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# Interventions for preventing falls in older people living in the community

Editors: Cochrane Bone, Joint and Muscle Trauma Group

Contact Person: Lesley D Gillespie (lesley.gillespie@yahoo.co.nz)

c/o Cochrane Bone, Joint and Muscle Trauma Group

Centre for Musculoskeletal Research, Institute of Inflammation and Repair, The University of Manchester

2nd Floor, Stopford Building

Oxford Road

Manchester

M13 9PT

UK

Lesley D Gillespie[ 1 ]

M Clare Robertson[ 2 ]

William J Gillespie[ 3 ]

Catherine Sherrington[ 4 ]

Simon Gates[ 5 ]

Lindy Clemson[ 6 ]

Sarah E Lamb[ 7 ]

[1] c/o Cochrane Bone, Joint and Muscle Trauma Group, Centre for Musculoskeletal Research, Institute of Inflammation and Repair, The University of Manchester, Manchester, UK

[2] Department of Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand

[3] Hull York Medical School, University of Hull, Hull, UK

[4] Institute for Musculoskeletal Health, School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia

[5] Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK

[6] Faculty of Health Sciences, The University of Sydney, Lidcombe, Australia

[7] Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK

Citation

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Gillespie LD , Robertson MC , Gillespie WJ , Sherrington C , Gates S , Clemson L , Lamb SE . Interventions for preventing falls in older people living in the community. Cochrane Database of Systematic Reviews 2012, Issue 9. Art. No.: CD007146. DOI: 10.1002/14651858.CD007146.pub3.

Dates

Revision published: Issue TBD, TBD (TBD)

Version published (citation changed): Issue 9, 2012 (2012-09-12)

Review first published: Issue 2, 2009

Protocol first published: Issue 2, 2008

# Abstract

## Background

Approximately 30% of people over 65 years of age living in the community fall each year. This is an update of a Cochrane review first published in 2009.

## Objectives

To assess the effects of interventions designed to reduce the incidence of falls in older people living in the community.

## Search methods

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (February 2012), CENTRAL (The Cochrane Library 2012, Issue 3), MEDLINE (1946 to March 2012), EMBASE (1947 to March 2012), CINAHL (1982 to February 2012), and online trial registers.

## Selection criteria

Randomised trials of interventions to reduce falls in community-dwelling older people.

## Data collection and analysis

Two review authors independently assessed risk of bias and extracted data. We used a rate ratio (RaR) and 95% confidence interval (CI) to compare the rate of falls (e.g. falls per person year) between intervention and control groups. For risk of falling, we used a risk ratio (RR) and 95% CI based on the number of people falling (fallers) in each group. We pooled data where appropriate.

## Main results

We included 159 trials with 79,193 participants. Most trials compared a fall prevention intervention with no intervention or an intervention not expected to reduce falls. The most common interventions tested were exercise as a single intervention (59 trials) and multifactorial programmes (40 trials). Sixty-two per cent (99/159) of trials were at low risk of bias for sequence generation, 60% for attrition bias for falls (66/110), 73% for attrition bias for fallers (96/131), and only 38% (60/159) for allocation concealment.

Multiple-component group exercise significantly reduced rate of falls (RaR 0.71, 95% CI 0.63 to 0.82; 16 trials; 3622 participants) and risk of falling (RR 0.85, 95% CI 0.76 to 0.96; 22 trials; 5333 participants), as did multiple-component home-based exercise (RaR 0.68, 95% CI 0.58 to 0.80; 7 trials; 951 participants and RR 0.78, 95% CI 0.64 to 0.94; 6 trials; 714 participants). For Tai Chi, the reduction in rate of falls bordered on statistical significance (RaR 0.72, 95% CI 0.52 to 1.00; 5 trials; 1563 participants) but Tai Chi did significantly reduce risk of falling (RR 0.71, 95% CI 0.57 to 0.87; 6 trials; 1625 participants). Overall, exercise interventions significantly reduced the risk of sustaining a fall-related fracture (RR 0.34, 95% CI 0.18 to 0.63; 6 trials; 810 participants).

Multifactorial interventions, which include individual risk assessment, reduced rate of falls (RaR 0.76, 95% CI 0.67 to 0.86; 19 trials; 9503 participants), but not risk of falling (RR 0.93, 95% CI 0.86 to 1.02; 34 trials; 13,617 participants).

Overall, vitamin D did not reduce rate of falls (RaR 1.00, 95% CI 0.90 to 1.11; 7 trials; 9324 participants) or risk of falling (RR 0.96, 95% CI 0.89 to 1.03; 13 trials; 26,747 participants), but may do so in people with lower vitamin D levels before treatment.

Home safety assessment and modification interventions were effective in reducing rate of falls (RaR 0.81, 95% CI 0.68 to 0.97; 6 trials; 4208 participants) and risk of falling (RR 0.88, 95% CI 0.80 to 0.96; 7 trials; 4051 participants). These interventions were more effective in people at higher risk of falling, including those with severe visual impairment. Home safety interventions appear to be more effective when delivered by an occupational therapist.

An intervention to treat vision problems (616 participants) resulted in a significant increase in the rate of falls (RaR 1.57, 95% CI 1.19 to 2.06) and risk of falling (RR 1.54, 95% CI 1.24 to 1.91). When regular wearers of multifocal glasses (597 participants) were given single lens glasses, all falls and outside falls were significantly reduced in the subgroup that regularly took part in outside activities. Conversely, there was a significant increase in outside falls in intervention group participants who took part in little outside activity.

Pacemakers reduced rate of falls in people with carotid sinus hypersensitivity (RaR 0.73, 95% CI 0.57 to 0.93; 3 trials; 349 participants) but not risk of falling. First eye cataract surgery in women reduced rate of falls (RaR 0.66, 95% CI 0.45 to 0.95; 1 trial; 306 participants), but second eye cataract surgery did not.

Gradual withdrawal of psychotropic medication reduced rate of falls (RaR 0.34, 95% CI 0.16 to 0.73; 1 trial; 93 participants), but not risk of falling. A prescribing modification programme for primary care physicians significantly reduced risk of falling (RR 0.61, 95% CI 0.41 to 0.91; 1 trial; 659 participants).

An anti-slip shoe device reduced rate of falls in icy conditions (RaR 0.42, 95% CI 0.22 to 0.78; 1 trial; 109 participants). One trial (305 participants) comparing multifaceted podiatry including foot and ankle exercises with standard podiatry in people with disabling foot pain significantly reduced the rate of falls (RaR 0.64, 95% CI 0.45 to 0.91) but not the risk of falling.

There is no evidence of effect for cognitive behavioural interventions on rate of falls (RaR 1.00, 95% CI 0.37 to 2.72; 1 trial; 120 participants) or risk of falling (RR 1.11, 95% CI 0.80 to 1.54; 2 trials; 350 participants).

Trials testing interventions to increase knowledge/educate about fall prevention alone did not significantly reduce the rate of falls (RaR 0.33, 95% CI 0.09 to 1.20; 1 trial; 45 participants) or risk of falling (RR 0.88, 95% CI 0.75 to 1.03; 4 trials; 2555 participants).

Thirteen trials provided a comprehensive economic evaluation. Three of these indicated cost savings for their interventions during the trial period: home-based exercise in over 80-year-olds, home safety assessment and modification in those with a previous fall, and one multifactorial programme targeting eight specific risk factors.

## Authors' conclusions

Group and home-based exercise programmes, and home safety interventions reduce rate of falls and risk of falling.

Multifactorial assessment and intervention programmes reduce rate of falls but not risk of falling; Tai Chi reduces risk of falling.

Overall, vitamin D supplementation does not appear to reduce falls but may be effective in people who have lower vitamin D levels before treatment.

# Plain language summary

# Interventions for preventing falls in older people living in the community

As people get older, they may fall more often for a variety of reasons including problems with balance, poor vision, and dementia. Up to 30% may fall in a year. Although one in five falls may require medical attention, less than one in 10 results in a fracture.

This review looked at the healthcare literature to establish which fall prevention interventions are effective for older people living in the community, and included 159 randomised controlled trials with 79,193 participants.

Group and home-based exercise programmes, usually containing some balance and strength training exercises, effectively reduced falls, as did Tai Chi. Overall, exercise programmes aimed at reducing falls appear to reduce fractures.

Multifactorial interventions assess an individual's risk of falling, and then carry out treatment or arrange referrals to reduce the identified risks. Overall, current evidence shows that this type of intervention reduces the number of falls in older people living in the community but not the number of people falling during follow-up. These are complex interventions, and their effectiveness may be dependent on factors yet to be determined.

Interventions to improve home safety appear to be effective, especially in people at higher risk of falling and when carried out by occupational therapists. An anti-slip shoe device worn in icy conditions can also reduce falls.

Taking vitamin D supplements does not appear to reduce falls in most community-dwelling older people, but may do so in those who have lower vitamin D levels in the blood before treatment.

Some medications increase the risk of falling. Three trials in this review failed to reduce the number of falls by reviewing and adjusting medications. A fourth trial involving family physicians and their patients in medication review was effective in reducing falls. Gradual withdrawal of a particular type of drug for improving sleep, reducing anxiety, and treating depression (psychotropic medication) has been shown to reduce falls.

Cataract surgery reduces falls in women having the operation on the first affected eye. Insertion of a pacemaker can reduce falls in people with frequent falls associated with carotid sinus hypersensitivity, a condition which causes sudden changes in heart rate and blood pressure.

In people with disabling foot pain, the addition of footwear assessment, customised insoles, and foot and ankle exercises to regular podiatry reduced the number of falls but not the number of people falling.

The evidence relating to the provision of educational materials alone for preventing falls is inconclusive.

# Background

## Description of the condition

About a third of community-dwelling people over 65 years old fall each year [1, 2], and the rate of fall-related injuries increases with age [3]. Falls can have serious consequences, e.g. fractures and head injuries [3]. Around 10% of falls result in a fracture [1, 2]; fall-associated fractures in older people are a significant source of morbidity and mortality [4]. Most fall-related injuries are minor: bruising, abrasions, lacerations, strains, and sprains.

Despite early attempts to achieve a consensus definition of "a fall" [5] many definitions still exist in the literature. It is particularly important to have a clear, simple definition for studies in which older people record their own falls; their concept of a fall may differ from that of researchers or healthcare professionals [6]. A recent consensus statement defines a fall as "an unexpected event in which the participant comes to rest on the ground, floor, or lower level" [7]. The wording recommended when asking participants is "In the past month, have you had any fall including a slip or trip in which you lost your balance and landed on the floor or ground or lower level?" [7].

Risk factors for falling have been identified by epidemiological studies of varying quality. These have been synthesised in a recent systematic review [8]. About 15% of falls result from an external event that would cause most people to fall, a similar proportion have a single identifiable cause such as syncope, and the remainder result from multiple interacting factors [9].

Since many risk factors appear to interact in those who suffer fall-related fractures [10], it is not clear to what extent interventions designed to prevent falls will also prevent hip or other fall-associated fractures. Falls can also have psychological consequences: fear of falling and loss of confidence that can result in self restricted activity levels leading to a reduction in physical function and social interactions [11]. Falling puts a strain on the family and is an independent predictor of admission to a nursing home [12].

## Description of the intervention

Many preventive intervention programmes based on reported risk factors for falls have been established and evaluated. Some of these specifically target people with a high risk of falling, for example history of a fall or specific fall risk factors. Interventions have included exercise programmes, education programmes, medication optimisation, and environmental modification. In some studies single interventions have been evaluated; in others, interventions with more than one component have been used. 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).

