reporting bias)Low riskNo protocol identified but all expected falls data comprehensively reported as falls, fallers, multiple fallers and fractures reported.
Method of ascertaining fallsLow riskData collected concurrently and clear definition.
Baseline imbalanceUnclear riskDifferences in cognition and medications at baseline, unclear if adjusted for in analysis.
Other biasLow riskNone identified.

Dykes 2010

MethodsRCT (cluster randomised) randomised 2 units matched on fall rates and patient days within each of 4 hospitals
ParticipantsSetting: 8 acute medical units, Boston, Massachusetts, USA N = 5264 patients aged ≥ 65. 8 clusters. Sample used in this review: patients aged ≥ 65 (% women not available)Age (years): mean 78.8 (SD 8.4) in patients aged ≥ 65

Inclusion criteria (units): fall rates higher than institution's mean rate for previous year; had a match within the institution (unit with similar fall rate and length of stay). Inclusion criteria (patients): all patients admitted to randomised units during study


Exclusion criteria (units): involved in other performance improvement efforts relating to fall prevention
Interventions
  • Falls Prevention Tool Kit (FPTK) software with strategies to improve unit‐level buy‐in: Morse Falls Scale completed using FPTK; software automatically‐generated evidence‐based/feasible interventions, tailored by nurse based on knowledge of patient; software automatically printed bed poster for patients at risk (updated with change in status); software generates tailored handout to educate patient/family (updated with change in status); tailored fall prevention plan automatically generated by software for documentation

  • Control: usual care in relation to fall prevention: Morse Falls Scale (MFS) completed using existing paper or electronic forms; “high risk of falls” signs above beds for patients with MFS > 45 points; educate patient/families with booklets or other handouts as needed; document plan manually in paper or electronic record


Both groups used Morse Falls Scale to assess risk of falls on admission, daily and with change in status
Outcomes
  • Rate of falls

  • Number of people falling

Duration of the study6 months
NotesData for participants aged < 65 and ≥ 65 reported separately in Dykes 2010. Only data for participants aged ≥ 65 included in this review
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote "Matched units were randomised"
Insufficient information to permit judgement
Allocation concealment (selection bias)High riskAt each hospital pairs of wards were allocated to intervention and control, then patients admitted to these wards were recruited
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: Not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote: “the intervention was not blinded and falls were reported by unit‐based caregivers who implemented fall prevention interventions.”
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: all patients included in ITT analysis.
Selective reporting (reporting bias)Low riskJudgement comment: falls outcomes reported consistent with trial registration
Method of ascertaining fallsLow riskJudgement comment: falls recorded concurrently and would be defined in hospital system.
Baseline imbalanceLow riskJudgement comment: no significant differences at baseline, potential confounders adjusted for.
Other biasLow riskJudgement comment: none identified.

Faber 2006

MethodsRCT (individually randomised) Facilities randomised to one of two interventions, then residents individually randomised to intervention or control group within facilities
ParticipantsSetting: 15 long‐term care residences (combined high‐ and intermediate‐level care within each), the Netherlands N = 238 Sample: 79% women Age (years): mean 84.9 (range 63 to 98)

Inclusion criteria: resident of facility


Exclusion criteria: unable to walk 6 metres unaided; poor cognition as judged by staff; GP contraindication
Interventions
  • Functional Walking (FW) (7 residences): 10 exercises (gait, balance, and co‐ordination + strength/resistance), 1 session per wk for 4 weeks then 2 sessions per week for 16 weeks; 90 minutes per session. Exercises individually tailored and delivered by an instructor

  • In Balance (IB) (8 residences): 3D exercises (based on Tai Chi). 1 session per week for 4 weeks followed by 2 sessions per week for 16 weeks. 90‐minute sessions. Exercises individually tailored and delivered by an instructor


Usual care (same 15 residences as above)
Outcomes
  • Rate of falls

  • Number of people falling

Duration of the study12 months
NotesOnly data for combined control groups reported in Faber 2006
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk15 centres cluster randomised to one of two exercise regimens using "sealed envelopes". Individuals then randomised into intervention and control within each participating centre using computer generated random numbers
Allocation concealment (selection bias)Unclear riskUnclear whether initial randomisation to clusters used  envelopes which were sequentially numbered, opaque and sealed. Insufficient information to permit judgement in relation to randomisation of individuals after cluster allocation
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff who recorded falls were likely to be aware of individual's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: withdrawals balanced across interventions
Selective reporting (reporting bias)Low riskJudgement comment: no protocol identified but all expected outcomes ‐ falls and fallers thoroughly reported.
Method of ascertaining fallsLow riskJudgement comment: falls defined and recorded concurrently.
Baseline imbalanceLow riskJudgement comment: no differences at baseline.
Other biasLow riskJudgement comment: none detected

Flicker 2005

MethodsRCT (individually randomised)
ParticipantsSetting: 60 assisted living facilities and 89 nursing homes (intermediate‐ and high‐level nursing care facilities), urban and rural Australia N = 693 Sample: 95% women Age (years): mean 83.4

Inclusion criteria: serum 25‐hydroxyvitamin D between 25 nmol/L and 90 nmol/L


Exclusion criteria: use of medications affecting bone and mineral metabolism; thyrotoxicosis within 3 years; primary hyperparathyroidism treated within 3 years; multiple myeloma; Paget's disease of bone, history of malabsorption, intercurrent active malignancy, other disorders affecting bone and mineral metabolism
Interventions
  • 10,000 IU oral ergocalciferol (vitamin D2) weekly (or 1000 IU oral ergocalciferol daily) plus 600 mg calcium carbonate daily

  • Placebo + 600 mg calcium carbonate daily

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (all fractures)

  • Adverse events

Duration of the study24 months
Notes58% of participants had a serum vitamin D between 25 nmol/L and 40 nmol/L at baseline
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Subjects were randomized via computer‐generated lists," "Within each institution … in blocks of eight."
Allocation concealment (selection bias)Low riskQuote: "Subjects were randomized to receive sequentially numbered bottles containing vitamin D supplementation or placebo." Individual not involved in contact with subjects or facilities performed randomisation
Blinding of participants and personnel (performance bias)
All outcomes
Low riskJudgement comment: double‐blind
Blinding of outcome assessment (detection bias)
All outcomes
Low riskResidential staff recording falls events blinded to whether participants were receiving vitamin D or placebo
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: ITT analyses performed.
Selective reporting (reporting bias)Low riskJudgement comment: no protocol identified but falls reported extensively as number of falls, fallers, fracture and ITT, raw and adjusted and additional analyses
Method of ascertaining fallsLow riskJudgement comment: falls clearly defined and recorded concurrently
Baseline imbalanceLow riskJudgement comment: groups balanced at baseline
Other biasLow riskJudgement comment: none identified

Frankenthal 2014

MethodsRCT (individually randomised)
ParticipantsSetting: 1 residential care facility, mixed level of care, Israel N = 359 residentsSample: 67% female, 46.8% 84 or overAge (years): mean 82.7 (SD 8.7)

Baseline Characteristics


Medication intervention (STOP/START)
  • N: 183

  • Age ‐ mean (SD) : Overall 82.7 (8.7)

  • Female ‐ N (%): 129 (70.5%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined? ‐ Y/N: N

  • Dependency defined? ‐ Y/N: Y

  • Cognitive status defined? ‐ Y/N: Y


Control
  • N: 176

  • Age ‐ mean (SD) : Overall 82.7 (8.7)

  • Female ‐ N (%): 110 (62.5%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined? ‐ Y/N: N

  • Dependency defined? ‐ Y/N: Y

  • Cognitive status defined? ‐ Y/N: Y


Inclusion criteria: all residents aged 65 and older in a chronic care geriatric facility in Israel, prescribed at least one daily medicine
Exclusion criteria: terminally ill residents, those whose stay in the facility was shorter than 3 months
Pretreatment differences: no significant differences
Interventions
  • Medication review by pharmacist with Screening Tool of Older Persons potentially inappropriate Prescriptions/Screening Tool to Alert doctors to Right Treatment (STOPP/START). Pharmacist made recommendations to chief physician who decided whether to implement changes. Review at study opening, 6 and 12 months later.

  • Control. No interventional recommendations made by pharmacist to chief physician.

Outcomes
Duration of the study12 months
Notes24 month follow‐up data reported as retrospective cohort data for those alive at 24 months. These data not considered eligible for inclusion in the review.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskJudgement comment: simple list generation. Fixed stratified randomisation ‐ level of independence and cognition levels
Allocation concealment (selection bias)Low riskJudgement comment: physician who were not involved in the study did randomisation. Use of sealed envelopes. Study pharmacist (main person determining intervention recommendations) not involved in allocation, but aware of group allocation after randomisation.
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: pharmacist was aware of group allocation when making recommendations and implementing intervention group recommendations. Was also aware of control group medication use as well, as recommendations were made but not implemented for this group.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Nurses who were unaware of participants’ group assignments assessed the outcome measures in the study population. The chief nurses routinely report falls, hospitalizations, and FIM in residents’ records."
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: similar loss to follow‐up between groups
Selective reporting (reporting bias)Low riskJudgement comment: protocol registered and outcome measures are reported as per protocol.
Method of ascertaining fallsLow riskJudgement comment: clear definition, concurrent reporting by nurses
Baseline imbalanceLow riskJudgement comment: no significant difference on main reported baseline measures.
Other biasLow riskJudgement comment: none detected

Fu 2015

MethodsRCT (individually randomised)
ParticipantsSetting: 1 residential care facility, ChinaN = 60Sample: 65% womenAge (years): 82

Baseline Characteristics


Wii Exercise
  • N: 30

  • Age ‐ mean (SD) : 82.3 (4.3)

  • Female ‐ N (%): 20 (67)

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined? ‐ Y/N: Y (PPA)

  • Dependency defined? ‐ Y/N: Y (FAC)

  • Cognitive status defined? ‐ Y/N: N


Conventional exercise
  • N: 30

  • Age ‐ mean (SD) : 82.4 (3.8)

  • Female ‐ N (%): 19 (63)

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined? ‐ Y/N: Y

  • Dependency defined? ‐ Y/N: Y

  • Cognitive status defined? ‐ Y/N: N


Inclusion criteria: 65 years and older, living in a nursing home, Functional Ambulation Category (FAC) grade 2 or 3, alert, medically stable and able to follow instructions, history of falls in the previous year.
Exclusion criteria: visual problems that might affect their training, unable to follow instructions, history of seizure, stroke, parkinsonism, or uncontrolled cardiovascular disease
Pretreatment differences: no important differences between groups on a wide range of potential confounders
Interventions
  • Exercise using a Wii Fit balance board to perform three balance training games: Soccer Heading, Table Tilt, and Balance Bubble. Tasks became progressively more difficult with improvements in performance. 1‐hour sessions, 3 sessions a week

  • Usual care. Conventional exercise: balance exercise regimen consisting of: lower limb strengthening; tandem standing, tandem walking, sideways and turnaround walking exercises in parallel bars; stepping exercise; sitting to standing exercise; and half‐squats (Otago balance programme). 1‐hour sessions, 3 sessions a week.

Outcomes
Duration of the study6 weeks
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Participants were randomly assigned to the conventional or Wii Fit balance training group by using a random number produced by the computerized method of minimization"
Allocation concealment (selection bias)Unclear riskJudgement comment: allocation not described
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not possible given nature of intervention
Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Nurses at the nursing home who documented falls were unaware of participants’ group allocation."
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: less than 10% missing from each group.
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol available
Method of ascertaining fallsLow riskJudgement comment: falls were recorded by the nursing staff according to a clear definition and reported to the investigator for each participants monthly over the 12‐month period after randomisation.
Baseline imbalanceLow riskQuote: "There was no statistically significant difference in age, sex, height, weight, body mass index, FAC distribution, or number of falls in the previous year between the 2 groups."
Other biasLow riskJudgement comment: none identified

Garcia Gollarte 2014

MethodsRCT (cluster randomised)
ParticipantsSetting: residential care facilities, mixed‐level care, 60 physicians, SpainN = 1018 residents. 59 physicians, 37 nursing home clusters.Sample: 73% women.Age (years): 84.4 (SD 12.7)

Baseline Characteristics


Educational intervention
  • N: 516

  • Age ‐ mean (SD): 84.24 (14.6)

  • Female (%): 382 (74.0)

  • Medical status defined? ‐ Y/N : No

  • Falls risk defined? ‐ Y/N: No

  • Dependency defined? ‐ Y/N: Y

  • Cognitive status defined? ‐ Y/N: Y


Control
  • N: 502

  • Age ‐ mean (SD): 84.5 (10.4)

  • Female (%): 362 (72.1)

  • Medical status defined? ‐ Y/N : N

  • Falls risk defined? ‐ Y/N: No

  • Dependency defined? ‐ Y/N: Y

  • Cognitive status defined? ‐ Y/N: Y


Inclusion criteria: facilities: owned by the same private company in Spain;Physicians: at included nursing homesResidents: older than 65 years; living in nursing home for at least 3 months; expected to stay for 6 months or longer; clinically stable (no changes in prescription in the last 2 months); accepted that their clinical data were used for the study

Exclusion criteria: residents: receiving palliative care; usually cared by other primary care providers outside the nursing home


Pretreatment differences: significant difference in Barthel index at baseline P = 0.003, indicated made no difference to results but methods of adjustment not reported
Interventions
  • Educational intervention. Structured educational intervention directed to nursing home physicians in reducing inappropriate prescription and improving health outcomes and resource utilisation. 10 hours educational programme, on demand support by phone for 6 months.

  • Control. No intervention or information about an educational intervention

Outcomes
  • Number of falls (post‐intervention)

  • Number of fallers (post‐intervention)

Duration of the study12 months total, 6 months intervention period. Baseline recorded following 3 months pre‐intervention. Endpoint at 12 months, for 3 months post‐intervention.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Randomization was done using random number tables and"
Judgement comment: random number tables.
Allocation concealment (selection bias)Unclear riskJudgement comment: details of timing of individual participant recruitment/person recruiting not reported (i.e. whether completed before cluster randomisation or not)
Blinding of participants and personnel (performance bias)
All outcomes
Low riskJudgement comment: physicians were blinded to purpose of trial. Unclear if participants were blinded but unlikely to be aware of educational interventions of physicians.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskJudgement comment: do not know who did outcome assessment or how
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: loss of one nursing home cluster after randomisation
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol available. Falls only reported for pre and post‐intervention periods
Method of ascertaining fallsHigh riskQuote: "We did not use a daily systematic registry of falls and delirium, therefore, some episodes may have gone unnoticed, as is suggested by our lower rates of both syndromes compared with similar studies."
Baseline imbalanceUnclear riskJudgement comment: significant difference in Barthel index at baseline. Results indicate that adjusting for this imbalance made no difference in results, however no details of how adjustment was performed are provided.
Other biasLow riskJudgement comment: none identified

Grieger 2009

MethodsRCT (individually randomised) 
ParticipantsSetting: 1 aged care facility (high and intermediate‐level care), Victoria, Australia N = 115 Sample: 65% women in analysisAge (years): not stated

Inclusion criteria: able to consume food orally


Exclusion criteria: residents in the dementia, rehabilitation and palliative care wards
Interventions
  • One multivitamin tablet (Heron Women's Multivitamin) daily for 6 months. Tablets included 400 IU vitamin D3 and 360 mg calcium carbonate.

  • Control: one placebo tablet daily for 6 months

Outcomes
  • Rate of falls

  • Number of people falling

  • Adverse events


Other outcomes not included in this review
Duration of the study6 months
NotesMean baseline serum vitamin D level 36 nmol/L
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number generator used in Excel
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
Low riskJudgement comment: double‐blind
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskDouble‐blind administration of tablets but no mention of maintaining blinding of researchers when falls were extracted from medical histories at the end of the 6‐month trial
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: large loss from groups as randomised. 25% loss as randomised from placebo group, 16% from intervention group.
Selective reporting (reporting bias)High riskJudgement comment: excluded multiple faller from number of falls data as outlier
Method of ascertaining fallsHigh riskJudgement comment: falls not clearly defined
Baseline imbalanceUnclear riskJudgement comment: baseline age, cognition, medical comorbidities not reported
Other biasLow riskJudgement comment: none identified

Haines 2004

MethodsRCT (individually randomised)
ParticipantsSetting: one hospital (three subacute wards), specialising in rehabilitation and care of elderly patient, sMelbourne, Australia, N = 626 Sample: 67% women Age (years): mean 80 (SD 9)

Inclusion criteria: all patients admitted to three subacute wards


Exclusion criteria: none stated
Interventions
  • Targeted falls risk prevention programme based on identified falls risk (Peter James Centre Falls Risk Assessment Tool) in additional to usual care. Potential interventions were:

    • supervised exercise programme: 45‐minute sessions 3 x per week from commencement of intervention until discharge. Exercises comprised gait, balance and coordination + strengthening/resistance + 3D (Tai Chi). Exercises were individually tailored. Exercises were delivered by physiotherapist

    • falls risk alert card

    • up to four educational sessions from OT at bedside to individual participants of up to 30‐minute duration

    • hip protectors

  • Usual care. Received usual care but none of the interventions from the falls prevention programme. Staff completed risk assessment and generated recommendations these recommendations were not instituted.

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (all fractures)

  • Adverse events

Duration of the study10 months recruitment. Follow‐up time was until participants were discharged from hospital
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "We randomly allocated participants by using a random number table held at the centre by one investigator (TPH) who revealed allocation on receipt of written consent." 
Allocation concealment (selection bias)Unclear riskSee above. Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: unblinding likely
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskStaff recorded falls on incident report forms likely to be aware of individual's allocation status. Survey of staff indicated they were relatively unaware of participant group allocation
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: ITT analysis
Selective reporting (reporting bias)Low riskJudgement comment: all outcome measures reported
Method of ascertaining fallsLow riskJudgement comment: falls clearly defined and recorded concurrently.
Baseline imbalanceLow riskJudgement comment: groups similar at baseline
Other biasLow riskJudgement comment: none identified.

Haines 2010

MethodsRCT (cluster randomisation of pairs of hospital wards matched on rate of falls in preceding 6 months)
ParticipantsSetting: 18 publicly funded hospital wards (acute and subacute), Queensland, AustraliaN = 11,099 patients. 18 clusters.Sample: patients admitted to study wards after October 2007 when beds provided to intervention wards (% women not stated)Age (years): not stated

Inclusion criteria: no previous access to or provision of low‐low beds


Exclusion criteria: none described
Interventions
  • Low‐low beds: provision of one low‐low bed for every 12 beds on a hospital ward. Lowered bed height 28.5 cm from the ground, highest bed height 64 cm. Written guidance on their use and for prioritising patients at greatest risk of falls

  • Control: usual care


Staff on intervention and control wards received falls incident reporting training video
Outcomes
Duration of the study6 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "...18 wards were then matched into pairs ... and ordered alphabetically within pairs. A research assistant in a separate location and blinded to this ordering flipped a coin to determine whether the first or second listed ward in the pair was to be allocated to the intervention group."
Allocation concealment (selection bias)Unclear riskSee above, but patients could have been allocated to a specific ward with the knowledge that it was an intervention or control ward
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not possible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskFalls recorded by ward staff using routine computer‐based incident reporting scheme. Would not be blind to allocation. No mention of blinding in relation to the person extracting data from centrally held database
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: ITT analysis performed.
Selective reporting (reporting bias)Low riskQuote: "(ANZCTR registration number: 12609000243213)."
Judgement comment: all outcome measures reported
Method of ascertaining fallsLow riskJudgement comment: falls clearly defined and recorded concurrently.
Baseline imbalanceHigh riskJudgement comment: patient level characteristics at baseline not reported. Intervention wards included 2 stand‐alone acute medicine wards, no standalone acute medicine wards in control arm.
Other biasLow riskJudgement comment: none identified.

Haines 2011

MethodsRCT (individually randomised)
ParticipantsSetting: 6 acute and subacute wards in 2 hospitals, Brisbane and Perth, Australia N = 1206 Sample: patients admitted to acute (orthopedic and acute‐respiratory medicine) and subacute (geriatric assessment and rehabilitation) wards of one hospital, and to the acute (medical‐surgical) and subacute (restorative–stroke rehabilitation) wards of a second hospital (53% women)Age (years): mean (SD) intervention group (complete programme) 75.3 (11.0), intervention group (materials only programme) 74.7 (11.7), control group 75.3 (10.1)

Inclusion criteria: aged > 60; expected to stay at least 3 days (acute wards only)


Exclusion criteria: medically too unwell; previously participated in the trial
Interventions
  • Complete programme: multimedia patient education programme involving written and video‐based materials combined with physiotherapist follow‐up

  • Materials only programme: multimedia patient education materials without physiotherapist follow‐up

  • Control: usual care

Outcomes
  • Rate of falls

  • Number of people falling

  • Adverse events

Duration of the study22 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "a computer‐generated random allocation sequence"
Allocation concealment (selection bias)Low riskQuote: "opaque, consecutively numbered envelopes"
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: participants not blinded, blinded assessment but treatment providers not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "research assistants ... completed weekly falls reviews ... were blind to group allocation"
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: ITT analysis, no loss.
Selective reporting (reporting bias)Low riskJudgement comment: falls reported as per publication, To check ACTRN12608000015347
Method of ascertaining fallsLow riskJudgement comment: falls clearly defined and recorded concurrently.
Baseline imbalanceLow riskJudgement comment: baseline characteristics similar.
Other biasLow riskJudgement comment: none identified

Healey 2004

MethodsRCT (cluster randomised by ward in matched pairs)
ParticipantsSetting: 8 elderly care wards (acute and subacute) in 1 hospital, York, UK N = 1654 participants, 32,528 bed days during intervention. 8 clusters. Sample: approximately 60% women Age (years): mean 81.3 (range 63 to 102)

Inclusion criteria: all patients admitted to target wards


Exclusion criteria: none specified
Interventions
  • Targeted risk factor reduction care plan for patients with a history of falls or a near fall during admission. Based on assessment (and subsequent referral/action) relating to: eyesight (referral to ophthalmologist); medications check for sedatives, anti‐depressants, diuretics, polypharmacy, etc (medical review of benefit vs harm); lying and standing blood pressure (advice to participant and referral to medical staff); ward urine test (mid‐stream urine if positive for nitrites, blood or protein); difficulty with mobility (referral to physiotherapist); review of bed rail use; footwear safety (advice on replacement); bed height (kept at lowest height); position in ward (placing high risk patients near nurses' station); environmental causes (act to correct); nurse call bell (explained and in reach)

  • Usual care. Managers on control wards were made aware of the study, and the need not to introduce the care plan in their area. Control wards made no other changes to practice or environment relevant to falls prevention during the study. Whilst nurses instigated the process, remedial interventions were multi‐disciplinary, including mobility assessment by physiotherapists and medication review by medical staff.

Outcomes
Duration of the study6 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod of randomisation not described. Quote: "The study wards were divided into matched pairs. In each pair, one ward was randomly allocated to control or intervention by lottery ..."
Allocation concealment (selection bias)Unclear riskIndividual study wards aware of their allocation from beginning of study. It is unclear whether knowledge of group status could have influenced admission of new patients during the study
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff at the wards who recorded falls were likely to be aware of their ward's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: ITT analysis. all occupied bed days and falls analysed, unlikely to be loss in hospital.
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified.
Method of ascertaining fallsHigh riskJudgement comment: no definition of falls used. Used accident and incidence reporting forms
Baseline imbalanceHigh riskJudgement comment: imbalance in length of stay and dementia diagnoses.
Other biasLow riskJudgement comment: none detected.

