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The Cochrane Database of Systematic Reviews logoLink to The Cochrane Database of Systematic Reviews
. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3

Interventions for preventing falls in older people living in the community

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
Editor: Cochrane Bone, Joint and Muscle Trauma Group
PMCID: PMC8095069  PMID: 22972103

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 (Campbell 1990; Tinetti 1988), and the rate of fall‐related injuries increases with age (Peel 2002). Falls can have serious consequences, e.g. fractures and head injuries (Peel 2002). Around 10% of falls result in a fracture (Campbell 1990; Tinetti 1988); fall‐associated fractures in older people are a significant source of morbidity and mortality (Keene 1993). Most fall‐related injuries are minor: bruising, abrasions, lacerations, strains, and sprains.

Despite early attempts to achieve a consensus definition of "a fall" (Kellogg 1987) 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 (Zecevic 2006). 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" (Lamb 2005). 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?" (Lamb 2005).

Risk factors for falling have been identified by epidemiological studies of varying quality. These have been synthesised in a recent systematic review (Deandrea 2010). 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 (Campbell 2006).

Since many risk factors appear to interact in those who suffer fall‐related fractures (Cummings 1995), 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 (Yardley 2002). Falling puts a strain on the family and is an independent predictor of admission to a nursing home (Tinetti 1997).

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 (Gillespie 2009), and interventions for preventing falls in nursing care facilities and hospitals (Cameron 2010).

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 (Cameron 2010) 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 (seeDifferences 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 (Lamb 2005). 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 (Lefebvre 2011), 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 (seeAppendix 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 (Higgins 2011a). 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 (Hannan 2010). We developed criteria for judging risk of bias in fall prevention trials (seeAppendix 2).

We found that many of the descriptive judgements proposed for assessment of attrition bias described in Table 8.5.d of the Cochrane Handbook (Higgins 2011a) 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 Higgins 2011a. We classified studies as low, high, or unclear risk of attrition bias using an Excel spreadsheet (seeAppendix 3 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 Excel 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 Stata. 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 (Higgins 2011b) if this was not done in the published report. We used an intra‐class correlation coefficient (ICC) of 0.01 reported in Smeeth 2002. 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 (Higgins 2003).

Data synthesis

We grouped interventions using the fall prevention classification system (taxonomy) developed by the Prevention of Falls Network Europe (ProFaNE) (Lamb 2011). Interventions have been grouped by combination (single, multiple, or multifactorial) and then by the type of intervention (descriptors). 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 (RevMan 5.1). 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 (seeMeasures 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 Excel.

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 (Higgins 2011c). We used the test for subgroup differences available in RevMan 5.1 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) (seeHiggins 2011a: Table 8.7.a).

Results

Description of studies

Results of the search

The search strategies identified a total of 9690 references (seeAppendix 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 (seeAppendix 4). This review now contains 159 trials with 79,193 participants. Details are provided in the Characteristics of included studies, 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 Appendix 4.

Design

The majority of included studies were individually randomised. Fourteen were cluster‐randomised by place of residence (Assantachai 2002; Huang 2010; Lord 2003; Vetter 1992; Wolf 2003), physician practice (Coleman 1999Pit 2007; Rubenstein 2007; Spice 2009; Tinetti 1994), health centre (Dangour 2011; Weber 2008), or senior centre (Reinsch 1992; Steinberg 2000).

Nine studies individually randomised participants but also allocated people residing in the same house to the same intervention arm (Brown 2002; Carpenter 1990; Cerny 1998; Dapp 2011; Fox 2010; Harari 2008; Hornbrook 1994; Stevens 2001; Van Rossum 1993). The study by Faes 2011 cluster‐randomised pairs of participants and their caregivers.

One trial used a cross‐over design (Parry 2009).

Sample sizes

Included trials ranged in sample size from 10 (Lannin 2007) to 9940 (Smith 2007). 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 (five countries including United Kingdom, and four other countries in Europe and North America), and Ralston 2011 (24 countries including United Kingdom, Belgium, France, USA).

Participants

Overall, 70% of included participants were women. All participants were women in 37 trials (seeAppendix 4), and men in two trials (Gill 2008; Rubenstein 2000).

The inclusion/exclusion criteria and other participant details are listed for each study in the Characteristics of included studies.

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 (seeAppendix 4). Lower serum vitamin D (i.e. vitamin D insufficiency or deficiency) was an inclusion criterion in four trials of vitamin D supplementation (Dhesi 2004; Pfeifer 2000; Pfeifer 2009; Prince 2008) (seeAppendix 5 for baseline vitamin D levels).

Seven trials recruited older people who had recently sustained a hip fracture (Bischoff‐Ferrari 2010; Di Monaco 2008; Harwood 2004; Huang 2005; Sherrington 2004; Shyu 2010) or fall‐related fracture (Grant 2005). Fourteen other trials recruited on the basis of a specific condition: severe visual impairment (Campbell 2005), operable cataract (Foss 2006; Harwood 2005), carotid sinus hypersensitivity (Kenny 2001; Parry 2009; Ryan 2010), osteoporosis or osteopenia (Grahn Kronhed 2009Liu‐Ambrose 2004Madureira 2010; Ralston 2011; Smulders 2010Swanenburg 2007), Alzheimer's disease (Sato 2005a (Retracted)), and chronic foot pain (Spink 2011).

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 (seeAppendix 4).

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 (seeAppendix 4); 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 (seeAppendix 4).

The trials were grouped by exercise modality into six categories using the ProFaNE taxonomy (seeAppendix 6). 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:

Eight trials compared different exercise programmes (Davis 2011a; Helbostad 2004; Kemmler 2010; Nitz 2004; Shigematsu 2008; Steadman 2003; Yamada 2010) or methods of delivery (Wu 2010).

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 (seeAppendix 4). 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 were non‐osteoporotic, and in Greenspan 2005 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 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 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, 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; Meredith 2002). 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; McMurdo 2009).

Psychological interventions

In two trials (Huang 2011; 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:

Knowledge/education interventions

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

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 (seeAppendix 4), with numerous combinations of interventions. All but two (Assantachai 2002; Carter 1997) 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 (seeAppendix 4), 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 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; Conroy 2010; Coleman 1999; Davison 2005; De Vries 2010; Hornbrook 1994; Huang 2005; Logan 2010; Lord 2005 (extensive intervention group); Markle‐Reid 2010; Salminen 2009; Shyu 2010; Spice 2009 (secondary care intervention group); Tinetti 1994; Vind 2009; Wyman 2005). 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 Appendix 7. 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 Appendix 8. 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 (seeAppendix 9 for links to references, and the Characteristics of excluded studies 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) or with Parkinson's disease (Green 2002; Sato 2006) 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 (seeCharacteristics of ongoing studies for details).

Studies awaiting classification

Eight studies are awaiting classification (seeCharacteristics of studies awaiting classification). We identified three abstracts for Bighea 2011 which appear to report interim analyses. The remaining trials (Adunsky 2011; Clemson 2012; Freiberger 2012; Glendenning 2012; Neelemaat 2012; Pérula 2012; Taylor 2012) were identified via weekly bulletins from SafetyLit after 1 March 2012 (our cut‐off date for inclusion) or personal communication. Sach 2012 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 Characteristics of included studies. 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.

1.

1

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

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) (seeFigure 2).

2.

2

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

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 (seeFigure 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) (seeFigure 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) (seeFigure 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 (seeFigure 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 (seeAppendix 6).

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]".

1.1. Analysis.

1.1

Comparison 1: Exercise vs control, Outcome 1: Rate of falls

1.2. Analysis.

1.2

Comparison 1: Exercise vs control, Outcome 2: Number of fallers

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).

2.1. Analysis.

2.1

Comparison 2: Group exercise: multiple categories of exercise vs control: subgroup analysis by falls risk at baseline, Outcome 1: Rate of falls

2.2. Analysis.

2.2

Comparison 2: Group exercise: multiple categories of exercise vs control: subgroup analysis by falls risk at baseline, Outcome 2: Number of fallers

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, 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.

3.1. Analysis.

3.1

Comparison 3: Group exercise: Tai Chi vs control: subgroup analysis by falls risk at baseline, Outcome 1: Rate of falls

3.2. Analysis.

3.2

Comparison 3: Group exercise: Tai Chi vs control: subgroup analysis by falls risk at baseline, Outcome 2: Number of fallers

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).

1.3. Analysis.

1.3

Comparison 1: Exercise vs control, Outcome 3: Number of people sustaining a fracture

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".

4.1. Analysis.

4.1

Comparison 4: Exercise vs exercise, Outcome 1: Rate of falls

4.2. Analysis.

4.2

Comparison 4: Exercise vs exercise, Outcome 2: Number of fallers

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; Bischoff‐Ferrari 2010; Dhesi 2004; Grant 2005; Harwood 2004; Kärkkäinen 2010; Latham 2003; Pfeifer 2000; Pfeifer 2009; Porthouse 2005; Prince 2008; Sanders 2010; Smith 2007; Trivedi 2003) (seeAppendix 5 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).

5.1. Analysis.

5.1

Comparison 5: Medication provision: vitamin D (with or without calcium) vs control/placebo/calcium, Outcome 1: Rate of falls

5.2. Analysis.

5.2

Comparison 5: Medication provision: vitamin D (with or without calcium) vs control/placebo/calcium, Outcome 2: Number of fallers

5.3. Analysis.

5.3

Comparison 5: Medication provision: vitamin D (with or without calcium) vs control/placebo/calcium, Outcome 3: Number of people sustaining a fracture

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.

6.1. Analysis.

6.1

Comparison 6: Vitamin D (with or without calcium) vs control: subgroup analysis by falls risk at baseline, Outcome 1: Rate of falls

6.2. Analysis.

6.2

Comparison 6: Vitamin D (with or without calcium) vs control: subgroup analysis by falls risk at baseline, Outcome 2: Number of fallers

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).

7.1. Analysis.

7.1

Comparison 7: Vitamin D (with or without calcium) vs control: subgroup analysis by vitamin D level at baseline, Outcome 1: Rate of falls

7.2. Analysis.

7.2

Comparison 7: Vitamin D (with or without calcium) vs control: subgroup analysis by vitamin D level at baseline, Outcome 2: Number of fallers

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 Appendix 10; 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).

8.1. Analysis.

8.1

Comparison 8: Medication provision: vitamin D 2000 IU/day vs vitamin D 800 IU/day, Outcome 1: Rate of falls

8.2. Analysis.

8.2

Comparison 8: Medication provision: vitamin D 2000 IU/day vs vitamin D 800 IU/day, Outcome 2: Number of people sustaining a fracture

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, alfacalcidol (1‐alpha hydroxycholecalciferol) supplementation did not result in a significant reduction in risk of falling (378 participants, Analysis 9.2.2).

9.1. Analysis.

9.1

Comparison 9: Medication provision: vitamin D analogue vs placebo, Outcome 1: Rate of falls

9.2. Analysis.

9.2

Comparison 9: Medication provision: vitamin D analogue vs placebo, Outcome 2: Number of fallers

9.3. Analysis.

9.3

Comparison 9: Medication provision: vitamin D analogue vs placebo, Outcome 3: Number of people sustaining a fracture

Reported vitamin D levels for trials administering vitamin D analogues are described in Appendix 5, and reported adverse effects in Appendix 10. 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).

9.4. Analysis.

9.4

Comparison 9: Medication provision: vitamin D analogue vs placebo, Outcome 4: Number of people developing hypercalcaemia

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.

10.1. Analysis.

10.1

Comparison 10: Medication provision: other medications vs control, Outcome 1: Rate of falls

10.2. Analysis.

10.2

Comparison 10: Medication provision: other medications vs control, Outcome 2: Number of fallers

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; seeAnalysis 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.

10.3. Analysis.

10.3

Comparison 10: Medication provision: other medications vs control, Outcome 3: Number of people sustaining a fracture

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).

11.1. Analysis.

11.1

Comparison 11: Medication withdrawal vs control, Outcome 1: Rate of falls

11.2. Analysis.

11.2

Comparison 11: Medication withdrawal vs control, Outcome 2: Number of fallers

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).

12.1. Analysis.

12.1

Comparison 12: Surgery vs control, Outcome 1: Rate of falls

12.2. Analysis.

12.2

Comparison 12: Surgery vs control, Outcome 2: Number of fallers

12.3. Analysis.

12.3

Comparison 12: Surgery vs control, Outcome 3: Number of people sustaining a fracture

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).

13.1. Analysis.

13.1

Comparison 13: Fluid or nutrition therapy vs control, Outcome 1: Number of fallers

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).

14.1. Analysis.

14.1

Comparison 14: Psychological interventions vs control, Outcome 1: Rate of falls

14.2. Analysis.

14.2

Comparison 14: Psychological interventions vs control, Outcome 2: Number of fallers

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).

15.1. Analysis.

15.1

Comparison 15: Environment/assistive technology interventions: home safety vs control, Outcome 1: Rate of falls

15.2. Analysis.

15.2

Comparison 15: Environment/assistive technology interventions: home safety vs control, Outcome 2: Number of fallers

15.3. Analysis.

15.3

Comparison 15: Environment/assistive technology interventions: home safety vs control, Outcome 3: Number of participants sustaining a fracture

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%).

16.1. Analysis.

16.1

Comparison 16: Home safety intervention vs control: subgroup analysis by risk of falling at baseline, Outcome 1: Rate of falls

16.2. Analysis.

16.2

Comparison 16: Home safety intervention vs control: subgroup analysis by risk of falling at baseline, Outcome 2: Number of fallers

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).

17.1. Analysis.

17.1

Comparison 17: Home safety intervention vs control: subgroup analysis by delivery personnel, Outcome 1: Rate of falls

17.2. Analysis.

17.2

Comparison 17: Home safety intervention vs control: subgroup analysis by delivery personnel, Outcome 2: Number of fallers

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.

18.1. Analysis.

18.1

Comparison 18: Environment/assistive technology interventions: vision improvement vs control, Outcome 1: Rate of falls

18.2. Analysis.

18.2

Comparison 18: Environment/assistive technology interventions: vision improvement vs control, Outcome 2: Number of fallers

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).

18.3. Analysis.

18.3

Comparison 18: Environment/assistive technology interventions: vision improvement vs control, Outcome 3: Number of people sustaining a fracture

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.

19.1. Analysis.

19.1

Comparison 19: Environment/assistive technology interventions: footwear modification vs control, Outcome 1: Rate of falls

19.2. Analysis.

19.2

Comparison 19: Environment/assistive technology interventions: footwear modification vs control, Outcome 2: Number of fallers

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).

20.1. Analysis.

20.1

Comparison 20: Knowledge/education interventions vs control, Outcome 1: Rate of falls

20.2. Analysis.

20.2

Comparison 20: Knowledge/education interventions vs control, Outcome 2: Number of fallers

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.

21.1. Analysis.

21.1

Comparison 21: Multiple interventions, Outcome 1: Rate of falls

21.2. Analysis.

21.2

Comparison 21: Multiple interventions, Outcome 2: Number of fallers

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 (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 (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 (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 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.

21.3. Analysis.

21.3

Comparison 21: Multiple interventions, Outcome 3: Number of people sustaining a fracture

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).

22.1. Analysis.

22.1

Comparison 22: Multifactorial intervention vs control, Outcome 1: Rate of falls

22.2. Analysis.

22.2

Comparison 22: Multifactorial intervention vs control, Outcome 2: Number of fallers

22.3. Analysis.

22.3

Comparison 22: Multifactorial intervention vs control, Outcome 3: Number of people sustaining a fracture

There were insufficient data to include Fabacher 1994 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).

23.1. Analysis.

23.1

Comparison 23: Multifactorial intervention vs control: subgroup analysis by falls risk at baseline, Outcome 1: Rate of falls

23.2. Analysis.

23.2

Comparison 23: Multifactorial intervention vs control: subgroup analysis by falls risk at baseline, Outcome 2: Number of fallers

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).

24.1. Analysis.

24.1

Comparison 24: Multifactorial intervention vs control: subgroup analysis by intensity of intervention, Outcome 1: Rate of falls

24.2. Analysis.

24.2

Comparison 24: Multifactorial intervention vs control: subgroup analysis by intensity of intervention, Outcome 2: Number of fallers

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 (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).

25.1. Analysis.

25.1

Comparison 25: Multifactorial intervention (setting 1) vs multifactorial intervention (setting 2), Outcome 1: Rate of falls

25.2. Analysis.

25.2

Comparison 25: Multifactorial intervention (setting 1) vs multifactorial intervention (setting 2), Outcome 2: Number of fallers

25.3. Analysis.

25.3

Comparison 25: Multifactorial intervention (setting 1) vs multifactorial intervention (setting 2), Outcome 3: Number of people sustaining a fracture

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 (seeAppendix 11).

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:

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 (seeAnalysis 7.1) and risk of falling (seeAnalysis 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 Sherrington 2011 for exercise, or other factors that may affect results such as recruitment rates or adherence (Nyman 2012). 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 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 (Lord 2008). 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 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 Appendix 7 demonstrate, some studies provided data for both falls and fallers, as recommended in Lamb 2005. 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 (Boutron 2008), including the extensions for pragmatic randomised trials (Zwarenstein 2008) and cluster‐randomised trials (Campbell 2004). Where factorial designs were employed, data for each treatment cell were not always reported (McAlister 2003).

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 (Lamb 2005).

The included studies also illustrated the wider problems of variation in the methods of ascertaining, recording, analysing, and reporting falls described in Hauer 2006. 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 (Lamb 2005). 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 (Hannan 2010).

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 (seeAppendix 12). 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; 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 (seeFigure 3).

3.

3

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

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 (Lamb 2005).

  • 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) (Robertson 2005). 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 (Boutron 2008; Zwarenstein 2008) including randomised sequence generation and allocation concealment prior to randomisation.

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

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

  • 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 (Davis 2011b). 

Feedback

Definition of terms, June 2009

Summary

Please could you clarify the definitions of falls risk and rate of falls? How do they differ from one another?

Reply

We are unclear as to whether the question relates to "falls risk" or whether Dr Foley is actually meaning "risk of falling".

In the review the term falls risk is used in relation to falls risk at enrolment. In subgroup analyses, we compared trials with participants at 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) (seeData collection and analysis: 'Subgroup analyses and investigation of heterogeneity').

The review reports two primary outcomes:

1. Rate of falls
This is the number of falls over a period of time: for example, number of falls per person year. The statistic used to report this is the rate ratio which compares the rate of events (falls) in the two groups during the trial, or during a number of trials if the data are pooled. Based on these statistics we report whether an intervention has a significant effect on the rate of falls.

2. Number of people falling during follow up
The statistic used to report this is the risk ratio which compares the number of participants in each group with one or more fall events during the trial, or during a number of trials if the data are pooled. Based on these statistics we report whether an intervention has a significant effect on the risk of falling.