## Why it is important to do this review

The best evidence for the efficacy of interventions to prevent falling should emerge from large, well-conducted randomised controlled trials, or from meta-analysis of smaller trials. A systematic review is required to identify the large number of trials in this area and summarise the evidence for healthcare professionals, researchers, policy makers, and others with an interest in this topic. This review is an update of a Cochrane review first published in 2009 when the Cochrane review 'Interventions for preventing falls in elderly people' was split into two separate reviews covering interventions for preventing falls in older people living in the community [13], and interventions for preventing falls in nursing care facilities and hospitals [14].

# Objectives

To assess the effects of interventions designed to reduce the incidence of falls in older people living in the community.

# Methods

## Criteria for considering studies for this review

### Types of studies

We included randomised controlled trials and quasi-randomised trials (e.g. allocation by alternation or date of birth).

### Types of participants

We included trials of interventions to prevent falls if they specified an inclusion criterion of 60 years or over. Trials that included younger participants have been included if the mean age minus one standard deviation was more than 60 years. We included trials where the majority of participants were living in the community, either at home or in places of residence that, on the whole, do not provide residential health-related care or rehabilitative services, for example hostels, retirement villages, or sheltered housing. Trials with mixed populations (community and higher dependency places of residence) were eligible for inclusion in both this review and the Cochrane review on fall prevention in nursing care facilities or hospitals [14] if data were provided for subgroups based on setting. Inclusion in either review was based on the proportion of participants from the relevant setting. We included trials recruiting participants in hospital if the majority were discharged to the community (where falls were recorded).

Trials testing interventions for preventing falls in people post stroke and with Parkinson's disease have been excluded from this version of the review (see Differences between protocol and review).

### Types of interventions

This review focuses on any intervention designed to reduce falls in older people (i.e. designed to minimise exposure to, or the effect of, any risk factor for falling). We included trials where the intervention was compared with 'usual care' (i.e. no change in usual activities) or a 'placebo' control intervention (i.e. an intervention that is not thought to reduce falls, for example general health education or social visits) or another fall-prevention intervention.

### Types of outcome measures

We included only trials that reported data relating to rate or number of falls, or number of participants sustaining at least one fall during follow-up (fallers). Prospective daily calendars returned monthly for at least one year from randomisation are the preferred method for recording falls [7]. However, we have also included trials where falls were recorded retrospectively, or not monitored continuously throughout the trial. The following are the outcomes for the review.

#### Primary outcomes

- Rate of falls

- Number of fallers

#### Secondary outcomes

- Number of participants sustaining fall-related fractures

- Adverse effects of the interventions

- Economic outcomes

## Search methods for identification of studies

### Electronic searches

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (February 2012), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2012, Issue 3), MEDLINE (1946 to March 2012), EMBASE (1947 to March 2012), CINAHL (Cumulative Index to Nursing and Allied Health Literature) (1982 to February 2012), and online trial registers. We did not apply any language restrictions.

In MEDLINE (OvidSP) subject-specific search terms were combined with the sensitivity-maximising version of the MEDLINE trial search strategy [15], but without the drug therapy floating subheading which produced too many spurious references for this review. The strategy was modified for use in The Cochrane Library, EMBASE, and CINAHL (see Supplementary material 1).

### Searching other resources

We checked reference lists of articles. We also identified ongoing and unpublished trials by contacting researchers in the field.

## Data collection and analysis

### Selection of studies

One review author (LDG) screened the title, abstract, and descriptors of identified studies for possible inclusion. From the full text, two authors independently assessed potentially eligible trials for inclusion and resolved any disagreement through discussion. We contacted authors for additional information if necessary.

### Data extraction and management

Pairs of review authors independently extracted data using a pre-tested data extraction form. Disagreement was resolved by consensus or third party adjudication.

### Assessment of risk of bias in included studies

Two review authors independently assessed risk of bias using the recommendations in the Cochrane Handbook for Systematic Reviews of Interventions [16]. Review authors were not blinded to author and source institution. They did not assess their own trials. Disagreement was resolved by consensus or third party adjudication.

We assessed the following domains: random sequence generation (selection bias); allocation concealment (selection bias); blinding of participants and personnel (performance bias); blinding of outcome assessment (detection bias) for falls and fallers, and for fractures separately; incomplete outcome data (attrition bias) for falls and fallers separately. We also assessed bias in the recall of falls due to unreliable methods of ascertainment [17]. We developed criteria for judging risk of bias in fall prevention trials (see Supplementary material 8).

We found that many of the descriptive judgements proposed for assessment of attrition bias described in Table 8.5.d of the Cochrane Handbook [16] were difficult to make and thus to achieve agreement upon. Missing data in falls prevention trials can result from incomplete monitoring of fall events, withdrawals, and deaths. Reasons for a participant withdrawing from a trial can be as diverse as unwillingness to exercise in an exercise group, refusal to maintain the control group activity (e.g. abstain from exercise), an adverse event related to the intervention, or an illness unrelated to falls. Participants who are frailer may be more likely to fall and also more likely to be lost to follow-up. The fact that fall events are self reported can result in under or over reporting in a particular group. Assessing the level of risk of bias by deciding the extent to which a combination of all potential factors might impact on the true rate of falls and risk of falling in each group was not possible.

Therefore we developed specific criteria for assessing attrition bias using the principles laid out in Section 8.13.2.1 of [16. We classified studies as low, high, or unclear risk of attrition bias using an [18] spreadsheet (see Supplementary material 9 for detailed methods).

To explore the possibility of publication bias we constructed funnel plots for all analyses that contained more than 10 data points.

### Measures of treatment effect

We have reported the treatment effect for rate of falls as a rate ratio (RaR) and 95% confidence interval. For number of fallers and number of participants sustaining fall-related fractures, we have reported a risk ratio (RR) and 95% confidence interval. We used results reported at one year if these were available for trials that monitored falls for longer than one year.

#### 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% confidence interval if these were reported in the paper. If both adjusted and unadjusted rate ratios were reported, we have 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 [18] to calculate a rate ratio and 95% confidence interval. 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.

#### 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).

We used a reported estimate of risk (hazard ratio for first fall, risk ratio (relative risk), or odds ratio) and 95% confidence interval 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 an effect estimate and 95% confidence interval was not, and appropriate data were available, we calculated a risk ratio and 95% confidence interval using the csi command in [19. 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 and the number with an adverse event, we used a risk ratio as described in ‘Risk of falling’ above.

### Unit of analysis issues

For trials which were cluster-randomised, for example by medical practice, we performed adjustments for clustering [20] if this was not done in the published report. We used an intra-class correlation coefficient (ICC) of 0.01 reported in [21. We ignored the possibility of a clustering effect in trials randomising by household.

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

### Assessment of heterogeneity

We assessed heterogeneity within a pooled group of trials using a combination of visual inspection of the graphs along with consideration of the Chi² test (with statistical significance set at P < 0.10), and the I² statistic [22].

### Data synthesis

We grouped interventions using the fall prevention classification system (taxonomy) developed by the Prevention of Falls Network Europe (ProFaNE) [23]. Interventions have been grouped by combination (single, multiple, or multifactorial) and then by the type of intervention (descriptors). 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. Full details are available in the ProFaNE Taxonomy Manual.

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 [24]. 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 had calculated from data presented in the paper (see Measures of treatment effect). The generic inverse variance option in Review Manager requires entering the natural logarithm of the rate ratio or risk ratio and its standard error for each trial; we calculated these in [18.

We calculated pooled rate ratios for falls and pooled risk ratios for fallers, fractures, and adverse events with 95% confidence intervals using the fixed-effect model. Where there was substantial statistical or clinical heterogeneity we pooled the data using the random-effects model.

### Subgroup analysis and investigation of heterogeneity

We minimised heterogeneity as much as possible by grouping trials as described previously. We explored heterogeneity by carrying out the following subgroup analyses.

- Higher versus lower falls risk at enrolment (i.e. comparing trials with participants selected for inclusion based on history of falling or other specific risk factors for falling, versus unselected) (a priori).

- For vitamin D interventions, trials that recruited participants with lower baseline vitamin D levels versus those that did not (a priori).

- For the multifactorial interventions, trials that actively provided treatment to address identified risk factors versus those where the intervention consisted mainly of referral to other services or the provision of information to increase knowledge (a priori).

- For home safety interventions we carried out a subgroup analysis based on delivery personnel (i.e. comparing trials with interventions carried out by occupational therapists versus those that were not) (post hoc).

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 [25]. We used the test for subgroup differences available in [24] to determine whether there was evidence for a difference in treatment effect between subgroups.

#### Economics issues

We have noted the results from any comprehensive economic evaluations incorporated in the included studies, and report the incremental cost per fall prevented and per quality of life year (QALY) gained by the intervention compared with the comparator, as stated by the authors. We also extracted from each trial reporting a cost analysis or cost description, the type of resource use (e.g. delivering the intervention, hospital admissions, outpatient visits) and the cost of the item for each group.

### Sensitivity analysis

We carried out post hoc sensitivity analyses to explore the possible impact of risk of bias on statistically significant pooled estimates of treatment effect. We removed trials from pooled analyses if they were assessed as high risk of bias in one or more key domains: random sequence generation (selection bias), allocation concealment (selection bias), blinding of outcome assessors (detection bias), and incomplete outcome data (attrition bias) (see [16: Table 8.7.a).

# Results

Full details of the analyses conducted for this review are available in Supplementary material 6 and Supplementary material 7.

## Description of studies

### Results of the search

The search strategies identified a total of 9690 references (see Supplementary material 1). Removal of duplicates and spurious records resulted in 4967 references. We obtained copies of 830 papers for consideration.

### Included studies

Fifty-one additional trials have been included in this update (see Supplementary material 10). This review now contains 159 trials with 79,193 participants. Details are provided in the Supplementary material 2, and are briefly summarised below. Due to the size of the review, not all links to references have been inserted in the text but can be viewed in Supplementary material 10.

#### Design

The majority of included studies were individually randomised. Fourteen were cluster-randomised by place of residence (Assantachai 2002 [26, 27]; Huang 2010 [28]; Lord 2003 [29]; Vetter 1992 [30]; Wolf 2003 [31, 32, 33, 34, 35]), physician practice (Coleman 1999 [36]; Pit 2007 [37]; Rubenstein 2007 [38, 39, 40]; Spice 2009 [41, 42, 43, 44, 45, 46]; Tinetti 1994 [47, 48, 49, 50, 51, 52, 53]), health centre (Dangour 2011 [54, 55, 56, 57]; Weber 2008 [58]), or senior centre (Reinsch 1992 [59, 60, 61, 62]; Steinberg 2000 [63, 64, 65, 66]).

Nine studies individually randomised participants but also allocated people residing in the same house to the same intervention arm (Brown 2002 [67, 68, 69]; Carpenter 1990 [70]; Cerny 1998 [71, 72]; Dapp 2011 [73, 74, 75, 76]; Fox 2010 [77]; Harari 2008 [78, 79, 80, 81, 82, 83]; Hornbrook 1994 [84, 85, 86]; Stevens 2001 [87, 88]; Van Rossum 1993 [89]). The study by Faes 2011 [90, 91, 92, 93] cluster-randomised pairs of participants and their caregivers.

One trial used a cross-over design (Parry 2009 [94]).

#### Sample sizes

Included trials ranged in sample size from 10 (Lannin 2007 [95]) to 9940 (Smith 2007 [96, 97, 98, 99, 100, 101, 102, 103, 104]). The median sample size was 230 participants.

#### Setting

The included trials were carried out in 21 countries. Two international multifactorial trials did not specify all the countries that were included: Ryan 2010 [105, 106, 107, 108, 109, 110, 111, 112, 113, 114] (five countries including United Kingdom, and four other countries in Europe and North America), and Ralston 2011 [115] (24 countries including United Kingdom, Belgium, France, USA).