Hill 2015

MethodsRCT (cluster‐randomised, stepped‐wedge)
ParticipantsSetting: 24 wards in 8 rehabilitation or geriatric evaluation and management units in Australian hospitals, Western Australia.N = 3606 admissions; 3121 unique patients. 24 clusters.Sample: 62% womenAge (years): 82

Baseline Characteristics


Individualized fall education programme
  • N : 1623 admissions, 1402 unique patients

  • Age ‐ mean (SD) : 81.4 (9.3)

  • Female ‐ N (%): 999 (62%)

  • Medical status defined? ‐ Y/N : Y

  • Falls risk defined? ‐ Y/N: N

  • Dependency defined? ‐ Y/N: Y

  • Cognitive impairment defined? Y/N: Y


Usual care
  • N : 1983 admissions, 1719 unique patients

  • Age ‐ mean (SD) : 82.1 (8.3)

  • Female ‐ N (%): 1211 (61%)

  • Medical status defined? ‐ Y/N : Y

  • Falls risk defined? ‐ Y/N: N

  • Dependency defined? ‐ Y/N: Y

  • Cognitive impairment defined? Y/N: Y


Inclusion criteria: for individuals on units to receive intervention: aged more than 60 years, projected length of stay of at least 3 days, basic cognitive functioning (MMSE > 23/30 and AMTS > 7/10), when the treating clinical team judged that the patient had a high enough level of cognition to benefit from the education
Exclusion criteria: for individuals on units not to receive intervention: diagnosis of delirium, patients with moderate or severe cognitive impairment (MMSE of less than 24/30 or AMTS of less than 8/10), permanently unable to mobilise and remain bed‐bound or are receiving palliative care
Pretreatment differences: significant difference in comorbidities at baseline (more comorbidities in intervention period), but confounding adjusted for in analysis.
Interventions
  • Individualised fall education programme. Safe Recovery programme for patients and staff. For patients, an individually‐tailored multimedia falls prevention education package (DVD and workbook) with further face to face follow‐up education (including workbook completion and goal setting) with a health professional was provided. Aimed to alert patients to their personal risk of falls, raise their knowledge about falls epidemiology and falls prevention, and to motivate them to engage in falls‐prevention strategies. Patients were eligible to receive the individualised education if they were aged more than 60 years, had a projected length of stay of at least 3 days, had basic cognitive functioning, and when the treating clinical team judged that the patient had a high enough level of cognition to benefit from the education. Basic cognition was defined as having a Mini‐Mental State Examination (MMSE) score of more than 23/30 or an Abbreviated Mental Test Score (AMTS) of more than 7/10.Staff education on the programme and feedback about patients' goals and perceived barriers, plus unit managers receive feedback on perceived barriers. Patient education sessions ranged between 15 and 35 minutes with 1‐4 sessions per patient. Staff training in the week of the start of the intervention on their unit and feedback to staff weekly, 56% of patients in the intervention arm were eligible to receive the intervention based on their cognitive status.

  • Usual care. Usual care includes patient’s screening, assessment and implementation of individualised falls prevention strategies, ongoing staff training and environmental strategies.

Outcomes
  • Ratio ratio

  • Odds of falling (per admission)

  • Number of fractures

  • Adverse events

Duration of the study50 weeks. After a 10‐week control period, two units started the intervention—this procedure continued at 10‐week intervals until all eight units had crossed over into the intervention period.
NotesOutcomes reported for subgroups by level of cognition.
Stable median site control falls rate and absence of interaction effect of time and falls outcomes indicates confounding by seasonal effects unlikely.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "computer‐generated, random allocation sequences."
Judgement comment: computer generated.
Allocation concealment (selection bias)Low riskJudgement comment: allocation concealed, no individual participant recruitment required.
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not possible.
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls collected by staff who are blinded, but entered into hospital report systems by unit staff who were not blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: no loss to follow‐up.
Selective reporting (reporting bias)Low riskJudgement comment: protocol available, outcome measures consistent with final report
Method of ascertaining fallsLow riskJudgement comment: falls clearly defined and collected concurrently.
Baseline imbalanceLow riskJudgement comment: imbalances at baseline adjusted for in analyses.
Other biasUnclear riskJudgement comment: stepped‐wedge design means there is a potential for bias due to systematic influence of other external factors during the conduct of the trial. Possible influence of seasonal trends addressed by pre‐specified statistical analysis.

Houghton 2014

MethodsRCT (cluster randomised)
ParticipantsSetting: 31 residential care facilities, mixed‐level care, UK N = 953 residents. 31 clusters.Sample: 76% womenAge (years): 87

Baseline Characteristics


Medication review
  • N: 381

  • Age ‐ mean (SD): 88.4 (6.5)

  • Female ‐ N (%): 303 (79.5%)

  • Medical status defined? ‐ Y/N : N

  • Falls risk defined? ‐ Y/N (at baseline with validated tool): N

  • Dependency defined? ‐ Y/N: N

  • Cognitive status defined? ‐ Y/N: Y


Control
  • N: 445

  • Age ‐ mean (SD): 86 (8.5)

  • Female ‐ N (%): 324 (72.8%)

  • Medical status defined? ‐ Y/N : N

  • Falls risk defined? ‐ Y/N (at baseline with validated tool): N

  • Dependency defined? ‐ Y/N: N

  • Cognitive status defined? ‐ Y/N: Y


Inclusion criteria: care homes: average age > 65, registered with GP in local area; registered with Care Quality Commission for at least 6 months.
Exclusion criteria: care homes specifically for people (of all ages) with learning disability, sensory impairment, mental health problems, physical disabilities and alcohol dependence; if have received a medication review service from the Primary Care Trust in the last 6 months; if they receive the services of a community geriatrician; or if they are subject to investigation of the safeguarding of vulnerable adults.Residents: those who self‐medicate; those in respite care.
Pretreatment differences: nil significant
Interventions
  • Medication review. Multi‐professional medication review service (MMRS): a meeting involving a clinical pharmacist and pharmacy technician from the Primary Care Trust Medicines Management Team, care home staff and GP(s) responsible for the medical care of residents. Review conducted twice: at baseline (approx 1 month) and 6 months. Each meeting considers 15 residents on average and lasts up to 2 hours, multiple meetings as necessary.

  • Usual care (support from the NHS).

Outcomes
Duration of the study6 months intervention, follow‐up to 12 months.
NotesISRCTN90761620 CAREMED trial
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "For practical (i.e. workload) reasons, consenting homes will be allocated to intervention or control sequentially after consent is obtained using minimisation."
Judgement comment: Sequential allocation by minimisation is equivalent to being random.
Allocation concealment (selection bias)Unclear riskJudgement comment: insufficient information for judgement.
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: staff were involved in medication review meetings so were not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls recorded by staff who were not blinded as they were involved in medication review meetings.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskJudgement comment: 1 care home lost from intervention group, reason unclear, unclear if accounted for in analysis.
Selective reporting (reporting bias)Unclear riskMethod of analysis of falls data as provided by author unclear. Unsure if falls analysed using a linear mixed model as per published abstract, impact unclear.
Method of ascertaining fallsUnclear riskInsufficient information for judgement.
Baseline imbalanceHigh riskJudgement comment: higher number of participants requiring nursing care in control group
Other biasLow riskJudgement comment: n0ne detected.

Huang 2016

MethodsRCT (individually randomised)
ParticipantsSetting: 6 residential care facilities, mixed‐level care, TaiwanN = 80Sample: 50% womenAge (years): 79.4

Baseline Characteristics:


Cognitive behavioural alone
  • N: 27

  • Age ‐ mean (SD) : 77.9 (7.3)

  • Female N (%): 16 (59.3)

  • Medical status defined? ‐ Y/N: Yes (medications, No chronic disease)

  • Falls risk defined? ‐ Y/N: N

  • Dependency defined? ‐ Y/N: Yes

  • Cognitive status defined? ‐ Y/N: Yes


Cognitive behavioural plus exercise
  • N: 27

  • Age ‐ mean (SD) : 79.1 (6.9)

  • Female N (%): 13 (48.1)

  • Medical status defined? ‐ Y/N: Yes

  • Falls risk defined? ‐ Y/N: N

  • Dependency defined? ‐ Y/N: Yes

  • Cognitive status defined? ‐ Y/N: Yes

Usual care
  • N: 26

  • Age ‐ mean (SD) : 81.3 (5.4)

  • Female N (%): 11 (42.3)

  • Medical status defined? ‐ Y/N: Yes

  • Falls risk defined? ‐ Y/N: N

  • Dependency defined? ‐ Y/N: Yes

  • Cognitive status defined? ‐ Y/N: Yes


Inclusion criteria: 65 years or over; MMSE 13 or over; ability to communicate in Mandarin or Taiwanese; Ability to ambulate independently or with an assistive device; CB group needed to complete all 8 sessions
Exclusion criteria: unstable physical condition or evidence of end stage terminal disease
Pretreatment differences: no significant group differences
Interventions
  • Cognitive‐behavioural intervention adapted for a Fear of Falling Management Model, with a focus on falls risk reduction, conducted by trained facilitator. 8 weekly sessions of 20 to 25 minutes, in groups of 6 to 8.

  • Cognitive‐behavioural intervention plus a supervised strength and balance exercise programme, twice a week for approx 30 minutes.

  • Usual care

Outcomes
Duration of the study8‐month trial: 8 weeks intervention, falls over monitored over 3 months pre‐intervention and 3 months post‐intervention.
Notes80 participants randomised, 5 withdrew during the study, final sample =75 participants.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "used a computer‐developed table to randomise patient assignment to each of the three groups in each nursing home."
Allocation concealment (selection bias)Low riskQuote: "Allocation was concealed from the recruiting RA."
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: unable to blind participants/personnel.
Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote "To achieve greater accuracy in the number of falls during the study period, we collected data from chart record, accident report, in charge staff, and participants."
Judgement comment: falls were recorded by participants and staff who were not blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: little missing data from randomisation, and are balanced across groups.
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified
Method of ascertaining fallsLow riskQuote: "we collected data from chart record, accident report, in charge staff, and participants."
Judgement comment: Quote " The number of falls was recorded using the Falls Record Checklist (Huang & Acton, 2004)" ‐ this is a checklist for concurrent recording of falls by participants.
Baseline imbalanceLow riskJudgement comment: no imbalance at baseline
Other biasLow riskJudgement comment: none detected

Imaoka 2016

MethodsRCT (individually randomised.)
ParticipantsSetting: residential care facility, high‐level care, JapanN = 91Sample: 76% womenAge (years): 84.8 (SD 8.8)

Baseline Characteristics


Usual care group
  • N phase 1: 23

  • Age: mean (SD) : 82.5 (10.9)

  • Female (%): 15 (65%)

  • Medical status defined? (Y/N): N

  • Falls risk defined?(Y/N): N

  • Dependency defined? (Y/N): Y

  • Cognitive status defined? (Y/N): Y

Reduced exercise group
  • N phase 1: 22

  • Age: mean (SD) : 82.6 (9.1)

  • Female (%): 16 (73%)

  • Medical status defined? (Y/N): N

  • Falls risk defined?(Y/N): N

  • Dependency defined? (Y/N): Y

  • Cognitive status defined? (Y/N): Y


Nutrition group
  • N phase 1: 23

  • Age: mean (SD) : 84.6 (7.7)

  • Female (%): 20 (87%)

  • Medical status defined? (Y/N): N

  • Falls risk defined?(Y/N): N

  • Dependency defined? (Y/N): Y

  • Cognitive status defined? (Y/N): Y


Multifactorial group
  • N phase 1: 23

  • Age: mean (SD) : 87.6 (6.5)

  • Female (%): 18 (78%)

  • Medical status defined? (Y/N): N

  • Falls risk defined?(Y/N): N

  • Dependency defined? (Y/N): Y

  • Cognitive status defined? (Y/N): Y


Inclusion criteria: residents of long‐term health facility, not received any regular supplementation of vitamin D during the previous 12 months
Exclusion criteria: receiving terminal care; with renal failure (chronic kidney disease [CDK] stage 3 or an estimated glomerular filtration rate [eGFR] of G2 or poorer); poor glycaemic control; a pacemaker
Pretreatment differences: nil significant
Interventions
  • Usual care: advice on environmental adaptations, falls prevention education for staff, care conference, selection of walking aids, plus undividualised exercise (gait, balance, strength, resistance) and group exercise (warm‐up exercises, sit‐to‐stand, balance and resistance). Two sessions of individualised exercise for 20 minutes per week, and group resistance exercise for 30 minutes per week. 1‐hour education to staff. Caregiver's conference. Assessment and trial of walking aid by physical therapist. Compared to nutrition vitamin D group, this is direct comparison of individual and group exercise to vitamin D. Compared to 'multifactorial group', this is direct comparison of vitamin D to group exercise alone.

  • Reduced exercise group. Same as usual care including individualised exercise only without group resistance exercise, plus other usual care interventions. Two sessions of individualised exercise for 20 minutes per week. 1 hour education to staff. Caregiver's conference. Assessment and trial of walking aid by physical therapist. Compared to usual care, inverting the ratios provides a evidence on effectiveness of additional group exercise.

  • Nutrition group. Administered oral vitamin D (900 IU/day) as Isocal jelly PCF (500 IU) and a supplement (400IU vitamin D3). Jelly vitamins were eaten at lunchtime and supplements were taken after dinner.

  • Multifactorial group. Low level of exercise (individualised but not group exercise) and vitamin D supplementation 900IU/day. Two sessions of individualised exercise for 20 minutes per week. 1‐hour education to staff. Caregiver's conference. Assessment and trial of walking aid by physical therapist.

Outcomes
  • Number of fallers

  • Hazard ratio for falling

Duration of the study3 months intervention, follow‐up to 9 months. Outcomes data exclude the intervention period.
NotesEffect of group exercise presented by comparing 'usual care' to 'reduced exercise' group.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskJudgement comment: envelope drawn
Allocation concealment (selection bias)Low riskJudgement comment: opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: outcome assessors not blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: loss generally balanced between groups.
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified.
Method of ascertaining fallsLow riskQuote: "Falls were carefully recorded by the staff who found a resident falling down."
Quote: "Falls were defined according to the International Classification of Diseases."
Baseline imbalanceLow riskJudgement comment: no significant differences at baseline.
Other biasLow riskJudgement comment: none identified

Irez 2011

MethodsRCT
ParticipantsSetting: 1 residential care facility in Ankara, Turkey, intermediate‐level care.N = 60Sample: 100% womenAge (years): 75.4

Baseline Characteristics


Exercise ‐ Pilates
  • N: 30

  • Age ‐ mean (SD) : 72.8 (6.7)

  • Female ‐ N (%): 30 (100%)

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: N


Usual care
  • N: 30

  • Age ‐ mean (SD) : 78.0 (5.7)

  • Female ‐ N (%): 30 (100%)

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: N


Inclusion criteria: female, healthy, over 65 years of age, and have been relatively sedentary (undertaking no leisure time physical activity or less than 30 minutes of physical activity per day) for at least a year
Exclusion criteria: male, significant general health problem or orthopaedic problem that would keep them from fully participating in the intervention protocol and/or the inability to attend at least 80% of the training sessions.
Pretreatment differences: intervention group younger. Falls risk factors not reported.
Interventions
  • Exercise ‐ Pilates. The first part (4 weeks) consisted of mat exercises (Pilates, 2001), in the second part, Thera‐Band elastic resistance exercises were added, and in the third part, the participants performed Pilates ball exercises for beginners. Classes led by certified Pilates instructor.Sessions 60 minutes, 3 days per week

  • Usual care. Instructed to refrain from beginning a new exercise programme or changing their current activity levels during this time period.

Outcomes
Duration of the study12 weeks
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskJudgement comment: method of randomisation not described
Allocation concealment (selection bias)Unclear riskJudgement comment: no information provided.
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls recorded by study participants who could not be blinded
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskJudgement comment: loss to follow‐up not reported
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified.
Method of ascertaining fallsHigh riskJudgement comment: patient reported falls, calendars collected monthly
Baseline imbalanceHigh risk 
Other biasLow riskJudgement comment:nNone identified

Jarvis 2007

MethodsRCT (individually randomised)
ParticipantsSetting: 1 elderly care rehabilitation ward (subacute), Leicester, UK N = 29 Sample: 100% women Age (years): not stated

Inclusion criteria: female patients admitted for rehabilitation


Exclusion criteria: acute stroke; Parkinson's disease; Abbreviated Mental Test Score ≤ 5; severe cardiac, lung or kidney disease; severe osteoarthritis or rheumatoid arthritis
Interventions
  • Intervention group: physiotherapy x 10 sessions per week. Once a week physiotherapy treatment at home after discharge. 8‐week intervention

  • Control group: physiotherapy x 3 sessions per week. Some seen 1 x per week in day hospital or no treatment after discharge. 8‐week intervention


Physiotherapy consisted of stretches, lower limb exercises, and balance and gait activities in both groups
Outcomes
  • Rate of falls

  • Number of people falling

Duration of the study8 weeks
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote: "... randomly assigned, using sealed envelopes ..." Insufficient information about the sequence generation process to permit judgement of 'Low risk' or 'High risk'
Allocation concealment (selection bias)Unclear riskQuote: "The elderly women fallers were randomly assigned, using sealed envelopes, to either a control group or intervention group." Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskPhysiotherapy team responsible for measurement of outcomes reported to be blinded of intervention. Some chance of unblinding of assessors
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: large loss to follow‐up; 28.6% dropout in intervention arm
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified
Method of ascertaining fallsLow riskJudgement comment: falls clearly defined and recorded concurrently.
Baseline imbalanceLow riskJudgement comment: groups balanced at baseline
Other biasLow riskJudgement comment: none identified

Jensen 2002

MethodsRCT (cluster randomised)
ParticipantsSetting: 9 residential care facilities (intermediate care), Umeå, Sweden N = 402. 9 clusters. Sample: 72% women Age (years): mean (range) intervention group 83 (65 to 97), control group 84 (65 to100)

Inclusion criteria: facilities with ≥ 25 residents; residents aged ≥ 65


Exclusion criteria: none stated
Interventions
  • Multidisciplinary programme including general and resident‐specific tailored interventions for 11 weeks: supervised exercises, medication review, modifying environmental hazards, supplying and repairing aids, hip protectors, education of staff, post fall problem solving conferences and staff guidance. Individually tailored supervised exercises (gait, balance, coordination and functional + strength/resistance) 2 to 3 x per week. Intervention delivered by registered nurses, physician and physiotherapists

  • Usual care. Physiotherapist tasks unchanged, no hip protectors provided, no systematic fall‐related problem‐solving conferences or major fall‐related environmental modifications

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (hip fracture)

Duration of the study34‐week follow‐up
NotesEight extra physiotherapists employed for intervention period (a total of 200 hours/week) and three during the follow‐up period (total of 10 hours/week)
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCluster‐randomised study in nine facilities, divided into groups A and B (control or intervention). Quote: "Two sealed, dark envelopes" were used. Carried out by a person not connected with the study. Insufficient information to permit judgement
Allocation concealment (selection bias)Low riskRandomisation achieved by using by sealed dark envelopes by a person with no knowledge of study. Particiating individuals underwent baseline assessment prior to the randomisation of facilities.
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff at the facilities who recorded falls were likely to be aware of their facility's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskLarge loss to follow‐up but loss is balanced and all patients included in fall analysis until lost.
Selective reporting (reporting bias)Low riskNo protocol identified but all expected falls outcomes reported: Falls, fallers, IRR and injuries reported and adjusted for clustering.
Method of ascertaining fallsLow riskFalls recorded concurrently with clear definition
Baseline imbalanceLow riskBaseline differences adjusted for in analysis
Other biasLow riskNone identified

Juola 2015

MethodsRCT (cluster randomised).
ParticipantsSetting: 20 wards of assisted living facilities in Helsinki, residential care, mixed‐level care, Finland. N = 227 residents. 20 clusters.Sample: 71% womenAge (years): 83

Baseline Characteristics

93% of population had dementia diagnosis.

Nursing educational intervention


  • N : 118

  • Age ‐ mean (SD): 82.9 (7.5)

  • Female ‐ N (%): 77 (65.3)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined? ‐ Y/N: N

  • Dependency defined? ‐ Y/N: Y

  • Cognitive status defined? ‐ Y/N: Y


Usual care
  • N : 109

  • Age ‐ mean (SD): 83.5 (6.9)

  • Female ‐ N (%): 84 (77.1)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined? ‐ Y/N: N

  • Dependency defined? ‐ Y/N: Y

  • Cognitive status defined? ‐ Y/N: Y


Inclusion criteria: age 65 years or older; living permanently in an assisted living facility; Finnish speaking; using at least one medication; having an estimated life expectancy of > 6 months; being able to provide written informed consent (or have a proxy who is able to provide written informed consent in the case of cognitive impairment)
Exclusion criteria: none provided
Pretreatment differences: significant baseline differences in Chalsons comorbidity index,dependence in mobility, prior stroke or transient ischaemic attack (TIA), 15D quality of life score; PRN dug use; proportion of sample using harmful medications; and borderline significant difference between groups in gender (P = 0.05). NOTE ‐ some of these reported in Pitkala paper, some in Joula paper
Interventions
  • Nursing educational intervention on harmful medications. Education based on constructive learning theory to recognise harmful medications and adverse drug events. Two x four‐hour interactive training sessions

  • Usual care. Nurses were free to participate in any other continuing education, including programmes relating to medication use

Outcomes
  • Incidence rate ratio

  • Number of fallers

  • Number with multiple falls

Duration of the study12 months
NotesACTRN12611001078943.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskJudgement comment: dyads of matched facilities, then random number generator
Allocation concealment (selection bias)Low riskJudgement comment: person independent of assessment procedures telephoned another person not familiar with wards or residents to receive allocation
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskJudgement comment: nursing staff were not aware that falls data was being analysed as part of the study, however, there is no explanation of whether attempts were made to keep participants and personnel blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskJudgement comment: nursing staff recorded falls as part of routine care ‐ not aware that data was being analysed (main study outcome / focus was change in medications)
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: imbalance in group losses, in addition to 3 intervention and 5 control participants not accounted for
Selective reporting (reporting bias)Low riskFalls outcomes additional in secondary analysis. Describes all outcomes reported as per methods in the paper.
Method of ascertaining fallsUnclear riskJudgement comment: no definition of falls provided
Baseline imbalanceHigh riskJudgement comment: significant baseline differences on mobility and Charlson comorbidity index, no adjustments reported
Other biasLow riskNone detected

Kennedy 2015

MethodsRCT (cluster‐randomised, pilot study)
ParticipantsSetting: 40 residential care facilities, mixed‐level care, Canada. Mean 137 beds.N = 5478. 40 clusters.Sample: 71% womenAge (years): 84.4 (SD 10.9)

Baseline Characteristics


ViDOS multifaceted KT intervention
  • N: 2185

  • Age ‐ mean (SD) : 84.0 (11.1)

  • Female ‐ N (%): 1,532/2,175 (70.4%)

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: N


Control
  • N: 3293

  • Age ‐ mean (SD) : 84.6 (10.7)

  • Female ‐ N (%): 2329/3277 (71.1%)

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: N


Inclusion criteria: facilities: long‐term care facilities ‐ serviced by a particular pharmacy provider; have more than one prescribing physician; residents: none
Exclusion criteria: residents: none
Pretreatment differences: mean facility size was larger in control (157 beds, SD 80.2) versus intervention homes (115 beds, SD 67.9); however, both study arms had a similar proportion of small (< 100 beds) and large (> 250 beds) homes.In the control arm, there was a higher prevalence of hip fractures; osteoporosis diagnoses; and baseline use of vitamin D≥ 800 IU/day, calcium≥ 500 mg/day, and osteoporosis medications
Interventions
  • ViDOS multifaceted KT intervention. Interactive educational sessions for an interdisciplinary team (comprising the Administrator, Medical Director, Director of Care, Consultant Pharmacist, Director of Food Services/Dietician, and other nursing, medical or rehabilitation staff) delivered via webinar with onsite study co‐ordinator, aimed at increasing prescription of adequate levels of vitamin D, calcium and osteoporosis medication. Includes presentation by expert opinion leaders, action planning for quality improvement, audit and feedback review. Quarterly meetings. 3 sessions, approx 6 months apart. First 2 45 to 60 minutes, third 30 minutes.