For further details, please refer to the Methods section in the review: 'Data relating to rate of falls' and 'Data relating to number of fallers or participants with fall‐related fractures'.

Contributors

Comment from: Dr Charlotte Foley, UK
Reply from: Mrs Lesley Gillespie, New Zealand

Availability of event rates in latest version of the review, July 2010

Summary

1. We are keen to know why the meta‐analyses in the updated Cochrane review do not display the mean event rates of included studies as is common in other Cochrane reviews as well as in earlier versions of this review.

As authors of a consumers' brochure on evidence‐based fall prevention we try to apply the principles of evidence‐based patient information and risk communication. For this purpose, communication of interventional effects as relative risks or risk ratios is inappropriate. The non‐availability of event rates of the original studies analysed in the Cochrane review or of mean event rates for meta‐analyses makes it impossible to transform the pooled relative risks into absolute risk reductions, which is the meaningful information that consumers and patients should get.

2. Generally, we wonder if it isn't time to make all raw data accessible which have been collected and archived during the preparation of a Cochrane review at least as electronic supplement to the Cochrane review.

Reply

1. Thank you; this is a useful comment. It refers to the raw data on numbers of participants and number of events in experimental and control groups in included studies of Cochrane reviews. These were visible in the analyses in the previous review "Interventions for preventing falls in elderly people", which has now been replaced. In "Interventions for preventing falls in older people living in the community" these data are no longer shown alongside the graphs in the analyses.

This is because they were not entered directly into RevMan to generate the risk ratios used in the meta‐analyses. We used the generic inverse variance option in RevMan, which involves entering the natural logarithm of a risk ratio and its standard error, which are then displayed. These were first calculated, as described in the methods section of the review, using Microsoft Excel. We did this because event rates (in this case, number of people falling) are not always available in trial reports, or from the authors of reports. Using the generic inverse variance method allows inclusion in the meta‐analyses of studies which report only the trialists' calculation of the risk ratio and a P‐value or confidence interval. It also allows inclusion of cluster‐randomised studies in which reported event rates have been adjusted for clustering by either the trial authors or review authors.

2. We appreciate that many researchers, health practitioners, and funders might like to use, for example, an Absolute Risk Reduction (ARR), or even, despite its many associated difficulties, Number Needed to Treat (NNT).1,2 In future updates, we will aim to include tables showing the data used to calculate estimates of effect and standard errors of studies included in meta‐analyses which have been conducted using the generic inverse variance option.

  1. Smeeth L, Haines A, Ebrahim S. Numbers needed to treat derived from meta‐analyses‐‐sometimes informative, usually misleading. BMJ 1999;318(7197):1548‐51.

  2. Stang A, Poole C, Bender R. Common problems related to the use of number needed to treat. Journal of Clinical Epidemiology 2010;63(8):820‐5.

Contributors

Comment from Gabriele Meyer and Sascha Köpke, Germany.
Reply from Lesley Gillespie, Corresponding Author, and Bill Gillespie, Feedback Editor, Cochrane Bone, Joint and Muscle Trauma Group.

Queries relating to Analysis 1.3, September 2012

Summary

1. Is there an error in Analysis 1.3 where the first two studies, Bischoff‐Ferrari 2010 and Haines 2009 have the exact same values?
2. Why did you choose to exclude Robertson 2001a from Analysis 1.3 in this update when it was previously included?

Reply

1. Thank you for alerting us to the problem in Analysis 1.3. We can confirm that there were indeed errors in the data entered for both Bischoff‐Ferrari 2010 and Haines 2009. These have now been corrected.
2. The unpublished fracture data for Robertson 2001a were withdrawn at the request of the principal investigator. The data for Robertson 2001a have been reinserted after discussion with the trial authors.

Contributors

Comment from: Fabienne El Khoury, France.
Reply from: Lesley Gillespie (Corresponding Author) and Clare Robertson (Author).

Retracted article, September 2020

Summary

Dear authors, This Cochrane review cited the following trial publication, as an included trial, which has been retracted: Sato Y, Kanoko T, Satoh K, Iwamoto J. Menatetrenone and vitamin D2 with calcium supplements prevent nonvertebral fracture in elderly women with Alzheimer’s disease. Bone 2005;36(1):61–8. Details of all Sato retractions may be found on Retraction Watch’s database https://retractionwatch.com/retraction-watch-database-user-guide/ and on the journal’s website. Do you believe that any action needs to be taken?

Reply

Thank you for alerting us to this retracted article and for submitting this comment to facilitate a formal public response. Given this is a ‘stable’ review, that will not be updated, I took an editorial decision to act on this. As noted in the revised published ‘Notes’ of the review, I took the pragmatic decision to retain this study as an included study. This decision reflected a) its minimal impact on the review’s findings, including that it did not appear in the summaries or affect the conclusions and b) the wish to avoid the risk of data discrepancies resulting from its removal from this very large 'stable' review. Actions taken were to relabel the study (Sato 2005a (Retracted)), reference the retraction notice, add information on the retraction to the Characteristics of included studies table entry, and remove outcome data from the results text and analyses. Thank you again for your comment.

Contributors

Comment from: Alison Avenell* Andrew Grey# Mark Bolland#
*Health Services Research Unit University of Aberdeen Aberdeen Scotland AB25 2ZD #Bone and Joint Research Group Department of Medicine Faculty of Medical and Health Sciences, University of Auckland Private Bag 92019, Auckland, New Zealand
Reply from: Helen Handoll, Co‐ordinating Editor, Cochrane Bone, Joint and Muscle Trauma Group

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 'Studies awaiting classification'.
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' (Gillespie 2003) is not being updated. Due to its size and complexity it was split into two reviews: 'Interventions for preventing falls in older people living in the community' and 'Interventions for preventing falls in older people in residential care facilities and hospitals'.

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

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 Appendix 6.

Appendices

Appendix 1. Search strategies and number of records identified

The Cochrane Library 2012, Issue 3 (Wiley InterScience)

#1 MeSH descriptor Accidental Falls, this term only (737)
#2 ("falls" or "faller*"):ti,ab (1756)
#3 (#1 OR #2) (1982)
#4 MeSH descriptor Aged explode all trees (793)
#5 ("older" or "senior*" or "elderly"):ti,ab (23049)
#6 (#4 OR #5) (23153)
#7 (#3 AND #6) in Trials (The Cochrane Central Register of Controlled Trials) (756)

* indicates truncation
ti,ab denotes word in the title or abstract

MEDLINE (Ovid Interface) (1946 to 1 March 2012)

1. Accidental Falls/ (12544)
2. (falls or faller$1).tw. (22940 )
3. or/1‐2 (29198 )
4. exp Aged/ (2059145 )
5. (senior$1 or elderly or older).tw. (336186)
6. or/4‐5 (2185007)
7. and/3,6 (12164)
8. randomized controlled trial.pt. (320017)
9. controlled clinical trial.pt. (83538)
10. randomized.ab. (225184)
11. placebo.ab. (128635)
12. randomly.ab. (162817)
13. trial.ab. (232226)
14. groups.ab. (1074761)
15. or/8‐14 (1573193)
16. humans.sh. (12076140)
17. and/15,16 (1192470)
18. and/7,17 (2770)

Ovid MEDLINE pending (searched 1 March 2012)

1. (falls or faller$1).tw. (1642)
2.  (senior$1 or elderly or older).tw. (16025)
3. and/1‐2 (369)
4. randomized controlled trial.pt. (813)
5. controlled clinical trial.pt. (47)
6. random$.tw. (37884)
7. placebo.tw. (4914)
8. trial.tw. (14097 )
9.  groups.tw. (67271)
10. or/4‐9 (102433)
11. and/3,10 (96)

EMBASE (Ovid Interface) (1947 to 1 March 2012)

1     Falling/ (19691)
2     (falls or fallers).tw. (34231)
3     or/1‐2 (44965)
4     exp Aged/ (1979140)
5     (elderly or senior$ or older).tw. (461797)
6     or/4‐5 (2200808)
7     and/3,6 (15329)
8     exp Randomized Controlled trial/ (300381)
9     exp Double Blind Procedure/ (107916)
10   exp Single Blind Procedure/ (14885)
11   exp Crossover Procedure/ (32263)
12   or/8‐11 (343532)
13   ((clinical or controlled or comparative or placebo or prospective$ or randomi#ed) adj3 (trial or study)).tw. (629658)
14   (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw. (146149)
15   ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)).tw. (147301)
16   (cross?over$ or (cross adj1 over$)).tw. (61912)
17   ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw. (191960)
18   or/13‐17 (944973)
19   or/12,18 (1059749)
20   Animal/ not Human/ (1279726)
21   19 not 20 (1029496)
22   and/7,21 (2456)

Footnote for OVID:
.pt. denotes a Publication Type term;
.ab. denotes a word in the abstract;
.sh. or / denotes a Medical Subject Heading (MeSH) term;
.ti. denotes a word in the title.

CINAHL (Ebsco) (1982 to 28 February 2012)

1. (MH "Accidental Falls") (10181)
2. TI ( falls or faller or fallers ) OR AB ( falls or faller or fallers ) (7898)
3. S1 or S2 (13330)
4. (MH Aged+) (357594)
5. TI ( senior or seniors or elderly or older ) OR AB ( senior or seniors or elderly or older ) (108768)
6. S4 or S5 (391502)
7. S3 and S6 (7562)
8. (MH "Clinical Trials+") (134839)
9. (MH "Evaluation Research+") (17947)
10. (MH "Comparative Studies") (65407)
11. (MH "Crossover Design") (8833)
12. PT clinical trial (69009)
13. (MH "Random Assignment") (31719)
14. S8 or S9 or S10 or S11 or S12 or S13 (221068)
15. TX ((clinical or controlled or comparative or placebo or prospective or randomi?ed) and (trial or study)) (382157)
16. TX (random* and (allocat* or allot* or assign* or basis* or divid* or order*)) (55209)
17.TX ((singl* or doubl* or trebl* or tripl*) and (blind* or mask*)) (602431)
18.TX ( crossover* or 'cross over' ) OR TX cross n1 over (11218)
19. TX ((allocat* or allot* or assign* or divid*) and (condition* or experiment* or intervention* or treatment* or therap* or control* or group*)) (68956)
20 S15 or S16 or S17 or S18 or S19 (912682)
21. S14 or S20 (968269)
22. S7 and S21 (3604)

Appendix 2. 'Risk of bias' assessment tool

Domain Criteria for judging risk of bias
Random sequence generation
Relating to selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Judgement of 'Low risk' if
A random component in the sequence generation was described, e.g. referring to a random number table; using a computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots; minimisation.
 
Judgement of 'High risk'if
A systematic non‐random method was used, e.g. date of admission; odd or even date of birth; case record number; clinician judgement; participant preference; patient risk factor score or test results; availability of intervention.
 
Judgement of 'Unclear'if
Insufficient information about the sequence generation process to permit judgement of 'Low risk' or 'High risk'.
Allocation concealment
Relating to selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement of 'Low risk'
in studies using individual randomisation if
Allocation concealment was described as by central allocation (telephone, web‐based, or pharmacy‐controlled randomisation); sequentially‐numbered identical drug containers; sequentially‐numbered, opaque, sealed envelopes.
 
in studies using cluster randomisation if
Allocation of all cluster units performed at the start of the study AND
Individual participant recruitment was completed prior to assignment of the cluster, and the same participants were followed up over time OR individual participants were recruited after cluster assignment, but recruitment carried out by a person unaware of group allocation and participant characteristics (e.g. fall history) OR individual participants in intervention and control arms were invited by mail questionnaire with identical information.
 
Judgement of 'High risk'
in studies using individual randomisation if
Investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, e.g. using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes unsealed, non‐opaque, or not sequentially numbered; alternation or rotation; date of birth; case record number; or any other explicitly unconcealed procedure.
in studies using cluster‐randomisation if
Individual participant recruitment was undertaken after group allocation by a person who was unblinded and may have had knowledge of participant characteristics.
 
Judgement of 'Unclear'if
Insufficient information to permit judgement of 'Low risk' or 'High risk'. This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definite judgement, e.g. if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque and sealed.
Blinding of participants and personnel
Relating to performance bias due to knowledge of the allocated interventions by participants and personnel carrying out the interventions
Judgement of 'Low risk'if 
Blinding of participants and personnel implementing the interventions ensured, and unlikely that the blinding could have been broken (e.g. control group received matching placebo medication prepared by a pharmacist) OR no blinding or incomplete blinding, but the review authors judge that the outcomes (falls and fractures) are not likely to be influenced by lack of blinding.
 
Judgement of 'High risk'if
Participants and/or intervention delivery personnel were not blind to group allocation (e.g. exercise intervention), and the outcomes (falls and fractures) are likely to be influenced by lack of blinding.
 
Judgement of 'Unclear'if
Insufficient information to make a judgement of 'Low risk' or 'High risk'.
Blinding of outcome assessment
Relating to detection bias due to knowledge of the allocated interventions by outcome assessors
a. Falls and fallers:Judgement of 'Low risk'if 
Falls were recorded/confirmed in all allocated groups using the same method AND the personnel recording/confirming falls were blind to group allocation.
 
Judgement of 'High risk'if
Falls were NOT recorded/confirmed in all allocated groups using the same method OR the personnel recording/confirming falls were NOT blind to group allocation.
Judgement of 'Unclear'if
Insufficient information to make a judgement of 'Low risk' or 'High risk'.
b. Fractures:Judgement of 'Low risk'if 
Fractures were recorded/confirmed in all allocated groups using the same method AND fractures were confirmed by the results of radiological examination or from primary care case records AND the personnel recording/confirming fractures were blind to group allocation.
 
Judgement of 'High risk' if
Fractures were NOT recorded/confirmed in all allocated groups using the same method OR the only evidence for fractures was from self reports from participants or carers.
 
Judgement of 'Unclear' if
Insufficient information to make a judgement of 'Low risk' or 'High risk'.
Incomplete outcome data
Relating to attrition bias due to amount, nature or handling of incomplete outcome data
a. Falls
SeeAppendix 3 for details.
b. Fallers
SeeAppendix 3 for details.
Method of ascertaining falls
Relating to bias in the recall of falls due to unreliable methods of ascertainment
Judgement of 'Low risk'if
The study used some form of concurrent collection of data about falling, e.g. participants given postcards to fill in daily and mail back monthly, calendar to mark etc, with monthly, or more frequent, follow‐up by the researchers.
 
Judgement of 'High risk' if
Ascertainment relied on participant recall at longer intervals than one month during the study or at its conclusion.
 
Judgement of 'Unclear' if
there was retrospective recall over a short period only, or details of ascertainment were not described, i.e. insufficient information was provided to allow a judgement of 'Low risk' or 'High risk'.

Adapted from Table 8.5.a 'The Cochrane Collaboration's tool for assessing risk of bias' and Table 8.5.d 'Criteria for judging risk of bias in the 'Risk of bias' assessment tool' (Higgins 2011a)

Appendix 3. 'Risk of bias' assessment methods for incomplete outcome data (attrition bias)

Falls

For studies reporting falls as an outcome, we first calculated a rate ratio (RaR1) by dividing falls per person year in the intervention group by falls per person year in the control group. If these data or the numbers lost to follow‐up in each group were not available we assessed the risk of bias as 'Unclear'. We estimated a second rate of falling for all participants randomised (RaR2) by using the conservative assumption that participants lost to follow‐up in the intervention group had the same rate of falls as observed in the control group, and vice versa.

A ratio of these rate ratios (RaR2/RaR1) of greater than 1.15 or less than 0.85 was assessed as 'High risk' indicating the possibility of clinically important bias; studies with values between 0.85 and 1.15 were assessed as 'Low risk'.

Fallers

For risk of falling, we first calculated for intervention and control groups in each study a risk of falling and a risk of falling ratio (RR1) using for each group the number of participants falling divided by the number analysed. Where the number analysed in each group was not provided, we used as denominator the number in each group providing complete data on falling throughout the study period. Where these data were not specifically mentioned, we used number of participants randomised less the number lost to follow‐up as the denominator.

Using the conservative assumption that participants lost to follow‐up in the intervention group had experienced the risk of falling observed in the control group, and vice‐versa, we calculated an estimated risk of falling ratio for all participants randomised (RR2). We added an imputed number of fallers in each group (the number of lost participants who might have experienced a fall) to the observed number of fallers in each group. The number randomised to that group was used as the denominator.

A ratio of the risk ratios RR2/RR1 of greater than 1.15 or less than 0.85 was assessed as 'High risk' indicating the possibility of clinically important bias; values between 0.85 and 1.15 were assessed as 'Low risk'. When data were not available to calculate RR1 and RR2, risk was assessed as 'Unclear'.