#### Participants

Overall, 70% of included participants were women. All participants were women in 37 trials (see Supplementary material 10), and men in two trials (Gill 2008 [116, 117]; Rubenstein 2000 [118]).

The inclusion/exclusion criteria and other participant details are listed for each study in the Supplementary material 2.

Eighty-three included studies specified a history of falling or evidence of one or more risk factors for falling (other than age or frailty) in their inclusion criteria (see Supplementary material 10). Lower serum vitamin D (i.e. vitamin D insufficiency or deficiency) was an inclusion criterion in four trials of vitamin D supplementation (Dhesi 2004 [119, 120, 121]; Pfeifer 2000 [122, 123, 124]; Pfeifer 2009 [125, 126, 127, 128, 129, 130]; Prince 2008 [131, 132]) (see Supplementary material 11 for baseline vitamin D levels).

Seven trials recruited older people who had recently sustained a hip fracture (Bischoff-Ferrari 2010 [133, 134]; Di Monaco 2008 [135]; Harwood 2004 [136, 137]; Huang 2005 [138]; Sherrington 2004 [139, 140, 141, 142, 143]; Shyu 2010 [144, 145, 146]) or fall-related fracture (Grant 2005 [147, 148, 149, 150, 151, 152]). Fourteen other trials recruited on the basis of a specific condition: severe visual impairment (Campbell 2005 [153, 154, 155, 156]), operable cataract (Foss 2006 [157, 158, 159]; Harwood 2005 [160, 161, 162, 163, 164]), carotid sinus hypersensitivity (Kenny 2001 [165, 166, 167, 168]; Parry 2009; Ryan 2010), osteoporosis or osteopenia (Grahn Kronhed 2009 [169]; Liu-Ambrose 2004 [170, 171, 172, 173]; Madureira 2010 [174, 175, 176]; Ralston 2011; Smulders 2010 [177, 178, 179]; Swanenburg 2007 [180]), Alzheimer's disease (Sato 2005a (Retracted) [181, 182]), and chronic foot pain (Spink 2011 [183, 184, 185, 186]).

Eighty-nine trials excluded participants with cognitive impairment, either defined as an exclusion criterion or implied by the stated requirement to be able to give informed consent and/or to follow instructions (see Supplementary material 10).

#### Interventions

Interventions have been grouped by combination (single, multiple, or multifactorial) and then by the type of intervention (descriptors) as described in Data synthesis.

Twenty-three trials tested more than one intervention, therefore some trials may appear in more than one category of intervention (and more than one comparison in the analyses).

##### Single interventions

A single intervention consists of only one major category of intervention which is delivered to all participants in the intervention group; these have been grouped by type of intervention.

##### Exercises

Fifty-nine trials (13,264 randomised participants) tested the effect of exercise on falls (see Supplementary material 10); only a small proportion of these (six trials) reported the number of people sustaining a fracture.

In most trials the exercise intervention was delivered in a group setting, but in 12 trials it was delivered at home (see Supplementary material 10).

The trials were grouped by exercise modality into six categories using the ProFaNE taxonomy (see Supplementary material 12). Most trials with exercise alone as an intervention included more than one category of exercise. In some trials the interventions were within one category only:

- gait, balance, and functional training (Cornillon 2002 [187]; Liu-Ambrose 2004; McMurdo 1997 [188]; Wolf 1996 [189, 190, 191, 192, 193, 194]);

- strength/resistance training (Davis 2011a [195, 196, 197, 198, 199, 200]; Fiatarone 1997 [201]; Latham 2003 [202]; Liu-Ambrose 2004; Woo 2007 [203, 204]);

- 3D training (constant repetitive movement through all three spatial planes): Tai Chi (Huang 2010; Li 2005 [205, 206]; Logghe 2009 [207, 208, 209]; Voukelatos 2007 [210, 211, 212, 213, 214, 215]; Wolf 1996; Wolf 2003; Woo 2007) and square stepping (Shigematsu 2008 [216, 217]);

- general physical activity (walking groups Pereira 1998 [218, 219, 220]; Resnick 2002 [221]; Shigematsu 2008);

- no trials reported results for flexibility training or endurance training alone.

Eight trials compared different exercise programmes (Davis 2011a; Helbostad 2004 [222, 223, 224]; Kemmler 2010 [225, 226, 227, 228]; Nitz 2004 [229, 230]; Shigematsu 2008; Steadman 2003 [231, 232]; Yamada 2010 [233]) or methods of delivery (Wu 2010 [234]).

##### Medication (drug target)

Sixteen trials (29,002 randomised participants) evaluated the efficacy of supplementation with vitamin D or an analogue, either alone or with calcium co-supplementation (see Supplementary material 10). Three trials tested more than one dose of vitamin D or different methods of delivery (Bischoff-Ferrari 2010; Grant 2005; Harwood 2004).

Six other trials tested the effect of administering medication to prevent falls. The women randomised to receive hormone replacement therapy (HRT) in Gallagher 2001 [235, 236, 237, 238, 239, 240, 241, 242] were non-osteoporotic, and in Greenspan 2005 [243, 244] they were calcium and vitamin D replete. Another intervention group in Gallagher 2001 received HRT plus calcitriol (a vitamin D analogue). Ralston 2011 studied the effect of alendronate plus vitamin D3 in women who were osteoporotic, vitamin D deficient, and at increased risk of falls. Falls were a secondary outcome in Reid 2006 [245, 246, 247, 248] where the intervention was calcium citrate. The effect of menatetranone (vitamin K2), vitamin D2, and calcium was reported as being tested in people with probable Alzheimer's disease in Sato 2005a (Retracted), and Vellas 1991 [249] administered a vaso-active medication (raubasine-dihydroergocristine) to older people with a history of a recent fall.

Five other trials investigated the effect of medication withdrawal. Campbell 1999 [250, 251, 252, 253], in a 2 x 2 factorial design, reported the results of an exercise programme and a placebo-controlled psychotropic medication withdrawal programme. Two studies tested pharmacist-led medication improvement programmes to reduce side effects including falls (Blalock 2010 [254, 255, 256, 257]; Meredith 2002 [258]). Medication review was carried out by a pharmacist or geriatrician in Weber 2008. In Pit 2007, the intervention involved physicians (an educational intervention to improve prescribing practices) and their patients (self completed risk assessment tool relating to medication), and subsequent medication review.

##### Surgery

Three trials reported the effectiveness of cardiac pacing in fallers with cardioinhibitory carotid sinus hypersensitivity (Kenny 2001; Parry 2009; Ryan 2010). Two other trials investigated the effect of expedited cataract surgery for the first eye (Harwood 2005) and second affected eye (Foss 2006).

##### Fluid or nutrition therapy

Three trials tested the effect of nutritional therapy (Dangour 2011; Gray-Donald 1995 [259]; McMurdo 2009 [260]).

##### Psychological interventions

In two trials (Huang 2011 [261, 262]; Reinsch 1992), one intervention group received a cognitive behavioural therapy intervention.

##### Environment/assistive technology

This category includes the following environmental interventions (or assessment and recommendations for intervention): adaptations to homes and the provision of aids for personal care and protection and personal mobility (e.g. walking aids), and aids for communication, information, and signalling (e.g. eyeglasses, hearing aids, personal alarm systems).

Thirteen trials evaluated the efficacy of environmental interventions alone:

- home safety (Campbell 2005 (severely visually impaired); Cumming 1999 [263, 264, 265]; Day 2002 [266, 267]; Lannin 2007; Lin 2007 [268]; Nikolaus 2003 [269, 270]; Pardessus 2002 [271]; Pighills 2011 [272, 273, 274]; Stevens 2001);

- interventions to improve vision (Cumming 2007 [275]; Day 2002; Haran 2010 [276, 277, 278]);

- footwear modifications in the form of the Yaktrax® walker, a device worn over usual footwear to increase grip in winter outdoor conditions (McKiernan 2005 [279]), and balance-enhancing insoles (Perry 2008 [280]).

##### Knowledge/education interventions

Five trials evaluated educational interventions designed to increase knowledge relating to fall prevention (Dapp 2011; Harari 2008; Huang 2010; Robson 2003 [281]; Ryan 1996 [282]).

##### Multiple interventions

Multiple interventions consist of a fixed combination of two or more major categories of intervention delivered to all participants in the intervention group.

This category includes 18 trials (see Supplementary material 10), with numerous combinations of interventions. All but two (Assantachai 2002; Carter 1997 [283]) contained an exercise intervention.

##### Multifactorial interventions

Multifactorial interventions consist of more than one main category of intervention, but participants receive different combinations of interventions based on an individual assessment to identify potential risk factors for falling.

This category includes 40 trials (see Supplementary material 10), some with more than one intervention arm. These were complex interventions which differed in the details of the assessment, treatment protocols, and referral processes.

The initial assessment was usually carried out by one or more health professionals; an intervention was then provided or recommendations given or referrals made for further action. In Carpenter 1990 and Jitapunkul 1998 [284] the assessment and health surveillance was carried out by non-professional personnel who referred participants to a health professional if a change in health status warranted it.

In 16 trials participants received an assessment and an active intervention rather than a referral (Close 1999 [285, 286, 287, 288, 289, 290, 291]; Conroy 2010 [292, 293, 294, 295, 296]; Coleman 1999; Davison 2005 [297, 298, 299, 300, 301, 302, 303]; De Vries 2010 [304, 305, 306, 307]; Hornbrook 1994; Huang 2005; Logan 2010 [308, 309, 310]; Lord 2005 [311] (extensive intervention group); Markle-Reid 2010 [312, 313, 314]; Salminen 2009 [315, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 327, 328]; Shyu 2010; Spice 2009 (secondary care intervention group); Tinetti 1994; Vind 2009 [329, 330, 331, 332, 333]; Wyman 2005 [334, 335, 336, 337, 338, 339, 340, 341, 342, 343]). The remaining trials plus Lord 2005 (minimal intervention group) and Spice 2009 (primary care intervention group) contained an intervention that consisted predominantly of assessment, and referral or the provision of information.

#### Outcomes

The source of data used for calculating outcomes for each trial for generic inverse variance analysis is shown in Supplementary material 13. Rate of falls were reported in 54 trials, and could be calculated from a further 41 trials. Data on risk of falling (number of fallers) were available in 48 trials and could be calculated for a further 79. Raw data for rate of falls and number of fallers when available are shown in Supplementary material 14. Some trials met our inclusion criteria but did not include any data that could be included in these analyses. Reported results from these trials are presented in the text. Forty-eight trials reported a fracture outcome. Where possible, we only included fall-related fractures (hip, wrist, humerus, etc), and not vertebral fractures, in the analyses (38 trials).

### Excluded studies

Sixty-five studies initially appeared to meet the inclusion criteria but were excluded (see Supplementary material 15 for links to references, and the Supplementary material 3 for details). Nine studies reporting falls outcomes were excluded because they were not RCTs. Of the identified trials, nine reported falls outcomes but did not meet the review's inclusion criterion for age (i.e. participants were too young and results were not presented by age group). Seven trials with falls outcomes were excluded because the majority of participants were not community-dwelling. Three trials that recruited people post stroke (Ashburn 2007 [344, 345, 346, 347]) or with Parkinson's disease (Green 2002 [348, 349]; Sato 2006 [350]) are listed because they were included in the previous version of this review. Eight studies were excluded because they did not report falls outcomes. A further 18 studies were excluded because the intervention was not aimed at preventing falls and they reported falls as adverse events. Eleven other RCTs were excluded for a variety of reasons.