  • Usual care ‐ no additional information except fracture prevention toolkits (provided to all homes in the province)

Outcomes
  • Number of falls

  • Number of fallers

  • Number with multiple falls

  • Number with fracture falls

Duration of the study12.2 months; final follow‐up 16 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskJudgement comment: computer‐generated random allocation sequence
Allocation concealment (selection bias)Low riskJudgement comment: allocation adequately concealed at unit level and individual residents not recruited
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: staff recording falls were not blinded
Incomplete outcome data (attrition bias)
All outcomes
High riskReports ITT for all participating facilities and also separately for the facilities in the intervention group who were "active". Large loss of intervention facilities from recruitment to active participation (7 of the 19 intervention facilities recruited did not proceed to implement the intervention). Baseline data are reported for all intervention and control facilities (i.e. all 19 intervention facilities), but there is no comparison between those who participated (n = 12) and those who were recruited but did not participate in the intervention (n = 7 facilities) to ensure the remaining sample were not biased in any way relative to the recruited and randomised intervention sample.
Selective reporting (reporting bias)Unclear riskProtocol indicated outcomes as per adjusted analyses would be reported but absolute number of falls and fractures only reported. Impact of this unclear
Method of ascertaining fallsHigh riskQuote: "Researchers provided the homes with a standardized data collection sheet and homes completed the information using various sources including electronic/paper‐based charts, internal monitoring systems, Resident Assessment Instrument ‐ Minimum Data Set 2.0 (RAI‐MDS 2.0), and critical incident reports."
Judgement comment: falls data collected for 3 month blocks from various data sources ‐ different homes had different reporting systems. This is acknowledged as a limitation.
Baseline imbalanceHigh riskJudgement comment: there were imbalances in baseline characteristics that may impact on falls rates (e.g. hip fractures), the protocol indicated adjustment in analyses (with generalised estimating equations) but adjusted analyses not reported for falls outcomes. P = 0.002 for hip fracture
Other biasLow riskJudgement comment: none detected

Kerse 2004

MethodsRCT (cluster randomised)
ParticipantsSetting: 14 mixed‐level dependency residential care homes (intermediate‐ and high‐level care), New Zealand N = 617 residents. 14 clusters. Sample: 72% women Age (years): mean 83.2 (SD 10.6)

Inclusion criteria: resident in one of the included residential care homes


Exclusion criteria: none stated but data excluded if enrolled in the study for < 2 days and had > 2 falls in one of those days
Interventions
  • Falls risk management programme of 12 months duration

    • Falls co‐ordinator in each home (carried out fall‐risk assessment of all residents using tool, developed specific recommendations and care plans, co‐ordinated with other healthcare professionals, and ensured that recommendations were followed)

    • Evidence‐based risk assessment tool + detailed management strategies relating to mobility impairments, mental impairments, medications, continence, sensory impairments

    • Tailored care plan based on assessment + OT, PT, medical and specialist referrals

    • Logo on high‐risk residents walls + colour‐coded dots showing fall‐prevention strategies

    • Manual containing the risk assessment form, information for strategies, high‐risk fall logos, all forms, and educational information for nurses, doctors, physiotherapists and OTs

  • Usual care

Outcomes
  • Rate of falls

  • Number of people falling

Duration of the study12 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "... homes were stratified by type, and an independent researcher, not involved in the study, block randomized them into intervention or control group using computer‐generated random numbers."
Allocation concealment (selection bias)Low riskSee above, and allocation of all cluster units performed at the start of the study AND individual participant recruitment was completed prior to assignment of the cluster, and the same participants were followed up over time
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff at the facilities who recorded falls were likely to be aware of their facility's allocation status
Incomplete outcome data (attrition bias)
All outcomes
High riskAll falls data included in analysis, but large imbalance in those transferred or discharged (15 vs 35
Selective reporting (reporting bias)Low riskFalls, fallers, injurious falls and rates of falls reported and appropriately adjusted.
Method of ascertaining fallsLow riskFalls clearly defined and recorded concurrently
Baseline imbalanceLow riskBaseline differences accounted for in analysis
Other biasLow riskNone identified.

Kerse 2008

MethodsRCT (cluster randomised)
ParticipantsSetting: 41 low‐level dependency residential care homes (intermediate‐level care), New Zealand. N = 682 residents. 41 clusters. Sample: 74% women Age (years): mean 84.3 (SD 7.2)

Inclusion criteria: able to engage in conversation about a goal; remember the goal; participate in a programme to achieve the goal


Exclusion criteria: unable to communicate to complete the study measures; anxiety as main diagnosis; acutely unwell; terminally ill
Interventions
  • Promoting independence in residential care (PIRC) intervention

    • Goal setting: resident + gerontology nurse (GN) set meaningful goal to promote progressive increase in activity. New goals set when one achieved

    • Functional assessment by GN and individualised programme developed to improve physical function. Physical activities based on repetitions of ADL, e.g. rising from a chair, additional walking, or repeated transfers. Exercise activities at least once a day. Physiotherapist and OT available to help achieve goal. Presciptive plan to increase independence in patient's file and above bed

    • GN trained health care assistants who helped implement programme, supervised by nursing staff

    • GN provided weekly staff support for 1 month, then monthly support

    • Six month intervention but staff expected to continue encouraging residents to activate after that.

  • Control: usual care + 2 social visits

Outcomes
  • Rate of falls

  • Number of people falling

  • Adverse events

Duration of the study12 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "After recruitment of all homes and residents and collection of baseline data, a biostatistician not involved in recruitment randomised homes to the intervention or control group by using computer generated random numbers." 
Allocation concealment (selection bias)Low riskAllocation of all cluster units performed at the start of the study. Individual participant recruitment was completed prior to assignment of the cluster, and the same participants were followed up over time
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff at the facilities who recorded falls were likely to be aware of their facility's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: losses balanced between groups. Falls data for 310/330 and 329/352
Selective reporting (reporting bias)Unclear riskJudgement comment: details of falls outcomes not reported in trials registration
Method of ascertaining fallsUnclear riskJudgement comment: falls clearly defined, but method of ascertainment unclear
Baseline imbalanceHigh riskJudgement comment: difference in antidepressants at baseline between groups
Other biasLow riskJudgement comment: none identified

Klages 2011

MethodsRCT (individually randomised)
ParticipantsSetting: 1 long‐term care home (appears to be high‐ and intermediate‐level care), Ontario, CanadaN = 24Sample: 68% women in the analysisAge (years): mean (SD) intervention group 84 (6.6), control group 89 (3.2)

Inclusion criteria: cognitively impaired (MMSE score < 25); able to follow simple walking instructions; able to walk with minimal assistance; no Snoezelen room attendance in 3 months prior to study


Exclusion criteria: history of seizures; legal blindness; profound hearing loss; history of limb fractures; extrapyramidal system disruptions (inability to remain motionless or to initiate movement)
Interventions
  • Multisensory stimulation in a Snoezelen room: individual 30‐minute sessions of stimulation and relaxation, 2 x per week for 6 weeks, with at least 2 days between sessions

  • Control: individual visits from volunteers (same frequency and duration): listening to readings of the newspaper, looking at magazines, playing cards or a board game, and talking

Outcomes
Duration of the study3 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "A total of 24 eligible residents were recruited. Prior to the commencement of the study a computer‐based random number generator was used to randomly select 12 numbers out of 24. These numbers were assigned to the intervention group. The remaining 12 numbers were allotted to participants in the control group."
Allocation concealment (selection bias)Low riskQuote: "As multiple recruitment packages were sent out simultaneously, and the participants were assigned a number in chronological order when a signed consent document was received, recruitment order and group allocation were unpredictable."
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskNursing staff recording falls were not blind to group allocation and "The investigator [reviewing charts] ... was not blind to group allocation."
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: one frequent faller excluded from the analysis
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified
Method of ascertaining fallsHigh riskJudgement comment: falls recorded concurrently, but falls definition not reported
Baseline imbalanceHigh riskJudgement comment: significant difference in age between groups
Other biasLow riskJudgement comment: none detected

Koh 2009

MethodsRCT (cluster randomised)
ParticipantsSetting: two acute care hospitals, SingaporeN = 1122 patients. 2 clusters.Sample: 641 nurses in medical, surgical and geriatric units in the two hospitals (% female patients not stated)Age (years) patients: mean 68

Inclusion criteria: all patients


Exclusion criteria: none stated
Interventions
  • Multifaceted strategy for implementation of Ministry of Health Fall Prevention Clinical Practice Guideline (CPG)

  • Revision of hospital's fall prevention policy in line with CPG

  • Identification of change champions from within staff

  • Educational sessions for staff aimed at promoting and supporting the adoption of the recommendations

  • Reminders and identification systems, e.g. mandatory fall risk‐assessment tool in nursing assessment notes, posters in ward toilets, high‐risk patients identified by pink name card above the bed, pink stickers on clinical/nursing notes, and pink identification bracelets

  • Audit and feedback on incidence of falls and compliance with use of risk assessment tool

  • Control: routine dissemination strategies for implementation of CPG

Outcomes
Duration of the study6 months
NotesIntervention targeted nursing staff.
Age of patients not stated in Koh 2009. Obtained by personal communication with author
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "The two study hospitals were randomly allocated either to the "intervention" site... or the "control” site". Author states carried out by supervised coin toss; heads gets the intervention
Allocation concealment (selection bias)High riskNo concealment. After first site randomised, second site automatically becomes the control group
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote: "Fall incidence and fall‐associated injury rates were obtained from the hospitals’ fall incidence database"
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: falls data for a random sample of medical records used. How representative these are of all patients and what proportion unknown
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified
Method of ascertaining fallsHigh riskJudgement comment: falls determined through audits of hospital records. Definitions and practices may vary between hospitals.
Baseline imbalanceUnclear riskJudgement comment: baseline characteristics of patients not reported
Other biasLow riskJudgement comment: none detected

Kovacs 2012

MethodsPilot RCT (individually randomised).
ParticipantsSetting: One residential care facility, intermediate‐level care, HungaryN = 41Sample: 100% womenAge (years): 69.2

Baseline Characteristics


Multimodal exercise plus osteoporosis exercise
  • N: 21

  • Age ‐ mean (SD) : 68.7 (6.9)

  • Female ‐ N (%): 21 (100%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y (Berg Balance Scale)

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: N


Osteoporosis exercise programme
  • N: 20

  • Age ‐ mean (SD) : 69.7 (6.5)

  • Female ‐ N (%): 20 (100%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: N


Inclusion criteria: living in the National Institution for Blind People (partial sightedness or blindness); aged 60 years or over; being female.
Exclusion criteria: being totally blind; had lived in the nursing home for less than 2 months; being unable to walk around their own residence; having progressive neurological, and unstable cardiovascular diseases that would limit participation in exercise programme; planned moving away from the nursing home during the study period and; participated in an exercise programme including balance exercise within 6 months.
Pretreatment differences: nil
Interventions
  • Multimodal exercise including strength, balance and progressive resistance based on Otago Exercise Programme, modified for visual impairment, plus walking programme plus standard osteoporosis exercise programme. Strength exercises were directed to major lower limb muscle groups playing roles in postural control, balance exercises were closely related to everyday activity. Group training in groups 3 to 6 supervised by physiotherapist. Plus flexibility warm‐up and cool‐down. 2 x weekly 30‐minute multimodal exercise plus 2 x weekly 30‐minute osteoporosis exercise, plus 20 to 30 minutes walking.

  • Osteoporosis exercise programme. Standard osteoporosis exercise programme alone with strength and flexibility exercises. Not progressive or individually tailored. Plus flexibility warm‐up and cool‐down. 30 minutes, 4 times per week.

Outcomes
  • Relative risk for falling

  • Adverse events

Duration of the study6 months
NotesVisually impaired participants.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskJudgement comment: details of sequence generation not reported
Allocation concealment (selection bias)Low riskJudgement comment: numbered opaque identical sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls extracted from staff records (medical and nursing documentation), blinding of staff not feasible
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: no loss to follow‐up
Selective reporting (reporting bias)High riskJudgement comment: number of falls in the follow‐up period not reported
Method of ascertaining fallsUnclear riskJudgement comment: falls clearly defined but details of documentation inadequate for judgement
Baseline imbalanceLow riskQuote: "There were no significant differences between groups on any baseline characteristics."
Other biasLow riskJudgement comment: none detected

Kovacs 2013

MethodsStudy design: RCT (individually randomised)
ParticipantsSetting: One residential care facility, mixed‐level care, Hungary.N = 86Sample: 81% womenAge (years): 77.9

Baseline Characteristics


Multimodal exercises programme
  • N: 43

  • Age ‐ mean (SD) : 76.4 (9.6)

  • Female ‐ N (%): 36 (83%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Control
  • N: 43

  • Age ‐ mean (SD) : 79.3 (12.7)

  • Female ‐ N (%): 34 (79%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Inclusion criteria: cognitive impairment (MMSE < 24), residents of nursing home, 60 years or over
Exclusion criteria: living in nursing home < 2 months, < 60 years of age, unable to walk 6 metres with or without walking aid, unable to follow simple verbal exercise instructions, unstable cardiovascular or pulmonary diseases that would limit participation in exercise programme, terminal illness, planned moving from the nursing home during the study, no consent
Pretreatment differences: using a frame (20.9% int, 41.9% con)
Interventions
  • A multimodal exercise programme based on Otago Exercise Programme consisting of strength, balance exercises plus 10 minutes flexibility warm‐up and cool down, with progressive resistance supervised by physiotherapist and group based (2 to 4 participants), and supervised walking training. Exercise programme twice weekly, walking once a week

  • Usual care: no exercise programme, participation in social activities

Outcomes
  • Rate ratio

  • Risk of falling

  • Number with multiple falls

Duration of the study12 months
NotesCompliance reported. Cognitively impaired participants.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskJudgement comment: insufficient detail for judgement
Allocation concealment (selection bias)Low riskQuote: "Consecutively numbered opaque identical sealed envelopes were used for allocation."
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: carers recorded falls not blinded to group allocation
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: attrition numbers and reasons balanced between groups
Selective reporting (reporting bias)Low riskJudgement comment: although no protocol was identified, falls outcomes were reported clearly and as multiple measures (fallers, falls, recurrent fallers, as n and RR)
Method of ascertaining fallsLow riskJudgement comment: falls recorded concurrently on calendar using clear definition
Baseline imbalanceHigh riskJudgement comment: significant difference between groups in the proportion using a frame, not adjusted for in analysis
Other biasLow riskJudgement comment: none detected

Lapane 2011

MethodsRCT (cluster randomised)
ParticipantsSetting: 25 nursing homes (appear to be high‐ and intermediate‐level care), Ohio, USAN = 3321 residents. 25 clusters. Sample: 73% womenAge (years): no overall age available

Inclusion criteria (facilities): facilities serviced by one of two Omincare pharmacies and with stable contracts; Medicare and Medicaid certified; ≥ 50 geriatric beds; few short‐stay residents


Exclusion criteria: none stated
Interventions
  • Clinical informatics tool (Geriatric Risk Assessment MedGuide (GRAM)) to assist consultant pharmacists and nursing staff identify residents at risk for delirium and falls based on prescribed medications, implement proactive monitoring plans as appropriate, and provide reports to assist consultant pharmacists conducting monthly medication review. Detailed instruction of staff on medications implicated in falls and delirium, use of reports, care plans and flow charts etc. Detailed instruction of consultant pharmacists providing targeted medication review for all high‐risk residents. Reports within 24 hours of admission for new admissions and used during monthly review, in addition to generation at time of Minimum Data Set reports or when falls or delirium triggered resident assessment protocols.

  • Control: usual care including monthly medication review by consultant pharmacist.

Outcomes
Duration of the study12 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote: "Homes were randomised ..." Insufficient information to permit judgement
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information to permit judgement, although clinical staff recording falls would have been aware of allocation of the nursing home
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskLoss to follow‐up not clearly reported
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified. Data not suitable for use of rate of falls or injurious falls in meta‐analysis as per review Appendix 6
Method of ascertaining fallsHigh riskJudgement comment: no definition of falls provided, only states "MDS data", may vary between sites
Baseline imbalanceHigh riskJudgement comment: number of falls in past 30 days was much higher in intervention group
Other biasLow riskJudgement comment: none detected

Law 2006

MethodsRCT (cluster randomised by unit).
ParticipantsSetting: 118 homes for elderly people, 223 units (intermediate‐ and high‐level care), throughout the UK N = 3717 residents. 223 clusters. Sample: 76% women Age (years): mean 85

Inclusion criteria: facility resident; aged ≥ 60


Exclusion criteria: temporary residents; taking vitamin D or calcium supplements or medications to increase bone density; sarcoidosis; malignancy; life threatening illness
Interventions
  • 2.5 mg oral ergocalciferol (vitamin D2) every 3 months (equivalent to 1100 IU/day)

  • Usual care (no placebo)

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (non vertebral fractures)

Duration of the studyMedian length of follow‐up 10 months (interquartile range 7 to 14)
NotesMean baseline serum vitamin D level collected from 1% of the intervention group; mean 59 nmol/L
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCluster randomisation by computer. No further information provided
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not possible to blind participants but personnel recorded the fall data were blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff at the facilities who recorded falls were likely to be aware of their facility's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: losses balanced between groups. 2.8% left care homes in intervention group, 3.3% control group, other losses due to death (p484 first para, text)
Selective reporting (reporting bias)Low riskJudgement comment: no protocol identified, but fractures, fallers and falls reported, adjusted for clustering
Method of ascertaining fallsHigh riskJudgement comment: falls not clearly defined. Study conducted across 118 homes which may have variations in reporting practice and definitions. Falls recorded daily
Baseline imbalanceUnclear riskJudgement comment: similar at baseline for demographic characteristics (e.g. age, gender), but did not discuss prognostic factors e.g. falls rate/ medical status
Other biasLow riskJudgement comment: none identified

Mador 2004

MethodsRCT (individually randomised)
ParticipantsSetting: two metropolitan acute hospitals, South AustraliaN = 71 Sample: 48% women Age (years): mean 82.5

Inclusion criteria: inpatients on medical and surgical wards; aged ≥ 60; confusion due to either dementia or delirium; problematic behaviour


Exclusion criteria: primary psychiatric illness; no next of kin available to give consent
Interventions
  • Participants assessed for causes of confusion and behavioural disturbance by extended practice nurse within 24 hours of referral. Management plan formulated with respect to non pharmacological strategies to help manage problematic behaviour which was discussed with nursing staff. Ongoing support and education provided to carry out strategies

  • Usual care

Outcomes
Duration of the study11 months. Median length of stay 12 days for intervention group and 9 days for control group
NotesPotential contamination as staff receiving training were also caring for controls
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Sequential sealed opaque envelopes were prepared by a person who was external to the study in blocks of ten stratified for the two hospitals, using a computer‐generated table of random numbers."
Allocation concealment (selection bias)Low riskQuote: "Sequential sealed opaque envelopes were prepared by a person who was external to the study..." Randomised by the Repatriation Hospital Pharmacy Department
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome assessors were not blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: little loss and ITT analysis conducted
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified
Method of ascertaining fallsHigh riskQuote: "Number of falls for each patient was extracted from the hospital’s database of critical incidents."
Judgement comment: no falls definition reported
Baseline imbalanceHigh riskQuote: "There was a significant difference for prior residence, with more control participants entering hospital from home com‐ pared with the intervention group ( p ¼ 0.035). The number of participants under the care of a geriatrician was greater in the intervention than in the control group ( p ¼ 0.006)."
Other biasLow riskJudgement comment: none identified

Mayo 1994

MethodsRCT (individually randomised)
ParticipantsSetting: rehabilitation (subacute) hospital, Canada N = 134 Sample: 46% women Age (years): mean (SD) intervention 70.9 (12.6), control 72.9 (11.8)

Inclusion criteria: one or more of the following: admission diagnosis of stroke or ataxia; an episode of incontinence; a history of multiple falls; aged ≥ 80; using topical eye medication, anticonvulsants, vitamin supplements or anti‐ulcer medications


Exclusion criteria: unable to understand what was being asked of them; participated in this study during a previous admission
InterventionsAll participants selected as being high risk of falling
  • Blue identification bracelet. Told to use bracelet as reminder to be careful when moving around hospital

  • Usual care: no blue bracelet

Outcomes
  • Rate of falls

  • Number of people falling

Duration of the study12 months. Median lengths of stay 75 days (intervention group), 65 days (control group)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote: "Subjects were interviewed to obtain baseline information ... and were then randomly assigned to either the intervention group or the control group."
Allocation concealment (selection bias)Unclear riskInsufficient information on process of allocation to permit judgement of 'Low risk' or 'High risk'
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not possible
Blinding of outcome assessment (detection bias)
All outcomes
High riskFalls ascertained through incident reports. Staff completing incident reports would have been aware of whether or not participant was wearing a blue bracelet
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: ITT analysis, rate of falls, all patients appear to have been included
Selective reporting (reporting bias)Low riskJudgement comment: data presented for number of falls, fallers and rate of falls as per methods
Method of ascertaining fallsUnclear riskJudgement comment: falls clearly defined and recorded concurrently
Baseline imbalanceHigh riskJudgement comment: some imbalance in ability to walk independently at baseline
Other biasLow riskJudgement comment: none identified

McMurdo 2000

MethodsRCT (cluster randomised)
ParticipantsSetting: 9 residential care facilities (intermediate‐level care), Dundee, Scotland, UK N = 133 residents. 9 clusters. Sample: 81% women Age (years): mean 84 (SD 7)

Inclusion criteria: aged ≥ 70


Exclusion criteria: MMSE score < 12
Interventions
  • Multifactorial, multidisciplinary intervention

    • Falls risk assessment and modification performed for each participant including medication review. Recommendations sent to participant's GP, optometrist review if indicated, and review of lighting levels

    • Supervised exercises to improve balance, strength and flexibility; 30 minutes 2 x per week for 6 months. Performed seated because of frailty of participants; not individually tailored. Not specified who delivered the exercise intervention

  • Control: reminiscence therapy

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (all fractures)

  • Adverse events

Duration of the study12 months. 6 month intervention + 6 months follow‐up
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote: "... allocated at random ..." Insufficient information about the sequence generation process to permit judgement of 'Low risk' or 'High risk'
Allocation concealment (selection bias)Unclear riskInsufficient information on process of allocation to permit judgement of 'Low risk' or 'High risk'
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff at the facilities recording falls in calendar were likely to be aware of their facility's allocation status
Incomplete outcome data (attrition bias)
All outcomes
High riskLarge difference in dropout rates between arms
Selective reporting (reporting bias)Unclear riskNumber of falls, fallers, multiple fallers and fracture falls reported. No adjustment for clustering. NIHR link broken
Method of ascertaining fallsLow riskFalls clearly defined and recorded daily on a falls calendar by staff
Baseline imbalanceLow riskGroups balanced at baseline
Other biasLow riskNone identified

Meyer 2009

MethodsRCT (cluster randomised)
ParticipantsSetting: 58 nursing homes (high‐level nursing care), Hamburg, Germany N = 1125 residents. 58 clusters. Sample: 85% womenAge (years): mean (SD) intervention group 86 (6), control group 87 (6)

Inclusion criteria (facilities): ≥ 30 residents; not using a fall risk assessment tool or willing to stop using a tool. Inclusion criteria (residents): ≥ 70 years; able to walk with or without assistance; living in the nursing home for > 3 months


Exclusion criteria: none stated
Interventions
  • Use of one fall risk assessment tool (Downton Index) by ward staff

  • Control: no fall risk assessment tool (nurses judgement of risk)

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (all fractures)

Duration of the study12 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Computer‐generated randomisation lists were prepared by the biostatistician for concealed allocation of clusters by external central telephone."
Allocation concealment (selection bias)Low riskSee above
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNursing staff recorded falls (presumably not blind). External investigator verified completeness of falls data – not clear if blind to group allocation
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: fall data reported for all participants for time in study
Selective reporting (reporting bias)Low riskJudgement comment: outcomes consistent with protocol and adjusted for clustering
Method of ascertaining fallsLow riskJudgement comment: falls recorded concurrently and clearly defined
Baseline imbalanceLow riskJudgement comment: balanced at baseline
Other biasLow riskJudgement comment: none detected

Michalek 2014

MethodsPilot RCT (pseudo‐randomised to one of two clusters)
ParticipantsSetting: Subacute hospital setting. Median length of stay 20 days. GermanyN = 114. 2 clusters.Sample: 79% womenAge (years): Mean NR

Baseline Characteristics


FORTA
  • Age ‐ MEDIAN (IQR): 84 (81‐87)

  • Female ‐ N (%): 42 (75%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: Y


Usual care
  • N: 56

  • Age ‐ MEDIAN (IQR): 83 (79‐87)

  • Female ‐ N (%): 48 (83%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: Y


Inclusion criteria: aged >70 years; stable health condition defined as no need for intermediate or intensive care unit treatment; at least three diseases in need for drug treatment; at least three medical prescriptions; admitted during the first 3 days of the week because of staff availability; patients or proxies had to give written informed consent.
Exclusion criteria: critical or terminal illness; dementia (MMSE <25); refusal to participate.
Pretreatment differences: nil significant reported at baseline, BMI Borderline (P = 0.052)
Interventions
  • FORTA. Drugs were classified according to the FORTA list, combining positive and negative labelling of drugs, ranging from A (indispensable), B (beneficial), C (questionable), D (avoid). Drugs were changed in first week of hospitalisation as guided by FORTA. Weekly meetings of drug evaluation and need encompassing patient disease, functional status, prognosis and need for drugs with decisions based on FORTA suggestions. Drugs were continued despite unfavourable FORTA labelling if patients insisted. Overprescription and under prescription were identified and corrected according to FORTA recommendations. Weekly meetings.