Appendix 4. Description of included studies: reference links

Study description Links to references
Additional studies included in this update N = 51: Beling 2009; Beyer 2007; Bischoff‐Ferrari 2010; Blalock 2010; Ciaschini 2009; Clemson 2010; Comans 2010; Conroy 2010; Dangour 2011; Dapp 2011; Davis 2011a; De Vries 2010; Di Monaco 2008; Faes 2011; Fox 2010; Grahn Kronhed 2009; Haines 2009; Haran 2010; Harari 2008; Huang 2010; Huang 2011; Iwamoto 2009; Kamide 2009; Kärkkäinen 2010; Kemmler 2010; Logan 2010; Logghe 2009; Liu‐Ambrose 2008; Madureira 2010; Markle‐Reid 2010; McMurdo 2009; Parry 2009; Perry 2008; Pfeifer 2009; Pighills 2011; Ralston 2011; Reid 2006; Russell 2010; Ryan 2010; Sanders 2010; Sato 2005a (Retracted); Shyu 2010; Smulders 2010; Spink 2011; Suman 2011; Trombetti 2011; Vind 2009; Von Stengel 2011; Weber 2008; Wu 2010; Yamada 2010
Setting (country) Australia (N = 27): Barnett 2003; Brown 2002; Carter 1997; Clemson 2004; Clemson 2010; Comans 2010; Cumming 1999; Cumming 2007; Day 2002; Haines 2009; Haran 2010; Lannin 2007; Lord 1995; Lord 2003; Lord 2005; Newbury 2001; Nitz 2004; Pit 2007; Prince 2008; Russell 2010; Sanders 2010; Sherrington 2004; Spink 2011; Steinberg 2000; Stevens 2001; Voukelatos 2007; Whitehead 2003Australia and New Zealand (N = 1): Latham 2003Austria and Germany (N = 1): Pfeifer 2009
Brazil (N = 1): Madureira 2010
Canada (N = 12): Carter 2002; Ciaschini 2009; Davis 2011a; Gallagher 1996; Gray‐Donald 1995; Hogan 2001; Liu‐Ambrose 2004; Liu‐Ambrose 2008; Markle‐Reid 2010; Perry 2008; Robson 2003; Gill 2008Chile (N = 2): Bunout 2005; Dangour 2011China (N = 1): Woo 2007
Denmark (N = 2): Beyer 2007; Vind 2009  
Finland (N = 4): Kärkkäinen 2010; Korpelainen 2006; Luukinen 2007; Salminen 2009France (N = 3): Cornillon 2002; Pardessus 2002; Vellas 1991Germany (N = 6): Dapp 2011; Hauer 2001; Kemmler 2010; Nikolaus 2003; Pfeifer 2000; Von Stengel 2011
Italy (N = 1): Di Monaco 2008  
Japan (N = 6): Iwamoto 2009; Kamide 2009; Sato 2005a (Retracted); Shigematsu 2008; Suzuki 2004; Yamada 2010Netherlands (N = 9): De Vries 2010; Faes 2011; Hendriks 2008; Logghe 2009; Schrijnemaekers 1995; Smulders 2010; Van Haastregt 2000; Van Rossum 1993; Weerdesteyn 2006New Zealand (N = 6): Campbell 1997; Campbell 1999; Campbell 2005; Elley 2008; Reid 2006; Robertson 2001aNorway (N = 1): Helbostad 2004
Sweden (N = 1): Grahn Kronhed 2009Switzerland (N = 4): Bischoff‐Ferrari 2010; Dukas 2004; Swanenburg 2007; Trombetti 2011Taiwan (N = 6): Huang 2004; Huang 2005; Huang 2010; Huang 2011; Lin 2007; Shyu 2010Thailand (N = 2): Assantachai 2002; Jitapunkul 1998
United Kingdom (N = 27): Carpenter 1990; Close 1999; Conroy 2010; Davison 2005; Dhesi 2004; Foss 2006; Grant 2005; Harari 2008; Harwood 2004; Harwood 2005; Hill 2000; Kenny 2001; Kingston 2001; Lightbody 2002; Logan 2010; McMurdo 1997; McMurdo 2009; Parry 2009; Pighills 2011; Porthouse 2005; Skelton 2005; Smith 2007; Spice 2009; Steadman 2003; Suman 2011; Trivedi 2003; Vetter 1992
United Kingdom, Europe and North America (5 countries) (N = 1) Ryan 2010
United Kingdom, Belgium, France, USA (and 20 other unspecified countries) (N = 1): Ralston 2011USA (N = 34): Ballard 2004; Beling 2009; Bischoff‐Ferrari 2006; Blalock 2010; Buchner 1997a; Cerny 1998; Coleman 1999; Fabacher 1994; Fiatarone 1997; Fox 2010; Gallagher 2001; Greenspan 2005; Hornbrook 1994; Li 2005; Mahoney 2007; McKiernan 2005; Means 2005; Meredith 2002; Morgan 2004; Pereira 1998; Reinsch 1992; Resnick 2002; Rubenstein 2000; Rubenstein 2007; Ryan 1996; Shumway‐Cook 2007; Tinetti 1994; Wagner 1994; Weber 2008; Wilder 2001; Wolf 1996; Wolf 2003; Wu 2010; Wyman 2005
Participants  
Trials in which all participants were women N = 37: Ballard 2004; Beyer 2007; Campbell 1997; Carter 2002; Davis 2011a; Di Monaco 2008; Foss 2006; Gallagher 2001; Grahn Kronhed 2009; Greenspan 2005; Harwood 2004; Harwood 2005; Hauer 2001; Kamide 2009; Kärkkäinen 2010; Kemmler 2010; Kingston 2001; Korpelainen 2006; Liu‐Ambrose 2004; Lord 1995; Madureira 2010; McMurdo 1997; Pereira 1998; Pfeifer 2000; Porthouse 2005; Prince 2008; Ralston 2011; Reid 2006; Resnick 2002; Ryan 1996; Sanders 2010; Sato 2005a (Retracted); Skelton 2005; Suzuki 2004; Swanenburg 2007; Von Stengel 2011; Wyman 2005
Trials recruiting on the basis of identified falls history or one or more risk factors N = 83: Barnett 2003; Beling 2009; Beyer 2007Bischoff‐Ferrari 2010Blalock 2010; Campbell 1999; Campbell 2005; Ciaschini 2009; Clemson 2004; Clemson 2010; Close 1999; Comans 2010; Conroy 2010; Davison 2005; De Vries 2010; Dhesi 2004; Di Monaco 2008; Elley 2008; Faes 2011; Foss 2006; Gallagher 1996; Grant 2005; Haines 2009Haran 2010; Harwood 2004; Harwood 2005; Hauer 2001; Helbostad 2004; Hendriks 2008; Hill 2000; Hogan 2001; Huang 2005; Iwamoto 2009; Kenny 2001; Kingston 2001; Lightbody 2002; Lin 2007; Liu‐Ambrose 2008; Logan 2010Logghe 2009; Lord 1995; Lord 2005; Luukinen 2007; Mahoney 2007; Markle‐Reid 2010; McKiernan 2005; McMurdo 2009; Nikolaus 2003; Nitz 2004; Pardessus 2002; Parry 2009; Pighills 2011; Porthouse 2005; Prince 2008; Ralston 2011; Rubenstein 2000; Rubenstein 2007; Russell 2010; Ryan 2010; Salminen 2009; Sanders 2010; Sato 2005a (Retracted); Schrijnemaekers 1995; Sherrington 2004; Shyu 2010; Skelton 2005; Smulders 2010; Gill 2008; Spice 2009; Spink 2011; Steadman 2003; Suman 2011; Tinetti 1994; Trombetti 2011; Van Haastregt 2000; Vellas 1991; Vind 2009; Weber 2008; Weerdesteyn 2006; Whitehead 2003; Wolf 2003; Wu 2010; Wyman 2005
Trials excluding participants with cognitive impairment N = 89: Barnett 2003; Beyer 2007Blalock 2010; Brown 2002; Bunout 2005; Campbell 1997; Campbell 1999; Clemson 2004; Clemson 2010; Coleman 1999; Comans 2010; Cornillon 2002; Dangour 2011; Dapp 2011; Davis 2011a; Davison 2005; Day 2002; De Vries 2010; Dhesi 2004; Di Monaco 2008; Dukas 2004; Elley 2008; Fabacher 1994; Faes 2011; Foss 2006; Fox 2010; Grahn Kronhed 2009; Grant 2005; Haines 2009Haran 2010; Harari 2008; Harwood 2004; Harwood 2005; Hauer 2001; Helbostad 2004; Hendriks 2008; Hill 2000; Hogan 2001; Hornbrook 1994; Huang 2004; Huang 2005; Huang 2011; Kenny 2001; Kingston 2001; Korpelainen 2006; Lannin 2007; Latham 2003; Li 2005; Liu‐Ambrose 2004; Liu‐Ambrose 2008; Lord 2003; Lord 2005; Mahoney 2007; Markle‐Reid 2010; McKiernan 2005; McMurdo 2009; Means 2005; Morgan 2004; Nikolaus 2003; Pardessus 2002; Parry 2009; Pit 2007; Porthouse 2005; Prince 2008; Resnick 2002; Robertson 2001a; Rubenstein 2000; Rubenstein 2007; Ryan 2010; Salminen 2009; Schrijnemaekers 1995; Sherrington 2004; Shumway‐Cook 2007; Shyu 2010; Skelton 2005; Gill 2008; Spice 2009; Spink 2011; Steadman 2003; Stevens 2001; Tinetti 1994; Vellas 1991; Vind 2009; Voukelatos 2007; Whitehead 2003; Wolf 1996; Wolf 2003; Wyman 2005; Yamada 2010
Interventions  
Single  
Exercises N = 59
Predominantly group‐based: Ballard 2004; Barnett 2003; Beyer 2007; Brown 2002; Buchner 1997a; Bunout 2005; Carter 2002; Cerny 1998; Cornillon 2002; Dangour 2011 (physical activity group); Davis 2011a; Day 2002; Grahn Kronhed 2009; Hauer 2001; Helbostad 2004; Huang 2010 (Tai Chi group); Iwamoto 2009; Kemmler 2010; Korpelainen 2006; Li 2005; Liu‐Ambrose 2004; Logghe 2009; Lord 1995; Lord 2003; Luukinen 2007; Madureira 2010; McMurdo 1997; Means 2005; Morgan 2004; Nitz 2004; Pereira 1998; Reinsch 1992; Resnick 2002; Rubenstein 2000; Sherrington 2004; Shigematsu 2008; Skelton 2005; Smulders 2010; Steadman 2003; Suzuki 2004; Trombetti 2011; Voukelatos 2007; Weerdesteyn 2006; Wolf 1996; Wolf 2003; Woo 2007; Wu 2010 (Comm‐ex group); Yamada 2010
Home‐based: Bischoff‐Ferrari 2010 (extended physiotherapy group); Campbell 1997; Campbell 1999; Clemson 2010; Fiatarone 1997; Haines 2009; Kamide 2009; Latham 2003; Lin 2007; Liu‐Ambrose 2008; Robertson 2001a; Wu 2010 (Tele‐ex and Home‐ex groups)
Medication (drug target, i.e. withdrawal, dose reduction or increase, substitution, provision) N = 26
Vitamin D: (Bischoff‐Ferrari 2006; Bischoff‐Ferrari 2010; Dhesi 2004; Dukas 2004; Gallagher 2001; Grant 2005; Harwood 2004; Kärkkäinen 2010; Latham 2003; Pfeifer 2000; Pfeifer 2009; Porthouse 2005; Prince 2008; Sanders 2010; Smith 2007; Trivedi 2003)
Other: Blalock 2010; Campbell 1999; Greenspan 2005; Meredith 2002; Pit 2007; Ralston 2011; Reid 2006; Sato 2005a (Retracted); Vellas 1991; Weber 2008
Surgery N = 5: Foss 2006; Harwood 2005; Kenny 2001; Parry 2009; Ryan 2010
Fluid or nutrition therapy N = 3: Dangour 2011 (nutritional supplementation group); Gray‐Donald 1995; McMurdo 2009
Psychological interventions N = 2: Huang 2011 (cognitive behavioural therapy group); Reinsch 1992
Environment/assistive technology N = 13: Campbell 2005; Cumming 1999; Cumming 2007; Day 2002; Haran 2010; Lannin 2007; Lin 2007; McKiernan 2005; Nikolaus 2003; Pardessus 2002; Perry 2008; Pighills 2011; Stevens 2001
Interventions to increase knowledge N = 5: Dapp 2011; Harari 2008; Huang 2010 (education group); Robson 2003; Ryan 1996
Multiple N = 18: Assantachai 2002; Beling 2009; Campbell 2005; Carter 1997; Clemson 2004; Comans 2010; Day 2002; Di Monaco 2008; Faes 2011; Hill 2000; Huang 2010 (Tai Chi + education group); Huang 2011 (Tai Chi + cognitive behavioural therapy group); Shumway‐Cook 2007; Spink 2011; Steinberg 2000; Swanenburg 2007; Von Stengel 2011; Wilder 2001
Multifactorial N = 40: Carpenter 1990; Ciaschini 2009; Close 1999; Coleman 1999; Conroy 2010; Davison 2005; De Vries 2010; Elley 2008; Fabacher 1994; Fox 2010; Gallagher 1996; Gill 2008; Hendriks 2008; Hogan 2001; Hornbrook 1994; Huang 2004; Huang 2005; Jitapunkul 1998; Kingston 2001; Lightbody 2002; Logan 2010; Lord 2005; Mahoney 2007; Markle‐Reid 2010; Newbury 2001; Rubenstein 2007; Russell 2010; Salminen 2009; Schrijnemaekers 1995; Shyu 2010; Spice 2009; Suman 2011; Tinetti 1994; Van Haastregt 2000; Van Rossum 1993; Vetter 1992; Vind 2009; Wagner 1994; Whitehead 2003; Wyman 2005

Appendix 5. Mean baseline vitamin D levels (25(OH)D) in included trials (nmol/L)

Study Overall Intervention Control Men Women Selection criterion
Bischoff‐Ferrari 2006 74.7 (SD 38.3) ND ND 82.9 (SD 44.9) 66.4 (SD 31.7) No
Bischoff‐Ferrari 2010 31.8 (SD 19.6)a Factorial design:
2000 IU/d 32.9 (SD 20.2)a
800 IU/d 30.7 (SD 19.2)a
extended PT 34.9 (SD 22.0)a
standard PT 28.7 (SD 17.0)a
NA ND ND No
Dhesi 2004 (range 23.7 to 28.0)a 26.7 (range 25.5 to 28.0)a 25.0 (range 23.7 to 26.1)a ND ND Yes
25(OH)D ≤ 30a
Dukas 2004 72.6 (SD 27.9)a 74.6 (SD 29.0)a 70.6 (SD 26.7)a ND ND No
Gallagher 2001 79.3 (SD 24.7) 78.0 (SD 21.6)b 80.5 (SD 27.4) ND ND No
Grant 2005 38.8 (SD 15.6)c 38.0 (SD 16.3)c 39.5 (SD 14.8)c ND ND No
Harwood 2004 29.5 (range 6 to 85) 29 (range 6 to 85) 30 (range 12 to 64) NA 29 (range 6 to 85) No
Kärkkäinen 2010 49.7 (SD18.3) 50.1 (SD 18.8) 49.2 (SD 17.7) NA 49.7 (SD 18.3) No
Latham 2003 ND 37.4 (95% CI 34.9 to 44.9)a 47.4 (95% CI 39.9 to 52.4)a ND ND No
Pfeifer 2000 25.2 (SD 12.9) 25.7 (SD 13.6) 24.6 (SD 12.1) NA ND Yes
25(OH)D < 50
Pfeifer 2009 54.5 (SD 18) 55 (SD 18) 54 (SD 18) ND ND YES
25(OH)D < 78
Porthouse 2005 ND ND ND ND ND No
Prince 2008 44.8 (SD 12.7)a 45.2 (SD 12.5)a 44.3 (SD 12.8)a ND ND Yes
25(OH)D < 59.9a
Sanders 2010 ND Median (IQR) 
53 (40 to 65)
Median (IQR)
45 (40 to 57)
NA ND 36% (819/2256) were classified as being at high risk of low vitamin D at baseline
Smith 2007 ND ND ND ND ND No
Trivedi 2003 ND ND ND ND ND No

a Converted from ng/mL (ng/mL x 2.496 = nmol/L)
b Calcitriol alone intervention group
c Data from two trial centres only (random as stratified by trial centre)
NA: not applicable
ND: no data available
25(OH)D: 25‐hydroxyvitamin D

Appendix 6. Categories of exercise (ProFaNE) in interventions containing exercise alone

Study ID Gait/balance/functional training Strength/resistance training Flexibility 3D (Tai Chi, dance etc) General physical activity Endurance Other
Ballard 2004 *****a ***** *****     *****  
Barnett 2003 ***** ***** *****     *****  
Beyer 2007 ***** ***** *****        
Bischoff‐Ferrari 2010 *****
extended physiotherapy groupsb
*****
extended physiotherapy groups
         
Brown 2002 ***** ***** *****     *****  
Buchner 1997a   *****       *****  
Bunout 2005   *****     *****    
Campbell 1997 ***** ***** *****   *****    
Campbell 1999 ***** ***** *****   *****    
Carter 2002 ***** ***** *****        
Cerny 1998 ***** ***** *****     *****  
Clemson 2010 *****
embedded in daily activities *****
embedded in daily activities          
Cornillon 2002 ***** ? ?     ? ?
Dangour 2011   *****   *****
(dance)
*****    
Davis 2011a *****
balance and tone group
*****
once‐weekly, and twice‐weekly resistance training groups
*****
balance and tone group
      *****
balance and tone group
(core strength, pelvic floor, relaxation)
Day 2002 ***** ***** *****        
Fiatarone 1997   *****          
Grahn Kronhed 2009 ***** ***** *****     *****  
Hauer 2001 ***** ***** *****     *****  
Helbostad 2004 ***** *****          
Haines 2009 ***** *****   *****
(dynamic slow movement similar to Tai Chi)
     
Huang 2010       *****      
Iwamoto 2009 ***** ***** *****       *****
(multi‐directional stepping to improve walking ability)
Kamide 2009 ***** ***** *****        
Kemmler 2010 *****
high‐intensity group
low‐intensity group
*****
high‐intensity group
low‐intensity group
*****
high‐intensity group
low‐intensity group
*****
high‐intensity group (dance)
low‐intensity group (dance)
  *****
high‐intensity group
low‐intensity group
 
Korpelainen 2006 *****     *****
(dance)     *****
(stamping)
Latham 2003   *****          
Li 2005       *****      
Lin 2007 ***** ***** *****        
Liu‐Ambrose 2004 *****
agility training group *****
resistance training group          
Liu‐Ambrose 2008 ***** ***** *****   *****    
Logghe 2009       *****      
Lord 1995 ***** ***** *****        
Lord 2003 ***** ***** ***** *****
(dance)      
Luukinen 2007 *****   *****   *****   *****
(self care)
Madureira 2010 *****   *****   *****    
McMurdo 1997 *****            
Means 2005 ***** ***** *****        
Morgan 2004 ***** ***** *****        
Nitz 2004 *****   *****     *****  
Pereira 1998         *****
(walking)
   
Reinsch 1992 *****
"stand up/step up" group *****
"stand up/step up" group          
Resnick 2002         *****
(walking)
   
Robertson 2001a ***** ***** *****   *****    
Rubenstein 2000 ***** *****       *****  
Sherrington 2004 ***** *****          
Shigematsu 2008       *****
square stepping group *****
walking group    
Skelton 2005 ***** ***** *****     *****  
Smulders 2010 *****       *****
(walking)
***** *****
(training in fall techniques, lifting techniques)
Steadman 2003 *****            
Suzuki 2004 ***** ***** ***** *****      
Trombetti 2011 *****   *****       *****
(multi‐directional weight‐shifting exercises while walking and standing to different music rhythms)
Voukelatos 2007       *****      
Weerdesteyn 2006 *****            
Wolf 1996 *****
balance platform training group     *****
Tai Chi group      
Wolf 2003       *****      
Woo 2007   *****
resistance training group   *****
Tai Chi group      
Wu 2010     *****
telecommunication group (home)
community‐centre group
DVD group (home)
*****
telecommunication group (home)
community‐centre group
DVD group (home)
     
Yamada 2010 ***** ***** *****   ***** *****  

a ***** indicates exercise categories in intervention

b "groups" are separate arms in the trial, i.e. people were randomised to the separate groups

Appendix 7. Source of data for generic inverse variance analysis (see footnotes for explanation of codes)