#### Ongoing studies

We identified 28 trials that are either ongoing, or completed but unpublished, in which falls appear to be an outcome (see Supplementary material 5 for details).

#### Studies awaiting classification

Eight studies are awaiting classification (see Supplementary material 4). We identified three abstracts for Bighea 2011 [351, 352, 353] which appear to report interim analyses. The remaining trials (Adunsky 2011 [354]; Clemson 2012 [355, 356]; Freiberger 2012 [357, 358, 359, 360, 361]; Glendenning 2012 [362, 363]; Neelemaat 2012 [364, 365, 366]; Pérula 2012 [367]; Taylor 2012 [368]) were identified via weekly bulletins from SafetyLit after 1 March 2012 (our cut-off date for inclusion) or personal communication. Sach 2012 [369] reports the economic evaluation alongside an included trial (Logan 2010) but was identified too late to add to the review.

## Risk of bias in included studies

Details of 'Risk of bias' assessment for each trial are shown in the Supplementary material 2. Summary results are shown in Figure 1. The assessment of risk of bias relied heavily on the reporting of trials and was unclear in many cases. 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

We assessed risk of bias in sequence generation as low in 62% (99/159), high in 2% (3/159), and unclear in the remaining 36% (57/159) of included trials. We judged methods for concealment of allocation prior to group assignment to carry low risk of bias in 38% (60/159), high in 6% (9/159), and to be unclear in the remaining 57% of trials (90/159) (see Figure 2).

### Blinding

As only a small proportion of included studies were placebo-controlled, allocation status would have been known to participants and personnel delivering interventions in most included studies, and falls were self reported. We judged the impact of this on risk of performance bias to be low in 18% (29/159) of trials (mostly placebo-controlled) and high in 13% (21/159). In the remaining 69% of trials (109/159), it was unclear whether awareness of group allocation would be likely to introduce performance bias (see Figure 2).

The likelihood of detection bias in relation to the ascertainment of self reported falls by outcome assessors was low in 47% of trials (75/159), high in 16% (26/159), and unclear in the remaining 36% (58/159). In trials with fracture outcomes, the risk of detection bias was low in 38% of trials (18/48), high in 25% (12/48), and unclear in the remaining 38% (18/48) (see Figure 2).

### Incomplete outcome data

In trials reporting outcomes based on number of falls, we judged risk of attrition bias to be low in 60% (66/110) of trials, high in 13% (14/110), and unclear in the remaining 27% (30/110). For outcomes based on number of people falling we assessed the risk to be low in 73% of trials (96/131), high in 16% (21/131), and unclear in the remaining 11% (14/131) (see Figure 2).

### Other potential sources of bias

#### Bias in recall of falls

Fifty-five per cent of included studies (87/159) were assessed as being at low risk of bias in the recall of falls, i.e. falls were recorded concurrently using methods such as postcards or diaries. In 29% of trials (46/159) there was potential for a high risk of bias in that ascertainment of falling episodes was by participant recall, at intervals during the study or at its conclusion. In 16% of trials (26/159) the risk of bias was unclear as retrospective recall was for a short period only, or details of ascertainment were not described (see Figure 2).

## Effects of interventions

### Single interventions

Single interventions consist of one major category of intervention only and are delivered to all participants in the group; we have grouped these by type of intervention and pooled data within types.

#### Exercises

We grouped the trials by exercise modality into six categories using the ProFaNE taxonomy (see Supplementary material 12).

##### Exercise versus control

We used the random-effects model to pool data in the following analyses due to substantial statistical and clinical heterogeneity in some of the interventions being combined.

##### Group exercise: multiple categories of exercise versus control

Overall, exercise classes containing multiple components (i.e. a combination of two or more categories of exercise) achieved a statistically significant reduction in rate of falls (pooled rate ratio (RaR) 0.71, 95% confidence interval (CI) 0.63 to 0.82; 3622 participants, 16 trials, Analysis 1.1.1) and risk of falling (pooled risk ratio (RR) 0.85, 95% CI 0.76 to 0.96; 5333 participants, 22 trials, Analysis 1.2.1). Grahn Kronhed 2009contained no poolable data but reported that the "Mean number of falls for the 1-year study period was 0.6 in the E-group [exercise group] and 0.8 in the C-group [control group]".

We carried out an a priori subgroup analysis of these group exercise trials with multiple components based on falls risk at enrolment, and found there was no difference in pooled estimates between trials with participants at higher risk of falling (history of falling or one or more risk factors for falls at enrolment) versus lower risk (not selected on falls risk at enrolment). The intervention was effective in both subgroups for rate of falls (P = 0.86, I² = 0%, Analysis 2.1). For risk of falling, there was also no evidence of a difference in treatment effect between the subgroups (P = 0.81, I² = 0%, Analysis 2.2).

##### Individual exercise at home: multiple categories of exercise versus control

Home-based exercises containing multiple components also achieved a statistically significant reduction in rate of falls (RaR 0.68, 95% CI 0.58 to 0.80; 951 participants, 7 trials, Analysis 1.1.2) and risk of falling (RR 0.78, 95% CI 0.64 to 0.94; 714 participants, 6 trials, Analysis 1.2.2). Clemson 2010 [370], in a small pilot study testing balance and strength training embedded in daily life activities, achieved a statistically significant reduction in rate of falls (RaR 0.21, 95% CI 0.06 to 0.71; 34 participants, Analysis 1.1.3) but not risk of falling (RR 0.73, 95% CI 0.39 to 1.37; 31 participants, Analysis 1.2.3)

##### Group exercise: Tai Chi versus control

Overall, in trials testing Tai Chi there was a reduction in rate of falls (RaR 0.72, 95% CI 0.52 to 1.00; 1563 participants, 5 trials, Analysis 1.1.4) but substantial statistical heterogeneity (P = 0.006; I² = 72%). Tai Chi significantly reduced the risk of falling (RR 0.71, 95% CI 0.57 to 0.87; 1625 participants, 6 trials, Analysis 1.2.4).

To explore the heterogeneity in these results, we carried out a subgroup analysis of Tai Chi trials based on falls risk at enrolment. For rate of falls, the treatment effect was greater in the subgroup not selected for higher risk of falling (P = 0.06, I² = 70.9%, Analysis 3.1). In the subgroup analysis for risk of falling this difference was statistically significant (P = 0.02, I² = 83%, Analysis 3.2). Tai Chi appears to be more effective in people who are not at high risk of falling.

##### Group and individual exercise: balance training versus control

In this group of trials, and the following groupings, the intervention was within one only of the categories of exercise using the ProFaNE classification.

Classes that included just gait, balance or functional training achieved a statistically significant reduction in rate of falls (RaR 0.72, 95% CI 0.55 to 0.94, 519 participants, 4 trials, Analysis 1.1.5) but not in risk of falling (RR 0.81, 0.62 to 1.07, 453 participants, 3 trials, Analysis 1.2.5).

Madureira 2010 contained no poolable data but reported no significant difference in mean number of falls. Individual computerised balance training on a force platform (Wolf 1996) also failed to achieve a significant reduction in rate of falls (128 participants, Analysis 1.1.6).

##### Group and individual exercise: strength/resistance training versus control

Strength/resistance training delivered in a group setting failed to achieve a significant reduction in rate of falls (64 participants, 1 trial, Analysis 1.1.7) or number of people falling (120 participants, 1 trial, Analysis 1.2.6). Fiatarone 1997 provided insufficient data to be included in this analysis but the authors reported that "no difference between groups was observed in the frequency of falls". Home-based resistance training in Latham 2003 also failed to achieve a statistically significant reduction in rate of falls (222 participants, Analysis 1.1.8) and risk of falling (Analysis 1.2.7).

Two of the trials testing resistance training reported adverse events resulting from the intervention. Latham 2003 reported significantly more adverse events in the resistance training group: "Eighteen people had musculoskeletal injuries in the exercise group, compared with five in the control group; RR 3.6, 95% CI 1.5–8.0", and in Liu-Ambrose 2004 "Musculoskeletal complaints (e.g., sore neck, bursitis of the hip) developed in 10 women in the resistance-training group, three in the agility-training group, and two in the stretching group."

##### Individual exercise: general physical activity (walking) versus control

Two trials investigated the effect of walking groups (Pereira 1998; Resnick 2002). There was no reduction in risk of falling in Pereira 1998 (Analysis 1.2.8). Resnick 2002 contained insufficient data to include in an analysis but reported no significant difference in number of falls.

##### Number of people sustaining a fracture

Overall, exercise interventions resulted in a statistically significant reduction in risk of fracture (RR 0.34, 95% CI 0.18 to 0.63; 810 participants, 6 trials, Analysis 1.3).

##### Exercise versus exercise

Seven trials compared different types of exercise, or methods of delivery. Kemmler 2010 (227 participants) compared higher intensity multiple component exercise with lower intensity exercise performed in groups and achieved a statistically significant reduction in rate of falls (RaR 0.60, 95% CI 0.47 to 0.76; Analysis 4.1.1) and risk of falling (RR 0.54, 95% CI 0.35 to 0.83; Analysis 4.2.1). In the remaining trials there was no significant reduction in rate of falls (Analysis 4.1) or risk of falling (Analysis 4.2). Three methods of delivery for a Tai Chi programme were compared in Wu 2010. Insufficient data for analysis were reported but "there was no significant group effect in the mean reduction of both falls and injurious falls".

#### Medication (drug target)

##### Medication provision: vitamin D (with or without calcium) versus control/placebo/calcium

Fourteen trials (28,135 randomised participants) evaluated the efficacy for fall prevention of supplementation with vitamin D, either alone or with calcium co-supplementation (Bischoff-Ferrari 2006 [371, 372, 373, 374]; Bischoff-Ferrari 2010; Dhesi 2004; Grant 2005; Harwood 2004; Kärkkäinen 2010 [375, 376, 377, 378]; Latham 2003; Pfeifer 2000; Pfeifer 2009; Porthouse 2005 [379, 380, 381, 382, 383]; Prince 2008; Sanders 2010 [384, 385, 386, 387, 388, 389, 390]; Smith 2007; Trivedi 2003 [391]) (see Supplementary material 11 for reported baseline vitamin D levels).

We used random-effects models to pool data in the overall analyses of vitamin D versus control. These did not show a statistically significant difference in rate of falls (RaR 1.00, 95% CI 0.90 to 1.11; 9324 participants, 7 trials, Analysis 5.1), risk of falling (RR 0.96, 95% CI 0.89 to 1.03; 26,747 participants, 13 trials, Analysis 5.2), or risk of fracture (RR 0.94, 95% CI 0.82 to 1.09; 27,070 participants, 10 trials, Analysis 5.3).

A pre-planned subgroup analysis showed no significant difference in either rate of falls (Analysis 6.1) or risk of falls (Analysis 6.2) between trials recruiting participants with higher falls risk and trials not so doing.

We carried out a subgroup analysis to explore the effect of only enrolling participants with lower vitamin D levels versus enrolling participants not so selected. The test for subgroup differences showed a significant difference between these two subgroups for rate of falls (P = 0.01, Analysis 7.1) and risk of falling (P = 0.003, Analysis 7.2). There was a greater reduction in rate of falls and risk of falling in the subgroups of trials only recruiting participants with lower vitamin D levels at enrolment: RaR 0.57, 95% CI 0.37 to 0.89 (260 participants, 2 trials) and RR 0.70, 95% CI 0.56 to 0.87 (804 participants, 4 trials). For the trials in which participants were not selected on the basis of their vitamin D levels the results were: RaR 1.02, 95% CI 0.93 to 1.13 (9064 participants, 5 trials) and RR 1.00, 95% CI 0.93 to 1.07 (25,943 participants, 9 trials).