  • Usual geriatric hospital care

Outcomes
  • Falls rate

  • Number of fallers

  • Number with multiple falls

Duration of the studyUntil discharge (median hospital stay 20 days)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskJudgement comment: patients were assigned randomly by number of entrance to one of two wards
Allocation concealment (selection bias)High riskJudgement comment: quasi randomised to one of two wards ‐ high risk of bias. Individuals randomised by number of entrance, sequence predictable
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible, patients admitted to intervention or control wards
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls recorded in hospital recording system by staff who will know ward allocation of patients
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: no reported loss to follow‐up during study period, attrition after enrolment unlikely in acute hospital setting, however falls data reported for 178 patients in Frohnhofen 2013 abstract
Selective reporting (reporting bias)Low riskJudgement comment: falls not recorded as outcome on trials registry but falls outcomes seems to be completely reported in multiple ways (fallers, falls rate)
Method of ascertaining fallsLow riskJudgement comment: falls clearly defined and likely concurrent through established hospital reporting system
Baseline imbalanceLow riskJudgement comment: groups balanced at baseline
Other biasHigh riskJudgement comment: analysis was by individual but quasi randomisation and it was to one of two clusters (although not specifically cluster randomised), which should have been addressed in the analysis

Mulrow 1994

MethodsRCT (individually randomised)
ParticipantsSetting: 9 nursing homes (high‐level nursing care), USA N = 194 Sample: 71% women Age (years): mean (SD) intervention group 79.7 (8.5), control group 81.4 (7.9)

Inclusion criteria: aged > 60; resident in nursing home for ≥ 3 months; dependant in ≥ 2 ADLs


Exclusion criteria: terminal illness; acute medical condition; MMSE score < 50%, unable to follow two‐step command; assaultive behaviour; received physiotherapy within last 2 months
Interventions
  • Tailored exercises 3 x per week for 30 to 45 minutes, 4 months duration. Exercises comprised gait, balance and co‐ordination + strength/resistance + flexibility exercises. Intervention delivered by physical therapists (one on one)

  • Friendly visit

Outcomes
  • Rate of falls

  • Number of people falling

  • Adverse events

Duration of the study4 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Randomization was performed after baseline assessments by calling a central number. Randomization was blocked in groups of four and stratified by nursing home site."
Allocation concealment (selection bias)Low riskRandomisation was performed after baseline assessments by calling a central number. No further description
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskFalls recorded in charts and incident reports. Staff recording falls likely to be aware of allocation status. Research assistants examining charts and incident reports were reported to be blinded to allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: 14 dropouts, 12 due to death, other 2 unexplained but unlikely to be related to outcome
Selective reporting (reporting bias)Low riskJudgement comment: falls and fallers outcomes reported
Method of ascertaining fallsHigh riskJudgement comment: no falls definition reported and may vary between sites
Baseline imbalanceLow riskJudgement comment: groups balanced at baseline
Other biasLow riskJudgement comment: none identified

Neyens 2009

MethodsRCT (cluster randomised by ward)
ParticipantsSetting: 12 nursing homes, psychogeriatric wards (high‐level nursing care), the Netherlands (6 wards in intervention group and 6 in control group). N = 518 residents. 12 clusters. Sample: 68% womenAge (years): mean (SD) intervention group 82.1 (7.7), control group 83.3 (7.7)

Inclusion criteria (wards): ≥ 25 beds; not using a fall prevention protocol; having the largest number of mobile patients


Exclusion criteria: none stated
Interventions
  • Multifactorial, multidisciplinary intervention:

    • General medical assessment by medical staff (at start of trial, on admission, if change in medical condition)

    • Assessment with fall risk evaluation tool (fall history, medication intake, mobility, use of assistive and protective aids) by multidisciplinary team (physician, 2 nurses, physiotherapist, OT) at start of trial, on admission, after a fall, at request of ward staff, 2 x per year for all residents)

    • Team decisions about individually‐tailored fall‐prevention activities, e.g. medication review, individually‐designed exercise programmes, assessing and providing assistive and protective aids. Fortnightly conferences discussing each assessed resident

    • Environmental hazard check on each ward by OT

    • Team could implement general fall prevention activities, e.g. staff training

  • Control: usual care, no insight on fall prevention programme

Outcomes
Duration of the study12 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "At random, using computer techniques, two intervention homes and two control homes were selected from each group [groups based on the mean fall incidence rate of psychogeriatric patients per psychogeriatric bed], resulting in a total of six intervention homes and six control homes."
Allocation concealment (selection bias)High riskOne ward per home was chosen after randomisation, based on inclusion criteria
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskStudy was cluster randomised and nursing staff recorded falls
Incomplete outcome data (attrition bias)
All outcomes
Low riskData analysed by ITT
Selective reporting (reporting bias)High riskNo protocol identified, fallers not reported
Method of ascertaining fallsUnclear riskNot stated whether falls clearly defined
Baseline imbalanceLow riskReasonable comparability. More falls pre‐trial in intervention arm, but adjusted for in analyses
Other biasLow riskNone identified

Nowalk 2001

MethodsRCT (individually randomised)
ParticipantsSetting: 2 long‐term care facilities (combined high‐level nursing care and independent living), USA N = 110 participants Sample: 86% women Age (years): mean 84

Inclusion criteria: aged ≥ 65; cognitively able to be tested; able to ambulate with or without assistive device; able to follow simple directions; co‐operative; capable of participating in group sessions


Exclusion criteria: unwilling or unable to complete baseline assessments
Interventions
  • "Fit NB Free" (FNBF): supervised exercises consisting of progressive strength training, flexibility, and endurance (treadmill and bicycling exercises), 3 x per week for 13 to 28 months. Duration of sessions not specified. Exercises were delivered by exercise physiologists. Exercises individually‐tailored based on exercise capacity of participants

  • "Living and Learning/Tai Chi (LL/TC): Tai Chi 3 x per week for 13 to 28 months + psychotherapeutic and behavioural methods to reduce fear of falling. Exercises not individually‐tailored. Tai Chi was delivered by professional instructor. Individualised assessment of participants not part of intervention

  • Usual routine activities


Note: all groups also exposed to educational activities
Outcomes
Duration of the study24 months
NotesTrue N for each group unknown and data discrepancies within published manuscript.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Following completion of all assessments, participants were randomly assigned to one of three groups ... using permuted blocks ..."
Allocation concealment (selection bias)Unclear riskInsufficient information on process of allocation to permit judgement of 'Low risk' or 'High risk'
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff who recorded falls on incident report forms were likely to be aware of individual's allocation status
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: attrition by allocation group unclear, but overall 41/112 lost, died or not followed for full time period
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified. Number of falls not reported
Method of ascertaining fallsLow riskJudgement comment: falls defined and reliant on facility incident reports
Baseline imbalanceLow riskJudgement comment: no important differences at baseline
Other biasLow riskJudgement comment: none identified

Patterson 2010

MethodsRCT (cluster‐randomised matched pairs of nursing homes)
ParticipantsSetting: 22 nursing homes (high‐ and intermediate‐level care), Northern Ireland N = 334 residents. 22 clusters. Sample: 73% womenAge (years): mean 82.7 (SD 8.4)

Inclusion criteria (facilities): > 30 resident beds (including homes for general nursing category residents and for elderly mentally infirm people). Inclusion criteria (residents): aged ≥ 65


Exclusion criteria (facilities): caring exclusively for terminally ill people. Exclusion criteria (residents): terminally ill; attending day care only
Interventions
  • Pharmacists visited intervention facilities monthly for 12 months. Reviewed residents' clinical and prescribing information, applied an algorithm to assess appropriateness of psychoactive medication, worked with nurses and prescribers to improve the prescribing of these drugs

  • Usual care

Outcomes
Duration of the study12 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "randomly assigned ... using a computer generated table of random numbers"
Allocation concealment (selection bias)Low riskAn independent researcher blind to the identity of the homes carried out the randomisation (after consent obtained from the homes)
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskRoutinely collected falls data were used. Staff not blinded to group allocation
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: loss to follow‐up entirely due to death, with similar percentages of deaths in each group. ITT analysis
Selective reporting (reporting bias)High riskJudgement comment: trial registry record indicates outcome as number of people falling, but only rate of falls reported
Method of ascertaining fallsHigh riskJudgement comment: falls definition not reported and reliant on falls reporting within each home which may vary
Baseline imbalanceLow riskJudgement comment: no major differences at baseline. Similar for falls risk factors. Main difference is more urban nursing homes in control group than in intervention group
Other biasLow riskJudgement comment: none identified

Peyro Saint Paul 2013

MethodsRCT (individually randomised)
ParticipantsSetting: hospital acute and residential care facility setting (92% residential care), France. N = 19 residentsSample: 58% womenAge (years): 89.9

Baseline Characteristics


Changing drug therapy
  • N: 9

  • Age ‐ mean (SD) : 90.8 (3.7)

  • Female ‐ N (%): 5 (56%)

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: N


Usual care
  • N: 10

  • Age ‐ mean (SD) : 89.0 (7.3)

  • Female ‐ N (%): 6 (60%)

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: N


Inclusion criteria: aged 65 and over; chronic moderate hyponatraemia (serum sodium 123 mEq/L to 134 mEq/L) detected using a biological control routine; in acute care unit or retirement home
Exclusion criteria:
Pretreatment differences: age and sex same, Nz level same, renal clearance worse in control
Interventions
  • Changing drug therapy. Review by pharmacist of drugs that may cause hyponatraemia.

  • Usual care. Routine management with no drug review

Outcomes
  • Number of falls

  • Number of fallers

  • Number with multiple falls

  • Adverse events

Duration of the study3 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskJudgement comment: Author correspondence, quote: "Random sequence was managed as a single randomization list managed by the sponsor". It is unclear how the randomisation sequence was generated.
Allocation concealment (selection bias)Low riskJudgement comment: Author correspondence, quote: "Random sequence was managed as a single randomization list managed by the sponsor. Allocation was concealed using masking envelope."
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: author correspondence: "Staff were not blind to group allocation. Residents were not blind to group allocation."
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: author correspondence, quote: "The fall was recorded as soon in the patient file by the first caregiver who noted: carer, nurse or doctor. Caregiver were not blind to group allocation."
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: the proportion of missing data is considered high enough to potentially have a relevant effect on the effect estimate: falls data only available for 9/19 randomised patients. Response to enquiry received 19/7 from Peyro Saint Paul ‐ participant flow chart still unclear
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified
Method of ascertaining fallsUnclear riskJudgement comment: author correspondence, quote: "the software allows to record falls in the patient file." Methods of ascertaining falls not reported
Baseline imbalanceUnclear riskJudgement comment: characteristics for key baseline factors (falls risk, medical status, dependency, cognitive status) relevant to falls are not reported.
Other biasLow riskJudgement comment: none detected. Main publication not in English

Potter 2016

MethodsRCT (individually randomised)
ParticipantsSetting: 4 care facilities, mixed level of care, rural Australia. N = 95 participants randomised; 93 in analysisSample: 52% womenAge (years): mean 84.3 (SD 6.9)

Baseline Characteristics


Deprescribing intervention
  • N: 47

  • Age ‐ mean (SD) : 84 (6)

  • Female ‐ N (%): 26 (55%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: Y


Usual care
  • N: 48

  • Age ‐ mean (SD) : 84 (8)

  • Female ‐ N (%): 23 (48%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: Y


Inclusion criteria: residents of residential aged care facilities aged 65 years or older
Exclusion criteria: taking no regular medicines; were in the final terminal stages of an illness; or if their usual general practitioner (GP) or the RACF nurse manager did not agree to their participation
Pretreatment differences: control participants had lower mean blood pressure.
Interventions
  • Deprescribing intervention. An individualised medicine review followed by the planned cessation of non‐beneficial medicines. The intention of deprescribing was to reduce the total number of unique medicines consumed. The review was led by a GP and a geriatrician who was also a clinical pharmacologist of older people. The medicine withdrawal plan, amended to reflect changes requested by participant, next‐of‐kin, or GP, was implemented over several months. The GP reviewed participants weekly during deprescribing.

  • Usual care. Medication review as per the control arm with no deprescribing (medication review plan not passed on to GPs).

Outcomes
  • Number of falls

  • Number of fallers

  • Number of multiple fallers

  • Number with fracture fall

  • Number with an adverse event.

Duration of the study12 months
NotesAfter 12 months, 59% of targeted medicines were deprescribed.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskJudgement comment: using a digital random number generator
Allocation concealment (selection bias)Low riskJudgement comment: sealed opaque envelopes opened after the medication review, withdrawal plan and baseline assessments
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: no blinding with reference to falls outcome assessment possible
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls outcomes were assessed by persons who would know the treatment allocation
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: no evidence of significant incompleteness of falls outcome data
Selective reporting (reporting bias)Low riskJudgement comment: protocol available, outcomes reported as per protocol
Method of ascertaining fallsLow riskJudgement comment: used routine data collection plus recall from relatives. Clear definition used.
Baseline imbalanceLow riskJudgement comment: difference in systolic blood pressure, however, deemed unlikely to significantly affect outcome
Other biasLow riskNone detected

Ray 1997

MethodsRCT (cluster randomised)
ParticipantsSetting: 14 nursing homes (high‐level nursing care), USA N = 499 participants. 14 clusters. Sample: 78% women Age (years): mean 83

Inclusion criteria: high risk of falls with potential problem in a safety domain; likely to remain in nursing home


Exclusion criteria: age < 65; anticipated stay < 6 months; bed bound; no fall in previous year
Interventions
  • Consultation service with individual assessment and recommendations targeting environmental and personal safety, wheelchair use, psychotropic medication use, transferring, and ambulation. Falls co‐ordinator at each site. Intervention delivered by study team

  • Usual care

Outcomes
  • Number having 2 or more falls

Duration of the study12 months
NotesNo published data on numbers of falls or fallers who had a single fall
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskSeven "matched" pairs of facilities participated. Quote: "The statistician ... generated sealed‐envelope random assignments for each pair from the SAS function RANUNI (using the clock for the seed)."
Allocation concealment (selection bias)Low riskStudy author (statistician) generated sealed envelope random number assignments for each pair using the SAS function from RANUNI using the clock for the seed
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff at the facilities who recorded falls were likely to be aware of their facility's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskITT analysis, little loss to follow‐up, reasons balanced
Selective reporting (reporting bias)Unclear riskNo protocol identified
Method of ascertaining fallsUnclear riskFalls clearly defined, relies on incidence reports, trial guidance on concurrent reporting unclear
Baseline imbalanceLow riskNo major differences. Difference in BMI, life space diameter, multivariate regression conducted, no differences in main falls risk factors
Other biasLow riskNone identified

Rosendahl 2008

MethodsRCT (cluster randomised)
ParticipantsSetting: 9 residential care facilities (intermediate‐ and high‐level nursing care), Sweden N = 191. 34 clusters. Sample: 73% women in 34 clusters (cluster equals 3 to 9 participants living on the same floor, wing, or unit)Age (years): mean 84.7 (SD 6.5)

Inclusion criteria: aged ≥ 65; dependent in ≥ 1 personal ADLs; able to stand from armchair with help from 1 person; MMSE score ≥ 10; physician approval


Exclusion criteria: none stated
Interventions
  • Functional exercise programme: weight‐bearing exercises challenging leg strength, postural stability, and gait ability. Physiotherapists selected exercises for each participant according to their functional deficits. High intensity and increasing load encouraged (5 sessions of 45 minutes every fortnight; total of 29 sessions)

  • Control: seated programme developed by OT, e.g. watching films, reading, singing (5 sessions of 45 minutes every fortnight)

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (hip fractures)

  • Adverse events

Duration of the study6 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Researchers not involved in the study performed the randomization by using lots in sealed non‐transparent envelopes."
Allocation concealment (selection bias)Low riskRandomisation by cluster was performed after the inclusion of participants and baseline assessments using sealed nontransparent envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff who recorded falls were likely to be aware of individual's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: losses balanced and unlikely to affect outcome
Selective reporting (reporting bias)Low riskJudgement comment: outcomes reported consistently with trial registration. All expected outcomes reported
Method of ascertaining fallsLow riskJudgement comment: falls clearly defined and recorded concurrently
Baseline imbalanceLow riskJudgement comment: no major differences at baseline. Difference in self‐perceived health but no differences in diagnoses, functional assessments, falls or drugs.
Other biasLow riskJudgement comment: none identified.

Rubenstein 1990

MethodsRCT (individually randomised)
ParticipantsSetting: long‐term care facility (intermediate‐ and high‐level nursing care), Los Angeles, USA N = 160 Sample: 85% women Age (years): mean (SD) intervention group 86.8 (0.6), control group 87.9 (0.7)

Inclusion criteria: fall within 7 days of nurse receiving fall incident report


Exclusion criteria: unable to walk; unable to be evaluated within 7 days of fall due to acute illness or hospitalisation; unable to understand English
Interventions
  • Comprehensive post fall assessment within 7 days of fall. Intervention delivered by nurse: physical examination including visual screening, extended pulse and blood pressure assessments with attention to postural changes, assessment of footwear and foot problems, a quantified gait and balance assessment, laboratory tests, ECG, 24 hours Holter monitoring, environmental assessment to identify potential hazards. Once only assessment with recommendations given to patient's primary care physician

  • Usual care. Control group did not receive the assessment and no recommendations were transmitted. "Less than half of the control group received no more than a brief check for injury after they fell."

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (all fractures

Duration of the study24 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Eligible fallers were ... randomly assigned to either the intervention or control group, using computer generated, randomly sequenced cards in sealed envelopes."
Allocation concealment (selection bias)Unclear riskInsufficient information on process of allocation to permit judgement of 'Low risk' or 'High risk'. It is unclear who conducted the randomisation and envelopes not described as opaque and sequentially numbered
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff who recorded falls after intervention were likely to be aware of individual's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskData balanced between arms
Selective reporting (reporting bias)Low riskNo protocol identified (1990 study) but expected falls outcomes reported as number of falls and fallers reported
Method of ascertaining fallsLow riskFalls clearly defined and recorded concurrently
Baseline imbalanceLow riskNo major differences between groups at baseline
Other biasLow riskNone identified

Sakamoto 2006

MethodsRCT (individually randomised)
ParticipantsSetting: nursing care facilities and rehabilitation outpatient departments (intermediate care), Japan N = 553 Sample: 74% women Age (years): mean 81.6 (SD 9.0)

Inclusion criteria: able to stand on their own while holding on to a bar


Exclusion criteria: severe dementia
Interventions
  • Single leg stance practice both legs for 1 minute each leg, 3 times daily

  • Usual care (without exercise)

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (hip fractures)

Duration of the study6 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Randomization of the subjects into an exercise group or a control group was performed by the Department of Information Science of our university." using a "table of random numbers".
Allocation concealment (selection bias)Unclear riskRandomisation by Department of Information Science. Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff who recorded falls were likely to be aware of individual's allocation status
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: greater loss from intervention group, 22 vs 4
Selective reporting (reporting bias)Low riskJudgement comment: no protocol identified, but number of falls, and fallers reported
Method of ascertaining fallsUnclear riskJudgement comment: no definition of falls. Method of ascertaining falls not described
Baseline imbalanceUnclear riskJudgement comment: baseline characteristics by group allocation unclear
Other biasLow riskJudgement comment: none identified

Sakamoto 2012

MethodsRCT (individually randomised)
ParticipantsSetting: 3 nursing homes (intermediate‐level care), Aomori, JapanN = 145Sample: 81% womenAge (years): mean (SD) intervention group 84.2 (7.8), control group 84.1 (7.7)

Inclusion criteria: aged ≥ 65; able to transfer independently with or without assistive devices


Exclusion criteria: non consenting; pica disorder (the desire to eat “unnatural” things) in case they ate the patches
Interventions
  • Lavender olfactory stimulation: commercially available white patch (1 cm x 2 cm, Aromaseal Lavender; Hakujuji Co., Tokyo, Japan) attached to inside of resident’s clothing near the neck: continuous olfactory exposure for 24 hours. Patches replaced daily for 1 year. Odour can only be sensed by person wearing the patch

  • Control: placebo patch (1 cm x 2 cm, unscented Aromaseal) replaced daily for 1 year

Outcomes
  • Rate of falls

  • Number of people falling

  • Adverse events

Duration of the study12 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "An independent statistician performed resident allocations using computer‐generated randomization of numbers at each nursing home."
Allocation concealment (selection bias)Low riskQuote: "An independent statistician performed resident allocations ... at each nursing home. Treatment allocation status was delivered to the head nurse at each nursing home, and patches were prepared accordingly."
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: placebo patch used but as was olfactory stimulation is a reasonable chance of unblinding
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskAlthough the staff recording falls were blind to group allocation, the head nurse who "supervised the recording of falls regularly", was not
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: approx 30% withdrawal due to death and discharge, balanced between study arms. ITT analysis performed
Selective reporting (reporting bias)Low riskJudgement comment: falls, falls rate, fallers and recurrent falls reported unadjusted and adjusted. Falls outcomes thoroughly and completely reported
Method of ascertaining fallsLow riskJudgement comment: falls clearly defined and recorded concurrently
Baseline imbalanceLow riskJudgement comment: no differences between groups at baseline
Other biasLow riskJudgement comment: none identified

Salvà 2016

MethodsRCT (cluster randomised).
ParticipantsSetting: 16 residential care facilities, mixed‐level care, Spain.N = 16 clusters randomised, 12 clusters in analysis.Sample: 72% womenAge (years): 84.4

Baseline Characteristics


Multifactorial falls prevention programme
  • N: 193

  • Age ‐ mean (SD) : 84.2 (6.8)

  • Female ‐ N (%): 141 (73.1)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: Y (MMSE 17(7))


Control
  • N: 137

  • Age ‐ mean (SD) : 84.5 (6.6)

  • Female ‐ N (%): 98 (71.5)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: Y (MMSE 18(8)


Inclusion criteria: 65 years or more; People with or without cognitive impairment living indefinitely in a nursing home place; Able to walk with or without any kind of help or able to self transfer (as defined in category d420 of the WHO International Classification of Functioning, Disability and Health) without help; Give their consent (or the legal guardian in case of cognitive impairment)
Exclusion criteria: terminal illness; occupying temporarily a nursing home place (convalescence period) or another kind of place (day centre, long‐term care, etc).
Pretreatment differences: nil
Interventions
  • Multifactorial falls prevention programme. Mini Falls Assessment Instrument and implementation of a multifactorial tailored programme to prevent falls. Interventions provided to address individual risk factors including: gait and balance impairment, cognitive impairment, polypharmacy, assistance with ADLs, lower limb pain, urinary incontinence, weakness, symptomatic heart disease, fear of falling, neuroleptics/psychotropic drugs, problems in feet, dizziness, visual impairment, depressive symptoms. 3 sessions weekly of 45 minutes

  • Control. Falls risk assessment, without intervention actions and usual care.

Outcomes
  • Rate ratio

  • Odds ratio for falling

  • Number of fractures

Duration of the study12 months
NotesAdditional information provided by author correspondence
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskJudgement comment: random draw with opaque envelopes
Allocation concealment (selection bias)High riskJudgement comment: allocation not concealed from the person performing recruitment, as per author correspondence
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: open‐label trial
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls recorded by staff who were not blinded
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: large loss to follow‐up after randomisation which is greater in the control arm (41%); 2 centres in control arm left the study (65 participants); 1 centre in each arm provided no falls data (14 participants in intervention group, 32 participants in control group)
Selective reporting (reporting bias)Low riskJudgement comment: all outcomes reported as specified in trial record, some by author correspondence
Method of ascertaining fallsUnclear riskJudgement comment: falls recording concurrent, unclear if a definition of falls was provided
Baseline imbalanceLow riskJudgement comment: no major imbalances. Imbalance in those with depression in dementia, however numbers are small
Other biasLow riskJudgement comment: none identified

Sambrook 2012

MethodsRCT (cluster randomised by facility).
ParticipantsSetting: 51 aged care facilities (intermediate care), North Sydney, AustraliaN = 602 residents. 51 clusters.Sample: 71% womenAge (years): mean 86.4 (SD 6.6)

Inclusion criteria: aged ≥ 70; ambulant; likely to survive for ≥ 12 months


Exclusion criteria: taking vitamin D or calcium supplements; history of skin cancer in previous 3 years
Interventions
  • UV: increased sunlight exposure to face, hands and arms, 30 to 40 minutes, 5 days per week

  • UV+: increased sunlight exposure (as above) + calcium carbonate 600 mg daily

  • Control: usual care + brochure on vitamin D deficiency and its treatment

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (all fractures)

  • Adverse events

Duration of the study12 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "The random allocation sequence ... was generated by a statistician who was not involved in the recruitment"
Allocation concealment (selection bias)Low riskQuote: "... it was concealed from the study coordinators until after randomisation."
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskStudy was cluster randomised and nursing staff reported falls. Researchers visited each home every two months to record falls
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: low loss to follow‐up and ITT analysis
Selective reporting (reporting bias)Low riskJudgement comment: falls, fallers, risk ratio and rate ratio reported, adjusted for clustering
Method of ascertaining fallsLow riskJudgement comment: clear definition, falls documented concurrently (in nursing notes and incident reports) and recorded by research staff monthly
Baseline imbalanceLow riskJudgement comment: only significant difference in cognition at baseline adjusted for in analysis
Other biasLow riskJudgement comment: none identified

Saravanakumar 2014

MethodsRCT (individually randomised)
ParticipantsSetting: residential care facilities, mixed‐level care, Australia
Baseline Characteristics
Tai chi group
  • N: 9

  • Age ‐ mean (SD) : 81.1 (8.0)

  • Female ‐ N (%): 8 (72.7%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Yoga group
  • N: 9

  • Age ‐ mean (SD) : 84.9 (6.7)

  • Female ‐ N (%): 10 (90.9%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Usual care
  • N: 11

  • Age ‐ mean (SD) : 85.4 (9.1)

  • Female ‐ N (%): 6 (54.5%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Inclusion criteria: aged 60 and over; able to stand with support; able to understand English; able to understand and follow simple instructions and demonstrations
Exclusion criteria: severe debilitating illness; severe cognitive impairment; severe hearing or visual impairment (as determined by the RCF staff)
Pretreatment differences: nil significant
Interventions
  • Tai chi. Modified Tai Chi programme beginning with warm‐up exercises of different joints and progressing through 18 individual Tai chi and qigong movement patterns, with repetitions for each pattern, using imagery, breathing and posture control. The movements were slow, controlled and circular using functional patterns and engaging the mind. Modifications were made for functional capacity. 30‐minute classes twice weekly.