Study ID Source for rate ratio
(falls)
Source for risk ratio
(fallers)
Source for risk ratio
(number with fractures)
Assantachai 2002 NA 7c NA
Ballard 2004 3 7 NA
Barnett 2003 1 5 NA
Beling 2009 3 NA NA
Beyer 2007 NA 7 NA
Bischoff‐Ferrari 2006 3 6a 7
Bischoff‐Ferrari 2010 1 NA 7
Blalock 2010 3 7 NA
Brown 2002  NA 7 NA
Buchner 1997a 1 4 NA
Bunout 2005 3 7 NA
Campbell 1997 2 4 NA
Campbell 1999 2a 5 NA
Campbell 2005 1 7 NA
Carpenter 1990 3 NA NA
Carter 1997 NA 7 NA
Carter 2002 3 NA NA
Cerny 1998 NA 7 NA
Ciaschini 2009 NA 5 5
Clemson 2004 1 5 NA
Clemson 2010 1 7 NA
Close 1999 3 6a 7
Coleman 1999 NA 7c NA
Comans 2010 1 7 NA
Conroy 2010 1a 4 7
Cornillon 2002 3 7 NA
Cumming 1999 2 4 NA
Cumming 2007 1 4 4
Dangour 2011 NA 7c ND
Dapp 2011 NA 7 NA
Davis 2011a 1 NA NA
Davison 2005 1 5 5
Day 2002 1 4 NA
De Vries 2010 NA 4 4
Dhesi 2004 3 7 NA
Di Monaco 2008 3 7 NA
Dukas 2004  NA 6a NA
Elley 2008 1 7 NA
Fabacher 1994 NA 7 NA
Faes 2011 1 7 NA
Fiatarone 1997 NA ND NA
Foss 2006 1 4 5
Fox 2010 NA 6a NA
Gallagher 1996 3 NA NA
Gallagher 2001 1a 6a (vitamin D group vs control)
7 (HRT group vs control and
vitamin D + HRT group vs control)
5
Gill 2008 NA 7 NA
Grahn Kronhed 2009 ND NA ND
Grant 2005 NA 4 4
Gray‐Donald 1995 NA 7 NA
Greenspan 2005 NA 7 NA
Haines 2009 1 7 7
Haran 2010 1 7 7
Harari 2008 NA ND (multiple fallers only) NA
Harwood 2004 NA 7 7
Harwood 2005 1 4 5
Hauer 2001 NA 5 NA
Helbostad 2004 3 7 NA
Hendriks 2008 NA 4 NA
Hill 2000 3 NA NA
Hogan 2001 2a 7 7
Hornbrook 1994 3 7 ND
Huang 2004 NA 7 NA
Huang 2005 NA 7 NA
Huang 2010 NA 7c NA
Huang 2011 3 7 NA
Iwamoto 2009   ND 7 ND
Jitapunkul 1998 NA 7 NA
Kamide 2009 ND 7 NA
Kärkkäinen 2010   3 5 4
Kemmler 2010  3 5 ND
Kenny 2001 1 NA 7
Kingston 2001 NA 7 NA
Korpelainen 2006 3 NA 7
Lannin 2007 NA 7 NA
Latham 2003 3 4 NA
Li 2005 2a 4 NA
Lightbody 2002 3 7 7
Lin 2007 3 NA NA
Liu‐Ambrose 2004 3 ND (multiple fallers only) NA
Liu‐Ambrose 2008 1 7 NA
Logan 2010 1a 4a ND
Logghe 2009 2 7 NA
Lord 1995 3 5 NA
Lord 2003 1a NA NA
Lord 2005 3 7 NA
Luukinen 2007 2 7 NA
Madureira 2010 ND NA NA
Mahoney 2007 1 NA NA
Markle‐Reid 2010 3 7 ND
McKiernan 2005 1 NA NA
McMurdo 1997 3 7 7
McMurdo 2009 ND 7 NA
Means 2005 3 7 NA
Meredith 2002 NA 7 NA
Morgan 2004 NA 7 NA
Newbury 2001 NA 6 NA
Nikolaus 2003 1 NA 7
Nitz 2004 3 NA NA
Pardessus 2002 NA 7 NA
Parry 2009   1a 7 ND
Pereira 1998 NA 7 NA
Perry 2008 NA 7 NA
Pfeifer 2000 3 7 7
Pfeifer 2009 ND 4 7
Pighills 2011 (OT) 1 7 NA
Pighills 2011 (non‐OT) 1 7 NA
Pighills 2011 (OT + non‐OT) ND 7 NA
Pit 2007 NA 6a NA
Porthouse 2005 3 6a 6a
Prince 2008 NA 6 ND
Ralston 2011 NA 4 NA
Reid 2006 ND NA 4
Reinsch 1992 NA 7c NA
Resnick 2002 ND NA NA
Robertson 2001a 1 7 7
Robson 2003 NA 7 NA
Rubenstein 2000 3 7 NA
Rubenstein 2007 3c 7c NA
Russell 2010 1 5 5
Ryan 1996 3 7 NA
Ryan 2010 1 4 NA
Salminen 2009 1 7 NA
Sanders 2010   1 4 7
Sato 2005a (Retracted) ND NA 7
Schrijnemaekers 1995 NA 7 NA
Sherrington 2004 NA 7 NA
Shigematsu 2008 3 7 NA
Shumway‐Cook 2007 1 5 NA
Shyu 2010 NA 6 NA
Skelton 2005 1 7 NA
Smith 2007 NA 4a 4a
Smulders 2010  1 7 7
Spice 2009 NA 7c NA
Spink 2011 1 5 5
Steadman 2003 3 NA NA
Steinberg 2000 3c 7c NA
Stevens 2001 1a 6b NA
Suman 2011 1 6 7
Suzuki 2004 3 7 NA
Swanenburg 2007 3 NA NA
Tinetti 1994 1ac 7c 7c
Trivedi 2003 NA 5a 5a
Trombetti 2011 1 4 NA
Van Haastregt 2000 NA 7 NA
Van Rossum 1993 ND NA NA
Vellas 1991 ND NA NA
Vetter 1992 NA 7 7
Vind 2009   1 4 ND
Von Stengel 2011   1 NA 7
Voukelatos 2007 1 4 NA
Wagner 1994 ND 7 NA
Weber 2008 ND ND NA
Weerdesteyn 2006 3 7 NA
Whitehead 2003 NA 6a NA
Wilder 2001 ND NA NA
Wolf 1996 3 NA NA
Wolf 2003 2b 7c NA
Woo 2007 NA 7 NA
Wu 2010 ND NA NA
Wyman 2005 1 7 NA
Yamada 2010 1 7 NA
Abbreviations:
OT: occupational therapist group
non‐OT: trained assessor group
OT + non‐OT: occupational therapist group + trained assessor group
Codes for source of rate ratio:
1: incidence rate ratio reported by trial authors
2: hazard ratio/relative hazard (multiple events) reported by trial authors
3: incidence rate ratio calculated by review authors
a: adjusted for confounders by trial authors
b: adjusted for clustering by trial authors
c: adjusted for clustering by review authors
Codes for source of risk ratio:
4: hazard ratio/relative hazard (first fall only) reported by trial authors
5: relative risk reported by trial authors
6: odds ratio reported by trial authors
7: relative risk calculated by review authors
a: adjusted for confounders by trial authors
b: adjusted for clustering by trial authors
c: adjusted for clustering by review authors
NA: not applicable. Falls (for rate ratio) or fallers (for risk ratio) or number of people sustaining a fracture (for risk ratio) not reported as an outcome in the trial
ND: outcomes relating to falls or fallers or fractures were reported, but there were no useable data; results from the paper reported in the text of the review

Appendix 8. Raw data for rate of falls and number of fallers when available

Study ID Intervention group: falls per person year  Control group: falls per person year Intervention group: number of fallers Intervention group: number in analysis  Intervention group: proportion of fallers Control group: number of fallers Control group: number in analysis Control group: proportion of fallers Follow‐up
Assantachai 2002 125 430 0.29 145 385 0.38 12 mo
Ballard 2004 0.16 0.41 4 20 0.20 7 19 0.37 16 mo
Barnett 2003 0.605 0.946 27 76 0.36 37 74 0.50 12 mo
Beling 2009 0.36 2.00 11 8 3 mo
Beyer 2007 12 24 0.50 14 29 0.48 12 mo
Bischoff‐Ferrari 2006 0.42 0.37 107 219 0.49 124 226 0.55 36 mo
Bischoff‐Ferrari 2010
Cholecalciferol 2000 IU/d vs 800 IU/d 1.63 1.25 86 87 12 mo
Extended vs standard physiotherapy 1.21 1.66 87 86 12 mo
Blalock 2010 2.16 2.13 53 93 0.57 52 93 0.56 12 mo
Brown 2002
Exercise classes vs control 20 39 0.51 21 32 0.66 14 mo
Social sessions vs control 24 37 0.65 21 32 0.66 14 mo
Buchner 1997a 0.49 0.81 29 70 0.41 18 30 0.60 25 mo
Bunout 2005 0.23 0.18 23 111 0.21 16 130 0.12 12 mo
Campbell 1997 0.87 1.34 53 116 0.46 62 117 0.53 12 mo
Campbell 1999
Home exercise vs remainder 0.71 0.97 12 45 0.27 16 48 0.33 11 mo
Withdrawal of psychotropic medication vs remainder 0.52 1.16 11 48 0.23 17 45 0.38 11 mo
Campbell 2005
Home exercise + vitamin D vs remainder 1.23 1.13 94 195 0.48 95 196 0.48 12 mo
Home safety vs remainder 0.90 1.47 83 198 0.42 106 193 0.55 12 mo
Carpenter 1990 0.80 2.32 181 186 1 mo
Carter 1997
Feedback on home safety checklist, pamphlet on medicines 19 163 0.12 29 161 0.18 3 mo
Home safety + medication review 19 133 0.14 29 161 0.18 3 mo
Carter 2002 0.46 0.52 40 40 5 mo
Cerny 1998 3 15 0.20 3 13 0.23 6 mo
Ciaschini 2009 26 101 0.26 17 100 0.17 6 mo
Clemson 2004 82 157 0.52 89 153 0.58 14 mo
Clemson 2010 8 17 0.47 9 14 0.64 6 mo
Close 1999 1.30 3.13 59 184 0.32 111 213 0.52 12 mo
Coleman 1999 34 79 0.43 24 63 0.38 12 mo
Comans 2010 1.1 2.3 12 32 0.38 27 41 0.66 6 mo
Conroy 2010 1.7 2.0 69 136 0.51 73 138 0.53 12 mo
Cornillon 2002 0.39 0.47 39 150 0.26 48 153 0.31 12 mo
Cumming 1999 96 264 0.36 119 266 0.45 12 mo
Cumming 2007 201 309 0.65 153 307 0.50 12 mo
Dangour 2011
Group exercise classes vs remainder
402 854 0.47 389 811 0.48 24 mo
Nutritional supplement vs remainder 404 865 0.47 387 800 0.48 24 mo
Dapp 2011 130 587 0.22 332 1376 0.24 12 mo
Davis 2011a
Once weekly resistance training vs balance and tone classes 54 49 12 mo
Twice weekly resistance training vs balance and tone classes 52 49 12 mo
Davison 2005 3.3 5.1 94 144 0.65 102 149 0.68 12 mo
Day 2002
Exercise vs remainder 0.91 1.14 279 541 0.52 327 549 0.60 18 mo
Vision intervention vs remainder 0.98 1.08 291 547 0.53 315 543 0.58 18 mo
Home safety intervention vs remainder 1.02 1.04 285 543 0.52 321 547 0.59 18 mo
Exercise + vision vs remainder 0.74 66 136 0.49 470 954 0.49 18 mo
Exercise + home safety vs remainder 0.88 72 135 0.53 471 955 0.49 18 mo
Vision + home safety vs remainder 1.06 78 137 0.57 469 953 0.49 18 mo
Exercise + vision + home safety vs remainder 0.96 65 135 0.48 471 955 0.49 18 mo
De Vries 2010 55 106 0.52 62 111 0.56 12 mo
Dhesi 2004 0.48 0.79 11 62 0.18 14 61 0.23 6 mo
Di Monaco 2008 0.37 0.79 6 45 0.13 13 50 0.26 6 mo
Dukas 2004 40 166 0.24 46 155 0.30 9 mo
Elley 2008 1.91 2.01 106 155 0.68 98 157 0.62 12 mo
Fabacher 1994 14 100 0.14 22 95 0.23 12 mo
Faes 2011 4.94 1.17 10 18 0.56 6 15 0.40 7 mo
Fiatarone 1997 4 mo
Foss 2006 1.06 1.57 48 120 0.40 41 119 0.34 12 mo
Fox 2010 288 264 12 mo
Gallagher 1996 3.40 4.20 50 50 6 mo
Gallagher 2001
Vitamin D vs control
0.27 0.43 50 101 0.50 72 112 0.64 36 mo
HRT vs control 0.39 0.43 57 100 0.57 72 112 0.64 36 mo
HRT + vitamin D vs control 0.35 0.43 59 102 0.58 72 112 0.64 36 mo
Gill 2008 51 117 0.44 53 117 0.45 12 mo
Grahn Kronhed 2009 12 mo
Grant 2005
Vitamin D vs no vitamin D 380 2649 0.14 381 2643 0.14 4 mo
Gray‐Donald 1995 0 22 0.00 5 24 0.21 3 mo
Greenspan 2005 93 187 0.50 94 185 0.51 36 mo
Haines 2009 11 19 0.58 20 34 0.59 6 mo
Haran 2010 1.54 1.66 170 299 0.57 175 298 0.59 13 mo
Harari 2008 12 mo
Harwood 2004 15 84 0.18 13 35 0.37 12 mo
Harwood 2005 0.37 0.55 76 142 0.54 69 131 0.53 12 mo
Hauer 2001  14 31 0.45 15 25 0.60 6 mo
Helbostad 2004 1.45 1.33 20 34 0.59 18 34 0.53 12 mo
Hendriks 2008 55 124 0.44 63 134 0.47 12 mo
Hill 2000 8.4 9.4 40 38 6 mo
Hogan 2001 54 75 0.72 61 77 0.79 12 mo
Hornbrook 1994 0.586 0.699 628 1611 0.39 691 1571 0.44 23 mo
Huang 2004 0 55 0.00 4 58 0.07 2 mo
Huang 2005 5 63 0.08 7 59 0.12 3 mo
Huang 2010
Education programme vs control 2 29 0.07 2 47 0.04 5 mo
Tai Chi classes vs control 0 31 0.00 2 47 0.04 5 mo
Tai Chi classes + education programme vs control 3 56 0.05 2 47 0.04 5 mo
Huang 2011
Cognitive behavioural therapy vs control 0.01 0.01 8 60 0.13 8 60 0.13 3 mo
Cognitive behavioural therapy + Tai Chi classes vs control 0.01 0.004 3 56 0.05 8 60 0.13 3 mo
Iwamoto 2009 0.00 0.29 0 34 0.00 4 33 0.12 5 mo
Jitapunkul 1998 3 57 0.05 6 59 0.10 3 mo
Kamide 2009 0 20 0.00 1 23 0.04 6 mo
Kärkkäinen 2010 0.39 0.41 812 1566 0.52 833 1573 0.53 36 mo
Kemmler 2010 0.17 0.28 112 115 18 mo
Kenny 2001 4.1 9.3 84 87 12 mo
Kingston 2001 4 51 0.08 5 41 0.12 3 mo
Korpelainen 2006 0.42 0.53 84 76 30 mo
Lannin 2007 1 5 0.20 2 5 0.40 3 mo
Latham 2003
Resistance training vs no resistance training 1.02 1.07 60 112 0.54 64 110 0.58 6 mo
Vitamin D vs no vitamin D 1.11 0.99 64 108 0.59 60 114 0.53 6 mo
Li 2005 0.80 1.57 27 95 0.28 43 93 0.46 6 mo
Lightbody 2002 1.82 2.15 39 155 0.25 41 159 0.26 6 mo
Lin 2007
Home safety vs education 0.40 0.88 6 mo
Home exercise vs education 0.58 0.88 6 mo
Liu‐Ambrose 2004
Group resistance training  vs stretching (sham) exercises 1.13 0.63 32 32 6 mo
Group agility training vs stretching (sham) exercises 0.65 0.63 34 32 6 mo
Liu‐Ambrose 2008 12 28 0.43 16 24 0.67 12 mo
Logan 2010 3.46 7.68 81 98 0.83 96 99 0.97 12 mo
Logghe 2009 58 138 0.42 59 131 0.45 12 mo
Lord 1995 0.53 0.63 26 75 0.35 33 94 0.35 12 mo
Lord 2003 0.67 0.85 259 249 12 mo
Lord 2005
Extensive intervention group vs control 0.906 0.871 93 202 0.46 90 201 0.45 12 mo
Minimal intervention group vs control 0.784 0.871 94 194 0.48 90 201 0.45 12 mo
Extensive + minimal intervention groups vs control 0.846 0.871 187 396 0.47 90 201 0.45 12 mo
Luukinen 2007 1.23 1.15 126 217 0.58 136 220 0.62 16 mo
Madureira 2010 30 30 12 mo
Mahoney 2007 1.88 2.31 172 172 12 mo
Markle‐Reid 2010 0.73 0.67 28 49 0.57 20 43 0.47 6 mo
McKiernan 2005 1.91 3.67 55 54 3 mo
McMurdo 1997 0.17 0.32 13 44 0.30 21 48 0.44 24 mo
McMurdo 2009 26 93 0.28 33 98 0.34 4 mo
Means 2005 0.48 1.18 22 144 0.15 36 94 0.38 6 mo
Meredith 2002 17 130 0.13 15 129 0.12 3 mo
Morgan 2004 34 119 0.29 34 110 0.31 12 mo
Newbury 2001 12 45 0.27 17 44 0.39 12 mo
Nikolaus 2003 0.965 1.243 140 139 12 mo
Nitz 2004 1.00 1.24 24 21 6 mo
Pardessus 2002 13 30 0.43 15 30 0.50 12 mo
Parry 2009a 6.51 8.31 16 25 0.64 14 25 0.56 6 mo
Pereira 1998 26 96 0.27 33 100 0.33 12 mo
Perry 2008 5 20 0.25 9 20 0.45 3 mo
Pfeifer 2000 0.24 0.45 11 70 0.16 19 67 0.28 12 mo
Pfeifer 2009 49 122 0.40 75 120 0.63 12 mo
Pighills 2011
Occupational therapist led environmental assessment vs control 50 85 0.59 54 77 0.70 12 mo
Trained assessor led environmental assessment vs control 50 71 0.70 54 77 0.70 12 mo
Occupational therapist group + trained assessor group combined vs control 100 156 0.64 54 77 0.70 12 mo
Pit 2007 70 350 0.20 94 309 0.30 12 mo
Porthouse 2005 0.51 0.57 329 1125 0.29 561 1877 0.30 12 mo
Prince 2008 80 151 0.53 95 151 0.63 12 mo
Ralston 2011 257 0.24 258 0.30 12 mo
Reid 2006 0.595 0.585 620 635 60 mo
Reinsch 1992
Exercise vs no exercise 55 129 0.43 34 101 0.34 12 mo
Cognitive‐behavioural vs no cognitive‐behavioural intervention 50 123 0.41 39 107 0.36 12 mo
Resnick 2002 10 7 6 mo
Robertson 2001a 0.69 1.01 38 121 0.31 51 119 0.43 12 mo
Robson 2003 41 235 0.17 55 236 0.23 4 mo
Rubenstein 2000 1.68 2.00 12 28 0.43 9 31 0.29 3 mo
Rubenstein 2007 1.51 1.27 160 327 0.49 167 352 0.47 12 mo
Russell 2010 2.77 4.24 163 320 0.51 151 330 0.46 12 mo
Ryan 1996 0.53 1.60 3 30 0.10 3 15 0.20 3 mo
Ryan 2010 1.71 1.32 44 66 0.67 33 62 0.53 24 mo
Salminen 2009 0.86 0.94 140 292 0.48 131 297 0.44 12 mo
Sanders 2010 0.834 0.727 837 1131 0.74 769 1125 0.68 60 mo
Sato 2005a (Retracted) 90 88 24 mo
Schrijnemaekers 1995 17 85 0.20 26 97 0.27 6 mo
Sherrington 2004
Weight‐bearing exercise vs control 11 35 0.31 15 36 0.42 4 mo
Non weight‐bearing exercise vs control 11 37 0.30 15 36 0.42 4 mo
Shigematsu 2008 0.234 0.333 4 32 0.13 7 36 0.19 8 mo
Shumway‐Cook 2007 1.33 1.77 124 226 0.55 130 227 0.57 12 mo
Shyu 2010 55 48 24 mo
Skelton 2005 35 43 0.81 23 27 0.85 9 mo
Smith 2007 2544 4727 0.55 2577 4713 0.55 36 mo
Smulders 2010 0.72 1.18 21 47 0.45 23 45 0.51 12 mo
Spice 2009 276 346 0.80 133 159 0.84 12 mo
Spink 2011 0.69 1.07 64 153 0.42 75 152 0.49 12 mo
Steadman 2003 7.13 7.13 69 64 1 mo
Steinberg 2000
Education + exercise vs education 0.76 0.85 39 69 0.57 42 63 0.67 17 mo
Education + exercise + home safety vs education 0.79 0.85 35 61 0.57 42 63 0.67 17 mo
Education + exercise + home safety + clinical assessment vs education 0.76 0.85 32 59 0.54 42 63 0.67 17 mo
Stevens 2001 0.69 0.72 524 1091 12 mo
Suman 2011 50 183 0.27 38 166 0.23 12 mo
Suzuki 2004 0.16 0.46 3 22 0.14 12 22 0.55 20 mo
Swanenburg 2007 10 10 12 mo
Tinetti 1994 0.62 0.94 52 147 0.35 68 144 0.47 12 mo
Trivedi 2003 254 1027 0.25 261 1011 0.26 12 mo
Trombetti 2011 0.7 1.6 19 66 0.29 32 68 0.47 6 mo
Van Haastregt 2000 63 127 0.50 53 120 0.44 12 mo
Van Rossum 1993 36 mo
Vellas 1991 48 47 6 mo
Vetter 1992 95 240 0.40 65 210 0.31 48 mo
Vind 2009 110 196 0.56 101 196 0.52 12 mo
Von Stengel 2011 0.43 1.14 47 50 18 mo
Voukelatos 2007 0.50 0.75 71 347 0.20 81 337 0.24 6 mo
Wagner 1994
Multifactorial intervention vs control 175 635 0.28 223 607 0.37 12 mo
Chronic disease prevention nurse visit vs control 94 317 0.30 223 607 0.37 12 mo
Weber 2008 15 mo
Weerdesteyn 2006 0.89 1.68 10 30 0.33 9 28 0.32 7 mo
Whitehead 2003 28 58 0.48 15 65 0.23 6 mo
Wilder 2001 12 mo
Wolf 1996
Tai Chi group vs education 0.86 1.29 72 64 8 mo
Balance training vs education 1.53 1.29 64 64 8 mo
Wolf 2003 69 145 0.48 85 141 0.60 11 mo
Woo 2007
Tai Chi group vs control 15 60 0.25 31 60 0.52 12 mo
Group resistance training vs control 24 60 0.40 31 60 0.52 12 mo
Wu 2010
Telecommunication‐based Tai Chi vs group Tai Chi 22 20 4 mo
Home video‐based Tai Chi vs group Tai Chi 22 20 4 mo
Wyman 2005 0.637 (12 mo) 0.888 (12 mo) 59 126 0.47 53 126 0.42 24 mo
Yamada 2010 5 29 0.17 11 29 0.38 12 mo