Not all trials recorded adverse effects resulting from the intervention, and there were insufficient data to create forest plots for those that did. Reported adverse effects for trials administering vitamin D are described in Supplementary material 16; none was considered to be serious.

Medication provision: vitamin D 2000 IU/day versus 800 IU/day

Bischoff-Ferrari 2010 compared vitamin D3 2000 IU per day with 800 IU per day in a placebo-controlled trial and although the results were not significant, the point estimate for rate of falls favoured the group receiving the lower dose (RaR 1.30, 95% CI 0.99 to 1.71; 173 participants, Analysis 8.1). The reverse was the case for the risk of sustaining a fracture (RR 0.51, 95% CI 0.13 to 1.98; Analysis 8.2).

##### Medication provision: vitamin D analogue versus placebo

Gallagher 2001 tested the effect of calcitriol (1:25 dihydroxy-vitamin D) alone and reported a statistically significant reduction in rate of falls (RaR 0.64, 95% CI 0.49 to 0.82; 213 participants, Analysis 9.1.1), and risk of falling (RR 0.54, 95% CI 0.31 to 0.93; 213 participants, Analysis 9.2.1), but not risk of fracture (Analysis 9.3.1). In Dukas 2004 [392, 393, 394, 395, 396, 397, 398, 399, 400], alfacalcidol (1-alpha hydroxycholecalciferol) supplementation did not result in a significant reduction in risk of falling (378 participants, Analysis 9.2.2).

Reported vitamin D levels for trials administering vitamin D analogues are described in Supplementary material 11, and reported adverse effects in Supplementary material 16. There was a statistically significant increase in risk of hypercalcaemia in participants receiving vitamin D analogues (RR 2.49, 95% CI 1.12 to 5.50; 624 participants, 2 trials, Analysis 9.4).

##### Medication provision: other medications versus control

There is no evidence to support the use of hormone replacement therapy (HRT) alone for reducing rate of falls (212 participants, 1 trial, Analysis 10.1.1) or risk of falling (585 participants, 2 trials, Analysis 10.2.1). In Gallagher 2001 HRT plus calcitriol significantly reduced the rate of falls (RaR 0.75, 95% CI 0.58 to 0.97; 214 participants, Analysis 10.1.2) as had administration of calcitriol alone in this trial. Risk of falling was not significantly reduced (RR 0.90, 95% CI 0.72 to 1.11, 214 participants, Analysis 10.2.2). Alendronate plus vitamin D3 did not significantly reduce risk of falling in Ralston 2011 (515 participants, Analysis 10.2.3). Reid 2006 tested the effect of calcium supplementation and reported no significant difference in rate of falls: "The incidence of falls was 595 per 1000 woman-years (95% CI, 566-626) for calcium, and 585 per 1000 woman-years (95% CI, 556-615) for placebo (P = .81)." Sato 2005a (Retracted) reported no significant differences between groups for percentage of fallers. Vellas 1991 (95 participants) reported that participants with a history of a recent fall who received six months of therapy with the vaso-active medication raubasine-dihydroergocristine "showed fewer new falls than the group receiving placebo", however, insufficient data were reported to determine whether this was a significant reduction.

Two trials reported fracture outcomes. Reid 2006 failed to achieve a significant reduction in risk of fracture (RR 0.90, 95% CI 0.69 to 1.16, 1255 participants; see Analysis 10.3). Sato 2005a (Retracted) reported data appearing to show a significant reduction in risk of fracture in people with "probable Alzheimer's disease" with a combination of vitamin K2, vitamin D2 and calcium; these data were removed from the review in 2020 as they were acknowledged by Sato to be fabricated.

##### Medication withdrawal versus control

Gradual withdrawal of psychotropic medication in a placebo-controlled trial (Campbell 1999) significantly reduced rate of falls (RaR 0.34, 95% CI 0.16 to 0.73; 93 participants, Analysis 11.1.1) but not risk of falling (RR 0.61, 95% CI 0.32 to 1.17; 93 participants, Analysis 11.2.1).

Medication review and modification was not effective in reducing rate of falls (186 participants, 1 trial, Analysis 11.1.2) or risk of falling (445 participants, 2 trials, Analysis 11.2.2). Weber 2008 provided insufficient data to be included in these analyses; the authors stated that "when data on self-reported falls [were] included, a nonsignificant reduction in fall risk was seen." In these three trials medication review was carried out by a pharmacist (or nurse or geriatrician) and recommendations regarding modification sent to the participant's family physician for implementation.

Pit 2007 included a major educational component for family physicians that included face-to-face education by a clinical pharmacist, feedback on prescribing practices, and financial rewards. This, combined with self assessment of medication use by their patients and subsequent medication review and modification, resulted in a significantly reduced risk of falling (RR 0.61, 95% CI 0.41 to 0.91; 659 participants, Analysis 11.2.3).

#### Surgery

##### Cardiac pacemaker insertion

Cardiac pacing in fallers with cardioinhibitory carotid sinus hypersensitivity was associated with a statistically significant reduction in rate of falls (RaR 0.73, 95% CI 0.57 to 0.93; 349 participants, 3 trials, Analysis 12.1.1) but not in the risk of falling (RR 1.20, 95% CI 0.92 to 1.55; 178 participants, 2 trials, Analysis 12.2.1) or risk of fracture (RR 0.78, 95% CI 0.18 to 3.39; 171 participants, 1 trial, Analysis 12.3.1).

##### Cataract surgery

In Harwood 2005, there was a significant reduction in rate of falls in people receiving expedited cataract surgery for the first eye (RaR 0.66, 0.45 to 0.95; 306 participants, Analysis 12.1.2), but not in risk of falling (RR 0.95, 95% CI 0.68 to 1.33, Analysis 12.2.2), or risk of fracture (RR 0.33, 95% CI 0.10 to 1.05, Analysis 12.3.2). In participants receiving cataract surgery for a second eye (Foss 2006), there was no evidence of effect on rate of falls (239 participants, Analysis 12.1.3), risk of falling (Analysis 12.2.3), or risk of fracture (Analysis 12.3.3).

#### Fluid or nutrition therapy

Risk of falling was not significantly reduced in older people receiving oral nutritional supplementation (RR 0.95, 95% CI 0.83 to 1.08; 1902 participants, 3 trials, Analysis 13.1).

#### Psychological interventions

The cognitive behavioural interventions showed no difference between the intervention and control groups for rate of falls (RaR 1.00, 95% CI 0.37 to 2.72; 120 participants, 1 trial, Analysis 14.1) or risk of falling (RR 1.11, 95% CI 0.80 to 1.54; 350 participants, 2 trials, Analysis 14.2).

#### Environment/assistive technology

##### Environment (home safety and aids for personal mobility)

Overall, home safety assessment and modification interventions were effective in reducing rate of falls (RaR 0.81, 95% CI 0.68 to 0.97; 4208 participants, 6 trials, Analysis 15.1) and risk of falling (RR 0.88, 95% CI 0.80 to 0.96; 4051 participants, 7 trials, Analysis 15.2). There was no significant reduction in risk of fracture (RR 1.32, 95% CI 0.30 to 5.87; 360 participants, 1 trial, Analysis 15.3).

##### Home safety intervention versus control: subgroup analysis by risk of falling at baseline

We carried out an a priori subgroup analysis by falls risk at enrolment to test whether the intervention effect was greater in participants at higher risk of falling (i.e. with a history of falling or one or more risk factors). Home safety interventions were more effective in reducing rate of falls in the higher risk subgroup (test for subgroup differences P = 0.0009, Analysis 16.1). There was no evidence of a difference in treatment effect between the subgroups for risk of falling (test for subgroup differences P = 0.57, Analysis 16.2). Each subgroup was homogeneous (I² = 0%).

##### Home safety intervention versus control: subgroup analysis by delivery personnel

We carried out a post hoc subgroup analysis based on whether the home safety assessment/intervention was carried out by an occupational therapist (OT), or by other personnel. We did this because Pighills 2011 randomised participants to two intervention groups to explore the effect of using differently trained personnel to deliver the intervention.

There was some evidence that OT led interventions were more effective than non-OT led interventions for rate of falls (test for subgroup differences P = 0.07, Analysis 17.1) and risk of falling (test for subgroup differences P = 0.05, Analysis 17.2).

Home safety interventions implemented by an occupational therapist resulted in a statistically significant difference in rate of falls (RaR 0.69, 95% CI 0.55 to 0.86; 1443 participants, 4 trials, Analysis 17.1.1) and risk of falling (RR 0.79, 95% CI 0.70 to 0.91; 1153 participants, 5 trials, Analysis 17.2.1).

In four trials the intervention was not occupational therapist-led: Day 2002 (trained nurses or community work volunteers); Lin 2007 (public health worker); Pighills 2011 (trained non-professionally qualified domiciliary support worker); Stevens 2001 (nurse). Pooled data from these trials showed no significant evidence of effect on rate of falls (RaR 0.91, 95% CI 0.75 to 1.11; 3075 participants, 4 trials, Analysis 17.1.2) or risk of falling (RR 0.94, 95% CI 0.85 to 1.05; 2975 participants, 3 trials, Analysis 17.2.2).

##### Environment (aids for communication, information, and signalling)

##### Vision improvement versus control

Three trials (Cumming 2007; Day 2002; Haran 2010) investigated the effect of interventions to improve vision. Results for each of these trials are shown in Analysis 18.1 and Analysis 18.2.

In Cumming 2007 (616 participants), the intervention involved vision assessment and eye examination and, if required, the provision of new spectacles, referral for expedited ophthalmology treatment, mobility training, and canes. This intervention resulted in a statistically significant increase in both rate of falls (RaR 1.57, 95% CI 1.19 to 2.06) and number of participants falling (RR 1.54, 95% CI 1.24 to 1.91).

Day 2002 (1090 participants) compared people who received a visual acuity assessment and referral with those who did not. There was no significant reduction in rate of falls (RaR 0.91, 95% CI 0.77 to 1.09) or risk of falling (RR 0.89, 95% CI 0.76 to 1.04).

Haran 2010 (597 participants) recruited regular wearers of multifocal glasses and provided the intervention group with single lens distance glasses to be used for most walking and standing activities (indoors and outdoors), while the controls continued to use their multifocal glasses. Overall, the intervention did not result in a significant reduction in rate of falls (RaR 0.92, 95% CI 0.73 to 1.17) or risk of falling (RR 0.97, 95% CI 0.85 to 1.11). Pre-planned subgroup analyses by the trial authors divided participants into those who regularly took part, or did not take part, in outside activities, defined using components of the Adelaide activities profile. In the more active subgroup the intervention was effective in significantly reducing all falls (inside plus outside) and outside falls, whereas there was a significant increase in outside falls in people in the intervention group who took part in little outside activity (interaction term in both models P < 0.001).

In both Cumming 2007, which also included prescription of new glasses, and Haran 2010, there was an increase in risk of fracture, although this was not statistically significant in either trial (Analysis 18.3).

##### Environment (body worn aids for personal care and protection)

##### Footwear modification versus control

McKiernan 2005 (109 participants) tested the effect of wearing a non-slip device (Yaktrax® walker) on outdoor shoes in hazardous winter conditions and achieved a statistically significant reduction in rate of outdoor falls (RaR 0.42, 95% CI 0.22 to 0.78, Analysis 19.1). In Perry 2008 (40 participants), the use of balance-enhancing insoles did not result in a significant reduction in risk of falling (RR 0.56, 95% CI 0.23 to 1.38, Analysis 19.2) when compared with 'normal' insoles.