  • Yoga. Modified traditional yoga exercises (asanas), breathing (pranayama), synchronising movements with breathing and yoga nidra, a type of relaxation. To make it suitable for frail residents, more seated exercises and preparatory movements were included. 30‐minute classes twice weekly.

  • Usual care. The care facility encouraged all residents to access the Staying Active programme with weekly half‐hour seated exercise sessions; physical culture, games and group activities like bingo, group reading, story‐telling, etc.; a gym with bicycles, pulleys and massage by trained staff; assisted and independent activities such as walking, gardening.

Outcomes
  • Mean number of falls

  • Number of adverse events

Duration of the study14 weeks
NotesACTRN12612000103864
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Permuted block randomisation with a block size of 6 was generated using MS office Excel."
Allocation concealment (selection bias)Low riskQuote: "After baseline assessments, participants were randomly allocated to tai chi, yoga or usual care groups by a researcher not involved in recruitment who prepared the randomised list in sealed envelopes that were given to the facility staff a day before the commencement of the interventions."
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls would recorded by care home staff in RCF records, who would not be blinded to the intervention
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: loss from groups Control 9%, Tai Chi 18%, Yoga 27%. Given small trial numbers losses may have impacted on outcomes
Selective reporting (reporting bias)Low riskJudgement comment: falls outcomes reported as per trial registration
Method of ascertaining fallsLow riskQuote: "Falls were defined as ‘events that resulted in a per‐ son coming to rest inadvertently on the ground or floor or other lower level, excluding inten‐ tional change in position to rest in furniture, wall or other objects’ (WHO, 2007). Fall incidence information was collected from the records main‐tained at the RCF. The data was collected for the period of 6 months pre‐intervention, intervention period and 6 months post‐intervention period."
Baseline imbalanceLow riskJudgement comment: no significant differences at baseline
Other biasLow riskJudgement comment: none identified

Schnelle 2003

MethodsRCT (individually randomised)
ParticipantsSetting: 4 nursing homes (high‐level nursing care), USA N = 190 Sample: 85% women Age (years): mean (SD) intervention group 87.3 (8.0), control group 88.6 (6.7)

Inclusion criteria: incontinent; no in‐dwelling catheter; follows one stage commands; not Medicare Part A for post acute care or terminal; occupying long stay bed


Exclusion criteria: none stated
Interventions
  • "FIT": incontinence care and functional exercises delivered by research staff. Every 2 hours from 08.00 to 16.00, 5 days a week, for 8 months. At each session patients prompted to toilet and changed if wet; encouraged to walk (or mobilise in wheel chair if not ambulatory); carried out sit‐to‐stand exercises with minimal assistance; offered fluids to drink before and after each episode. Upper body resistance training (arm curls and arm raises) at one episode per day. Individually tailored to meet weekly goals (up to 8 sit‐to‐stands, and up to 10 minutes walking (wheeling) per episode)

  • Control: usual care

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (all fractures)

Duration of the study8 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "... subjects were randomized within NHs by computerized programs into intervention and control groups."
Allocation concealment (selection bias)Unclear riskInsufficient information on process of allocation to permit judgement of 'Low risk' or 'High risk'
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskFalls recorded in medical records. Staff recording falls were likely to be aware of allocation status. Researchers examining records were blinded to allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: ITT analysis
Selective reporting (reporting bias)Low riskJudgement comment: falls, fallers, injurious falls, fracture falls and falls incidence reported
Method of ascertaining fallsHigh riskJudgement comment: no falls definition reported
Baseline imbalanceLow riskJudgement comment: groups balanced at baseline
Other biasLow riskJudgement comment: none identified

Schoenfelder 2000

MethodsRCT (individually randomised)
ParticipantsSetting: 2 nursing homes (high‐level nursing care), USA N = 16 Sample: 75% women Age (years): mean 82.8 (range 66 to 95)

Inclusion criteria: aged ≥ 65; ambulating independently with or without assistive device; understand English; MMSE score > 20


Exclusion criteria: unstable physical condition; terminal illness; history of acting out or abusive behaviour
Interventions
  • Supervised ankle strengthening exercises followed by up to 10 minutes of walking, total time 20 minutes, 3 x per wk for 3 months. Exercises individually tailored. Intervention delivered by research member

  • Control: usual care

Outcomes
  • Rate of falls

  • Number of people falling

  • Adverse events

Duration of the study6 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information about the sequence generation process to permit judgement of 'Low risk' or 'High risk'. Quote: "... subjects were matched in pairs and assigned randomly within each pair to the intervention or control group."
Allocation concealment (selection bias)High riskAllocation concealment not described and researchers changed group allocation of one participant after randomisation
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff who recorded falls after intervention were likely to be aware of individual's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: no loss to follow‐up
Selective reporting (reporting bias)High riskJudgement comment: no fallers data reported
Method of ascertaining fallsUnclear riskJudgement comment: methods of collecting falls data unclear, no definition provided
Baseline imbalanceHigh riskJudgement comment: differences in gender and falls efficacy at baseline
Other biasLow riskJudgement comment: none identified

Serra‐Rexach 2011

MethodsRCT (individually randomised)
ParticipantsSetting: 1 geriatric nursing home (intermediate‐level care), Madrid, Spain N = 40 Sample: 80% womenAge (years): mean 92 (SD 2)

Inclusion criteria: aged ≥ 90; planning to stay in the same nursing home during the study; able to ambulate with or without cane, walker, or parallel bars); able to communicate; able and willing to consent


Exclusion criteria: acute or terminal illness; myocardial infarction in previous 3 months; unstable medical condition; upper or lower extremity fracture in previous 3 months; severe dementia; neuromuscular disease; using drugs affecting neuromuscular function
Interventions
  • Training group: training sessions 45 to 50 minutes per day, 3 days per week for 8 weeks (stretching exercises to warm up and cool down + aerobic training on cycle ergometer (up to 15 minutes), strength training with leg press with variable resistance (2 to 3 sets of 8 to 10 repetitions with rests between), + upper limb resistance training with weights or resistance bands. Also received usual care physiotherapy (mobility exercises, i.e. passive and active stretching of joints, 40 to 45 minutes per day, 2 days per week)

  • Control: usual care physiotherapy (mobility exercises, i.e. passive and active stretching of joints, 40 to 45 minutes per day, 5 days per week)

Outcomes
  • Number of falls

  • Adverse events

Duration of the study12 weeks (8 weeks intervention and further 4 weeks follow‐up)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "computer generated randomization sequence"
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "The assessment staff was blinded to participant randomization assignment. Participants were... reminded not to discuss their randomization assignment with assessment staff."
"An independent researcher was in charge of auditing all nursing and medical records to record the number of falls in each participant over the study period"
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: loss to follow‐up low and reasons balanced.
Selective reporting (reporting bias)Unclear riskJudgement comment: falls a secondary outcome. Falls defined as adverse event in published protocol but not final publication
Method of ascertaining fallsLow riskQuote: "In our study, we will define falls as "unexpected event in which the participants come to rest on the ground, floor, or other lower level" [61,62]. An independent researcher will be in charge of auditing all nursing and medical records to record all falls in the participants over the study period."
Judgement comment: falls defined and recorded concurrently
Baseline imbalanceLow riskJudgement comment: groups similar at baseline
Other biasLow riskJudgement comment: none identified

Shaw 2003

MethodsRCT (individually randomised)
ParticipantsSetting: 2 accident and emergency (A&E) departments, Newcastle, UK N = 308 Sample: 79% of participants lived in high and intermediate nursing care facilities (personal communication), (80% women) Age (years): mean 84 (range 71 to 97)

Inclusion criteria: presenting to A&E after a fall; age ≥ 65; MMSE score < 24; consent from patient; immediate carer and next of kin


Exclusion criteria: unable to walk; medical diagnosis likely to have caused index fall, e.g. stroke; unfit for investigation within 4 months; unable to communicate for reasons other than dementia; living outside of a 15‐mile radius of recruitment site; no major informant
Interventions
  • Multifactorial, multidisciplinary assessment and intervention to identify and manage risk factors.

    • Assessment of feet and footwear, gait and balance (physiotherapist): provision of walking aids and footwear, chiropody referral if required. Home‐based tailored exercise programme supervised by physiotherapist (gait training, balance, transfer and mobility interventions, functional limb strengthening and flexibility exercises) for 3 months

    • Medical intervention comprised investigation and management of untreated medical problems, medication review, vision assessment and referral if indicated and psychogeriatric review if indicated

    • Cardiovascular review and advice and/or treatment of identified cardiac risk factors for falls

    • OT assessment of environmental fall hazards using a standard checklist, and hazard modification if indicated

  • Multifactorial, multidisciplinary assessment without intervention + usual care

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (hip fractures)

Duration of the study12 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "We randomised patients by block randomisation using computer generated random numbers"
Allocation concealment (selection bias)Low riskQuote: "Group allocation was performed by a researcher who was independent of the recruitment process and blind to baseline interview data"
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskData from postcards processed and coded off site by researcher blind to group allocation
Incomplete outcome data (attrition bias)
All outcomes
Low riskMost losses due to death, withdrawals low and balanced
Selective reporting (reporting bias)Unclear riskNo protocol identified
Method of ascertaining fallsLow riskFalls clearly defined and recorded concurrently
Baseline imbalanceLow riskBalanced at baseline
Other biasLow riskNone identified

Shimada 2004

MethodsRCT (individually randomised)
ParticipantsSetting: 1 long‐term care facility (intermediate‐level care), Japan N = 32 Sample: 78% women Age (years): mean (SD) intervention group 81.8 (5.9), control group 83.1 (6.4)

Inclusion criteria: none stated


Exclusion criteria: not able to walk more than 3 minutes on treadmill at greater than 0.5 km/hour; unable to participate because of recognisable dementia; unspecified health problems
Interventions
  • Supervised perturbed gait exercises on a treadmill (individually tailored) for 6 months (gait, balance and co‐ordination + endurance) in addition to usual exercise. Complete programme of 600 minutes over 6 months, 1 to 3 x per week. Intervention delivered by physical therapists

  • Usual exercise. Programs consisting of stretching, resistance training, group training, and outdoor gait training.

Outcomes
  • Rate of falls

  • Number of people falling

Duration of the study6 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote: "The 32 subjects were randomly divided into two groups ..." Insufficient information to permit judgement
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible for participants
Blinding of outcome assessment (detection bias)
All outcomes
High riskCollection of falls data not described but states "This study ... was carried out without blinding." Staff who recorded falls were likely to be aware of individual's allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: losses similar between groups
Selective reporting (reporting bias)Low riskJudgement comment: fall rates, number of falls and time to first fall reported
Method of ascertaining fallsUnclear riskJudgement comment: falls ascertainment not reported
Baseline imbalanceLow riskJudgement comment: groups similar at baseline
Other biasLow riskJudgement comment: one detected

Shorr 2012

MethodsRCT (cluster randomised).
ParticipantsSetting: 16 nursing units in an urban community hospital, acute care, USAN = 27,672 participants. 16 clusters.Sample: not stated.Age (years): not stated.

Baseline Characteristics


Automated tele‐vigilance system
  • N: 11,115 participants

  • Age ‐ mean (SD) : NR

  • Female ‐ N (%): NR

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: N


Usual care
  • N: 17,436 participants

  • Age ‐ mean (SD) : NR

  • Female ‐ N (%): NR

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: N


Inclusion criteria: admission to one of 16 general medical‐surgical nursing units in Methodist Healthcare‐University Hospital, Memphis, Tennessee, during period 1 May 2006 to 30 Oct 2007
Exclusion criteria: nil.
Pretreatment differences: baseline characteristics of patients unknown. Staffing hours significantly differ between groups, but controlled for in analysis.
Interventions
  • Automated tele‐vigilance system. Education, training, and technical support to promote use of a standard bed alarm system which uses 1 to 2 weight‐sensitive sensor pads applied to the bed, chair or commode. When contact is broken this activates alarm in patient's room and call at nurses' station. Automated tele‐vigilance system cameras installed, cameras can work in visible or infrared range, physically linked to a server that will store encrypted video and analyse images data in real‐time, sending an alert to the care staff via their computers and personal pagers if it detects a fall. Physician can also watch images in order to determine the cause of the incident and then act preventively and induce treatment/care strategies.

  • Usual care

Outcomes
  • Rate of falls

  • Risk of falling

  • Injurious falls

  • Number of adverse events

Duration of the studyAdmission period. Trials recruitment over 18 months.
NotesAdditional data provided by author.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer‐generated randomisation on the basis of baseline fall rates
Allocation concealment (selection bias)High riskAllocation of clusters unblinded and recruitment of participants in acute hospital wards occurred over May 2006 ‐ Oct 2007 after cluster allocation
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of staff not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome assessors were likely to be unblinded due to the cluster randomisation
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss of two clusters due to closure of the units, but reason for loss not related to outcome and appropriately accounted for in analysis
Selective reporting (reporting bias)Low riskFalls, fallers and injurious falls reported
Method of ascertaining fallsLow riskFalls clearly defined and recorded concurrently
Baseline imbalanceUnclear riskStaffing hour for all 3 staff types significantly differ between groups, but controlled for in analysis. However baseline characteristics at patient level not known
Other biasLow riskAllocation of clusters occurred in pairs of units with similar falls rates within one hospital which may allow the randomisation sequence to be predicted. However this issue already considered under allocation concealment. No other risk identified.

Sihvonen 2004

MethodsRCT (individually randomised)
ParticipantsSetting: 2 residential care homes (intermediate‐level care), Finland N = 28 Sample: 100% women Age (years): mean (SD) intervention group 80.7 (6.1), control group 82.9 (4.2)

Inclusion criteria: aged ≥ 70; able to stand without walking aid; able to visualise feedback from a computer; able to follow instructions


Exclusion criteria: acute illness; dementia; impending hip surgery
Interventions
  • Balance training using computerised visual feedback and a force platform (gait, balance and co‐ordination exercises), 20 to 30‐minute sessions, 3 x per week, for 4 weeks. Exercises individually tailored. Intervention delivered by the research team

  • Control: usual care

Outcomes
  • Rate of falls

  • Number of people falling

Duration of the study12 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "The subjects … were randomly assigned to an exercise group or a control group ... Since the study was carried out in two separate places, the randomization was done in blocks." "Randomisation was carried out by drawing lots."
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskFalls recorded by participants who were aware of group allocation. No mention of blinding of researchers contacting participants for details or if no diary returned
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: low loss to follow‐up, unlikely to affect outcome
Selective reporting (reporting bias)Low riskJudgement comment: no protocol identified. Falls and fallers reported, falls rate calculable
Method of ascertaining fallsUnclear riskJudgement comment: falls recorded by participants
Baseline imbalanceLow riskJudgement comment: groups balanced at baseline
Other biasLow riskJudgement comment: none identified

Sitja Rabert 2015

MethodsRCT (individually‐randomised, multicentre trial)
ParticipantsSetting: 10 residential care facilities, mixed‐level care, SpainN =Sample:Age (years):

Baseline Characteristics


WBV + exercise
  • N: 81

  • Age ‐ mean (SD) : 82.30 (7.75)

  • Female ‐ N (%): 53 (65%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Exercise (control)
  • N: 78

  • Age ‐ mean (SD) : 82.55 (7.12)

  • Female ‐ N (%): 54 (69%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Inclusion criteria: volunteers of either sex aged older than 65 years; resident in a nursing home; and able to adopt a squat position on a vibrating platform
Exclusion criteria: acute illness (not resolved within 10 days); epilepsy; severe heart disease; use of a pacemaker; high risk of thromboembolism; a hip or knee replacement; musculoskeletal disorders; cognitive or physical disorders that could interfere with training methods
Pretreatment differences: nil significant
Interventions
  • Whole body vibration + exercise: static/dynamic exercises (balance and resistance training) performed on a vibratory platform (frequency: 30‐35 Hz; Amplitude: 2 mm to 4 mm). 3 x per week for 6 weeks.Warm‐up and cool down exercises performed at each session. 30‐minute sessions, 3 sessions per week, training volume increased progressively.

  • Exercise alone: same exercise programme with no whole body vibration. Group‐based progressive static and dynamic exercise programme, involving balance and strength training. Warm up and cool down exercises performed at each session without vibration platform.

Outcomes
  • Number of fallers

  • Number with multiple falls

  • Number with fracture fall

  • Adverse events

Duration of the study6 weeks, total follow‐up 6 months
Notes{"type":"clinical-trial","attrs":{"text":"NCT01375790","term_id":"NCT01375790"}}NCT01375790
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "computer generated randomisation list will be generated for participants at each nursing‐home using the statistical software SPSS17."
Allocation concealment (selection bias)Low riskQuote: "Allocation to treatment will be centralized by telephone. All the researchers will be blinded to the randomisation sequence list."
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: open‐label trial
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls collected from nursing home staff or relatives who were not blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: losses to follow‐up balanced between groups, reasons balanced
Selective reporting (reporting bias)High riskJudgement comment: number of falls not reported by group allocation
Method of ascertaining fallsLow riskJudgement comment: fall definition provided in Clinical Trial Registry ({"type":"clinical-trial","attrs":{"text":"NCT01375790","term_id":"NCT01375790"}}NCT01375790).Quote: "Fall: an unexpected event in which the participants come to rest on the ground, floor, or lower level". Concurrently recorded. Additional information from author 11/7: Report calendar: During the study, every falls was registered in a register falls specially created by the study and data concerning falls were regularly collected from each nursing home or from relatives if a participant had moved to a different address. During the follow‐up period, systematically every week the two blinded physiotherapists registered the falls occurred
Baseline imbalanceLow riskJudgement comment: groups well balanced at baseline
Other biasLow riskJudgement comment: none identified

Stenvall 2007

MethodsRCT (individually randomised)
ParticipantsSetting: acute hospital wards (geriatric and orthopaedic), Umeå, Sweden N = 199 Sample: 74% women Age (years): mean 82.2 (SD 6.3)

Inclusion criteria: admitted to hospital with femoral neck fracture; aged ≥ 70


Exclusion criteria: severe rheumatoid arthritis; severe hip osteoarthritis; pathological fracture of the femoral neck; severe renal failure; bedridden prior to the fracture
Interventions
  • Post‐operative care in a geriatric orthopaedic service in a geriatric ward: multidisciplinary team providing comprehensive geriatric assessment, management, and rehabilitation

  • Control: usual care in an orthopaedic ward

Outcomes
  • Rate of falls

  • Number of people falling

  • Number sustaining a fracture (all fractures)

Duration of the study32 months. Follow‐up time was until participants were discharged from hospital
NotesDementia subgroup analysis published in Stenvall 2012.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Patients were randomized ... in opaque sealed envelopes. The lots in the envelopes were sequentially numbered ... Persons not involved in the study performed these procedures."
Allocation concealment (selection bias)Low riskUsed sequentially numbered, opaque sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskQuote: "The staffs on the intervention and control wards were not aware of the nature of the present study."
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: all patients included in analysis (ITT)
Selective reporting (reporting bias)Low riskJudgement comment: no protocol identified but falls outcomes thoroughly reported. Falls, fallers, falls incidence and fracture falls reported, plus data by dementia subgroup
Method of ascertaining fallsLow riskJudgement comment: falls clearly defined and recorded concurrently
Baseline imbalanceLow riskJudgement comment: significant imbalance in depression and non‐significant imbalance in dementia at baseline adjusted for in analyses
Other biasLow riskJudgement comment: none detected

Streim 2012

MethodsRCT
ParticipantsSetting: residents in nursing homes and assisted living facilities within 30 miles of Philadelphia, USA. Mixed levels of care.N = 94 (36 randomised, 56 in a non‐randomised patient preference arm)Sample: NRAge (years): NR

Baseline Characteristics

Age (years): range 60 to 95. Baseline characteristics not provided.

Inclusion criteria: 65 years and older; ambulatory; cognitively intact or with mild‐moderate impairment but capable of self‐reporting depression symptoms; receiving antidepressant treatment for a single episode of depression; in full remission for at least six months


Exclusion criteria: bedridden; severe cognitive impairment
Pretreatment differences: no differences in race and gender. Differences in medication use at baseline (benzodiazepines P = 0.034, serotonin norepinephrine reuptake inhibitors P = 0.0004, Lexapro P < 0.0001).
Interventions
  • Discontinue taking antidepressants

  • Control: continue taking antidepressants


A third non‐randomised arm of people choosing to discontinue antidepressants
Outcomes
Other outcomes not included in this review, e.g. depression and cognition
Duration of the study
NotesTrial identified as an abstract only, with no falls results reported. Excerpt from unpublished manuscript provided by author correspondence.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskJudgement comment: insufficient information for judgement
Allocation concealment (selection bias)Unclear riskJudgement comment: insufficient information for judgement
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskJudgement comment: insufficient information for judgement
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskJudgement comment: insufficient information for judgement
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskJudgement comment: insufficient information for judgement
Selective reporting (reporting bias)Unclear riskNo details of falls outcomes provided in trial registry
Method of ascertaining fallsUnclear riskJudgement comment: insufficient information for judgement
Baseline imbalanceHigh riskJudgement comment: differences in medication use between randomised groups at baseline
Other biasUnclear riskJudgement comment: imbalance in randomisation due to high number of patients choosing third 'preference' arm of study

Tideiksaar 1993

MethodsRCT (individually randomised)
ParticipantsSetting: acute geriatric care hospital ward, New York city, USA N = 70 Sample: 86% women Age (years): mean 84 (range 67 to 97)

Inclusion criteria: one or more abnormal factors on a 9 point performance orientated environmental mobility screen (indicating impaired bed mobility)


Exclusion criteria: none stated
Interventions
  • Bed alarm system to alert staff when patient leaves their bed. Intervention delivered by nurses

  • Control: usual care

Outcomes
  • Rate of falls

  • Adverse events

Duration of the study9 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote: "Patients … were randomly assigned to either the experimental group … or the control group". Insufficient information to permit judgement.
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff who recorded falls not blinded to individual participants' allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: no loss to follow‐up, acute setting
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified
Method of ascertaining fallsUnclear riskJudgement comment: definition of falls provided but not clearly. Falls recorded concurrently
Baseline imbalanceUnclear riskJudgement comment: baseline characteristics not reported
Other biasLow riskJudgement comment: none identified

Toulotte 2003

MethodsRCT (individually randomised)
ParticipantsSetting: nursing care facility, France. Published data implies residents receiving mixed high and intermediate levels of care N = 20 Sample: % women not stated Age (years): mean 81.4 (SD 4.7)

Inclusion criteria: dementia (MMSE score < 21); history of ≥ 2 falls (not involving an environmental hazard) in previous 3 months; able to walk 10 metres without human assistance


Exclusion criteria: none stated
Interventions
  • Supervised exercises 1 hour, 2 x per week for 16 weeks in groups of 5. Exercises incorporated gait, balance and co‐ordination, strength/resistance, and flexibility. Exercises not individually tailored. Two physicians delivered intervention in each group. Individualised assessment of participants not part of intervention

  • Usual care

Outcomes
Duration of the study4 months follow‐up
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote: "A randomised cross‐over design was used." Insufficient information about the sequence generation process to permit judgement
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskPhysician conducting tests was blinded to allocation status. Unlikely that these tests included recording of falls. Staff who recorded falls likely to be aware of individual participants' allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: loss to follow‐up unclear
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified
Method of ascertaining fallsUnclear riskJudgement comment: falls clearly defined but method of recording falls unclear
Baseline imbalanceLow riskJudgement comment: groups balanced at baseline
Other biasLow riskJudgement comment: none identified

Treacy 2015

MethodsRCT (individually randomised)
ParticipantsSetting: general rehabilitation ward (subacute) at one hospital, AustraliaN =Sample:Age (years):

Baseline Characteristics


Standing balance circuit classes
  • N: 81

  • Age ‐ mean (SD) : 82.6 (7.3)

  • Female ‐ N (%): 51 (62%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: Y


Usual care
  • N: 81

  • Age ‐ mean (SD) : 81.4 (7.8)

  • Female ‐ N (%): 53 (65%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: Y


Inclusion criteria: 18 years or over; admission to the general rehabilitation ward a Bankstown‐Lidcombe Hospital, NSW; no medical contraindications to exercise; able to: fully weight bear; stand unaided independently for at least 30 seconds; and participate in group therapy sessions with minimal supervision
Exclusion criteria: 1. unable to fully weight bear as ordered by a medical officer (i.e. non, partial or touch weight bearing status through one or both legs).2. Have a medical condition precluding exercise, e.g. unstable cardiac disease, uncontrolled hypertension, uncontrolled metabolic diseases, large abdominal aortic aneurysm. 3. Have an identified multi‐resistant organism infection or other infection that would pose a significant risk to others in a group setting.
Pretreatment differences: no imbalances. See online appendix.
Interventions
  • Standing balance circuit classes. Group training, supervised by 2 physiotherapists standing balance circuit class programme focused on posture whilst standing and stepping. Involving 7 exercise stations, with 3 levels of difficulty, each with a specific balance exercise, plus standard rehabilitation. Six 1‐hour classes over 2 weeks.