a cross‐over trial
mo: months

Appendix 9. Description of excluded studies: reference links

Reason for exclusion Links to references
Types of studies  
Not an RCT N = 9: Alexander 2003; Barr 2005; Graafmans 1996; Inokuchi 2007; Jee 2004; Kerschan‐Schindl 2000; Robertson 2001b; Rucker 2006; Ytterstad 1996
Types of participants  
Not meeting age criteria N = 9: Alp 2007; Armstrong 1996; Bea 2011; Ebrahim 1997; Kruse 2010; Lawton 2008; Reid 2008; Ringe 2007; Teixeira 2010
Not predominantly community‐dwelling N = 7: Berggren 2008; Chapuy 2002; Faber 2006; Sakamoto 2006; Sambrook 2012; Shaw 2003; Shimada 2003
Participants post stroke N = 1: Green 2002
Participants with Parkinson's disease N = 2: Ashburn 2007; Sato 2006
Types of outcome measures  
Falls outcomes not reported N = 8: Kiehn 2009; Peterson 2004; Sohng 2003; Stineman 2011; Wolfson 1996; Yardley 2007; Yates 2001; Zhang 2006
Falls reported as adverse events N = 18: Aisen 2011; Crotty 2002; De Deyn 2005; Dubbert 2002; Dubbert 2008; Elley 2003; Gill 2002; Kerse 2010; McMurdo 2010; Orwig 2011; Rosie 2007; Singh 2005; Sumukadas 2007; Tennstedt 1998; Tinetti 1999; Vogler 2009; Witham 2010; Zijlstra 2009
Other reasons N = 11: Edwards; Iwamoto 2005; Larsen 2005Lehtola 2000; Means 1996; N0025078568; N0084162084; N0105009461; N0582105006; Sato 2005b; Xia 2009

Appendix 10. Adverse effects possibly attributable to vitamin D or vitamin D analogues reported in included studies

Study ID Hypercalcaemia Renal disease Gastrointestinal effects Other
Bischoff‐Ferrari 2006 (reported in Dawson‐Hughes 1999) ND Only side effects resulting in discontinuation of treatment. Calcium–vitamin D group: hypercalciuria 1/219 Only side effects resulting in discontinuation of treatment. Placebo group: epigastric distress 2/216.
Calcium–vitamin D group: constipation 3/219, epigastric distress 1/219
Only side effects resulting in discontinuation of treatment. Placebo group: flank pain 1/216. Calcium–vitamin D group:
sweating 1/219.
Bischoff‐Ferrari 2010 At 7 to 10 days mild hypercalcaemia was recorded in two 800 IU participants and one 2000 IU participant. 
At 6‐month follow‐up mild hypercalcaemia was recorded in one 800 IU participant, and in two 2000 IU participants. 
“Creatinine clearance did not differ significantly between groups at baseline or at 7 to 10 days, or 6 and 12 months of follow‐up. There was no report of nephrolithiasis throughout the trial period.” ND  ND
Dhesi 2004  —
Dukas 2004 "During the 36 weeks of intervention, six cases (1 in the placebo group and 5 in the alfacalcidol group) of slight transient hypercalcemia (one measurement of serum
calcium above normal with subsequent (1 week later)
control measurement within normal ranges) were observed..." "The difference in the incidence of hypercalcaemia between study groups was not significant (P=0.0621)." ND ND “Frequency of reported side effects was equally distributed between treatment groups (82 cases in placebo vs 75 cases in alfacalcidol, P = 0.850. The most common side effects were itching (placebo treatment group: 23 cases; alfacalcidol treatment group: 22 cases) and skin eruption (placebo treatment group: 11 cases; alfacalcidol
treatment groups: 15 cases)." 
Gallagher 2001 Mild hypercalcaemia occurred in 6% of placebo participants and 12% of calcitriol participants "At least one episode of hypercalciuria (400 mg or 10 mmol) occurred in 8% of the patients on placebo, 26% on calcitriol ...There were 58 cases of hypercalciuria occurring on calcitriol alone" Gastrointestinal problems were reported in the calcitriol group (N = 20) and the placebo group (N = 22)  ND
Grant 2005 21 participants developed hypercalcaemia; there was no significant difference between groups 7 participants developed renal insufficiency and 4 developed renal stones. No significant difference between groups. 428/2617 (16.4%) allocated to calcium; 319/2675 (11.9%) not allocated to calcium.
363/2646 (13.7%) allocated to vitamin D3; 386/2643 (14.7%) not allocated to vitamin D3
 
 ND
Harwood 2004 No cases occurred in either participant group ND ND  ND
Kärkkäinen 2010 ND ND Adverse events in the intervention group (N = 1586) resulting in discontinuation of the intervention. Gastrointestinal symptoms (abdominal pain and heartburn) 64/1586, nausea 12/1586 Adverse events in the intervention group (N = 1586) resulting in discontinuation of the intervention
Skin reactions 9/1586, miscellaneous other adverse effects (not individually listed) 28/1586
Latham 2003  —
Pfeifer 2000  —
Pfeifer 2009  —
Porthouse 2005  —
Prince 2008 One participant in the ergocalciferol group had mild asymptomatic hypercalcaemia on one occasion ND Constipation: ergocalciferol group 16/151 (10.6%) vs control group 18/151 (11.9%) No difference in incidence of cancer, ischaemic heart disease, or stroke
Sanders 2010 ND ND ND “Serious adverse events (International Conference on Harmonization/WHO Good Clinical Practice definition including hospitalization or death) did not differ significantly. None of the serious adverse events were considered related to study medication.”
Smith 2007  —
Trivedi 2003 ND ND ND The incidence of major health events did not differ significantly between groups.

—: adverse events not described in the study

ND: no incidence available for this adverse event

Appendix 11. Studies reporting cost‐effectiveness, cost‐utility, or costs of the intervention and/or healthcare resource use

Study ID (source if not primary reference), sample, efficacy analyses, type of evaluation  Intervention(s) and comparator (N in analysis) Perspective(s), type of currency, price year, time horizon  Cost items measured Mean (SD) intervention cost per person Healthcare service costs Incremental cost per fall prevented/per QALY gained 
Buchner 1997a
•Patients from a HMO, mild deficits in strength and balance, mean age 75 years
•Analysis 1.1, 1.2, 2.1, 2.2
•Cost analysis
 
•Centre based endurance training and/or strength training, supervised for 24 to 26 weeks then self supervised (N = 75) vs no intervention (N = 30)
 
•HMO
•US dollar
•Not specified (presumed 1992)
•Period 7 to 18 months after randomisation
 
•Hospital costs, ancillary outpatient costs (from HMO computerised records)
 
  •Hospitalised control participants more likely to have hospital costs > USD 5000 (P < 0.05)
 
 
Campbell 1997 and Campbell 1999c (Robertson 2001c)
•Women aged ≥ 80 years from 17 general practices, mean age (SD) 84.1 (3.3) years
•Analysis 1.1, 1.2
•Cost‐effectiveness analysis
 
•Specific set of muscle strengthening and balance retraining exercises individually prescribed at home (OEP) by physiotherapist, 4 home visits and monthly phone calls in year 1, phone contact only in year 2 (N = 116) vs social visits and usual care (N = 117)
 
•Societal
•New Zealand dollar
•1995
•During participation in trial (up to 2 years)
 
•Intervention costs (recruitment, programme delivery, overheads)
•Healthcare costs resulting from falls (actual costs of hospital admissions and outpatient services, estimates of GP visits and other costs)
•Total healthcare resource use (actual costs of hospital admissions and outpatient services)
 
In research setting:
•NZD 173 (0) in year 1
•NZD 22 (0) in year 2
 
•No difference between the 2 groups for healthcare costs resulting from falls or for total healthcare costs
•27% of hospital admission costs during trial resulted from falls
 
At 1 year:
•NZD 314 per fall prevented (programme implementation costs only)
At 2 years:
•NZD 265 per fall prevented (programme implementation costs only)
 
Campbell 1999 (Robertson 2001d)
•Men and women aged ≥ 65 years currently taking psychotropic medication, mean (SD) age 74.7 (7.2) years
•Analysis 11.1, 11.2
•Cost‐effectiveness analysis
 
•Gradual withdrawal of psychotropic medication over 14 weeks (N = 48) vs continued to take psychotropic medication (N = 45) (double‐blind)
 
•Health system
•New Zealand dollar
•1996
•During participation in trial (44 weeks)
 
•Intervention costs (recruitment, medication preparation and delivery, overheads)
•Healthcare costs resulting from falls (actual costs of hospital admissions and outpatient services, emergency department, community services)
•Total healthcare resource use (actual costs of hospital admissions and outpatient services, emergency department, community services)
 
In research setting:
•NZD 258 (0) for 44 weeks
 
•Total hospital admission costs NZD 21,871 intervention group NZD 68,006 control group (P = 0.044) •NZD 538 per fall prevented (programme implementation costs only)
 
Campbell 2005
•People aged ≥ 75 years with severe visual impairment, mean (SD) age 83.6 (4.8) years
•Analysis 15.1, 15.2, 16.1, 16.2, 17.1, 17.2
•Cost‐effectiveness analysis
 
•Home safety assessment and modification programme, 1 to 2 home visits by experienced occupational therapist (N = 198) vs no home safety programme (N = 193)
 
•Health system
•New Zealand dollar
•2004
•During trial period (1 year)
 
•Intervention costs (training; recruitment; occupational therapists’ time, transport, administration; services and equipment installed in homes; overhead costs)
 
•NZD 325 (292)
 
•Not calculated (preplanned, no significant difference in number of fall injuries in the 2 groups)
 
•NZD 650 per fall prevented (home safety programme implementation costs only)
 
Close 1999 (Close 2000)
•People aged ≥ 65 years attending emergency department with a fall, mean (SD) age 78.2 (7.5) years
•Analysis 22.1, 22.2, 22.3, 23.1, 23.2, 24.1, 24.2
•Cost analysis
 
•Multifactorial medical and occupational therapy assessment with referral to relevant services if indicated, 1 visit to day hospital for assessments, 1 home visit by occupational therapist (N = 184) vs usual care (N = 213)
 
•Health system
•Pounds sterling
•Not specified (presumed 1995)
•For 12 months after randomisation
 
•Medical and occupational therapy assessment (unit cost GBP 90.00), hospital admissions (unit cost GBP 220.77), outpatient visits (unit cost GBP 58.38), GP visits (unit cost GBP 17.89)
 
•GBP 74 (0) for medical and occupational therapist assessment
 
•No difference between the 2 groups for health service costs (GBP 1953 intervention groups, GBP 2549 control group)
 
 
Coleman 1999
•Patients from a HMO aged ≥ 65 years at high risk of hospitalisation and functional decline, mean age 77.3 years
•Analysis 22.2, 23.2, 24.2
•Cost analysis
 
•Multifactorial at a primary care clinic, half‐day clinic held every 3 to 4 months (5 physicians, N = 96) vs usual care (4 physicians, N = 73)
 
•Health system
•US dollar
•Not specified
•During trial period (24 months)
 
•Medical care (hospitalisation, emergency, and outpatient visits, pharmacy costs)
 
  •No difference between the 2 groups for pharmacy costs or total health service costs
 
 
Conroy 2010 (Irvine 2010)
•Community‐living, aged ≥ 70, at high risk of falling (defined using modified Falls Risk Assessment Tool questionnaire)
•Analysis 22.1, 22.2, 22.3, 23.1, 23.2, 24.1, 24.2
•Cost‐effectiveness analysis
 
•Multifactorial programme at day hospital (physiotherapy, occupational therapy, nurse, medical review, referral to specialist) (N = 172 of 183) vs falls prevention information booklet only (N = 171 of 181)
 
•National Health Service, personal social services
•Pound sterling
•2007‐8
•12‐month study period
 
•Screening, recruitment, intervention programme (multidisciplinary staff time), health services potentially relevant to falls (GP and practice nurse consultations, outpatient first visit, emergency, inpatient bed days)
 
•GBP 349 (316)
 
•Mean total healthcare costs GBP 2238 (4957) intervention group GBP 1659 (5100) control group (mean incremental cost GBP 578 (95% CI ‐12,593 to 17,264)
 
•GBP 3320 per fall prevented
 
Cumming 1999 (Salkeld 2000)
•Men and women recruited primarily before discharge from selected hospital wards, mean age 77 years
•Analysis 15.1, 15.2, 16.1, 16.2; 17.1, 17.2
•Cost‐effectiveness analysis
 
•Home safety visit by experienced occupational therapist, environmental hazard assessment, facilitation for necessary modifications, 1 home visit, follow‐up telephone call 2 weeks later (N = 264) vs routine care (N = 266)
 
•Societal
•Australian dollar
•1997
•1 year from trial entry
 
In subsample of 103 intervention group and 109 control group (last 212 recruited into trial):
•Hospitalisation, other healthcare costs provided in an institutional setting (e.g. outpatients), healthcare costs provided in the home (e.g. home nursing), informal care costs (e.g. personal care provided by a relative or friend, help around the home), home modification costs, occupational therapist (intervention costs)
 
•AUD 223 (0) intervention group, AUD 15 control group (home modification and occupational therapist intervention costs only)
 
•Mean total healthcare costs AUD 10,084 intervention group, AUD 8279 control group (P = 0.26 for median costs)
 
•AUD 4986 per fall prevented (all N = 527 participants)
•AUD 3980 per fall prevented for participants reporting a fall in previous year (N = 203 participants)
•< AUD 0 per fall prevented i.e. cost saving for participants reporting a fall in previous year (sensitivity analysis, outliers removed)
 
Dangour 2011
•People aged 65 to 67.9 years living in low‐middle socioeconomic status municipalities in Santiago, Chile
•Analysis 1.2, 2.2, 13.1
•Cost analysis
 