#### Knowledge/education interventions

In interventions designed to reduce falls by increasing knowledge about fall prevention, there was no evidence of a reduction in rate of falls (45 participants, 1 trial, Analysis 20.1) or risk of falling (2555 participants, 4 trials, Analysis 20.2). There were insufficient data available for Harari 2008 to include in these analyses but the odds of having multiple falls was not reduced (odds ratio 1.15, 95% CI 0.87 to 1.54) (personal communication).

### Multiple interventions

Multiple interventions consist of the same combination of single categories of intervention delivered to all participants in the group. We have grouped these by combinations of interventions; each combination was analysed separately.

Nineteen pair-wise combinations of interventions (from 14 trials) provided data on rate of falls (Analysis 21.1) and 18 (from 13 trials) provided data on risk of falling (Analysis 21.2). Of these, 18 and 15 respectively contained an exercise component of varying intensity combined with one or more other interventions. The control group for each comparison is shown in Analysis 21.1 and Analysis 21.2.

In Day 2002 (1090 participants), a significant reduction in rate of falls was achieved when the effective exercise intervention in Analysis 1.1 was combined with the home safety intervention (RaR 0.77, 95% CI 0.61 to 0.98), with vision assessment (RaR 0.72, 95% CI 0.57 to 0.91), and with home safety plus vision assessment (RaR 0.71, 95% CI 0.53 to 0.96). Similarly the risk of falling was significantly reduced when the effective exercise intervention in Analysis 1.2 was combined with the home safety intervention (RR 0.76, 95% CI 0.60 to 0.97), with vision assessment (RR 0.73, 95% CI 0.59 to 0.91), and with vision assessment plus home safety (RR 0.67, 95% CI 0.51 to 0.88).

A combination of exercise, education, and a home safety intervention achieved a significant reduction in rate of falls in Clemson 2004 [401, 402, 403, 404] (RaR 0.69, 95% CI 0.50 to 0.96; 285 participants), but not risk of falling.

Swanenburg 2007 (20 participants) investigated the effect of exercise plus nutritional supplementation in vitamin D and calcium-replete women. Although a highly significant reduction in rate of falls was achieved (RaR 0.19, 95% CI 0.05 to 0.68) these results should be treated with caution due to the very small sample size (N = 20).

In Comans 2010 [405, 406, 407, 408] (76 participants), there were significantly fewer falls in the group receiving a centre-based rehabilitation programme that included exercise and education, when compared with a comparable home-based programme (RaR 0.46, 95% CI 0.22 to 0.97). This approach also reduced risk of falling (RR 0.57, 95% CI 0.35 to 0.93).

Von Stengel 2011 [409, 410, 411, 412, 413, 414] (97 participants) compared multifunctional training plus whole body vibration with light physical exercise and achieved a statistically significant reduction in rate of falls (RaR 0.46, 95% CI 0.27 to 0.79).

In Spink 2011 (305 participants), a significant reduction in rate of falls was achieved in people with disabling foot pain receiving "multifaceted podiatry" (customised orthoses, footwear review, foot and ankle exercises, fall prevention education, and "usual podiatry care") compared with "usual podiatry care" alone (RaR 0.64, 95% CI 0.45 to 0.91).

Assantachai 2002 (815 participants) achieved a statistically significant reduction in risk of falling with an educational intervention combined with free access to a geriatric clinic (RR 0.77, 95% CI 0.63 to 0.94).

None of the remaining comparisons in Analysis 21.1 or Analysis 21.2 achieved a significant reduction in rate of falls or risk of falling.

Wilder 2001 [415] found home safety plus exercise to be "significantly different from [home safety alone or no intervention] on ... number of falls recorded in the home over twelve months."

Two trials included fracture outcomes (Spink 2011; Von Stengel 2011); neither achieved a statistically significant reduction in risk of fracture (Analysis 21.3). We did not pool data due to the clinical heterogeneity of the interventions.

### Multifactorial interventions

Multifactorial interventions consist of more than one main category of intervention and participants receive different combinations of the interventions based on an individual assessment to identify potential risk factors for falling. We have analysed these trials as one group because there were several intervention components within each trial, and too many different combinations of components to allow grouping of trials with similar interventions.

#### Multifactorial intervention versus control

Multifactorial interventions significantly reduced the rate of falls (RaR (random-effects) 0.76, 95% CI 0.67 to 0.86; 9503 participants, 19 trials, Analysis 22.1), but there was substantial heterogeneity between individual studies (I² = 85%, P < 0.00001). Current evidence does not confirm a significant reduction in risk of falling (RR (random-effects) 0.93, 95% CI 0.86 to 1.02; 13,617 participants, 34 trials, Analysis 22.2). There was also substantial heterogeneity between individual studies in this analysis (I² = 69%, P < 0.00001). Pooled data from 11 trials (3808 participants) did not show a significant reduction in risk of fracture (RR 0.84, 95% CI 0.67 to 1.05, Analysis 22.3).

There were insufficient data to include Fabacher 1994 [416] or Van Rossum 1993 in these analyses. In Fabacher 1994 "Self-reported fall rates were not significantly different between groups", and in Van Rossum 1993 there were "no differences between the two groups with respect to these health aspects", which included falls.

#### Exploration of statistical heterogeneity

To explore possible reasons for heterogeneity we carried out two pre-planned subgroup analyses. The subgroup analysis by falls risk at enrolment showed no evidence of difference in treatment effect between subgroups for both rate of falls (P = 0.50, I² = 0%, Analysis 23.1) and risk of falling (P = 0.88, I² = 0%, Analysis 23.2).

The subgroup analysis by scope and intensity of intervention showed no evidence of difference in treatment effect between subgroups for rate of falls (P = 0.36, I² = 0%, Analysis 24.1). For risk of falling there was evidence to suggest that the intervention may be more effective in the subgroup that received an assessment and active intervention compared with the subgroup that received assessment followed by referral or provision of information (P = 0.05, I² = 74.3%, Analysis 24.2).

Statistical heterogeneity in the trials was not explained by these subgroup and sensitivity analyses, but may relate to the extent of risk assessment, the varying interventions included in these trials, and how the interventions were implemented.

#### Multifactorial interventions delivered in different settings

Two trials compared settings for carrying out multifactorial interventions. Suman 2011 [417] (349 participants) compared a multifactorial intervention in a family physician surgery with a hospital-based falls clinic intervention and found no significant difference in rate of falls (Analysis 25.1.1), risk of falling (Analysis 25.2.1), or risk of fracture (Analysis 25.3.1). Gill 2008 (234 participants) compared a Specialised Geriatric Service and the participant's family physician for the intervention and found no significant difference in the number of people falling (Analysis 25.2.2).

### Economic evaluations

A total of 24 studies included in this review reported a comprehensive economic evaluation (cost-effectiveness or cost-utility analysis), the cost of delivering the intervention, or other healthcare cost items as an outcome measure (see Supplementary material 17).

A cost-effectiveness analysis compares the costs and consequences of alternative treatments or approaches with the same clinically relevant outcome (e.g. falls). Cost-effectiveness, in terms of incremental cost per fall prevented, was established for the following:

- exercise programmes (Campbell 1997 [418, 419, 420, 421, 422, 423, 424]; Davis 2011a; Liu-Ambrose 2008 [425, 426, 427, 428]; Robertson 2001a [429, 430, 431, 432]; Voukelatos 2007);

- a home safety assessment and modification programme delivered to those with severe vision loss in Campbell 2005 and those recently in hospital (Cumming 1999);

- the double-blind gradual withdrawal of psychotropic medication (Campbell 1999);

- multifactorial programmes (Conroy 2010; De Vries 2010; Tinetti 1994); and

- first eye cataract surgery within one month after randomisation compared with the routine 12-month wait (Harwood 2005).

The time period for these analyses was the trial duration, but the perspectives taken and the cost items measured and methods for valuing the items varied, so that comparison of incremental cost-effectiveness ratios for the interventions was difficult even for evaluations carried out within similar health systems.

The results from three studies demonstrated the potential for cost savings from delivering the intervention to particular subgroups of older people at high risk of falling. One trial of the Otago Exercise Programme showed cost savings in those aged ≥ 80 years resulting from fewer hospital admissions (Robertson 2001a). Cost savings were also demonstrated for a home safety programme when delivered to the participants with a previous fall (Cumming 1999) and a multifactorial intervention for those with four or more of the eight targeted risk factors (Tinetti 1994).

In addition, cost-utility analyses were reported for the studies that tested first (Harwood 2005) and second (Foss 2006) eye expedited cataract surgery, resistance training programmes (Davis 2011a), and a multifactorial programme (De Vries 2010). A cost-utility analysis compares cost outcomes in terms of quality adjusted life years (QALYs) gained. For both first and second eye cataract surgery the incremental cost per QALY gained at one year was above a currently accepted UK threshold of willingness to pay per QALY gained of GBP 30,000. If, however, the time frame of the analyses was extended to the person's expected lifetime, the incremental cost per QALY gained was below this threshold at GBP 13,172 and GBP 17,299 respectively.

# Discussion

## Summary of main results

There is now strong evidence of effect in preventing falls for some interventions and no evidence of effect for others.

### Exercises

This review endorsed the previously established effectiveness of certain exercise programmes in preventing falls. Programmes containing multiple categories of exercise were effective in reducing both rate of falls and risk of falling when delivered as group classes or when individually prescribed at home. The types of exercise commonly included were balance retraining and muscle strengthening. Overall, group exercise classes were effective whether or not the trial had recruited only people at higher risk of falling.

Tai Chi classes reduced risk of falling (six trials) but were less effective in trials selecting participants at higher risk of falling (two versus four trials).

Other than for Tai Chi, there was no evidence that single category programmes were effective, for example balance retraining or muscle strengthening exercises alone.

Overall, exercise significantly reduced risk of sustaining a fracture, although only six trials contributed data to this outcome.

### Medication (drug target)

#### Vitamin D supplementation

Despite the addition of four new trials (5939 participants) bringing the total number randomised to 28,135, the evidence regarding vitamin D (with or without calcium) remained unchanged from the previous version of this review. Overall, vitamin D did not reduce either rate of falls or risk of falling, whether or not the trial had recruited only people at higher risk of falling. However, subgroup analysis showed that supplementation appeared effective in reducing rate of falls (see Analysis 7.1) and risk of falling (see Analysis 7.2) when administered to those selected on the basis of lower vitamin D levels at enrolment.

Vitamin D analogues (calcitriol and alfacalcidol) may be effective but the evidence base is limited and their use is associated with a significantly raised incidence of reported hypercalcaemia compared with placebo (Dukas 2004; Gallagher 2001).

#### Medication withdrawal interventions

Three trials involving medication review by a pharmacist (or nurse or geriatrician) but requiring implementation by participants' family physicians were not effective in reducing falls. However, the intensive educational programme for primary care physicians in Pit 2007, that included academic detailing and patient involvement, significantly reduced risk of falling in older people under their care. Gradual withdrawal of psychotropic medication reduced rate of falls, but not risk of falling (Campbell 1999).

### Surgery

Pacemakers reduced rate of falls in people with carotid sinus hypersensitivity but not risk of falling. First eye cataract surgery in women reduced rate of falls but second eye cataract surgery did not.

### Fluid or nutrition therapy

Nutritional supplementation has not been shown to reduce the risk of falling.

### Psychological interventions

For cognitive behavioural interventions there is no evidence of effect on rate of falls or risk of falling.

### Environment/assistive technology

Home safety interventions reduced rate of falls and risk of falling. Furthermore, subgroup analyses showed that home safety interventions were more effective in reducing rate of falls in participants who were at higher risk of falling (four versus four trials). These interventions appear to be more effective when delivered by an occupational therapist.