  • Usual care. Assessment and treatment by the multidisciplinary ward team. Patients are predominately treated within a group setting in physiotherapy with additional one‐to‐one sessions as required with the focus being on weight bearing exercises. Outpatient therapy, as required. Once or twice per day at least two hours per day.

Outcomes
  • Rate ratio for falls

  • Adverse events

Duration of the study2 weeks
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "The allocation schedule was computer generated using randomly ordered blocks of four and six."
Allocation concealment (selection bias)Low riskQuote: "A concealed allocation procedure (numbered sealed opaque envelopes)"Quote: "Randomisation schedule and envelopes were prepared and held by a staff member not involved in study recruitment or intervention. Participants and therapists were made aware of group allocation once the envelopes had been opened."

Judgement comment: allocation adequately concealed

Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls reliant on self‐report, person responsible and hospital incident reporting system. Not possible to blind staff
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: little loss to follow‐up at 2 weeks
Selective reporting (reporting bias)Low riskJudgement comment: protocol available and outcomes reported as planned
Method of ascertaining fallsLow riskJudgement comment: Trial registry: "Fall incidence will be measured by participant and/or 'person responsible' self‐report. In‐patient fall data will also be collected via the hospital Incident Information Management System (incident reporting system)."Hospital system will have clear definition and concurrent recording of falls"
Baseline imbalanceLow riskJudgement comment: groups balanced on range of demographic variables at baseline
Other biasLow riskJudgement comment: none detected

Tuunainen 2013

MethodsRCT (individually randomised)
ParticipantsSetting: residential care facility, mixed‐level care, FinlandN =Sample:Age (years):

Baseline Characteristics


Strength training
  • N: 18

  • Age ‐ mean (SD) : 84.7 (5.5)

  • Female ‐ N (%): 12 (67%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Balance and strength training
  • N: 18

  • Age ‐ mean (SD) : 85 (4.2)

  • Female ‐ N (%): 16 (89%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Self‐administered training
  • N: 19

  • Age ‐ mean (SD) : 86.1 (7.3)

  • Female ‐ N (%): 14 (74%)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Inclusion criteria: participant's ability to raise himself/herself from a chair without using hands or arms for support.Willingness to participate. Prof Pyykko stated in email 31/8/16 additional inclusion criteria: could move independently, arise from a chair 5 times in a row, follow instructions.
Exclusion criteria: nil stated.
Pretreatment differences: the Strength training group had 33% male, The Balance and Muscle Training had 11% male, The self‐administered group had 26% male.In the Strength training group, 39% were prescribed sleeping medications. In the balance and muscle training group, 56% were prescribed sleeping medications. In the self‐administered group, 68% were prescribed sleeping medications.
Interventions
  • Strength training. groups of 5, under supervision by 2 physiotherapists. Progressively graded strengthening exercises for hip and other postural muscles using 1.2 kg weights attached to ankles from 6th session and using stairs from the 19th session. Twice‐weekly for approx 1 hour.

  • Balance and strength training. Groups of 5, under supervision by 2 physiotherapists. Progressively challenging balance tasks. Strength training similar to strength training group but ankle weights not used. Twice weekly for approx 1 hour.

  • Self‐administered training. Nurses provided encouragement to keep to self‐guided training tasks. Written exercise instructions provided by physiotherapists, comprising stretching from a sitting position, crouching and rising. Twice‐weekly for approx 1 hour.

Outcomes
  • Number of falls

  • Falls rate

  • Number of fallers

  • Number with multiple falls

  • Compliance


Other outcomes not included in this review
Duration of the study13 weeks. Follow‐up 3 years.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskJudgement comment: drawing of envelopes
Allocation concealment (selection bias)Unclear riskJudgement comment: details of allocation concealment not reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls recorded by ward nurses who are unlikely to be blinded
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: it appears that the residents in the intervention groups who stopped training were not included in the analysis
Selective reporting (reporting bias)Unclear riskJudgement comment: study protocol not available. In correspondence, author states data on fracture falls data was collected but not included
Method of ascertaining fallsUnclear riskJudgement comment: insufficient information to enable judgement
Baseline imbalanceHigh riskJudgement comment: larger proportion of prescribing of sleeping medications in the Self administered group may have contributed to that group's higher falls rate
Other biasLow riskJudgement comment: none identified

Van de Ven 2014

MethodsRCT (cluster randomised).
ParticipantsSetting: 34 units from 11 residential care facilities, high‐level care, the Netherlands.N = 318. 11 clusters.Sample: 75% womenAge (years): 84.7

Baseline Characteristics


Dementia care mapping
  • N: 154

  • Age ‐ mean (SD) : 84.8 (6.0)

  • Female ‐ N (%): 118 (76.6)

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Usual care
  • N: 164

  • Age ‐ mean (SD) : 84.59 (6.6)

  • Female ‐ N (%): 121 (73.8)

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Inclusion criteria (facilities): those with Dementia‐Special Care Units (DSCUs).Residents: Age of 65 years or more;Dementia diagnosed by an elderly care physician according to the Diagnostic and statistical manual of mental disorders‐IV criteria for dementia; Approval of the elderly care physician for inclusion; At least one of the following neuropsychiatric symptoms: aggression, motor or verbal agitation,psychosis, depression, and apathy; Informed consent given by the residents themselves, their families, or their legal guardians; The resident must use the common areas, such as the shared living room, at least 4 hours a day.
Exclusion criteria: residents: an estimated life expectancy of 6 weeks; those who are physically unable to spend time in common areas of the facility; withdrawal of consent
Pretreatment differences: the intervention and control groups differed in terms of the proportions of staff in permanent positions. There were no other statistically significant differences at baseline between the intervention and control groups
Interventions
  • Dementia Care Mapping (DCM) based on principles of person‐centred care, involving action plans based on systematic observations of care. Nurses received DCM training, a DCM organisational briefing day and conducted the 4‐months DCM‐intervention twice during the study. single DCM cycle consists of observation, feedback to the staff, and action plans for the residents. 10 staff members attended basic and advanced training to become certified DCM mappers, then attended an organisational briefing day. Intervention delivered twice.

  • Usual care without DCM training.

Outcomes
  • Number of falls

  • Falls rate

  • Costs

Duration of the study18 months
NotesAuthor contact: Geertje van de Ven, Radboud University, . Author clari fied study details by email.
Dutch Trials Registry NTR2314http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2314
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskJudgement comment: computer‐generated sequence "soft‐ware"
Allocation concealment (selection bias)Low riskQuote: "Randomisation will take place after the study sample has been recruited and informed consent has been given,"
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls recorded by staff who are not blinded
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskJudgement comment: attrition rates due to no medical file higher in the intervention group (44% 68/154) vs control group (21% 35/164). (Fig 1). Unclear if medical file is source of falls data
Selective reporting (reporting bias)Low riskJudgement comment: outcomes reported as per protocol
Method of ascertaining fallsUnclear riskJudgement comment: insufficient information for judgement
Baseline imbalanceHigh riskJudgement comment: large difference in baseline fall rates. Baseline data for many potential confounders for falls outcomes not recorded.
Other biasLow riskJudgement comment: none identified

Van Gaal 2011a

MethodsRCT (cluster randomised by ward)
ParticipantsSetting: 6 nursing homes, 10 wards (high‐level nursing care), the Netherlands N = 392 participants included in study. 10 clusters. Sample: 66% women Age (years): mean (SD) intervention group 78 (9.9), control group 78 (11.7)

Inclusion criteria (facilities): 2 or 4 more or less comparable wards. Inclusion criteria (residents): none stated


Exclusion criteria: none stated
Interventions
  • Implementation of 3 guidelines (falls, urinary tract infection, pressure ulcers) targeting ward nursing staff

    • Educational meetings for all nurses (90 minutes) on the causes of 3 adverse events, assessment of patients at risk and prevention

    • Two case discussions on every ward (30 minutes) covering these topics

    • CD‐ROM with education material issued to every ward (information, test and feedback)

    • Information leaflets and oral information regarding prevention of pressure ulcers, urinary tract infection and falls issued to at‐risk patients

    • Nurses recorded presence or absence of adverse events in a computerised registration system daily. This programme generated feedback on process and outcome indicators to the nurses

  • Control: usual care

Outcomes
Duration of the study23 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskStates randomised after stratification. Insufficient information to permit judgement
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding of staff not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff recording falls would be aware of allocation. Cluster randomised trial so likely the person collecting data from patient files would be aware also
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: high loss to follow‐up for Van Gaal 2011a (nursing home setting)
Selective reporting (reporting bias)Low riskJudgement comment: falls reported as per protocol and adjusted for clustering
Method of ascertaining fallsHigh riskJudgement comment: falls clearly defined but reliant on existing reporting systems in patient records which may vary between sites
Baseline imbalanceHigh riskJudgement comment: 2011a (NH): nurse characteristics balanced at baseline but significant difference in physically impaired patients (reviewer P < 0.001 Chi2), rehabilitation patients (reviewer Chi‐2 P < 0.001)
Other biasLow riskJudgement comment: none detected

Van Gaal 2011b

MethodsRCT (cluster randomised).
ParticipantsSample: 4 hospitals (acute care), 10 wards, the NetherlandsN = 2201 participants included in study. 10 clusters. Sample: 55% women Age (years): mean (SD) intervention group 66 (14.5), control group 64 (16.9)

Inclusion criteria (hospitals): 2 or 4 more or less comparable wards. Inclusion criteria (patients): expected length of stay of ≥ 5 days


Exclusion criteria: none stated
Interventions
  • Implementation of 3 guidelines (falls, urinary tract infection, pressure ulcers) targeting ward nursing staff

    • Educational meetings for all nurses (90 minutes) on the causes of 3 adverse events, assessment of patients at risk and prevention

    • Two case discussions on every ward (30 minutes) covering these topics

    • CD‐ROM with education material issued to every ward (information, test and feedback)

    • Information leaflets and oral information regarding prevention of pressure ulcers, urinary tract infection and falls issued to at‐risk patients

    • Nurses recorded presence or absence of adverse events in a computerised registration system daily. This programme generated feedback on process and outcome indicators to the nurses

  • Control: usual care

Outcomes
Duration of the study23 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskStates randomised after stratification. Insufficient information to permit judgement
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding of staff not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff recording falls would be aware of allocation. Cluster‐randomised trial so likely the person collecting data from patient files would be aware also
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: high loss to follow‐up for van Gaal 2011b (hospitals)
Selective reporting (reporting bias)Low riskJudgement comment: falls reported as per protocol and adjusted for clustering
Method of ascertaining fallsHigh riskJudgement comment: falls clearly defined but reliant on existing reporting systems in patient records which may vary between sites
Baseline imbalanceHigh riskJudgement comment: 2011a (NH): nurse characteristics balanced at baseline but significant difference in physically impaired patients (reviewer P < 0.001 Chi‐2), rehabilitation patients (reviewer Chi‐2 P < 0.001).
Other biasLow riskJudgement comment: none detected

Van het Reve 2014

MethodsRCT (individually randomised)
ParticipantsSetting: residential care, intermediate‐level care, Switzerland (13 care facilities) and Germany (1 facility).N = 182Sample: 55% womenAge (years): 81.5 (SD 7.3)

Baseline Characteristics


Strength‐balance‐cognitive training
  • N: 88

  • Age ‐ mean (SD) : 81.1 (8.3)

  • Female ‐ N (%): 49 (58.3)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Strength‐balance training
  • N: 94

  • Age ‐ mean (SD) : 81.9 (6.3)

  • Female ‐ N (%): 52 (53.1)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: Y


Inclusion criteria: older than 65 years; able to walk 20 meters with or without aids; signed informed consent statement
Exclusion criteria: severe cognitive impairment (Mini‐Mental State Examination below 22 points); rapidly progressive or terminal illness, acute illness or unstable chronic illness
Pretreatment differences: nil significant
Interventions
  • Multiple intervention: strength‐balance‐cognitive training. Same exercise programme as strength‐balance training group plus a computer‐based cognitive training programme, with a focus on improving attention. Cognitive intervention: 10 minutes, 3 times per week. Exercise programme: 30 minutes resistance and 10 minutes balance training, 2 times per week.

  • Exercise: strength‐balance training. Exercise programme consisting of progressive resistance training on age‐adapted machines and balance training. Flexibility exercises followed each training session. 30 minutes resistance and 10 minutes balance training, 2 times per week

Outcomes
  • Falls rate

  • Number of falls

  • Number of fallers

  • Compliance

Duration of the study15 months comprising 12 weeks intervention and 12 months post‐intervention follow‐up period.
NotesISRCTN75134517
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "using simple (unrestricted) randomisation [70] based on a table of random numbers."
Allocation concealment (selection bias)High riskJudgement comment: an "assessor" performed the randomisation and group allocation
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: unable to blind participants and personnel
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls calendars filled in by staff. "Blinding of investigator was not possible."
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: approximately 25% missing data for falls
Selective reporting (reporting bias)Low riskJudgement comment: protocol available (ISRCTN75134517) with falls reported as per protocol.
Method of ascertaining fallsLow riskQuote: "Falls, defined as ‘unexpected events in which the participant comes to rest on the ground, floor or lower level, were assessed from 6 months retrospectively to 12 months prospectively using a fall calendar."
Baseline imbalanceLow riskJudgement comment: nil significant
Other biasLow riskJudgement comment: four participants with vision impairment reallocated to control group, however, this number is small relative to intervention group sizes

Wald 2011

MethodsCCT (odd vs even medical record number)
ParticipantsSetting: acute medical units in 1 hospital, Colorado, USA N = 217 Sample: 55% womenAge (years): mean (SD) intervention group 80.5 (6.5), control group 80.7 (7.0) 

Inclusion criteria: aged ≥ 70


Exclusion criteria: patients admitted to medical subspecialty service (cardiology, pulmonary, oncology)
Interventions
  • Hospitalist‐run acute care for the elderly service (ACE) (interdisciplinary team approach): admitted to 12‐bed medical unit when beds available, attendance of patients by doctor with additional training in geriatrics, standardised geriatric assessment, daily (Monday to Friday), interdisciplinary rounds focusing on geriatric syndromes, standardised geriatric screens, clinical focus on mitigating harm and discharge planning; novel inpatient geriatrics training curriculum

  • Control: usual care. Admitted to general internal medicine unit with general medical teams with daily discharge planning rounds with social worker and discharge planner

Outcomes
Duration of the study22 weeks
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskA systematic non‐random method was used (odd /even case record number)
Allocation concealment (selection bias)High riskNot possible to blind prior to allocation (see above)
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskFalls from hospital event reports. Last digit of medical record number was used for group allocation. Allocation not concealed
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: all patients included in analyses of other outcomes. Falls incidence per patient days reported
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified
Method of ascertaining fallsUnclear riskJudgement comment: falls definition not reported. Falls determined from standard reporting system which will be concurrent
Baseline imbalanceLow riskJudgement comment: groups balanced at baseline
Other biasLow riskJudgement comment: none identified.

Walker 2015

MethodsRCT (cluster randomised).
ParticipantsSetting: 6 residential care facilities, mixed‐level care, UKN = 52 residents. 6 clusters.Sample: 67% womenAge (years): 83

Baseline Characteristics


Implementation of the Guide to Action Care Home tool
  • N: 25 (3 sites)

  • Age ‐ mean (SD) : 84 (14.8)

  • Female ‐ N (%): 18 (72%)

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: N


Usual care
  • N: 27 (3 sites)

  • Age ‐ mean (SD) : 82 (13.4)

  • Female ‐ N (%): 17 (63%)

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: N

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: N


Inclusion criteria: care homes: listed on the Care Quality Commission database, long stay, old age, dementia or learning disability registration, nursing/residential registration, over 10 residents, no prior experience of Guide to Action Care Home. Care homes were purposively selected from those who replied expressing interest, to reflect a range of ownership, size and registration. Residents: (high risk): aged over 50 years, fallen at least once in the past year
Exclusion criteria: bed‐bound, hoist‐dependent or terminally ill
Pretreatment differences: nil
Interventions
  • Implementation of the Guide to Action Care Home tool. Training in Guide to Action Care Home tool (a checklist of falls risk factors with suggested actions), with reference manual and certificate on training completion. Plus standard care. Intervention takes 15 to 20 minutes, can lead to interventions which take an average of 2 hours to complete.

  • Usual care. Access to standard care, but no Guide to Action Care Home training or manual.

Outcomes
  • Falls rate

  • Injurious falls rate

Duration of the study6 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskJudgement comment: randomisation done
Allocation concealment (selection bias)Low riskJudgement comment: allocation concealed according to standard operating procedure
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: 26% missing data (7/27) from control arm vs 12% intervention arm
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls would have been recorded by staff who would not be blinded to the intervention (staff training)
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: 26% missing data (7/27) from control arm vs 12% intervention arm
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified
Method of ascertaining fallsLow riskJudgement comment: no information on most potential confounders (e.g. medical status, dependency)
Baseline imbalanceUnclear riskJudgement comment: none detected
Other biasLow riskJudgement comment: blinding not feasible

Ward 2010

MethodsRCT (cluster randomised by facility).
ParticipantsSetting: 88 residential aged care facilities (high‐care, low‐care and dementia‐specific), New South Wales, Australia N = 5391 residents. 88 clusters. Sample: 73% womenAge (years): median age 86

Inclusion criteria (facilities): ≥ 20 beds


Exclusion criteria: none stated
Interventions
  • Intervention: full‐time project nurse to assist facilities in using evidence‐based approaches to falls injury prevention relating to risk assessment; mobility assessment; use of hip protectors; calcium and vitamin D supplementation; continence management; exercise programs; appropriate footwear; medication review; and post‐fall management review. Project nurse provided intervention facilities with information and resources on preventing falls and fractures. Initial training session followed by 3‐monthly network meetings. Intervention staff also could attend workshop on planning and running exercise programs

  • Control: usual care. Staff attended a workshop where data collection procedures were explained

Outcomes
  • Number of falls

  • Number sustaining a fracture (hip fractures)

Duration of the study17 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "randomly allocated within strata into intervention or control groups by the statistician ... using the procedure "surveyselect" in SAS statistical software"
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskStaff recording falls and carrying out monthly record audit were aware of group allocation. Failure to produce monthly data followed up by project nurse (also aware of group allocation)
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskJudgement comment: losses balanced but large loss of 3 facilities/arm of study.
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified, fallers data not reported
Method of ascertaining fallsHigh riskJudgement comment: no definition of falls. Fall data retrieved by facility through record audit ‐ likely to be variable reporting between facilities
Baseline imbalanceHigh riskJudgement comment: although data in table 1 (limited participant variables) show reasonable balance between groups, there was moderate difference (2 falls
/month) between groups in the 7‐month pre‐intervention falls data
Other biasLow riskJudgement comment: none detected

Whitney 2017

MethodsCluster RCT (pilot, cross‐over study).
ParticipantsSetting: Four nursing homes and five residential homes in London, UK, mixed‐level care, 97% cognitively impaired. 9 clusters: 5 intervention, 4 usual care.N = 191 participants. 9 clusters.Sample: 69% womenAge (years): mean 83.5 (SD 8.8)

Baseline Characteristics


Individualised fall prevention programme
  • N: 103

  • Age ‐ mean (SD) : 84.6 (5.6)

  • Female ‐ N (%): 92 (46.0)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: N

  • Cognitive status defined? Y/N: N


Usual care
  • N: 88

  • Age ‐ mean (SD) : 84.1 (7.7)

  • Female ‐ N (%): 173 (56.1)

  • Medical status defined? ‐ Y/N: Yes

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: No

  • Dependency defined? Y/N: No

  • Cognitive status defined? Y/N: N


Inclusion criteria: over 65 years; admitted to rehabilitation ward
Exclusion criteria: restricted to bed; refused to participate
Pretreatment differences (phase 1): longer stay in the control group patients (P <0.001); higher percentage of females in the control group (P =0.03)
Interventions
  • Multifactorial intervention (exercise, dementia related behaviour management, comprehensive geriatric assessment including medication review, staff training, movement sensors). Falls risk assessment and management: including medical interventions, environmental modifications, equipment modifications, cognitive and behavioural treatment, family guidance. Mobility restrictions and optimising location on ward instituted in high risk patients. For moderate‐risk patients mobility (transfers,walking, toilets usage, etc.) was done only under supervision and/or assistance of a professional staff member. High‐risk patients had permanent personal supervision. Weekly assessment.

  • Usual care. Any activities undertaken by the participants recommended or administered by their treating team

Outcomes
  • Rate ratio

  • Risk ratio

  • Numbers on injurious falls and fractures

  • Adverse events

Duration of the study6 months
NotesCosts of the programme to be reported. Other outcomes not included in this review.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskJudgement comment: computer‐generated randomisation, stratified by nursing home beds
Allocation concealment (selection bias)Low riskJudgement comment: randomisation conducted by separate clinical trials unit. Allocation concealed and no recruitment after allocation revealed
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: blinding not feasible
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls recorded by care home staff who were not blinded
Incomplete outcome data (attrition bias)
All outcomes
High riskJudgement comment: 17.8% loss to follow‐up. Large amounts of missing data on many outcomes (up to 60%). Not clear what loss to follow‐up/missing data for falls outcome
Selective reporting (reporting bias)Low riskJudgement comment: falls, fallers, injury and fracture falls data reported
Method of ascertaining fallsUnclear riskJudgement comment: falls definition used.Facilities used their "usual reporting mechanisms" for falls ‐ no detail of what these mechanisms were or if they varied substantially between facilities
Baseline imbalanceHigh riskJudgement comment: significant baseline differences in number of medical conditions, time to complete Timed Up and Go, and likelihood on being in nursing home bed. Although analysis involved some adjustments (for the baseline score on the outcome being investigated) it does not appear these baseline differences were adjusted for across the outcome measures.
Other biasLow riskNone detected

Wolf 2013

MethodsRCT (individually randomised)
ParticipantsSetting: Subacute hospital setting, single geriatric ward, GermanyN = 98Sample: 65% womenAge (years): 76.1

Baseline Characteristics


Bed‐exit alarm
  • N: 48

  • Age ‐ mean (SD) : NR

  • Female ‐ N (%): NR

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: N


Usual care
  • N: 50

  • Age ‐ mean (SD) : NR

  • Female ‐ N (%): NR

  • Medical status defined? ‐ Y/N: N

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: N


Inclusion criteria: patients at high risk of falls defined by a score of 3 or more in STRATIFY; requirement for assistance with mobilization during resting time
Exclusion criteria: immobility; participation in another trial
Pretreatment differences: NR
InterventionsIntervention Characteristics
  • Bed‐exit alarm. Patients fitted with sensors to upper leg at rest time. Based on Wireless Sensing Triple Axis Reference Design. Sensors worn during rest periods 1 to 3 pm and 8 pm to 6 am.