2 x 2 factorial trial:
•Nutritional supplement for 24 months (10 health centres, N = 865) vs remainder (10 health centres, N = 800)
•Multicomponent exercise classes, 2 x 1‐hour supervised classes per week for 24 months (10 health centres, N = 854) vs remainder (10 health centres, N = 811)
 
•Societal and health system
•Chilean peso converted to US dollar
•2007
•During 2‐year trial
From 94 exit interviews:
•Nutritional supplementation intervention
From 93 exit interviews:
•Physical activity intervention
 
•USD 91 for nutritional supplement
•USD 164 for physical activity intervention
 
  •Not calculated (neither intervention reduced risk of falling; cost‐effectiveness of physical activity intervention reported as USD 4.84 per extra metre walked)
 
Davis 2011a •Community‐living women aged 65 to 75 years
•Analysis 4.1
•Cost‐effectiveness analysis, cost‐utility analysis
 
•Once weekly resistance training (N = 54) vs twice weekly balance and tone classes (N = 49)
•Twice weekly resistance training (N = 51) vs twice weekly balance and tone classes (N = 49)
 
•Health service
•Canadian dollar
•2008
•9 months
 
•Costs of delivering the interventions (staff time, room use, equipment, building overhead costs); visits to health professionals; all visits, admissions, and procedures in hospital; laboratory and diagnostic tests
 
•CAD 353 once weekly resistance training
•CAD 706 twice weekly resistance training
•CAD 706 twice weekly balance and tone classes
 
•Mean healthcare costs resulting from falls, mean total healthcare costs respectively:
CAD 547, CAD 1379 once weekly resistance training
•CAD 184, CAD 1684 twice weekly resistance training
•CAD 162, CAD 1772 twice weekly balance and tone classes
 
•Both once and twice weekly resistance training dominated balance and tone classes in terms of both falls and QALYs (i.e. less costly, more effective)
 
De Vries 2010 (Peeters 2011)
•People aged ≥ 65 years who consulted their GP or emergency department after a fall event within the previous 3 months, risk score ≥ 8 or living in a residential home
•Analysis 22.2, 22.3, 23.2, 24.2
•Cost‐effectiveness analysis, cost‐utility analysis
 
•Multifactorial risk assessment by geriatrician at a geriatric outpatient clinic, individually tailored intervention regimen (e.g. withdrawal of psychotropic medication, balance and strength exercises by a physiotherapist, home hazard reduction by an occupational therapist, referral to ophthalmologist or cardiologist) (N = 106) vs usual care (N = 111)
 
•Societal
•Euro (The Netherlands)
•2007
•During 1 year from baseline
 
•Healthcare costs (e.g. geriatrician consult, GP care, specialist care, therapy, medication, hospitalisation, nursing home admission), patient and family costs (e.g. informal care), costs in other sectors (e.g. medical devices, home modifications, transportation aids)
 
  •Mean of total healthcare costs intervention group EUR 7740 (9129) control group EUR 6838 (8623), difference EUR 902 (95% CI ‐1534 to 3357)
 
•EUR 226 per percentage reduction in fallers
•If EUR 300,000 invested, probability that the intervention would improve quality of life (utility) by 1 point was 0.30 (incremental cost per QALY gained not reported)
 
Foss 2006 (Sach 2010)
•Women aged > 70 years with one unoperated cataract
•Analysis 12.1, 12.2, 12.3
•Cost‐utility analysis
 
•Second eye cataract surgery, routine post surgery care (N = 116) vs first eye cataract surgery only ( N = 113)
 
•National Health Service, personal social services
•Pound sterling
•2004
•During participation in 1 year trial; participants’ expected lifetime
 
•Secondary healthcare (cataract operation, bed days, outpatient, emergency department, lower and upper limb fractures), primary health care (GP visits, practice/district nurse visits), personal social services (home care, day care centre, residential and nursing home care, meals on wheels, special equipment), patient and carers’ costs (home care, carer time costs)
 
•Cataract operation GBP 672 (0)
 
•Mean of total healthcare costs intervention group GBP 646 (95% CI 16 to 1276) more than control group
 
•Incremental cost per fall prevented not calculated as intervention did not reduce falls
At 1 year:
•GBP 44,263 per QALY gained (excluding carer costs)
•GBP 58,667 per QALY gained (including carer costs)
Over participants’ expected lifetime:
•GBP 17,299 per QALY gained (discount rate 3.5% per annum)
 
Harwood 2005 (Sach 2007)
•Women aged > 70 years with bilateral cataracts, mean (SD) age 84.1 (3.3) years
•Analysis 12.1, 12.2, 12.3
•Cost‐effectiveness analysis, cost‐utility analysis
 
•Expedited (4 weeks) first eye cataract surgery, routine post surgery care (N = 148) vs control (routine, 12 months wait) (N = 140)
 
•National Health Service, personal social services
•Pound sterling
•2004
•During participation in 1 year trial; participants’ expected lifetime
 
•Secondary healthcare (cataract operation, bed days, outpatient, emergency department, lower and upper limb fractures), primary health care (GP visits, practice/district nurse visits), personal social services (home care, day care centre, residential and nursing home care, meals on wheels, special equipment), patient and carers’ costs (home care, carer time costs)
 
•Cataract operation GBP 672 (0)
 
•Mean of total healthcare costs intervention group GBP 2004 (95% CI 1363 to 2833) more than control group
 
At 1 year:
•GBP 4390 per fall prevented (excluding carer costs)
•GBP 3983 per fall prevented (with carer costs included)
•GBP 35,704 per QALY gained (excluding carer costs)
Over participants’ expected lifetime:
•GBP 13,172 per QALY gained (discount rate 3.5% per annum)
 
Hendriks 2008
•Patients aged ≥ 65 years who visited the emergency department or GP for the consequences of a fall
•Analysis 22.2, 23.2, 24.2
•Cost analysis
 
•Multifactorial programme (detailed medical and occupational therapy assessment with referral to relevant services if indicated) approximately 3.5 months after baseline assessment (N = 166) vs usual care (N = 167)
 
•Societal
•Euro (The Netherlands)
•2004
•During participation in 1 year trial
 
For 120 of intervention group and 129 of control group:
•Programme costs (time for geriatrician, nurse, occupational therapist and administration)
•Health service costs (GP, specialist, hospital admission, nursing home admission, allied health care, aids and assistive devices, home care, medication)
•Participant and family costs (home modifications, out‐of‐pocket expenses)
 
•EUR 385 (0)
 
•EUR 4857 (4470) intervention group and EUR 4991 (6835) control group for mean total healthcare costs (P = 0.856)
 
•Incremental ratios not calculated as intervention did not reduce falls or result in QALY gains
 
Hornbrook 1994
•Patients from a HMO aged ≥ 65 years, mean (SD) age 73.4 (6.1) years
•Analysis 22.1, 22.2, 23.1, 23.2, 24.1, 24.2
•Cost description
 
•Multifactorial including 90 minute group meetings for 4 weeks led by health behaviourist and physical therapist (environmental, behavioural and physical risk factors, 20 minutes of exercises), encouraged to walk 3 times a week, quarterly follow‐up sessions (N = 1611) vs information on home safety (N = 1571)
 
•Study plus personal
•US dollar
•Not specified
•During intervention
 
•Subsidised home safety repairs (e.g. bath tub grab bars, stair railings) in intervention group •Project‐subsidised repairs USD 78 (subsidy USD 46, participant contribution USD 32)
 
   
Kemmler 2010
•Women aged ≥ 65 living independently
•Analysis 4.1, 4.2
•Cost analysis
 
•Multicomponent exercise, two 60‐minute classes and two 20‐minute home training sessions weekly for 18 months (N = 115) vs control (low‐intensity exercise classes 60 minutes once weekly for 10 weeks followed by 10 weeks of rest) (N = 112)
•All participants received calcium (1500 m/d) and cholecalciferol (500 IU/d) supplements
 
•Health system
•Euro (Germany)
•Not specified
•During participation in 18 month trial
 
•Total healthcare costs (no details provided)
 
  •EUR 2255 (2596) exercise group and EUR 2780 (3318) control group for mean total healthcare costs (P = 0.20)
 
 
 
Liu‐Ambrose 2008 (Davis 2009)
•Women and men aged ≥ 70 years recruited from 2 referral based falls clinics
•Analysis 1.1, 1.2
•Cost‐effectiveness analysis
•Specific set of muscle strengthening and balance retraining exercises individually prescribed at home (OEP) by trained physiotherapist for 1 year (N = 36) vs guideline care (N = 38)
•All participants received falls risk assessment, comprehensive geriatric assessment and treatment
 
•Health system
•Canadian dollar
•Not specified
•12 months
 
•Cost of delivering the intervention
•Cost of the falls clinic
•CAD 14,285   •CAD 247 per fall prevented (comparable to incremental cost‐effectiveness ratios in New Zealand studies of the Otago Exercise Programme)
Markle‐Reid 2010
•Community‐living aged ≥ 75, newly referred to and eligible for home support services; reported a fall in previous year, fear of falling or unsteady on feet
•Analysis 22.1, 22.2, 23.1, 23.2, 24.1, 24.2
•Cost analysis
 
•Multifactorial individually tailored home visits (case manager, registered nurse, occupational therapist, physiotherapist, registered dietitian) once per month for 6 months in addition to standard home care services (N = 49) vs control (standard home care services) (N = 43) •Societal
•Canadian dollar
•2006
•6 months
 
•Primary care; emergency department and specialists;
hospital days; 7 types of other health and social professionals; medications; laboratory services using the Health and Social Services Utilization Inventory
 
 
 
•Mean total direct healthcare costs CAD 5126 intervention group, CAD 4800 control group at 6 months (P = 0.330) •Not calculated (intervention did not reduce falls)
Robertson 2001a
•Men and women aged ≥ 75 years from 17 general practices, mean (SD) age 80.9 (4.2) years
•Analysis 1.1, 1.2, 1.3
•Cost‐effectiveness analysis
 
•Specific set of muscle strengthening and balance retraining exercises individually prescribed at home (OEP) by trained district nurse, supervised by physiotherapist, 5 home visits and monthly phone calls for 1 year (N = 121) vs usual care (N = 119)
 
•Health system
•New Zealand dollar
•1998
•During participation in 1‐year trial
 
•Intervention costs (training, recruitment, programme delivery, supervision of exercise instructor, overheads)
•Hospital admission costs resulting from fall injuries during trial (actual costs of hospital admissions)
 
In community health service setting:
•NZD 432 (0) for 1 year
 
•5 hospital admissions due to fall injuries in control group, none in exercise group (cost savings of NZD 47,818)
 
•NZD 1803 per fall prevented (programme implementation costs only)
•NZD 155 per fall prevented (programme implementation costs and hospital admission cost savings)
 
Tinetti 1994 (Rizzo 1996)
•Men and women aged ≥ 70 years with ≥ 1 risk factor for falling (postural hypotension; use of sedatives; ≥ 4 medications; impairment in arm or leg strength or range of motion, balance, gait, transfer skills; environmental hazards), mean (SD) age 77.9 (5.3) years
•Analysis 22.1, 22.2, 22.3, 23.1, 23.2, 24.1, 24.2
•Cost‐effectiveness analysis
 
•Multifactorial targeted intervention for 3 months after the baseline assessment, extended if health problems had interfered with ability to exercise (behavioural instructions, exercise programmes, adjustment to medications, home safety) delivered by physician and at home by nurse and physiotherapist (8 physicians, N = 148) vs home visits by social work student (8 physicians, N = 140)
 
•Health system
•US dollar
•1993
•The year following study enrolment
 
•Intervention costs (developmental and training costs, recruitment costs, overheads, equipment, and staff related costs)
•Health services (hospitalisation and emergency department, outpatient, home care, skilled nursing facilities)
 
•USD 905 (range 588 to 1346)
 
•Mean total healthcare costs USD 8310 intervention group and USD 10,439 control group
 
Using mean costs:
•USD 1772 per fall prevented (intervention costs only)
•< USD 0 per fall prevented, i.e. cost saving (total healthcare costs)
•< USD 0 per ‘medical’ fall prevented, i.e. cost saving (total healthcare costs)
 
Van Rossum 1993
•General population aged 75 to 84 years, 73% aged 75 to 79 years
•No data available for pooling
•Cost analysis
 
•Multifactorial home visits 4 times a year for 3 years, extra visits if necessary by public health nurses lasting 45 to 60 minutes (N = 292) vs no home visits (N = 288)
 
•Health system
•Dutch guilder
•Not specified
•During 3 year trial period
 
•Health services (community care services, hospital, long term institutional care, home visits) •Total 393,981 Dutch guilders for intervention group home visits
 
•Total health service costs were 4% per person less for control (mean 19,321 guilders) than intervention group (mean 20,080 guilders)
 
 
Voukelatos 2007 (Haas 2006)
•Healthy community‐living people aged ≥ 60 years, mean (SD) age 69 (6.5) years
•Analysis 1.1, 1.2, 3.1, 3.2
•Cost‐effectiveness analysis
 
•Tai Chi classes 1 hour weekly for 16 weeks (N = 347) vs no intervention (N = 337)
 
•Public health system (NSW Health)
•Australian dollar
•Not specified (presumed 2001)
•During 24 week trial period
 
•Intervention costs (cost of venues, advertising, instructors)
•Health service use related to falls from health care use diary and hospital records, valued at standard costs (GP, specialist, tests, hospitalisations, medications)
 
•AUD 245 (0) intervention group plus charge AUD 44 per participant
 
•Mean total healthcare costs higher for Tai Chi group (AUD 55) than control group (AUD 17) (P < 0.0001)
 
•AUD 1683 per fall prevented (includes cost offset by charging AUD 44 per instruction course)
 
Weber 2008
•Community
living patients of the Geisinger Health System, rural Pennsylvania aged ≥ 70 years, ≥ 4 prescription medications, ≥ 1 psychoactive medications
•No data available for pooling
•Cost analysis
 
•Standardised medication review by clinical pharmacist or geriatrician, recommendations to the primary physician via an electronic medical record system (15 clinic sites, N = 413) vs usual care (3 clinic sites, N = 207)
 
•Geisinger Health System •US dollar
•Not specified (presumed 2003)
•From date of electronic message (intervention) or 30 January 2003 (comparator) to end of 15 month study
 
•Health services (outpatient, inpatient, emergency department, total costs calculated from the Geisinger Health Plan insurance database)
 
  •No significant trends in health service costs
 
 
Wyman 2005 (Findorff 2007)
•Women aged ≥ 70 years, mean (SD) 78.8 (5.6) years
•Analysis 22.1, 22.2, 23.1, 23.2, 24.1, 24.2
•Cost description
 
•Multifactorial home‐based programme for 12 weeks followed by 16 weeks of computerised telephone support (risk factor assessment, tailored counselling, education, exercise, walking programme, referrals as needed) delivered by nurses (N = 137) vs health education (N = 135)
 
•Health system
•US dollar
•Not specified
•From end of 28 week intervention period, end point not reported
 
•Health service costs associated with falls (clinic visit, emergency department, ambulance, hospital inpatient, outpatient physical therapy, rehabilitation centre, home care)
 
  •Mean cost of an injurious fall USD 6606 (range 63 to 85,984), median USD 658
(costs not broken down by group)
 
 

See also Davis 2010
GP: general practitioner
HMO: health maintenance organisation
OEP: Otago Exercise Programme
QALY: quality adjusted life year

Appendix 12. Sensitivity analyses exploring impact of risk of bias on effect sizes

Intervention Number of trials (participants) in the analysis Pooled effect size, 95% CI Number of trials (participants) in the sensitivity analysisa Pooled effect size, 95% CI Impact
Group exercise: multiple categories of exercise (Analysis 1.1.1) 16 (3622)
 
RaR 0.71, 95% CI 0.63 to 0.82 11 (2978) RaR 0.79, 95% CI 0.71 to 0.88 Remained statistically significant
Group exercise: multiple categories of exercise (Analysis 1.2.1) 22 (5333) RR 0.85, 95% CI 0.76 to 0.96 12 (2454) RR 0.86, 95% CI 0.79 to 0.94 Remained statistically significant
Individual exercise at home: multiple categories of exercise (Analysis 1.1.2) 7 (951)
 
RaR 0.68, 95% CI 0.58 to 0.80 4 (559) RaR 0.69, 95% CI 0.55 to 0.86 Remained statistically significant
Individual exercise at home: multiple categories of exercise (Analysis 1.2.2) 6 (714) RR 0.78, 95% CI 0.64 to 0.94 3 (386) RR 0.81, 95% CI 0.63 to 1.04 No longer statistically significant
Group exercise: Tai Chi (Analysis 1.1.4) 5 (1563) RaR 0.72, 95% CI 0.52 to 1.00 4 (1375) RaR 0.81, 95% CI 0.61 to 1.09 No longer statistically significant
Group exercise: Tai Chi (Analysis 1.2.4) 6 (1625) RR 0.71, 95% CI 0.57 to 0.87  3 (1239)  RR 0.80, 95% CI 0.67 to 0.95 Remained statistically significant
Group exercise: gait, balance or functional training (Analysis 1.1.5) 4 (519)
 
RaR 0.72, 95% CI 0.55 to 0.94 1 (303) RaR 0.82, 95% CI 0.58 to 1.17 No longer statistically significant
Cardiac pacing (Analysis 12.1.1) 3 (349) RaR 0.73, 95% CI 0.57 to 0.93 3 (349) RaR 0.73, 95% CI 0.57, 0.93 Unchanged
Home safety intervention (OT) (Analysis 17.1.1) 4 (1446) RaR 0.69, 95% CI 0.55 to 0.86 4 (1446) RaR 0.69, 95% CI 0.55 to 0.86 Unchanged
Home safety intervention (OT) (Analysis 17.2.1) 5 (1156) RR 0.79, 95% CI 0.69 to 0.90 4 (1146) RR 0.79, 95% CI 0.69 to 0.90 Unchanged
Multifactorial intervention (Analysis 22.1) 19 (9503) RaR 0.76, 95% CI 0.67 to 0.86 16 (8153) RaR 0.80, 95% CI 0.72 to 0.87 Remained statistically significant

aAfter removing trials 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).