Providing single lens glasses reduced falls in those spending more time outdoors, but increased outdoor falls in frailer people (Haran 2010). An anti-slip shoe device for icy conditions significantly reduced outside falls in winter (McKiernan 2005).

### Knowledge/education interventions

The evidence relating to the provision of educational materials alone for preventing falls is inconclusive.

### Multiple interventions

Few multiple interventions were effective. Spink 2011 provided new evidence to support "multifaceted" podiatry, including foot and ankle exercises, as an effective intervention for preventing falls in older people with disabling foot pain. Exercise was included in all but one of the other multiple interventions that were effective.

### Multifactorial interventions

The addition of outcomes from nine new trials made no change to the findings for multifactorial interventions in the previous version of this review. Multifactorial interventions reduced the rate of falls but not the risk of falling. Neither the intensity of the intervention nor level of risk at recruitment explained the considerable statistical heterogeneity between studies, which may be due to differences in component interventions, settings, or healthcare systems.

### Economic evaluations

In 13 studies in this review, the authors reported a comprehensive economic evaluation which provided an indication of value for money for the interventions being tested. Variations in the methods used, however, made comparisons across studies difficult. There was some, although limited, evidence that falls prevention strategies can be cost-saving during the trial period, and may also be cost-effective over the participants' remaining lifetime. The results indicate that, to obtain maximum value for money, effective strategies need to be targeted at particular subgroups of older people.

## Overall completeness and applicability of evidence

### Participants

The 159 trials in this review included 79,193 community-dwelling older people, predominantly women (70%). A wide range of ages were included as few trials set upper age limits. Participant characteristics varied greatly due to the recruitment methods used, and the inclusion and exclusion criteria applied. Participants in some trials were healthy volunteers; in others they were more representative of older people as a whole having been randomly sampled from databases such as electoral rolls. Some trials recruited people being treated in hospital clinics or with specific conditions such as operable cataracts or severe visual impairment. Eighty-three trials (52%) recruited participants with a history of falls or one or more risk factors for falling.

As the majority of trials specifically excluded older people who were cognitively impaired, the results of this review may not be applicable to this important group of people at risk.

We have excluded trials recruiting people with Parkinson's disease and post stroke from this review update as we felt the results of interventions for those neurological conditions were not necessarily applicable to older people as a whole. Fall prevention trials in these populations often include a wider age range which would result in some being excluded from this review; Cochrane reviews for each of these specific groups (including all age groups) would be preferable for summarising the evidence.

### Interventions

Fall prevention interventions tested in a further 51 randomised controlled trials were included in this update. In some instances the additional trials had minimal impact on the size and precision of the results. For multifactorial interventions the addition of four trials (1363 participants) changed the rate ratio and 95% confidence interval by around 1% only (previous version rate ratio (RaR) 0.75, 95% confidence interval (CI) 0.65 to 0.86; this update RaR 0.76, 95% CI 0.67 to 0.85). Also, the addition of nine trials (2678 participants) changed the risk ratio and 95% confidence interval by a similar amount (previous version risk ratio (RR) 0.95, 95% CI 0.88 to 1.02; this update 0.94, 95% CI 0.86 to 1.02). Minimal effects were seen also with the addition of six trials (2899 participants) to the analysis for group exercise (previous version RR 0.83, 95% CI 0.72 to 0.97; this update RR 0.85, 95% CI 0.76 to 0.96).

This review differs from many in The Cochrane Library by including a large number of interventions. This precludes in-depth subgroup analyses exploring the effect of different components within interventions such as those undertaken in [433] for exercise, or other factors that may affect results such as recruitment rates or adherence [434]. This is an argument for splitting this review into a number of separate reviews focusing on specific interventions.

The included trials were conducted in over 21 countries, using a variety of healthcare models. The effectiveness of some interventions may be sensitive to differences between healthcare systems, structures, and networks at local and national level. For example Hendriks 2008 [435, 436, 437, 438, 439, 440, 441] reported the results of a study which aimed to reproduce, in The Netherlands, the successful integrated multifactorial intervention reported by Close 1999 from the UK. Major differences in the health operational networks in The Netherlands health system compared with those in the UK appear to have made timely direct contact with the appropriate health professionals impossible to achieve [442]. That risk of falling was not reduced in Hendriks 2008 may be due to these differences in healthcare systems, rather than to sample variation, as negative results were also reported by Van Haastregt 2000 [443, 444, 445] and Van Rossum 1993 in the same healthcare setting.

Interventions targeting most risk factors for falls have now been well researched. Gaps include interventions addressing the management of urinary incontinence, foot problems, and dementia. Further research is required to increase implementation of effective interventions by healthcare professionals.

### Outcomes

We sought data for rate of falls, number of people falling, and number of people sustaining a fall-related fracture, although few studies provided fracture data. As the analyses and Supplementary material 13 demonstrate, some studies provided data for both falls and fallers, as recommended in [7. Others provided data only for one or other fall outcome. In most analyses we were able to pool more data on risk of falling than on rate of falls. Since robust statistical methods are now available to deal with comparison of the number of falls occurring in each group of a study, the use of rate of falls has a number of attractions. First, it improves power. In the sense that every fall carries a risk of injury, an intervention which reduces the number of times a faller falls, even if not the number of fallers, has clinical, public health, and economic relevance. However from a public health perspective, fall prevention lies between primary and secondary prevention. Older people who are not yet 'fallers', however defined, might wish to know how best to prolong their time free from falls.

## Quality of the evidence

This review containing 159 trials (79,193 participants) provides robust evidence regarding effective interventions for reducing falls. However, not all studies met the contemporary standards of the CONSORT statement [446], including the extensions for pragmatic randomised trials [447] and cluster-randomised trials [448]. Where factorial designs were employed, data for each treatment cell were not always reported [449].

The fact that the outcome of interest, falling, was not always defined, is a continuing concern. The use of two definitions in Wolf 1996 demonstrated that the definition of falling used can alter the significance of the results. Comparability of future research findings would be facilitated by adoption of the consensus definition of a fall developed for trials in community-dwelling populations by the Prevention of Falls Network Europe [7].

The included studies also illustrated the wider problems of variation in the methods of ascertaining, recording, analysing, and reporting falls described in [450. Studies should use consensus recommendations for conducting fall prevention trials which include the daily recording of falls, with monthly, or more frequent, follow-up by the researchers blind to group allocation [7]. Forty-five per cent did not do this, despite empirical evidence showing a 25% underreporting of falls when data were collected retrospectively by telephone at the end of a three-month period, compared with data collected daily and returned monthly over the same period [17].

We included 11 analyses with statistically significant pooled effect measures in our sensitivity analyses exploring the possible impact of risk of bias on the treatment effect. When trials with higher risk of bias in any of the pre-determined domains were removed, the results remained statistically significant in all but three analyses (see Supplementary material 18). These analyses indicate that the results in this review are robust to key risks of bias.

## Potential biases in the review process

We attempted to minimise publication bias in the review by searching multiple databases and contacting authors of studies identified in trials registers that were completed, but for which full reports had not been identified. We included five abstracts not published as full reports (Cerny 1998; Fiatarone 1997; Hill 2000 [451, 452, 453]; Wilder 2001; Wyman 2005) and obtained supplementary information from authors of 29 studies. We also included studies published in languages other than English.

To explore the possibility of publication bias, we constructed funnel plots for all analyses that contained more than 10 data points. For exercise interventions and multifactorial interventions, asymmetry in the funnel plots was minimal (figures not shown). For vitamin D supplementation, there was asymmetry in the risk of falling plot which could indicate the absence of trials with negative results, i.e. publication bias (see Figure 3).

We excluded 18 trials reporting falls as adverse effects, although in some instances the intervention might plausibly have reduced falls. Increased publication of protocols in trials registers will make it easier to establish whether the aim of the study was to prevent falls, thus making it eligible for inclusion in this review.

# Authors' conclusions

## Implications for practice

We found evidence of effectiveness for a number of different approaches to fall prevention, some in all older people living in the community and others in particular subgroups. This evidence may not be applicable to older people with dementia as most included studies excluded them from participation.

- There is strong evidence that certain exercise programmes prevent falls. Group exercise classes and exercises individually delivered at home reduce rate of falls and risk of falling. Tai Chi as a group exercise reduces risk of falling, but is less effective in people at higher risk of falling. Overall, exercise programmes aimed at reducing falls appear to reduce fractures.

- Multifactorial interventions integrating assessment with individualised intervention, usually involving a multidisciplinary team, are effective in reducing rate of falls but not risk of falling.

- Home safety interventions reduce rate of falls and risk of falling. These interventions are more effective in people at higher risk of falling, and when delivered by an occupational therapist. An anti-slip shoe device for icy conditions significantly reduced winter outside falls in one study.

- There is limited evidence for the effectiveness of interventions targeting medications (e.g. withdrawal of psychotropic medications, educational programmes for family physicians).

- Overall, vitamin D does not appear to prevent falls in all older people living in the community but appears to be effective in people who have lower vitamin D levels before treatment.

- In people with severe visual impairment, there is evidence from one trial for the effectiveness of a home safety assessment and modification intervention. Expedited first eye cataract surgery for people on a waiting list significantly reduces rate of falls compared with waiting list controls. Older people may be at increased risk of falling while adjusting to new spectacles or major changes in prescription.

- In one study rate of falls was reduced in people with disabling foot pain receiving "multifaceted podiatry" (customised orthoses, footwear review, foot and ankle exercises, fall prevention education in addition to "usual podiatry care").

- Evidence from three studies indicates that cardiac pacing in people with carotid sinus hypersensitivity, and a history of syncope and/or falls, reduces rate of falls.

- The evidence relating to the provision of educational materials alone for preventing falls is inconclusive.

## Implications for research

Aspects of particular interventions to be addressed in future studies include:

- Research targeting health professionals to increase implementation of effective interventions, i.e. translation of research into practice.

- Methods for increasing uptake and adherence to effective programmes by older people.

- Investigation of different methods for delivering proven programmes (e.g. peer exercise instructors, academic detailing, electronic media).

- The impact of management programmes for risk factors such as cognitive impairment and urinary incontinence.

Aspects of research methods that need to be adopted in all future studies:

- Studies evaluating fall prevention should be adequately powered and use a contemporary standard definition of a fall [7].

- Falls should be recorded daily and monitored monthly. Falls should be monitored and verified 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; rate of falls (falls per person year); and number in each analysis.

- Results should be analysed using appropriate, pre-specified methodology (e.g. negative binomial regression, survival analysis) [454]. Group comparisons should be expressed as incidence rate ratios and risk ratios with 95% confidence intervals.

- Design and reporting of trials should meet the contemporary standards of the CONSORT statement [446, 447] including randomised sequence generation and allocation concealment prior to randomisation.

- Design and reporting of cluster-randomised trials should follow contemporary guidance [448] 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 [449].

- 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 recently been published [455].

# Supplementary materials

[print-only] Supplementary materials are available with the online version of this article: https://doi.org/10.1002/14651858.CD007146.pub3.

[web-only] Supplementary materials published alongside this article contain additional data and information that support or enhance the content of the article. The supplementary materials are not subject to the same editorial process as the article and therefore may not have been checked for accuracy, copyedited, typeset or proofread. The content and accuracy of the supplementary materials is the responsibility of the author(s). Cochrane gives no representations or warranties as to the accuracy of the supplementary materials. To the fullest extent permitted by law, Cochrane disclaims all liability arising from any reliance on or use of the supplementary materials.