  • Usual care

Outcomes
  • Number of falls

  • Number of fallers

Duration of the studyDuring admission period, total trial period 13 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskJudgement comment: method of sequence generation not described in adequate detail
Allocation concealment (selection bias)Unclear riskJudgement comment: no information provided about allocation methods
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not blinded
Blinding of outcome assessment (detection bias)
All outcomes
High riskJudgement comment: falls recorded by nurses who were not blinded
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: author correspondence indicated no loss to follow‐up
Selective reporting (reporting bias)Unclear riskJudgement comment: no protocol identified
Method of ascertaining fallsUnclear riskJudgement comment: no falls definition provided, standard reporting mechanisms used
Baseline imbalanceUnclear riskJudgement comment: inadequate details on baseline characteristics of patients to make a judgement
Other biasLow riskJudgement comment: none detected

Yokoi 2015

MethodsRCT (cluster randomised).
ParticipantsSetting: 5 residential care facilities, intermediate‐level care, JapanN = 105 participants. 5 clusters.Sample: 60% womenAge (years): 79.4

Baseline Characteristics


Short stick exercises
  • N: 51

  • Age ‐ mean (SD) : 80.2 (7.9)

  • Female ‐ N (%): 33 (64.7)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y (TUG)

  • Dependency defined? Y/N: Y (independent for inclusion & SF‐8 performed)

  • Cognitive status defined? Y/N: Y (MMSE)


Usual care
  • N: 54

  • Age ‐ mean (SD) : 78.5 (5.2)

  • Female ‐ N (%): 30 (55.6)

  • Medical status defined? ‐ Y/N: Y

  • Falls risk defined (with valid tool at baseline)? ‐Y/N: Y

  • Dependency defined? Y/N: Y

  • Cognitive status defined? Y/N: Y


Inclusion criteria (facilities): with 50 beds in the Kinki area in Japan; where no intervention for fall prevention was conducted. Residents: able to walk without assistive devices and take care of themselves without assistance; had sufficient cognition to follow directions; had never performed an SSE before; were allowed by their chief physician to exercise
Exclusion criteria: residents: with dementia or severe cardiac, pulmonary or musculoskeletal disorders that are associated with a higher fall risk
Pretreatment differences: BMI significantly less in the Intervention group, but as both groups were in normal range, probably would not have had impact on outcome.
InterventionsIntervention Characteristics
  • Short stick exercises. Group‐based supervised short stick exercises, performed in a seated position, and performing 6 activities with a rolled Japanese newspaper as the stick (warm up included). 25 minute sessions, twice weekly.

  • Usual care. Daily housekeeping, hobbies, work and 10‐minute group stretching exercises were continued.

Outcomes
  • Time to first fall

  • Number of falls

  • Number of fallers

  • Compliance

Duration of the study12 months, 6 months intervention period.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskJudgement comment: randomisation of the 5 facilities was by lottery using envelopes by a researcher not involved with study. Insufficient information but reason for not using sequence generation not really valid despite only 5 facilities, so some risk of bias
Allocation concealment (selection bias)Unclear riskJudgement comment: allocation of facilities probably adequate, assuming envelopes were sealed and opaque. It does not appear that individual participant recruitment was completed prior to cluster allocation. The study states that research assistants were not informed of the results of randomisation, but it appears that the research assistants were involved with falls data collection, not with recruitment.
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not possible to blind participants. Highly unlikely that personnel could be blinded
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskQuote: "Research assistants were not informed of the results of the randomization. The staff was asked not to tell the research assistants about which group was undergoing the intervention." Judgement comment: unblinding is likely.
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: losses to follow‐up balanced between groups with similar reasons
Selective reporting (reporting bias)High riskJudgement comment: the number of falls were not reported
Method of ascertaining fallsUnclear riskFalls determined by interviews with staff and medical records. Not clear whether staff were asked to recall for periods longer than one month. Unclear whether the method and reliability of staff recording falls in patient records were the same in all the facilities.
Baseline imbalanceUnclear riskJudgement comment: baseline characteristics of individuals in the facilities appear to be reasonably balanced although BMI significantly different but both groups within normal range for BMI so not likely to be important. Baseline characteristics of the facilities were not compared ‐ in particular the rates of falling in each of the facilities prior to the intervention.
Other biasLow riskNone detected

Zermansky 2006

MethodsRCT (individually randomised)
ParticipantsSetting: 65 care homes for the elderly (high, intermediate and mixed levels of care), UK N = 661 Sample: 77% women Age (years): mean 85 (interquartile range 80 to 90)

Inclusion criteria: aged ≥ 65; resident in a care home with ≥ 6 residents


Exclusion criteria: participating in another trial; terminally ill; already receiving clinical medication review; at GP request
Interventions
  • Clinical medication review by a pharmacist comprising a review of the GP record and consultation with the participant and their carer. Written recommendations forwarded to participant GPs

  • Control: usual care

Outcomes
  • Rate of falls

  • Number of people falling

Duration of the study6 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "After collection of baseline data, patients were randomised in randomly sized blocks of two to eight patients using an algorithm written in Visual Basic in Microsoft Access."
Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes
High riskJudgement comment: not possible to blind the intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskFalls data collected from accident book. Unclear whether staff recording falls in accident book would have been aware of allocation status
Incomplete outcome data (attrition bias)
All outcomes
Low riskJudgement comment: loss to follow‐up similar in both groups, as was main reason for loss (death)
Selective reporting (reporting bias)Unclear riskJudgement comment: falls not reported as an outcome in trial registration
Method of ascertaining fallsHigh riskJudgement comment: no falls definition reported
Baseline imbalanceLow riskJudgement comment: groups balanced at baseline
Other biasLow riskJudgement comment: none detected

StudyReason for exclusion
Barreca 2004RCT. Falls outcomes. Supervised exercises in older people post stroke
Bernhardt 2008RCT. Falls recorded as adverse events. Early rehabilitation post stroke
Bosner 2012Not randomised. Five nursing homes agreed to participate; three were assigned sequentially for the intervention and two for the control group
Bouwen 2008RCT (cluster randomised). Nursing homes. Outcome of the study was a subgroup of falls only (falls with medical consequences)
Capezuti 1998RCT (cluster randomised). Nursing homes. The intervention was designed to minimise restraints, not to reduce falls. Falls reported as adverse events
Crotty 2002RCT. Accelerated discharge after hip fracture and home based rehabilitation in the community. Not designed to reduce falls. Falls recorded as adverse events
Cucca 2017Falls recorded as adverse events
Cummings 2015Falls recorded as adverse events
Dattalo 2015Wrong setting, participants likely to be in the community. Attempts to contact authors unsuccessful.
Davison 2005RCT. Post‐fall intervention with falls outcomes. Only one participant in residential/nursing care
de Morton 2007CCT. The primary outcome was discharge destination. Falls were recorded as adverse events
de Souto 2016Falls recorded as adverse events
de Souto 2017Falls recorded as adverse events
DeSure 2013RCT, cross‐over trial. Exercise Program to Prevent Falls in Institutionalized Elderly with Cognitive Deficits. Falls data for phase 1 not clearly reported, falls data for phase 2 has contamination of intervention group. Attempts to contact author unsuccessful. Available falls data considered invalid.
Donat 2007RCT. Exercise interventions in nursing homes. No falls outcomes
Drahota 2013Pilot RCT. Intervention was intended to reduce fall injuries, rather than falls.
Fiatarone 1994RCT. Boston FICSIT study in nursing home residents. No falls outcomes
Forster 2017Falls recorded as adverse events
Fossey 2006RCT. Nursing homes. Intervention to reduce antipsychotics in people with severe dementia. Falls were recorded as adverse events
Galik 2014Falls reported as adverse events
Galik 2015Falls recorded as adverse events
Gianturco 2013Wrong setting, RCT conducted at a geriatric day service with community‐dwelling participants
Ginde 2017Falls recorded as adverse events
Graafmans 1996Wrong setting. 49% residing in homes for the elderly, included in community review.
Grant 2005RCT. Participants recruited in hospital after a hip fracture. Preventing falls in older people living in the community
Greenspan 2013Wrong study design, not an RCT.
Greenspan 2015Falls recorded as adverse events
Gruber‐Baldini 2011RCT. Intervention to motivate nursing assistants to actively engage nursing home residents in functional and physical activities. Falls recorded as adverse events
Gu 2006Non‐randomised controlled trial of exercise intervention in nursing homes. Experimental group was a convenience sample from two nursing homes; matched control group selected from another nursing home [personal communication]
Hardin 2013Wrong patient population. Hospital setting. Author confirmed age of participants unknown
Harwood 2004RCT. Participants recruited at the end of ward rehabilitation post hip fracture. Preventing falls in older people living in the community
Hauer 2001RCT. Exercise intervention. Recruited at the end of ward rehabilitation. Majority were community‐dwelling (4% living in nursing homes)
Heiberg 2017Falls recorded as adverse events
Herrmann 2016Falls reported as adverse events
Hopman‐Rock 1999RCT. Participants with dementia in homes for the elderly. Falls recorded as safety issue, i.e. as adverse events
Huang 2005RCT. Discharge planning intervention to prevent falls in older people living in the community
Il'nitskii 2014Wrong study design, not an RCT
Ilfeld 2010Falls recorded as adverse events
Jarret 2015RCT. Intervention delivered in a rehabilitation setting, patients admitted from community, no falls in hospitals, falls outcomes recorded post‐discharge. Included in community review.
Jeon 2015Only injurious falls reported
JPRN‐UMIN0000167Wrong setting: likely community. Attempts to contact author unsuccessful. Trial discontinued.
Kato 2006Not RCT. "Prospective clinical trial" of an exercise programme in a long‐term care facility with falls outcomes. Nurses volunteered their ward to be an intervention ward (personal communication from authors)
Katz 2004RCT in residential care population. Intervention: three doses of risperidone in people with dementia and psychosis or agitation. Post hoc subgroup analysis of falls based on 85.9% of those randomised. Falls reported as adverse events
Katz 2005This study was not primarily a falls prevention intervention. Falls reported as adverse events
Kenny 2001RCT. Follow‐up of falls outcomes appears to be primarily in the community
Koczy 2011The intervention was designed to minimise restraints, not to reduce falls. Falls reported as adverse events
Kopke 2012RCT (cluster randomised). Nursing homes. The intervention was designed to minimise restraints, not to reduce falls. Falls reported as adverse events
Kwok 2006RCT. Intervention to determine whether bed‐chair pressure sensors reduced physical restraint use. Falls reported as adverse events
Lackner 2008RCT in cognitively impaired nursing home residents with urge urinary incontinence. Falls reported as adverse events
Li 2017Falls recorded as adverse events
Lord 2003bRCT. Majority of participants community‐dwelling. Only 121/551 participants were residents of an intermediate level nursing care facility
Mailhot 2012Falls recorded as adverse events
Mailhot 2014Falls reported as adverse events
Mak 2016Wrong setting. Intervention delivered in hospital, falls recorded in the community
Mansfield 2015Falls recorded as adverse events
McRae 1996Not RCT. Falls and fallers were not primary outcomes but were monitored as possible adverse events
Mudge 2008Non‐randomised controlled study. Patients admitted to an intervention ward or control ward
{"type":"clinical-trial","attrs":{"text":"NCT00973297","term_id":"NCT00973297"}}NCT00973297Wrong population: Patients post‐stroke
{"type":"clinical-trial","attrs":{"text":"NCT01054287","term_id":"NCT01054287"}}NCT01054287Author correspondence confirmed that study unpublished and unlikely to be published as primary author has left the institution. Trial discontinued (results unavailable)
{"type":"clinical-trial","attrs":{"text":"NCT01523600","term_id":"NCT01523600"}}NCT01523600Trial discontinued due to lack of funding.
{"type":"clinical-trial","attrs":{"text":"NCT01618786","term_id":"NCT01618786"}}NCT01618786Intervention intended to reduce injuries not falls.
{"type":"clinical-trial","attrs":{"text":"NCT02686515","term_id":"NCT02686515"}}NCT02686515Wrong population: Patients post‐stroke
Nyaruhirira 2013Wrong setting. Setting unclear, attempts to contact author unsuccessful.
Ouslander 2005RCT testing 'Functional Incidental Training' in nursing homes. Not designed to reduce falls. Falls recorded as adverse events
Parasurum 2011Wrong patient population. Hospital mental health setting, patient age unknown, attempt to contact authors unsuccessful, participants unlikely to be elderly.
Pedreira 2014Wrong population: Patients post‐stroke
Peng 2014Falls recorded as adverse events
Peri 2008RCT (cluster). Pilot for Kerse 2008 (same intervention). Excluded because falls were recorded as possible adverse effects of the intervention
Rantz 2001RCT. Quality improvement intervention in nursing care facilities targeting 29 quality indicators, of which falls was one. Only included 87/113 homes in the analysis (23% loss). Insufficient information provided on falls outcomes to use in this review
Ray 2005RCT. Study of falls related injuries. No data provided on falls or fallers
Reinhardt 2014Falls reported as adverse events
Resnick 2002Participants resident in continuing care retirement community but all living independently
Resnick 2012RCT in assisted living facilities. Testing changing model of care to function‐focused care. Falls monitored as a safety issue, i.e. adverse events. Hypothesised that the intervention might increase the likelihood of falling
Richter 2015Falls recorded as adverse events
Rolland 2007RCT. Exercise programme to improve ability to perform ADL for people with Alzheimer's disease in nursing homes. Falls monitored as a safety issue, i.e. adverse events
Sackley 2009RCT. Falls described as an outcome at trial registration but not mentioned as an outcome in the published paper
Sahota 2014Specific type of falls only, reported bedside and injurious falls, not total falls.
Said 2012Falls recorded as adverse events
Said 2015RCT. Falls recorded as adverse events
Sato 2000RCT. Etidronate versus placebo in older people with post stroke hemiplegia. Falls outcomes. Wrong population; article subsequently retracted
Sato 2005aRCT. Vitamin D vs placebo in older people with post stroke hemiplegia. Falls outcomes. Wrong population; article subsequently retracted
Sato 2005bRCT. Folate and mecobalamine (vitamin B12) vs placebo in older people with post stroke hemiplegia. Falls outcomes. Wrong population; article subsequently retracted
Sato 2011RCT. Aledronate versus alphacalcidol in older people post‐stroke. Falls outcomes. Wrong population; scientific misconduct also likely
Schneider 2006The objective of this study was to determine the effectiveness of atypical antipsychotic medications. Falls were monitored as a potential adverse effect
Schwendimann 2006Not RCT. Described as quasi‐randomised in abstract but author confirmed that all consecutively admitted patients were allocated at non‐random order either to nursing unit A or B whenever a free hospital bed was available (1 to 5 admissions/discharges per day). Nurse‐led fall prevention programme
Sherrington 2016aWrong setting, correspondence with the author indicated 3% participants were in care ‐ excluded as majority living in a community setting
Shimada 2003RCT. Majority of participants community‐dwelling (62%)
Shimada 2009Not RCT. Exercise intervention versus control in a residential‐care facility. Falls outcomes. Intervention on 2 days per week and 2 other days randomly selected to be control days
Siddiqi 2016No falls outcomes
Sjoberg 2013Wrong setting. Intervention partly in hospital and partly in community. Author confirmed that < 50% residing in nursing homes at 6 and 12 months
Smith 2017Falls data not reported separately to slips and trips. Not an RCT
Sola 2014RCT. Setting unclear, likely to be in the community. Attempts to contact author unsuccessful
Southard 2006RCT with no falls outcomes. Balance and confidence were the primary outcomes of this study
Steadman 2003RCT. Participants were attendees of a hospital‐based falls clinic. "Prevously living in the community" [personal communication]. Not preventing falls in hospital or nursing care facility
Tanikawa 2014Falls recorded as adverse events
Tariot 2004RCT. Trial testing effectiveness of memantine in people with Alzheimer's disease already receiving donepezil. Falls were monitored as a potential adverse effect of the intervention
Tariot 2005RCT. Trial testing effectiveness of divalproex sodium in nursing home residents with possible or probable Alzheimer disease. Falls were monitored as a potential adverse effect of the intervention
Teresi 2013Wrong study design. Not an RCT, random selection for data collection, rather than allocation
Underwood 2011Ongoing RCT (cluster randomised). Exercise intervention in residential and nursing homes Primary outcome depression. No falls outcomes. Recording peripheral fractures and fear of falling
van Ooijen 2013Wrong setting. Intervention delivered in hospital, author confirmed falls recorded post dischage and the majority of participants were in the community.
Vassallo 2004Non‐randomised controlled trial of a multidisciplinary fall‐prevention programme in hospital. Falls outcomes
Visvanathan 2015Not an RCT
Von Koch 2001RCT. Intervention: rehabilitation at home after a stroke. Not intervention to prevent falls; falls recorded as adverse events
Wolf 2003RCT. Participants in independent living facilities or congregate living facilities, i.e. not nursing care facilities. Community‐dwelling
Zhong 2007RCT. Institutionalised participants with dementia randomised to quetiapine 200 mg per day, 100 mg per day, or placebo. Falls monitored as a potential adverse effect of the intervention

Dever 2016

MethodsRCT
ParticipantsSetting and sample: 26 care facilities, N = 150, Canada
Age (years): mean 86
Interventions
  • Falls‐risk assessment

  • Usual care

Outcomes
NotesArticle located in search update (August 2017); pending processing
Falls reported as medians with range

Frohnhofen 2013

MethodsRCT
ParticipantsSetting and sample: Hospital setting, N = 178 geriatric patients during rehabilitation
InterventionsFORTA (Fit‐for‐the‐Aged) medication review
Outcomes
NotesConference abstract only. Publication likely to be same study as Michalek 2014, attempts to contact author unsuccessful 6/7/16 and 26/10/16.

Hewitt 2014

MethodsRCT (cluster randomised)
ParticipantsInclusion criteria: residential‐aged care facilities: have a mix of high‐care residents and/or low‐care residents; likely to have 15 residents willing to participate; the facility manager consents to participation in the trial and to the allocation of staff time.Participants: permanently reside in residential‐aged care
Exclusion criteria: terminal or unstable illness; significant advanced cognitive decline (Mini Mental State Examination </= 15); physical symptoms that preclude the safe use of exercise equipment in a group setting (e.g.. Parkinson’s disease or hemiplegia); permanently wheelchair‐ or bed‐bound; performed a similar balance and/or resistance training programme within the previous 12 months.
InterventionsSUNBEAM program (Strength and Balance Exercise in Aged Care) conducted in group settings; comprising progressive resistance training and balance exercises from 0‐6 months; then maintenance exercises for 7‐12 months
Usual care
Outcomes
  • Number of falls

  • Falls rate

NotesACTRN12613000179730

MacRitchie 2001

MethodsRCT
ParticipantsSetting and sample: two nursing homes, Connecticut, USAN = 88Age (years): mean 84 (SD 6.9), range 65 to 98

Inclusion criteria: none stated

Interventions
  • Standing‐exercise Functional Maintenance programme of 4 months duration

  • Control

Outcomes
NotesThesis identified in the Cochrane Library (CENTRAL). No usable falls data in abstract. No published papers identified.

Raymond 2017

MethodsRCT
ParticipantsSetting and sample: Hospital setting, sub‐acute, N = 468, Australia.
≥ 65 years.
Interventions
  • Standing high‐intensity functional group exercise 3x week plus individual physiotherapy 2x week.

  • Daily individual physiotherapy exercises.

Outcomes
  • Number of falls

  • Number of fallers

NotesArticle located in search update (August 2017); pending processing.
Few falls (total 12), not reported by group allocation.

Tallon 2013

MethodsRCT
ParticipantsSetting and sample: residential care
Inclusion criteria: living in nursing home, able to walk, no contra‐indication to whole body vibration
Interventions
  • Exercise with whole body vibration, 3 times weekly for 20 minutes

  • Standard exercise: same exercises on a non‐vibrating platform

Outcomes
  • Number of falls

  • Risk of falling

NotesStudy completed. Conference abstract available. Author indicated study completed but analysis ongoing, study unpublished [email 11/7/16]. No response received to follow‐up email 31/1/2017.

ACTRN12613000228785

Trial name or titlePreventing falls and fractures in low‐level aged‐care residents by increasing dairy food intake by two serves per day
MethodsRCT
ParticipantsLow‐level aged care residents with dietary calcium intake below 600 mg/day
Interventions
  • Additional 2 serves of dairy foods per day

  • Usual diet

Outcomes
Starting dateNot commenced.
Contact informationDr Sandra IulianoEndocrinology,Level 2 Centaur BuildingHeidelberg Repatriation HospitalWaterdale Rd,West Heidelberg, VIC, 3081Australia+61394963216

Notes 

ACTRN12615000817549

Trial name or titleEstablishing the effectiveness, cost‐effectiveness and student experience of simulation training for the prevention of falls amongst hospitalised inpatients
MethodsRCT
ParticipantsInclusion criteria: patients admitted to intervention wards within a public hospital.
Group 1
  • All health professional undergraduate students from Monash University attending placement at Peninsula Health for at least two weeks or more.

  • Placement on wards which have been randomised to the intervention or control.


Group 2
Patients admitted to intervention wards within PH
Interventions
  • Health professional students attend a four hour simulation training session

  • Usual care

Outcomes
  • Rate of falls

  • Proportion of fallers

  • Rate of injurious falls

Starting date17/08/2015
Contact informationDr Cylie Williams Peninsula Health 2 Hastings Rd Frankston, VIC, 3199, Australia

+61 3 97848125

Notes 

ACTRN12617000314325

Trial name or titleDoes abbreviating patient falls risk screening in documentation impact on falls in hospital inpatients: a stepped wedge cluster randomised control trial
MethodsRCT (stepped wedge)
ParticipantsAll patients who are admitted to intervention wards at Peninsula Health, Non inclusion of paediatric and maternity wards.
Interventions
  • The short Falls Risk Assessment Tool (FRAT) ‐ a template which guides the user to falls intervention strategies only.

  • Patient focused falls interventions will be documented on a Short FRAT based on observed and personalised need rather then the risk level.

  • Control: the traditional FRAT

Outcomes
Starting dateMarch 2017.
Contact informationDr Cylie WilliamsPeninsula HealthLevel 3 ‐ Office for Research2 Hastings Rd,Frankston VIC 3199Australia

NotesTrial may be eligible depending on mean age of patients on trial completion.

Dal Bello‐Haas 2012

Trial name or titleThe effects of a long‐term care walking programme on balance, falls and well‐being
MethodsRCT
ParticipantsInclusion criteria: 60 years or older; living in long‐term care facility; able to follow simple instructions; able to ambulate with or without an aid for at least 10 m; available Monday to Friday; willing to participate in a 5 days per week walking programme over a 4‐month period.
Exclusion criteria: recent cardiovascular event; uncontrolled hypertension; uncontrolled epilepsy; recent fracture; unable to satisfactorily comply with the protocol requirements; recent admission into an acute care facility (past 4 months); scheduled for surgery or hospitalisation in the next 6 months; participating in another regular exercise programme (half an hour or more, three or more times per week ) aimed at improving balance or strength
Interventions
  • Individualised; progressive; one‐to‐one supervised walking programme provided by study personnel and supervised by a licensed physiotherapist

  • Usual care

Outcomes1. Falls incidence
Starting dateDecember 2010
Estimated completion December 2016
Contact informationVanina PM Dal Bello‐HaasSchool of Rehabilitation Sciences, McMaster University, 1400 Main Street West, 403/E, Hamilton, Ontario L8S 1C7, Canada

NotesCT.gov {"type":"clinical-trial","attrs":{"text":"NCT01277809","term_id":"NCT01277809"}}NCT01277809

Hassett 2016

Trial name or titleActivity and MObility UsiNg Technology (AMOUNT) rehabilitation trial
MethodsRCT
ParticipantsInclusion criteria: admitted for rehabilitation or assessment at one of the 3 study sites with: reduced mobility (Short Physical Performance Battery score of less than 12); clinician‐assessed capacity for improvement in mobility; likely life expectancy of more than 12 months; anticipated length of stay of greater than or equal to 10 days; ability to maintain a standing position with 1 person assist as a minimum standard
Exclusion criteria: marked cognitive impairment; insufficient English language skills to participate in rehabilitation and no available interpreter; inadequate vision to use the devices; medical condition precluding exercise (unstable cardiac disease, uncontrolled hypertension, uncontrolled metabolic diseases, large abdominal aortic aneurysm or a weight‐bearing restriction); lack of interest in the use of the technologies; anticipated discharge to nursing home; discharge location too far from study site to complete home visits and follow‐up assessments.
Interventions
  • Tailored technology use (video and computer games/exercises and tablet applications as well as activity monitors) to promote physical activity in addition to usual care

  • Usual care

Outcomes1. Number of falls.
Starting dateSeptember 2014. Data collection completed.
Contact informationProf Cathie SherringtonThe George Institute for Global Health PO Box M201, Missenden Road Sydney NSW 2050 AustraliaPhone: +61280524300

Email:

NotesANZCTR. ACTRN12614000936628

ISRCTN34353836

Trial name or titleFinch: Falls in care homes study
MethodsRCT (cluster randomised)
ParticipantsInclusion criteria: Care Home inclusion criteria
  • Long stay with old age and/or dementia registration

  • 10 or more potentially eligible residents

  • Routinely record falls in resident personal records and on incident sheets

  • Consent of care home manager to comply with the protocol and identify a care home fall champion


Resident inclusion criteria
  • All long‐term care home residents


Staff Inclusion Criteria (Process Evaluation Only)
  • Employed by a Care Home participating in FINCH and selected for participation in the Process Evaluation

  • Employed in a caring role


Exclusion criteria: Care Home exclusion criteria
  • Participated in GtACH pilot/feasibility studies

  • Homes exclusively providing care for those with learning difficulties or substance dependency

  • Homes with contracts under suspension with health or social providers, or that are currently subject to safeguarding investigations or homes under CQC special measures

  • Homes with a significant proportion of beds taken up by health‐service commissioned intermediate‐care services

  • Trained and routinely using a systematic falls prevention programme


Resident exclusion criteria
  • Residents on short‐term care (e.g. respite)

  • Residents identified to be in the last few days of life


Staff Exclusion Criteria (Process Evaluation Only)
  • Have a significant proportion of time caring for residents in health‐service commissioned intermediate‐care services funded beds

Interventions
  • Guide to Action Care Home (GtACH) fall‐prevention programme

  • Usual care

Outcomes
  • Rate of falls

  • Rate of fractures

  • Injurious falls

Starting date1 November 2016
No longer recruiting
Contact informationPip LoganB108a Div Rehab and Ageing Medical School Queen's Medical CentreNG7 2UHNottinghamUnited Kingdom

Notes 

ISRCTN42003273

Trial name or titlePolypharmacy reduction in patients treated for chronic diseases (POLITE‐RCT)
MethodsRCT (cluster randomised)
ParticipantsHospital (acute care) inpatients aged 65 and over
Interventions
  • Medication review

  • Usual care

Outcomes
  • Number of falls

  • Fall related injury

  • Fall related fractures

Starting date1 November 2013. Completed October 2016.
Contact informationProf Attila AltinerRostock University Medical CenterInstitute of General Practice(Universitätsmedizin RostockInstitut für Allgemeinmedizin)POB 100888Rostock18055Germany+49 (0)381 4942481

‐rostock.de

Notes 

JPRN‐UMIN000000555

Trial name or titleThe effects of whole body vibration for the prevention of falls in elderly
MethodsRCT
Participants≥ 65 years, resident of senior citizen institution
Excluded criteria: bedridden
Interventions
  • Whole Body Vibration; 3 minutes twice weekly for 12 months

Outcomes
Starting dateStudy registered 25/12/2006
Study completed. Analysis completed 1/6/2009.
Contact informationTatsuya Koike, Osaka City University Medical School, Abenoku Asahimachi 1‐4‐3, Osaka, 545‐8585, Japan
NotesTrials registry page last updated on 28/11/2012 .Attempt to contact author 3/7/16 unsuccessful.