Data and analyses

Comparison 1. Exercise vs control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1.1 Rate of falls 34   Rate Ratio (IV, Random, 95% CI) Subtotals only
1.1.1 Group exercise: multiple categories of exercise vs control 16 3622 Rate Ratio (IV, Random, 95% CI) 0.71 [0.63, 0.82]
1.1.2 Individual exercise at home: multiple categories of exercise vs control 7 951 Rate Ratio (IV, Random, 95% CI) 0.68 [0.58, 0.80]
1.1.3 Individual exercise: LiFE (balance and strength training in daily life activities) vs control 1 34 Rate Ratio (IV, Random, 95% CI) 0.21 [0.06, 0.71]
1.1.4 Group exercise: Tai Chi vs control 5 1563 Rate Ratio (IV, Random, 95% CI) 0.72 [0.52, 1.00]
1.1.5 Group exercise: gait, balance or functional training vs control 4 519 Rate Ratio (IV, Random, 95% CI) 0.72 [0.55, 0.94]
1.1.6 Individual exercise: balance training vs control 1 128 Rate Ratio (IV, Random, 95% CI) 1.19 [0.77, 1.82]
1.1.7 Group exercise: strength/resistance training vs control 1 64 Rate Ratio (IV, Random, 95% CI) 1.80 [0.84, 3.87]
1.1.8 Individual exercise at home: resistance training vs control 1 222 Rate Ratio (IV, Random, 95% CI) 0.95 [0.77, 1.18]
1.2 Number of fallers 40   Risk Ratio (IV, Random, 95% CI) Subtotals only
1.2.1 Group exercise: multiple categories of exercise vs control 22 5333 Risk Ratio (IV, Random, 95% CI) 0.85 [0.76, 0.96]
1.2.2 Individual exercise at home: multiple categories of exercise vs control 6 714 Risk Ratio (IV, Random, 95% CI) 0.78 [0.64, 0.94]
1.2.3 Individual exercise: LiFE (balance and strength training in daily life activities) vs control 1 31 Risk Ratio (IV, Random, 95% CI) 0.73 [0.39, 1.37]
1.2.4 Group exercise: Tai Chi vs control 6 1625 Risk Ratio (IV, Random, 95% CI) 0.71 [0.57, 0.87]
1.2.5 Group exercise: gait, balance or functional training vs control 3 453 Risk Ratio (IV, Random, 95% CI) 0.81 [0.62, 1.07]
1.2.6 Group exercise: strength/resistance training vs control 1 120 Risk Ratio (IV, Random, 95% CI) 0.77 [0.52, 1.14]
1.2.7 Individual exercise at home: resistance training vs control 1 222 Risk Ratio (IV, Random, 95% CI) 0.97 [0.68, 1.38]
1.2.8 Individual exercise: general physical activity (walking) vs control 1 196 Risk Ratio (IV, Random, 95% CI) 0.82 [0.53, 1.26]
1.3 Number of people sustaining a fracture 6 810 Risk Ratio (IV, Fixed, 95% CI) 0.34 [0.18, 0.63]

Comparison 2. Group exercise: multiple categories of exercise vs control: subgroup analysis by falls risk at baseline.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
2.1 Rate of falls 16   Rate Ratio (IV, Random, 95% CI) Subtotals only
2.1.1 Selected for higher risk of falling 9 1261 Rate Ratio (IV, Random, 95% CI) 0.70 [0.58, 0.85]
2.1.2 Not selected for higher risk of falling 7 2361 Rate Ratio (IV, Random, 95% CI) 0.72 [0.58, 0.90]
2.2 Number of fallers 22   Risk Ratio (IV, Random, 95% CI) Subtotals only
2.2.1 Selected for higher risk of falling 12 1430 Risk Ratio (IV, Random, 95% CI) 0.87 [0.78, 0.97]
2.2.2 Not selected for higher risk of falling 10 3903 Risk Ratio (IV, Random, 95% CI) 0.85 [0.68, 1.06]

Comparison 3. Group exercise: Tai Chi vs control: subgroup analysis by falls risk at baseline.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
3.1 Rate of falls 5   Rate Ratio (IV, Random, 95% CI) Subtotals only
3.1.1 Selected for higher risk of falling 2 555 Rate Ratio (IV, Random, 95% CI) 0.95 [0.62, 1.46]
3.1.2 Not selected for higher risk of falling 3 1008 Rate Ratio (IV, Random, 95% CI) 0.59 [0.45, 0.76]
3.2 Number of fallers 6   Risk Ratio (IV, Random, 95% CI) Subtotals only
3.2.1 Selected for higher risk of falling 2 555 Risk Ratio (IV, Random, 95% CI) 0.85 [0.71, 1.01]
3.2.2 Not selected for higher risk of falling 4 1070 Risk Ratio (IV, Random, 95% CI) 0.58 [0.46, 0.74]

Comparison 4. Exercise vs exercise.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
4.1 Rate of falls 7   Rate Ratio (IV, Fixed, 95% CI) Subtotals only
4.1.1 Group exercise: higher intensity multiple components vs lower intensity multiple components 1 227 Rate Ratio (IV, Fixed, 95% CI) 0.60 [0.47, 0.76]
4.1.2 Group exercise: resistance training 1x per week vs balance and tone 1 103 Rate Ratio (IV, Fixed, 95% CI) 0.73 [0.44, 1.22]
4.1.3 Group exercise: resistance training 2x per week vs balance and tone 1 101 Rate Ratio (IV, Fixed, 95% CI) 0.88 [0.67, 1.16]
4.1.4 Group exercise: balance training in workstations vs 'conventional' fall‐prevention exercise class 1 45 Rate Ratio (IV, Fixed, 95% CI) 0.81 [0.37, 1.78]
4.1.5 Group exercise: enhanced balance therapy vs conventional physiotherapy post hip fracture 1 133 Rate Ratio (IV, Fixed, 95% CI) 1.00 [0.64, 1.57]
4.1.6 Group exercise: square stepping vs walking 1 68 Rate Ratio (IV, Fixed, 95% CI) 0.70 [0.23, 2.13]
4.1.7 Group exercise: exercise class + "trail walking" vs exercise class + indoor walking 1 58 Rate Ratio (IV, Fixed, 95% CI) 0.45 [0.14, 1.49]
4.1.8 Group exercise + home exercise vs home exercise 1 68 Rate Ratio (IV, Fixed, 95% CI) 1.09 [0.74, 1.62]
4.2 Number of fallers 4   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
4.2.1 Group exercise: higher intensity multiple components vs lower intensity multiple components 1 227 Risk Ratio (IV, Fixed, 95% CI) 0.54 [0.35, 0.83]
4.2.2 Group exercise: square stepping vs walking 1 68 Risk Ratio (IV, Fixed, 95% CI) 0.64 [0.21, 1.95]
4.2.3 Group exercise: exercise class + "trail walking" vs exercise class + indoor walking 1 58 Risk Ratio (IV, Fixed, 95% CI) 0.45 [0.18, 1.13]
4.2.4 Group exercise + home exercise vs home exercise: multiple components 1 68 Risk Ratio (IV, Fixed, 95% CI) 1.11 [0.72, 1.70]

Comparison 5. Medication provision: vitamin D (with or without calcium) vs control/placebo/calcium.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
5.1 Rate of falls 7 9324 Rate Ratio (IV, Random, 95% CI) 1.00 [0.90, 1.11]
5.1.1 Vitamin D3 (by mouth) vs control or placebo 2 2478 Rate Ratio (IV, Random, 95% CI) 1.14 [1.03, 1.27]
5.1.2 Vitamin D3 (by mouth) + calcium vs control or placebo 3 6586 Rate Ratio (IV, Random, 95% CI) 0.96 [0.89, 1.04]
5.1.3 Vitamin D3 (by mouth) + calcium vs calcium 1 137 Rate Ratio (IV, Random, 95% CI) 0.54 [0.30, 0.98]
5.1.4 Vitamin D2 (by injection) vs placebo 1 123 Rate Ratio (IV, Random, 95% CI) 0.61 [0.32, 1.17]
5.2 Number of fallers 13 26747 Risk Ratio (IV, Random, 95% CI) 0.96 [0.89, 1.03]
5.2.1 Vitamin D3 (by mouth) vs control or placebo 3 4516 Risk Ratio (IV, Random, 95% CI) 1.08 [0.93, 1.26]
5.2.2 Vitamin D3 (by mouth) + calcium vs control or placebo 3 6576 Risk Ratio (IV, Random, 95% CI) 0.98 [0.92, 1.03]
5.2.3 Vitamin D3 (by mouth) + calcium vs calcium 2 379 Risk Ratio (IV, Random, 95% CI) 0.70 [0.53, 0.92]
5.2.4 Vitamin D2 (by mouth) + calcium vs placebo + calcium 1 302 Risk Ratio (IV, Random, 95% CI) 0.66 [0.41, 1.05]
5.2.5 Vitamin D2 (by injection) vs placebo 2 9563 Risk Ratio (IV, Random, 95% CI) 0.98 [0.92, 1.04]
5.2.6 Vitamin D (by mouth or by injection) with or without calcium vs control: studies with multiple arms combined 2 5411 Risk Ratio (IV, Random, 95% CI) 0.73 [0.37, 1.44]
5.3 Number of people sustaining a fracture 10 27070 Risk Ratio (IV, Random, 95% CI) 0.94 [0.82, 1.09]
5.3.1 Vitamin D3 (by mouth) vs control or placebo 2 4942 Risk Ratio (IV, Random, 95% CI) 0.97 [0.63, 1.51]
5.3.2 Vitamin D3 (by mouth) + calcium vs control or placebo 3 6898 Risk Ratio (IV, Random, 95% CI) 0.83 [0.59, 1.16]
5.3.3 Vitamin D3 (by mouth) + calcium vs calcium 2 379 Risk Ratio (IV, Random, 95% CI) 0.54 [0.26, 1.15]
5.3.4 Vitamin D2 (by injection) vs placebo 1 9440 Risk Ratio (IV, Random, 95% CI) 1.09 [0.94, 1.28]
5.3.5 Vitamin D (by mouth or by injection) with or without calcium vs control: studies with multiple arms combined 2 5411 Risk Ratio (IV, Random, 95% CI) 0.90 [0.53, 1.53]

Comparison 6. Vitamin D (with or without calcium) vs control: subgroup analysis by falls risk at baseline.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
6.1 Rate of falls 7   Rate Ratio (IV, Random, 95% CI) Subtotals only
6.1.1 Selected for higher risk of falling 3 5381 Rate Ratio (IV, Random, 95% CI) 1.02 [0.85, 1.23]
6.1.2 Not selected for higher risk of falling 4 3943 Rate Ratio (IV, Random, 95% CI) 1.00 [0.86, 1.17]
6.2 Number of fallers 13   Risk Ratio (IV, Random, 95% CI) Subtotals only
6.2.1 Selected for higher risk of falling 6 11094 Risk Ratio (IV, Random, 95% CI) 0.93 [0.78, 1.11]
6.2.2 Not selected for higher risk of falling 7 15653 Risk Ratio (IV, Random, 95% CI) 0.96 [0.90, 1.02]

Comparison 7. Vitamin D (with or without calcium) vs control: subgroup analysis by vitamin D level at baseline.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
7.1 Rate of falls 7   Rate Ratio (IV, Random, 95% CI) Subtotals only
7.1.1 Selected for lower vitamin D levels 2 260 Rate Ratio (IV, Random, 95% CI) 0.57 [0.37, 0.89]
7.1.2 Not selected for lower vitamin D levels 5 9064 Rate Ratio (IV, Random, 95% CI) 1.02 [0.93, 1.13]
7.2 Number of fallers 13   Risk Ratio (IV, Random, 95% CI) Subtotals only
7.2.1 Selected for lower vitamin D levels 4 804 Risk Ratio (IV, Random, 95% CI) 0.70 [0.56, 0.87]
7.2.2 Not selected for lower vitamin D levels 9 25943 Risk Ratio (IV, Random, 95% CI) 1.00 [0.93, 1.07]

Comparison 8. Medication provision: vitamin D 2000 IU/day vs vitamin D 800 IU/day.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
8.1 Rate of falls 1 173 Rate Ratio (IV, Fixed, 95% CI) 1.30 [0.99, 1.71]
8.2 Number of people sustaining a fracture 1 173 Risk Ratio (IV, Fixed, 95% CI) 0.51 [0.13, 1.98]

Comparison 9. Medication provision: vitamin D analogue vs placebo.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
9.1 Rate of falls 1   Rate Ratio (IV, Fixed, 95% CI) Subtotals only
9.1.1 Calcitriol vs placebo 1 213 Rate Ratio (IV, Fixed, 95% CI) 0.64 [0.49, 0.82]
9.2 Number of fallers 2   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
9.2.1 Calcitriol vs placebo 1 213 Risk Ratio (IV, Fixed, 95% CI) 0.54 [0.31, 0.93]
9.2.2 Alfacalcidol vs placebo 1 378 Risk Ratio (IV, Fixed, 95% CI) 0.69 [0.41, 1.17]
9.3 Number of people sustaining a fracture 1   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
9.3.1 Calcitriol vs placebo 1 246 Risk Ratio (IV, Fixed, 95% CI) 0.60 [0.28, 1.29]
9.4 Number of people developing hypercalcaemia 2 624 Risk Ratio (M‐H, Fixed, 95% CI) 2.49 [1.12, 5.50]

Comparison 10. Medication provision: other medications vs control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
10.1 Rate of falls 1   Rate Ratio (IV, Fixed, 95% CI) Subtotals only
10.1.1 Hormone replacement therapy vs placebo 1 212 Rate Ratio (IV, Fixed, 95% CI) 0.88 [0.65, 1.18]
10.1.2 Hormone replacement therapy + calcitriol vs placebo 1 214 Rate Ratio (IV, Fixed, 95% CI) 0.75 [0.58, 0.97]
10.2 Number of fallers 3   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
10.2.1 Hormone replacement therapy vs control/placebo 2 585 Risk Ratio (IV, Fixed, 95% CI) 0.94 [0.81, 1.08]
10.2.2 Hormone replacement therapy + calcitriol vs placebo 1 214 Risk Ratio (IV, Fixed, 95% CI) 0.90 [0.72, 1.11]
10.2.3 Alendronate + vitamin D3 vs control 1 515 Risk Ratio (IV, Fixed, 95% CI) 0.82 [0.59, 1.14]
10.3 Number of people sustaining a fracture 1   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
10.3.1 Calcium vs placebo 1 1255 Risk Ratio (IV, Fixed, 95% CI) 0.90 [0.69, 1.16]
10.3.2 Vitamin K2 + vitamin D2 + calcium vs control (Alzheimer's disease) 0 0 Risk Ratio (IV, Fixed, 95% CI) Not estimable

Comparison 11. Medication withdrawal vs control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
11.1 Rate of falls 2   Rate Ratio (IV, Fixed, 95% CI) Subtotals only
11.1.1 Psychotropic medication withdrawal vs control 1 93 Rate Ratio (IV, Fixed, 95% CI) 0.34 [0.16, 0.73]
11.1.2 Medication review and modification vs usual care 1 186 Rate Ratio (IV, Fixed, 95% CI) 1.01 [0.81, 1.25]
11.2 Number of fallers 4   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
11.2.1 Psychotropic medication withdrawal vs control 1 93 Risk Ratio (IV, Fixed, 95% CI) 0.61 [0.32, 1.17]
11.2.2 Medication review and modification vs usual care 2 445 Risk Ratio (IV, Fixed, 95% CI) 1.03 [0.81, 1.31]
11.2.3 GP educational programme + medication review and modification vs control 1 659 Risk Ratio (IV, Fixed, 95% CI) 0.61 [0.41, 0.91]

Comparison 12. Surgery vs control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
12.1 Rate of falls 5   Rate Ratio (IV, Fixed, 95% CI) Subtotals only
12.1.1 Cardiac pacing vs control 3 349 Rate Ratio (IV, Fixed, 95% CI) 0.73 [0.57, 0.93]
12.1.2 Cataract surgery (1st eye) vs control 1 306 Rate Ratio (IV, Fixed, 95% CI) 0.66 [0.45, 0.95]
12.1.3 Cataract surgery (2nd eye) vs control 1 239 Rate Ratio (IV, Fixed, 95% CI) 0.68 [0.39, 1.17]
12.2 Number of fallers 4   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
12.2.1 Cardiac pacing vs control 2 178 Risk Ratio (IV, Fixed, 95% CI) 1.20 [0.92, 1.55]
12.2.2 Cataract surgery (1st eye) vs control 1 306 Risk Ratio (IV, Fixed, 95% CI) 0.95 [0.68, 1.33]
12.2.3 Cataract surgery (2nd eye) vs control 1 239 Risk Ratio (IV, Fixed, 95% CI) 1.06 [0.69, 1.63]
12.3 Number of people sustaining a fracture 3   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
12.3.1 Cardiac pacing vs control 1 171 Risk Ratio (IV, Fixed, 95% CI) 0.78 [0.18, 3.39]
12.3.2 Cataract surgery (1st eye) vs control 1 306 Risk Ratio (IV, Fixed, 95% CI) 0.33 [0.10, 1.05]
12.3.3 Cataract surgery (2nd eye) vs control 1 239 Risk Ratio (IV, Fixed, 95% CI) 2.51 [0.50, 12.52]

Comparison 13. Fluid or nutrition therapy vs control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
13.1 Number of fallers 3   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
13.1.1 Nutritional supplementation vs control 3 1902 Risk Ratio (IV, Fixed, 95% CI) 0.95 [0.83, 1.08]

Comparison 14. Psychological interventions vs control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
14.1 Rate of falls 1   Rate Ratio (IV, Fixed, 95% CI) Subtotals only
14.1.1 Cognitive behavioural intervention vs control 1 120 Rate Ratio (IV, Fixed, 95% CI) 1.00 [0.37, 2.72]
14.2 Number of fallers 2   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
14.2.1 Cognitive behavioural intervention vs control 2 350 Risk Ratio (IV, Fixed, 95% CI) 1.11 [0.80, 1.54]

Comparison 15. Environment/assistive technology interventions: home safety vs control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
15.1 Rate of falls 6 4208 Rate Ratio (IV, Random, 95% CI) 0.81 [0.68, 0.97]
15.2 Number of fallers 7 4051 Risk Ratio (IV, Fixed, 95% CI) 0.88 [0.80, 0.96]
15.3 Number of participants sustaining a fracture 1 360 Risk Ratio (IV, Fixed, 95% CI) 1.32 [0.30, 5.87]

Comparison 16. Home safety intervention vs control: subgroup analysis by risk of falling at baseline.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
16.1 Rate of falls 6   Rate Ratio (IV, Random, 95% CI) Subtotals only
16.1.1 Selected for higher risk of falling 3 851 Rate Ratio (IV, Random, 95% CI) 0.62 [0.50, 0.77]
16.1.2 Not selected for higher risk of falling 3 3357 Rate Ratio (IV, Random, 95% CI) 0.94 [0.84, 1.05]
16.2 Number of fallers 7   Risk Ratio (IV, Random, 95% CI) Subtotals only
16.2.1 Selected for higher risk of falling 3 684 Risk Ratio (IV, Random, 95% CI) 0.85 [0.75, 0.97]
16.2.2 Not selected for higher risk of falling 4 3367 Risk Ratio (IV, Random, 95% CI) 0.90 [0.80, 1.00]