## Supplementary material 1

CD007146-SUP-01-searchStrategy.html

Search strategies

## Supplementary material 2

CD007146-SUP-02-characteristicsOfIncludedStudies.html

Characteristics of included studies

## Supplementary material 3

CD007146-SUP-03-characteristicsOfExcludedStudies.html

Characteristics of excluded studies

## Supplementary material 4

CD007146-SUP-04-characteristicsOfAwaitingStudies.html

Characteristics of studies awaiting classification

## Supplementary material 5

CD007146-SUP-05-characteristicsOfOngoingStudies.html

Characteristics of ongoing studies

## Supplementary material 6

CD007146-SUP-06-analyses.html

Analyses

## Supplementary material 7

CD007146-SUP-07-dataPackage.zip

Data package

## Supplementary material 8

CD007146-SUP-08-other.html

'Risk of bias' assessment tool

## Supplementary material 9

CD007146-SUP-09-other.html

'Risk of bias' assessment methods for incomplete outcome data (attrition bias)

## Supplementary material 10

CD007146-SUP-10-other.html

Description of included studies: reference links

## Supplementary material 11

CD007146-SUP-11-other.html

Mean baseline vitamin D levels (25(OH)D) in included trials (nmol/L)

## Supplementary material 12

CD007146-SUP-12-other.html

Categories of exercise (ProFaNE) in interventions containing exercise alone

## Supplementary material 13

CD007146-SUP-13-other.html

Source of data for generic inverse variance analysis (see footnotes for explanation of codes)

## Supplementary material 14

CD007146-SUP-14-other.html

Raw data for rate of falls and number of fallers when available

## Supplementary material 15

CD007146-SUP-15-other.html

Description of excluded studies: reference links

## Supplementary material 16

CD007146-SUP-16-other.html

Adverse effects possibly attributable to vitamin D or vitamin D analogues reported in included studies

## Supplementary material 17

CD007146-SUP-17-other.html

Studies reporting cost-effectiveness, cost-utility, or costs of the intervention and/or healthcare resource use

## Supplementary material 18

CD007146-SUP-18-other.html

Sensitivity analyses exploring impact of risk of bias on effect sizes

# Acknowledgements

The authors would like to thank Lindsey Elstub, Joanne Elliott, and Catherine Deering for their support at the editorial base. We are grateful to Prof RG Cumming and Prof BH Rowe for their previous contributions as review authors. We thank the following for their useful and constructive comments on earlier versions of the protocol and/or review: Prof Clemens Becker, Assoc Prof Jacqueline Close, Dr Helen Handoll, Prof Peter Herbison, Prof Rajan Madhok, Dr Kilian Rapp, Prof Dawn Skelton, Prof Chris Todd, and Dr Janet Wale. In addition, we would also like to thank Geraldine Wallbank of the George Institute for Global Health, Sydney for preparing Supplementary material 12.

# What's new

Date | Event | Description
18 June 2021 | Amended | Note added addressing concerns raised on the use of the data from two trials (Pfeifer 2000 and Pfeifer 2009); see Published notes.

# History

Protocol first published: Issue 2, 2008  Review first published: Issue 2, 2009

Date | Event | Description
6 October 2020 | Amended | Upon notification via a Comment submitted to the Cochrane Library (30 September 2020) that an included trial had been retracted, changes were made to the review to alert the reader to this, including relabelling the study: Sato 2005a (Retracted); see Published notes.
30 April 2015 | Amended | A statement has been added to the Published notes to clarify that this is the final version of this review. In addition, the contact author's email address has been changed.
24 September 2013 | Amended | Contact author address changed
9 October 2012 | Feedback has been incorporated | Prompted by feedback, received 27 September 2012, corrections were made to Analysis 1.3 (Exercise vs control: Number of people sustaining a fracture) and associated text.
27 July 2012 | New search has been performed | 1. Search updated to September 2011 and trials included. Updated again in March 2012 and trials placed in 'Supplementary material 4'.  2. Fifty-one additional trials (24,177 participants) included in this update.  3. Three previously included trials excluded as they recruited people with Parkinson's disease (Ashburn 2007; Sato 2006) and post stroke (Green 2002), which are not within the scope of this version of the review.  4. Data for fall rates added for Day 2002 (published in Fitzharris 2010) and for fracture risk in Salminen 2009 (previously included as Salminen 2008).  5. 'Risk of bias' assessment items for performance bias, detection bias, and attrition bias were added and applied to all included studies.  6. Table added presenting the raw data for rate of falls and number of fallers when available for the included trials.
27 July 2012 | New citation required and conclusions have changed | 1. Conclusions changed for home safety interventions.  2. Results from two additional interventions included: enhanced podiatry (Spink 2011) and single lens glasses (Haran 2010).  3. There has been a change in authorship.
25 August 2010 | Feedback has been incorporated | Feedback added about the availability of event rates
10 August 2009 | Feedback has been incorporated | Feedback added to clarify terms used
13 May 2009 | Amended | Correction of several typographical errors
27 October 2008 | Amended | Converted to new review format
19 February 2008 | Amended | The published review 'Interventions for preventing falls in elderly people' [456] 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 residential care facilities and hospitals'.

# Contributions of authors

LD Gillespie, the guarantor for this review, conceived, designed, and co-ordinated the review, developed the search strategy and carried out the searches, screened search results and obtained papers, screened retrieved papers against inclusion criteria, carried out 'Risk of bias' assessment and data extraction, entered data into RevMan, and wrote the review.

MC Robertson contributed to the 'Risk of bias' assessment, extracted data from papers, managed data and carried out statistical calculations, wrote the economic evaluation section and Supplementary material 17, and wrote the review. In addition she provided additional data about papers, and a methodological perspective for measurement of outcomes and statistical analyses used in the papers and the economic evaluations.

WJ Gillespie conceived and designed the review, screened retrieved papers against inclusion criteria, carried out 'Risk of bias' assessment and data extraction, entered data into RevMan, and commented on drafts of the review.

C Sherrington carried out 'Risk of bias' assessment and data extraction, and commented on drafts of the review.

S Gates carried out 'Risk of bias' assessment and data extraction, and commented on drafts of the review.

LM Clemson carried out 'Risk of bias' assessment and data extraction, and commented on drafts of the review.

SE Lamb conceived and led the design of the ProFaNE taxonomy that provided the framework for the structure of the review, carried out 'Risk of bias' assessment and data extraction, and commented on drafts of the review.

# Declarations of interest

Four review authors were investigators for 10 included studies: LM Clemson (Clemson 2004; Clemson 2010), WJ Gillespie (Carter 1997), MC Robertson (Campbell 1997; 457; Campbell 2005; Davis 2011a; Elley 2008 [458, 459, 460]; Robertson 2001a) and C Sherrington (Sherrington 2004). Investigators did not carry out 'Risk of bias' assessment on their own studies. No other conflicts are declared.

# Sources of support

## Internal sources

- University of Otago, Dunedin, New Zealand

  Computing, administration, and library services (LDG, MCR)

- University of Sydney, Australia

  Salary (LC)

- University of Warwick, Coventry, UK

  Salary (SG)

## External sources

- National Health and Medical Research Council, Australia

  Salary (CS, LC)

- National Institute for Health Research, UK

  Department of Health Cochrane Review Incentive Scheme

# Differences between protocol and review

## Criteria for considering studies for this review

Trials including only participants with Parkinson's disease or post stroke have been excluded from this version of the review. In [13, data from these studies were not pooled with studies recruiting more representative samples of older people as it was thought that interventions specifically targeting people with neurological conditions such as Parkinson's disease or post stroke were not generalisable to older people as a whole. A protocol for a Cochrane review on fall prevention interventions post stroke has been published [461].

## 'Risk of bias' assessment

The protocol was completed and submitted for publication prior to the general release of Review Manager Version 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 [456. Rather than use that tool, in [13] we made a post hoc decision to convert a number of these items for use in the new Cochrane Collaboration tool for assessing risk of bias [16]. For this update we have used two additional 'Risk of bias' items: 'Random sequence generation' and 'Incomplete outcome data'.

## Subgroup analysis

We carried out a post hoc subgroup analysis based on whether home safety interventions were carried out by an occupational therapist (OT), or by other personnel. We did this because Pighills 2011 randomised participants to two intervention groups to explore the effect of using differently trained personnel to deliver the intervention.

# Notes

Due to its size and complexity, this review is not being updated. Instead, the topic area is being split and separate reviews of the main interventions will be conducted.

Upon notification via a comment from Alison Avenell (received 30 September 2020) that an included study (Sato 2005a (Retracted)) had been retracted, Helen Handoll (Co-ordinating Editor, Cochrane Bone, Joint and Muscle Trauma Group) took the pragmatic decision to retain this study as an included study. This decision reflected both its minimal impact on the review findings, including that it did not appear in the summaries or affect the conclusions, and the wish to avoid the risk of data discrepancies resulting from its removal from this large and 'stable' review. As well as relabelling the study, the retraction notice was referenced and information on the retraction added into the Characteristics of included studies table, and outcome data removed from text and the analyses.

Note added 18.06.21: Concerns have been raised on the use of the data from two trials (Pfeifer 2000 and Pfeifer 2009) testing vitamin D [e.g. 1]. We decided it would be useful to check on the contribution of these two small trials to the evidence for this intervention by conducting sensitivity analyses. Excluding the data from these trials from the analyses did not result in any important differences in the results for the three outcomes: rate of falls (sensitivity analysis: RaR 1.01, 95% CI 0.92 to 1.12 compared with RaR 1.00, 95% CI 0.90 to 1.11 (Analysis 5.1)); number of fallers (sensitivity analysis: RR 0.98, 95% CI 0.92 to 1.06 compared with RR 0.96, 95% CI 0.89 to 1.03 (Analysis 5.2)); or numbers of people sustaining a new fracture (sensitivity analysis: RR 0.96, 95% CI 0.83 to 1.11 compared with RR 0.94, 95% CI 0.82 to 1.09 (Analysis 5.3)). Sensitivity analysis upheld the results from subgroup analyses (6.1 and 6.2) showing no significant difference between trials recruiting participants with higher falls risk and trials with broader inclusion criteria. However, the removal of the Pfeifer trials from subgroup analyses (7.1 and 7.2) exploring the effect of only enrolling participants with lower vitamin D levels versus enrolling participants not so selected resulted in substantively underpowered subgroup analyses. We consider that the tentative conclusion that vitamin D “appears to be effective in people who have lower vitamin D levels before treatment” is not upheld with the exclusion of the Pfeiffer trials.

There is substantial discussion elsewhere of the methodological and analytical approaches used in these two trials authored by Pfeifer, but we confirm here that inclusion or exclusion of these trials makes no material difference to the overall findings of the review. A review that includes vitamin D, and thus will provide an update of the evidence on this intervention, is planned in due course.

[1] Bolland MJ, Grey A. Different outcomes of meta-analyses and data inconsistency: response to comments by Pfeifer. Archives of Osteoporosis 2015;10:43

Note agreed by Sallie Lamb, on behalf the authors, and Helen Handoll, Editor of the BJMT Group

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Green J , Forster A , Bogle S , Young J . Physiotherapy for patients with mobility problems more than 1 year after stroke: a randomised controlled trial. Lancet 2002;359(9302):199-203. 2651812 Study: Green 2002

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Figures

## Figure 1

'Risk of bias' summary: review authors’ judgments about each methodological quality  item for each included study

## Figure 2

'Risk of bias' graph: review authors’ judgments about each methodological quality item  presented as percentages across all included studies.

## Figure 3

Funnel plot of Analysis 5.2: vitamin D (with or without calcium) vs control/placebo/calcium: number of fallers