JPRN‐UMIN000008361

Trial name or titleMulticenter, randomised, double‐blind, placebo controlled, parallel group trial to evaluate the effect of Vitamin D supplementation for fall prevention
MethodsRCT (double‐blind)
ParticipantsResidents in the social welfare corporation kensyokai associated facilities
Interventions
  • Beverage contained Vitamin D supplement (liquid), 1 drop/day (1,000 IU) for 1 year

  • Placebo beverage without Vitamin D supplement for 1 year

Outcomes
Starting dateStart: 20 Jan 2013. Data analysis completed 31/12/2014. No publication identified
Contact informationTetsuya EnishiDivision of Rehabilitation, Tokushima University Hospital, Tokushima University

enishi.tetsuya@tokushima‐u.ac.jp

NotesAuthors contacted 16/5/16, no response received. Last modified 17/8/2017, status indicates unpublished.

McCullagh 2016

Trial name or titleA twice‐daily individual targeted exercise program in frail hospitalised older medical in‐patients (APEP)
MethodsRCT
ParticipantsInclusion criteria: ≥65 years, medical patients, anticipated length of stay greater than 2 days, planned for discharge home, mobility aid and /or assistance required on admission.
Exclusion criteria: contraindications to exercise, unable to follow commands in the English language, unable to exercise with the assistance of one person only, when active palliative care is required, when full isolation for containment of a contagious infection is required
Interventions
  • Twice‐daily, individual, targeted, strengthening, balance and endurance exercise sessions

  • Twice‐daily, individual, stretching and relaxation exercise sessions (sham exercise)

Outcomes
  • Number of falls

  • Number of falls injuries

Starting dateMarch 2015.
Estimated completion May 2017.
Contact informationDr Suzanne Timmons,Senior Lecturer in Gerontology and Rehabilitation,

University College Cork

Notes{"type":"clinical-trial","attrs":{"text":"NCT02463864","term_id":"NCT02463864"}}NCT02463864

Mestres 2017

Trial name or titleSupporting Clinical Rules Engine in the Adjustment of Medication (SCREAM)
MethodsRCT (cluster randomised)
ParticipantsInclusion criteria: residents living in a nursing home in the Netherlands. The nursing homes are able to deliver the medication and lab data electronically
Interventions
  • Medication review. A clinical decision support system, the CRR (clinical rule reporter) will be used to weekly screen medication list, laboratory values and medical history in order to obtain potential clinical relevant remarks that will be sent to the correspondent physician with an advice on how to improve/solve the situation.

  • Usual care.

Outcomes
  • Number of falls (as part of composite measure)

Starting dateJune 2013.
Planned completion June 2016.
Contact informationDr. PHM van der Kuy
NotesNTR5165

Mudge 2017

Trial name or titleCHERISH (Collaborative for Hospitalised Elders: Reducing the Impact of Stays in Hospital)
MethodsRCT (cluster randomised)
ParticipantsInclusion criteria: ≥ 65 years, admitted to hospital for 3 or more days, with admission to nominated intervention or control ward.
Exclusion criteria: discharged from hospital within 2 days; palliative intent of care.
Interventions
  • "Eat Walk Engage", a quality improvement programme designed to enhance uptake of evidence‐based processes of care for older inpatients.The target processes are early mobility; adequate oral nutritional intake; and meaningful, cognitively stimulating activities.

  • Usual care, including any facility based improvement programmes.

Outcomes
  • Number of falls (as part of composite measure)

Starting dateOctober 2015.
Contact informationProf Alison MudgeBuilding C28 Level 1 Royal Brisbane and Women's Hospitals Herston Queensland 4029 Australia

Email

NotesACTRN12615000879561

{"type":"clinical-trial","attrs":{"text":"NCT01483456","term_id":"NCT01483456"}}NCT01483456

Trial name or titleImpact of multidisciplinary program on falls in elderly inpatients (IPR)
MethodsRCT (stepped wedge)
ParticipantsSetting: hospitals (rehabilitation wards and geriatric acute wards), FranceN = 1680 (target sample size)

Inclusion Criteria: aged ≥ 65; admitted during study; consenting


Exclusion Criteria: cognitively impaired (MMSE < 10); psychiatric pathology; bedridden
Interventions
  • Multifactorial intervention; identification of patient's fall risk; multifactorial fall‐prevention programme (integrated actions targeted on risk factors; exercise programs and review of the hospital environment); "Get up" workshop and morbidity and mortality conferences related to fall cases

  • Usual care

Outcomes
  • Incidence of falls

  • Incidence of fall‐related injury

Starting dateJuly 2011
Contact informationP Krolak‐SalmonHospices Civils de Lyon

Email: pierre.krolak‐salmon@chu‐lyon.fr

NotesIPR (in French "Identifier, Prévenir, Relever"). Study design described as "Intervention model: single group assignment" no mention of a control group. Contact person has confirmed that this is an RCT.
Author correspondence confirmed trial design. Enquired about study completion 13 Jan 2017, no response received.

{"type":"clinical-trial","attrs":{"text":"NCT01551121","term_id":"NCT01551121"}}NCT01551121

Trial name or titleAssessment of an automated telesurveillance system on the incidence of serious falls in nursing homes
(TELEHPAD)
MethodsRCT (individually randomised)
ParticipantsSettting: 3 Nursing homes in the Limousin region
Target sample size: N = 216
Sample: people admitted to Limoges or Gueret nursing homes
Inclusion criteria: aged 75; consenting; able to understand the study and complete evaluations; able to stand up from the bed; covered by French health insurance
Exclusion criteria: short‐term prognosis; in multiple bed room and one co‐occupant does consent to participate
Interventions
  • Installation of automated telesurveillance system (camera installed in room)

  • Usual care

OutcomesDuration: 1 year
Starting dateMarch 2012.
Contact informationThierry Dantoine, MD University Hospital Limoges

Email: thierry.dantoine@chu‐limoges.fr

NotesCorrespondence with T Dantoine confirmed study ongoing 10 August 2016. Study listed as recruiting as at 10 November 2017.

{"type":"clinical-trial","attrs":{"text":"NCT01561872","term_id":"NCT01561872"}}NCT01561872

Trial name or titleAssessment of an automated telesurveillance system on serious falls prevention in an elderly suffering from dementia specialized care unit: the URCC (GET‐BETTER)
MethodsRCT (individually randomised)
ParticipantsSetting: Limoges and Brive's URCCTarget sample size = 350

Inclusion Criteria: men and women aged > 65; admitted to Limoges or Brive's URCC (dementia care unit); consenting; covered by French health insurance


Exclusion Criteria: short‐term prognosis
Interventions
  • Automated telesurveillance system (camera installed)

  • Control: usual care (no telesurveillance)

OutcomesDuration of study: 6 months
  • Rate of falls

  • Rate of injurious falls

Starting dateApril 2012.Completed 2016
Contact informationDr T DantoineUniversity HospitalLimogesFrance

Email: thierry.dantoine@chu‐limoges.fr

NotesURCC: Unité de Réadaptation Cogintico‐Comportementale (Unit for demented patients’ rehabilitation) (Dantoine T, personal communication Oct 20 2012). Correspondence with T Dantoine confirmed study completed, analysis ongoing as at 10 August 2016

{"type":"clinical-trial","attrs":{"text":"NCT02604056","term_id":"NCT02604056"}}NCT02604056

Trial name or titlePragmatic cluster trial for nursing home antipsychotic prescribing
MethodsRCT (cluster randomised)
ParticipantsInclusion Criteria
  • Nursing homes within pre‐determined regions of Ontario that expressed an interest in the full intervention (the regions; or hubs; contain a wide variety of nursing home types within a reasonable travel distance [i.e. < 100 km])

  • Nursing homes within the hubs in which the medical and administrative leads agree to and support the project


Exclusion Criteria
  • Nursing homes with a previous or ongoing involvement in externally supported quality improvement initiatives focusing on antipsychotic medications

  • Nursing homes without any prescribers caring for at least 10 residents routinelyNursing homes with fewer than 30 residents

Interventions
  • Audit & feedback & educational outreach. Educational Outreach offered to each prescriber and team members in the home

  • Usual care: Audit & feedback. Standard quality improvement supports (including online Audit and Feedback reports for each prescriber in the home)

Outcomes
Starting dateSeptember 2015. Estimated completion December 2017
Contact informationWomen's College Hospital, Ontario Ministry of Health, Long Term Care, Ontario Medical Association, Health Quality Ontario, Centre for Effective Practice
Notes 

{"type":"clinical-trial","attrs":{"text":"NCT02702037","term_id":"NCT02702037"}}NCT02702037

Trial name or titleOlder Person's Exercise and Nutrition study (OPEN): a simple physical exercise combined with protein supplement ‐ effects on functional status and independence among older people: a cluster randomised controlled trial
MethodsRCT (individually randomised)
ParticipantsInclusion Criteria
  • 75 Years and older

  • Able to rise independently from a seated position to standing

  • Nursing home setting


Exclusion Criteria
  • BMI >30

  • Severe dysphagia

  • Tube feeding

  • Severe kidney failure

  • Bedridden people

  • Terminal stage of life

  • Lack of informed consent

Interventions
  • The participants will be supported to perform the sit‐to‐stand exercise at least four times per day during 12 weeks (7 days/week). The participants will also be offered an oral protein‐rich supplement (125 mL, 18 g protein (24% of RDI), 300 kcal) twice a day in conjunction with two of the four sit‐to‐stand exercises during 12 weeks (7 days/week)

  • Usual care

Outcomes
Starting dateMarch 2016
Contact informationKarolinska Institute, Nutricia Foundation
NotesAnne‐Marie Bostrom, PhDKarolinska InstitutetStockholm, Sweden

anne‐

{"type":"clinical-trial","attrs":{"text":"NCT02714257","term_id":"NCT02714257"}}NCT02714257

Trial name or titleSeniors avoiding falls through exercise study
MethodsRCT
ParticipantsInclusion Criteria
  • ≥ 65 years old

  • Previous Fragility Fracture (FF) in past 5 years

  • Able to speak and understand English

  • Participants will need to be willing to try exercising and agree to annual follow‐up measurements

Interventions
  • Enhanced Usual Care plus Exercise Coaching Intervention. Participants will receive the three printed pamphlets on fall risks and exercising in groups (same as the controls) plus; (1) an exercise programme that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in‐person and telephone support/feedbacks to enhance participation in the exercise programme; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 12 weeks, to communicate the patient's progress

  • 2. Usual care. Enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximise patient safety, the investigators will communicate the baseline bone density results (measured by Dual‐energy X‐ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure

Outcomes
  • Number of falls

  • Injurious falls

Starting dateSeptember 2016
Estimated study completion August 2020
Contact informationSol M Rodriguez‐ColonPenn State Hershey Medical CenterHershey, Pennsylvania, USA, 17033

NotesThe intervention will be held in churches, community centres, and senior residential facilities. Study may be eligible depending on proportion of participants in aged‐care facilities.

{"type":"clinical-trial","attrs":{"text":"NCT02714582","term_id":"NCT02714582"}}NCT02714582

Trial name or titleFeasibility, appropriateness, meaningfulness and effectiveness of bedside shift reporting
MethodsRCT
ParticipantsInclusion Criteria
  • Admitted on a participating hospital ward

  • Be conscious

  • Speak Dutch

  • Participated in at least 3 bedside shift reports


Exclusion Criteria
  • Dementia or other severe cognitive/mental disorders

Interventions
  • Bedside Shift Reporting (BSR). The experimental group (nurses and patients) will:

    • develop a tailored BSR‐intervention by use of co‐design; diagnostic interviews and pilot testing

    • use the tailored BSR‐intervention, with participation of the patient; instead of the regular nurse shift report

  • Usual care. No bedside shift report

Outcomes
Starting dateMarch 2016
Estimated completion February 2018
Contact informationAnn Van Hecke, MSc, PhD
Ghent University/Ghent University Hospital
Notes 

{"type":"clinical-trial","attrs":{"text":"NCT02757131","term_id":"NCT02757131"}}NCT02757131

Trial name or titleDedicated ambulator‐assisted physical activity to improve hospital outcome measures in elderly patients
MethodsRCT
ParticipantsHospital setting.
Inclusion Criteria
  • Men or women 60 years of age or older admitted as inpatients to participating wards in the Medicine Institute, Cleveland Clinic Main Campus during the study time period

  • Hospitalised for a medical illness

  • Complete history and physical examination on file

  • Physical therapy consult and 6‐Clicks score between 16‐20 a. This is based on a usual care assessment ordered by a physician that will happen prior to any study recruitment ‐ it is entirely independent of the study


Exclusion Criteria
  • Observational status

  • Admission to ICU

  • Surgical patients

  • Patients diagnosed with: decompensated heart failure, unstable angina, other medical conditions precluding participation in exercise/ambulation

  • Comfort care measures only

Interventions
  • Ambulator‐assisted physical therapy, Ambulation protocol as directed by physical therapist and three times daily under supervision of dedicated ambulator patient care nursing assistant

  • Usual care

Outcomes
Starting dateJuly 2016.
Completed July 2017.
Contact informationAaron Hamilton, MDCleveland Clinic Foundation

Cleveland, Ohio, USA, 44195

Notes 

{"type":"clinical-trial","attrs":{"text":"NCT02969343","term_id":"NCT02969343"}}NCT02969343

Trial name or titlePatient safety learning laboratory: making acute care more patient‐centered
MethodsRCT (stepped wedge)
ParticipantsHospital settingEstimated enrolment 21,000 participants.

Inclusion Criteria: patients 18‐99 years of age on hospital care units where the PSLL patient safety health information technology tools are implemented.

Interventions
  • Implementation of three Patient Safety Learning Laboratory (PSLL) toolkits. 1) Patient‐centered fall‐prevention toolkit 2) Patient safety checklist tool and 3) MySafeCare Patient Safety Reporting System

  • Usual care

Outcomes
  • Rate of falls

  • Rate of injurious falls

Starting dateApril 2015.
Estimated completion September 2018.
Contact informationPrincipal Investigator: David W. Bates, MD, MSc, Brigham and Women's HospitalContact: Alexandra C Businger 617‐732‐7063 : Patricia Dykes, RN PhD 617‐732‐8925

Boston, Massachusetts, USA, 02115

NotesTrial may be eligible depending on age of patients on trial completion.

{"type":"clinical-trial","attrs":{"text":"NCT03019211","term_id":"NCT03019211"}}NCT03019211

Trial name or titleFeasibility aquatic physical exercise to reduce falls in institutionalized elderly (PrePhysFalls)
MethodsRCT
ParticipantsInclusion criteria
  • Be institutionalised in a care centre

  • Participate voluntarily and sign the informed consent

  • Have a punctuation of 2 or more in The Downton Fall Risk Index


Exclusion criteria
  • Suffer from a condition that can be affected or hinder exercise

  • Acute disease unresolved in 10 days

  • Not controlled hypertension

  • Contagious skin disorder

  • Urinary or faecal incontinence

Interventions
  • Hydrotherapy. Static/dynamic exercises (balance and resistance training) in an aquatic environment

  • Control. Exercises out of a water environment

Outcomes
Starting dateStarted April 2016.
Completed March 2017.
Contact informationMercè Sitjà Rabert
Universitat Ramon Llull, Barcelona, Spain
Notes 

NTR5015

Trial name or titleRandomized controlled intervention trial on falling and functional decline in the hospitalised elderly
MethodsRCT (cross‐over trial)
ParticipantsInclusion criteria: patients >70 years; stay in hospital > 3 days; agreement by the attending doctor; informed consent; ability to read and write Dutch
Exclusion criteria: patients in isolation precautions; patients who can not go to the room where the activity programme is given; patients participating in another study
Interventions
  • A daily two hours activities of daily life programme with occupational therapy by volunteers; physiotherapy and ergotherapy to improve the physical and mental condition

Outcomes
Starting date5 January 2015
Contact informationSandra Koster
NotesAuthor correspondence indicated that quote: "we can inform you that the main group of participants can be defined as elderly patients (> 65 year)"

Scheffers‐Barnhoorn 2017

Trial name or titleFIT‐HIP. Fear of falling intervention in hip fracture geriatric rehabilitation: a cluster randomised controlled trial
MethodsRCT (cluster randomised)
ParticipantsInclusion criteria
  • Aged 65 years or older

  • Admitted to a geriatric rehabilitation (GR) unit for rehabilitation due to a hip fracture

  • Concerned to fall. This is measured by the one item fear of falling question (answering ‘positively’ in the category sometimes, often or very often)


Exclusion criteriaThe patient has a condition interfering with learning ability, such as:
  • A diagnosis of dementia or score on the 'hetero‐anamnesis list cognition' > 1, suggesting pre‐morbid cognitive problems

  • A major psychiatric disease

  • Insufficient mastery of Dutch language

  • The patient has a limited life expectancy

  • The patient has a pathological hip fracture

  • Pre‐fracture Barthel‐index score < 15 (as a measure of ADL dependency)

Interventions
  • Treatment of fear of falling. The FIT‐HIP intervention consists of various elements of cognitive‐behaviour therapy (guided exposure, psycho‐education, cognitive restructuring, relapse prevention). This will be combined with exercise training in the physiotherapy sessions

  • Usual care

Outcomes
Starting dateMarch 2016.
Contact informationMaaike Scheffers‐BarnhoornLeiden University Medical Center (LUMC), Department of Public Health and Primary Care

The Netherlands.

NotesNTR5695

In this version of the review, we now exclusively assess risk of bias of each included study based on the recommended tool described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011b). We also assessed bias in the recall of falls due to less reliable methods of ascertainment (Hannan 2010).

We now use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the quality of the body of evidence. We prepared 'Summary of findings' tables for each of the main categories of interventions, for the listed outcomes. The risk of bias has been assessed according to the Cochrane tool for assessing risk of bias, plus two items relating to method of ascertaining falls and baseline imbalance.

Where the reported trial outcomes did not include falls during the intervention period, we did not pool these data with those of other trials.

In addition to subgroup analyses by intervention types according to the Prevention of Falls Network Europe (ProFaNE) fall‐prevention taxonomy (Lamb 2007; Lamb 2011), we conducted sensitivity analyses of exercise trials excluding those with 20 participants or less in each arm of the trial. We also conducted a sensitivity analysis of medication review excluding one trial with three participants with more than 30 falls in the intervention arm of the trial. In the previous version of this review, subgroup analyses were conducted according to level of cognition and level of care in care facilities. In this update, we have added subgroup analysis by level of care (setting) in hospitals. We have conducted a sensitivity analysis for the rate of falls analysis for exercise versus usual care in care facilities to test the exclusion of one trial with zero falls recorded in the intervention arm of the trial.

Upon further consideration, we have re‐categorised some interventions across different ProFaNE categories that fall within the social environment classification. Stenvall 2007 has been reclassified as a social environment intervention (previously multifactorial). Koh 2009 and Van Gaal 2011b remain classified within the social environment ProFaNE category but are considered as organisational service model change rather than staff training as these interventions are primarily to introduce new guidelines and staff training was secondary.

Trials including only participants after stroke were excluded as a protocol for a Cochrane Review on interventions for preventing falls in people after stroke has been published (Verheyden 2010).

We reported the results for care facilities and hospitals separately as the primary analyses because this is likely to be more useful to the users of this review. Interventions will be organised differently in these two types of settings and there may be different effectiveness of similar interventions between the two settings.

The protocol was completed and submitted for publication prior to the general release of RevMan 5 and the supporting version of the Cochrane Handbook for Systematic Reviews of Interventions (version 5.0) in February 2008. In the protocol, we stated that we would assess methodological quality using the 11‐item tool used in Gillespie 2003.

For this version of the review, we used three criteria from the Cochrane tool for assessing risk of bias: 'Random sequence generation', 'Allocation concealment', and 'Blinding of outcome assessment', and eight items from the 11‐item tool (seeAppendix 2). The items relating to allocation concealment and blinding of outcome assessors have not been used (now redundant). Also, the item relating to appropriateness of duration of clinical surveillance was not used due to very poor agreement between assessors during preparation of the first version of this review.

Interventions were classified using the Prevention of Falls Network Europe (ProFaNE) fall‐prevention taxonomy (Lamb 2007; Lamb 2011). Subgroup analyses were conducted to explore heterogeneity where appropriate.

ID Cameron, the guarantor for this review, conceived and designed the review and for this update contributed to assessment of retrieved studies against inclusion criteria, carried out 'Risk of bias' assessment, data extraction and assessment of GRADE quality of the evidence, assisted with categorisation of trial interventions using the ProFaNE taxonomy, and commented on drafts of the review.

SM Dyer for this update co‐ordinated the review, carried out trial registry searches, screened search results and obtained papers, screened retrieved papers against inclusion criteria, carried out 'Risk of bias' assessment, data extraction and assessment of GRADE quality of the evidence, managed data and carried out statistical calculations, entered data into Review Manager, and drafted the review.

CE Panagoda screened search results and obtained papers, screened retrieved papers against inclusion criteria, carried out 'Risk of bias' assessment and data extraction, and commented on drafts of the review.

GR Murray carried out 'Risk of bias' assessment, data extraction and assessment of GRADE quality of the evidence, assisted with categorisation of trial interventions using the ProFaNE taxonomy, and commented on drafts of the review.

KD Hill carried out 'Risk of bias' assessment and data extraction, and commented on drafts of the review.

RG Cumming carried out 'Risk of bias' assessment and data extraction, and commented on drafts of the review.

N Kerse carried out 'Risk of bias' assessment and data extraction, and commented on drafts of the review.

See Appendix 12 for 'Contribution of authors' for the previous version of this review.

  • John Walsh Centre for Rehabilitation Research, Kolling Institute, The University of Sydney, Australia.

    Salary, administration, computing, and library services (IDC, RGC)

  • Illawarra Shoalhaven Local Health Network, Warrawong, Australia.

    Computing and library services (GM)

  • Curtin University, Perth, Australia.

    Salary, administration, computing, and library services (KDH)

  • University of Auckland, New Zealand.

    Salary, administration, computing and library services (NK)

  • National Health and Medical Research Council, Practitioner Fellowship, Australia.

    Salary contribution (IDC)