Comparison 17. Home safety intervention vs control: subgroup analysis by delivery personnel.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
17.1 Rate of falls 7   Rate Ratio (IV, Random, 95% CI) Subtotals only
17.1.1 Home safety intervention (OT) vs control 4 1443 Rate Ratio (IV, Random, 95% CI) 0.69 [0.55, 0.86]
17.1.2 Home safety intervention (not OT) vs control 4 3075 Rate Ratio (IV, Random, 95% CI) 0.91 [0.75, 1.11]
17.2 Number of fallers 7   Risk Ratio (IV, Random, 95% CI) Subtotals only
17.2.1 Home safety intervention (OT) vs control 5 1153 Risk Ratio (IV, Random, 95% CI) 0.79 [0.70, 0.91]
17.2.2 Home safety intervention (not OT) vs control 3 2975 Risk Ratio (IV, Random, 95% CI) 0.94 [0.85, 1.05]

Comparison 18. Environment/assistive technology interventions: vision improvement vs control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
18.1 Rate of falls 3   Rate Ratio (IV, Fixed, 95% CI) Subtotals only
18.1.1 Vision assessment and eye examination + intervention (with or without referral) vs control 1 616 Rate Ratio (IV, Fixed, 95% CI) 1.57 [1.19, 2.06]
18.1.2 Visual acuity assessment and referral vs remainder 1 1090 Rate Ratio (IV, Fixed, 95% CI) 0.91 [0.77, 1.09]
18.1.3 Single lens distance glasses vs usual glasses (multifocal) 1 597 Rate Ratio (IV, Fixed, 95% CI) 0.92 [0.73, 1.17]
18.2 Number of fallers 3   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
18.2.1 Vision assessment and eye examination + intervention (with or without referral) vs control 1 616 Risk Ratio (IV, Fixed, 95% CI) 1.54 [1.24, 1.91]
18.2.2 Visual acuity assessment and referral vs remainder 1 1090 Risk Ratio (IV, Fixed, 95% CI) 0.89 [0.76, 1.04]
18.2.3 Single lens distance glasses vs usual glasses (multifocal) 1 597 Risk Ratio (IV, Fixed, 95% CI) 0.97 [0.85, 1.11]
18.3 Number of people sustaining a fracture 2   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
18.3.1 Vision assessment and eye examination + intervention (with or without referral) vs control 1 616 Risk Ratio (IV, Fixed, 95% CI) 1.73 [0.96, 3.12]
18.3.2 Single lens distance glasses vs usual glasses (multifocal) 1 597 Risk Ratio (IV, Fixed, 95% CI) 1.58 [0.74, 3.40]

Comparison 19. Environment/assistive technology interventions: footwear modification vs control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
19.1 Rate of falls 1   Rate Ratio (IV, Fixed, 95% CI) Subtotals only
19.1.1 Anti‐slip shoe device for icy conditions vs control 1 109 Rate Ratio (IV, Fixed, 95% CI) 0.42 [0.22, 0.78]
19.2 Number of fallers 1   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
19.2.1 Balance‐enhancing insoles vs conventional insoles 1 40 Risk Ratio (IV, Fixed, 95% CI) 0.56 [0.23, 1.38]

Comparison 20. Knowledge/education interventions vs control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
20.1 Rate of falls 1   Rate Ratio (IV, Fixed, 95% CI) Subtotals only
20.1.1 Education interventions vs control 1 45 Rate Ratio (IV, Fixed, 95% CI) 0.33 [0.09, 1.20]
20.2 Number of fallers 4   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
20.2.1 Education interventions vs control 4 2555 Risk Ratio (IV, Fixed, 95% CI) 0.88 [0.75, 1.03]

Comparison 21. Multiple interventions.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
21.1 Rate of falls 14   Rate Ratio (IV, Fixed, 95% CI) Subtotals only
21.1.1 Exercise + home safety vs remainder 1 1090 Rate Ratio (IV, Fixed, 95% CI) 0.77 [0.61, 0.98]
21.1.2 Exercise + vision assessment vs remainder 1 1090 Rate Ratio (IV, Fixed, 95% CI) 0.72 [0.57, 0.91]
21.1.3 Exercise + home safety + vision assessment vs remainder 1 1090 Rate Ratio (IV, Fixed, 95% CI) 0.71 [0.53, 0.96]
21.1.4 Home safety + vision assessment vs remainder 1 1090 Rate Ratio (IV, Fixed, 95% CI) 0.89 [0.70, 1.12]
21.1.5 Exercise + home safety +education vs control 1 285 Rate Ratio (IV, Fixed, 95% CI) 0.69 [0.50, 0.96]
21.1.6 Exercise + home safety + education vs education 1 124 Rate Ratio (IV, Fixed, 95% CI) 0.93 [0.61, 1.44]
21.1.7 Exercise + home safety + education + clinical assessment vs education 1 122 Rate Ratio (IV, Fixed, 95% CI) 0.89 [0.58, 1.37]
21.1.8 Exercise + home safety + multifactorial assessment and referral vs multifactorial assessment and referral 1 19 Rate Ratio (IV, Fixed, 95% CI) 0.18 [0.02, 1.59]
21.1.9 Exercise + vitamin D vs no exercise/no vitamin D (severe visual impairment) 1 391 Rate Ratio (IV, Fixed, 95% CI) 1.15 [0.82, 1.61]
21.1.10 Exercise + nutrition + calcium + vitamin D vs calcium + vitamin D 1 20 Rate Ratio (IV, Fixed, 95% CI) 0.19 [0.05, 0.68]
21.1.11 Exercise + cognitive behavioural therapy vs control 1 116 Rate Ratio (IV, Fixed, 95% CI) 0.38 [0.10, 1.47]
21.1.12 Exercise + "individualised fall prevention advice" vs control 1 78 Rate Ratio (IV, Fixed, 95% CI) 0.89 [0.71, 1.10]
21.1.13 Centre‐based rehabilitation (exercise + education) vs home‐based rehabilitation (exercise + education) 1 76 Rate Ratio (IV, Fixed, 95% CI) 0.46 [0.22, 0.97]
21.1.14 Physical training + education vs control 1 33 Rate Ratio (IV, Fixed, 95% CI) 2.12 [0.59, 7.57]
21.1.15 Exercise + education vs education 1 132 Rate Ratio (IV, Fixed, 95% CI) 0.90 [0.61, 1.33]
21.1.16 Exercise + education + risk assessment vs control 1 453 Rate Ratio (IV, Fixed, 95% CI) 0.75 [0.52, 1.09]
21.1.17 Multifunctional training + whole body vibration vs light physical exercise 1 97 Rate Ratio (IV, Fixed, 95% CI) 0.46 [0.27, 0.79]
21.1.18 Multifaceted podiatry including foot and ankle exercises vs routine podiatry care 1 305 Rate Ratio (IV, Fixed, 95% CI) 0.64 [0.45, 0.91]
21.1.19 Multidisciplinary rehabilitation + home safety visit vs multidisciplinary rehabilitation (no home visit) 1 95 Rate Ratio (IV, Fixed, 95% CI) 0.46 [0.21, 1.00]
21.2 Number of fallers 13   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
21.2.1 Exercise + home safety vs remainder 1 1090 Risk Ratio (IV, Fixed, 95% CI) 0.76 [0.60, 0.97]
21.2.2 Exercise + vision assessment vs remainder 1 1090 Risk Ratio (IV, Fixed, 95% CI) 0.73 [0.59, 0.91]
21.2.3 Exercise + home safety + vision assessment vs remainder 1 1090 Risk Ratio (IV, Fixed, 95% CI) 0.67 [0.51, 0.88]
21.2.4 Home safety + vision assessment vs remainder 1 1090 Risk Ratio (IV, Fixed, 95% CI) 0.81 [0.65, 1.01]
21.2.5 Exercise + home safety + education vs control 1 310 Risk Ratio (IV, Fixed, 95% CI) 0.90 [0.74, 1.09]
21.2.6 Exercise + home safety + education vs education 1 124 Risk Ratio (IV, Fixed, 95% CI) 0.87 [0.61, 1.24]
21.2.7 Exercise + home safety + education + clinical assessment vs education 1 122 Risk Ratio (IV, Fixed, 95% CI) 0.83 [0.57, 1.20]
21.2.8 Exercise + vit D vs no exercise/no vit D (severe visual impairment) 1 391 Risk Ratio (IV, Fixed, 95% CI) 0.99 [0.81, 1.20]
21.2.9 Exercise + cognitive behavioural therapy vs control 1 116 Risk Ratio (IV, Fixed, 95% CI) 0.40 [0.11, 1.45]
21.2.10 Centre‐based rehabilitation (exercise + education) vs home‐based rehabilitation (exercise + education) 1 73 Risk Ratio (IV, Fixed, 95% CI) 0.57 [0.35, 0.93]
21.2.11 Physical training + education vs control 1 33 Risk Ratio (IV, Fixed, 95% CI) 1.39 [0.66, 2.93]
21.2.12 Exercise + education vs control 1 103 Risk Ratio (IV, Fixed, 95% CI) 1.68 [0.16, 17.67]
21.2.13 Exercise + education vs education 1 132 Risk Ratio (IV, Fixed, 95% CI) 0.84 [0.59, 1.20]
21.2.14 Exercise + education + risk assessment vs control 1 453 Risk Ratio (IV, Fixed, 95% CI) 0.96 [0.82, 1.12]
21.2.15 Multifaceted podiatry including foot and ankle exercises vs routine podiatry care 1 305 Risk Ratio (IV, Fixed, 95% CI) 0.85 [0.66, 1.10]
21.2.16 Home safety + medication review vs control 1 294 Risk Ratio (IV, Fixed, 95% CI) 0.79 [0.46, 1.34]
21.2.17 Education + free access to geriatric clinic vs control 1 815 Risk Ratio (IV, Fixed, 95% CI) 0.77 [0.63, 0.94]
21.2.18 Multidisciplinary rehabilitation + home safety visit vs multidisciplinary rehabilitation (no home visit) 1 95 Risk Ratio (IV, Fixed, 95% CI) 0.51 [0.21, 1.24]
21.3 Number of people sustaining a fracture 2   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
21.3.1 Multifaceted podiatry including foot and ankle exercises vs routine podiatry care 1 305 Risk Ratio (IV, Fixed, 95% CI) 0.14 [0.02, 1.05]
21.3.2 Multifunctional training + whole body vibration vs light physical exercise 1 97 Risk Ratio (IV, Fixed, 95% CI) 0.46 [0.13, 1.64]

Comparison 22. Multifactorial intervention vs control.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
22.1 Rate of falls 19 9503 Rate Ratio (IV, Random, 95% CI) 0.76 [0.67, 0.86]
22.2 Number of fallers 34 13617 Risk Ratio (IV, Random, 95% CI) 0.93 [0.86, 1.02]
22.3 Number of people sustaining a fracture 11 3808 Risk Ratio (IV, Random, 95% CI) 0.84 [0.67, 1.05]

Comparison 23. Multifactorial intervention vs control: subgroup analysis by falls risk at baseline.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
23.1 Rate of falls 19   Rate Ratio (IV, Random, 95% CI) Subtotals only
23.1.1 Selected for higher risk of falling 17 5954 Rate Ratio (IV, Random, 95% CI) 0.77 [0.66, 0.90]
23.1.2 Not selected for higher risk of falling 2 3549 Rate Ratio (IV, Random, 95% CI) 0.57 [0.23, 1.38]
23.2 Number of fallers 34   Risk Ratio (IV, Random, 95% CI) Subtotals only
23.2.1 Selected for higher risk of falling 25 7536 Risk Ratio (IV, Random, 95% CI) 0.94 [0.85, 1.03]
23.2.2 Not selected for higher risk of falling 9 6081 Risk Ratio (IV, Random, 95% CI) 0.92 [0.76, 1.11]

Comparison 24. Multifactorial intervention vs control: subgroup analysis by intensity of intervention.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
24.1 Rate of falls 19   Rate Ratio (IV, Random, 95% CI) Subtotals only
24.1.1 Assessment and active intervention 11 6338 Rate Ratio (IV, Random, 95% CI) 0.74 [0.61, 0.89]
24.1.2 Assessment and referral or provision of information 9 3376 Rate Ratio (IV, Random, 95% CI) 0.82 [0.71, 0.95]
24.2 Number of fallers 34   Risk Ratio (IV, Random, 95% CI) Subtotals only
24.2.1 Assessment and active intervention 16 7315 Risk Ratio (IV, Random, 95% CI) 0.87 [0.76, 0.98]
24.2.2 Assessment and referral or provision of information 20 6662 Risk Ratio (IV, Random, 95% CI) 1.02 [0.93, 1.12]

Comparison 25. Multifactorial intervention (setting 1) vs multifactorial intervention (setting 2).

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
25.1 Rate of falls 1   Rate Ratio (IV, Fixed, 95% CI) Subtotals only
25.1.1 Community‐based intervention vs hospital‐based intervention 1 349 Rate Ratio (IV, Fixed, 95% CI) 0.84 [0.49, 1.46]
25.2 Number of fallers 2   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
25.2.1 Community‐based intervention vs hospital‐based intervention 1 349 Risk Ratio (IV, Fixed, 95% CI) 1.27 [0.78, 2.08]
25.2.2 Specialised Geriatric Service intervention vs family physician intervention 1 234 Risk Ratio (IV, Fixed, 95% CI) 0.96 [0.72, 1.29]
25.3 Number of people sustaining a fracture 1   Risk Ratio (IV, Fixed, 95% CI) Subtotals only
25.3.1 Community‐based intervention vs hospital‐based intervention 1 219 Risk Ratio (IV, Fixed, 95% CI) 1.17 [0.20, 6.85]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Assantachai 2002.

Study characteristics
Methods CCT (cluster‐randomised by community)
Participants Setting: Bangkok, Thailand
N = 1043
Sample: people living in 11 selected urban communities (64% women)
Age (years): mean 67.6 (SD 6.2)
Inclusion criteria: aged at least 60; living in one of the selected communities
Interventions 1. Educational leaflet and free access to geriatric clinic. Leaflet about locally identified risk factors for falling (kyphoscoliosis, nutritional status, ADL, hypertension, special sense function, cognitive problems) and ways of preventing, correcting, coping with them. Assessed musculoskeletal deformity, arthralgia, hypertension, ADL, mobility, gait, hearing, vision, and presumably any problems addressed at geriatric clinic
2. Control: no intervention
Outcomes 1. Number of people falling
Duration of the study 1 year
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Communities drawn from pool of 20 until 1043 subjects recruited. Communities then allocated to intervention (odd number) or control (even number) using enrolment sequence (information provided by author).
Allocation concealment (selection bias) High risk Alternation
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Cluster‐randomised by community. Control groups received leaflet and offer of hospital access and self reported falls every 2 months. Insufficient information to judge risk of bias.
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Falls recorded in both groups by participants who were aware of their group allocation. Blinding of assessors not described. 
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Interval recall. Falls ascertained by postcards every 2 months, and phone call if no card returned.

Ballard 2004.

Study characteristics
Methods RCT
Participants Setting: USA
N = 40
Sample: volunteers (100% women)
Age (years): mean 72.9 (SD 6)
Inclusion criteria: aged ≥ 65; ambulatory; community‐dwelling; history of falling in previous year or fear of future fall; able to moderate exercise
Exclusion criteria: cardiovascular disease or extreme vertigo that might prohibit moderate exercise; requiring walker for support
Interventions 1. Exercise sessions (warm up, low impact aerobics, exercise for strength and balance, cool down) 1 hour, 3 x per wk, for 15 wk. Plus 6 home safety education classes.
2. Control: exercise sessions as above 1 hour, 3 x per wk, for 2 wk + videotape so could continue at home. Plus 6 home safety education classes as above.
Outcomes 1. Rate of falls
2. Number of people falling
Falls a secondary outcome of study
Other outcomes reported but not included in this review
Duration of the study 16 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "assigned to exercise and control groups using stratified randomisation".
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Control group had 2 wk exercise programme ‐ study group 15 wk. Neither participants or study personnel blinded.  
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Falls data collected by telephone at 1 year. Blinding of telephone assessors not reported.  
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Falls identified retrospectively during intervention at each home safety class (every 2 months), and by telephone follow‐up 1 year after end of intervention

Barnett 2003.

Study characteristics
Methods RCT
Participants Setting: Australia
N = 163
Sample: elderly people identified (67% women) as at risk of falling by general practitioner or hospital physiotherapist using assessment tool
Age (years): mean 74.9 (SD 10.9)
Inclusion criteria: age over 65 years; identified as 'at risk' of falling (1 or more of the following risk factors: lower limb weakness, poor balance, slow reaction time)
Exclusion criteria: cognitive impairment; degenerative conditions, e.g. Parkinson's disease or medical condition involving neuromuscular, skeletal, or cardiovascular system that precluded taking part in exercise programme
Interventions 1. Exercise sessions (stretching, and for strength, balance, co‐ordination, aerobic capacity) by accredited exercise instructor, in groups of 6 to 18, 1 hour per wk for 4 terms for 1 year (37 classes)
Home exercise programme based on class content + diaries to record participation
2. Control: no exercise intervention
Both groups received information on strategies for avoiding falls, e.g. hand and foot placement if loss of balance occurred
Outcomes 1. Rate of falls
2. Number of people falling
Other outcomes reported but not included in this review
Duration of the study 1 year
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomised in matched blocks" (N = 6)
Allocation concealment (selection bias) Low risk Consecutively numbered, opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Both groups received information on strategies for avoiding falls. Intervention group received structured weekly exercise sessions. Blinding not reported, but impact of non‐blinding unclear.
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Falls reported by participants who were aware of their group allocation, by postal surveys monthly in both groups. Telephone interview if not  returned by 2 weeks. Unclear whether those conducting telephone check were unblinded.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Unclear risk Interval recall. Falls identified by postal survey at the end of each calendar month. Phoned if not returned within 2 weeks.

Beling 2009.

Study characteristics
Methods RCT
Participants Setting: California State University, Northridge, California, USA
N = 23
Sample: volunteers recruited through press releases, newspaper advertisements and university website (42% women)
Age (years): mean 80 (SD 5.7)
Inclusion criteria: ≥ 65 years; community‐dwelling; English speaking; minimal vision and hearing deficit; access to transportation; consenting; with physician approval to participate; MMSE ≥ 24/30; 3 m TUG test ≥ 13.5 sec and/or to have ≥ 2 falls in past year and/or 1 injurious fall in the past year
Exclusion criteria: cardiac conditions; musculoskeletal and/or neurological impairment that could result in falls, e.g. stroke, Parkinson's disease, lower extremity joint replacement, fracture in last year
Interventions Both groups received multifactorial intervention (assessment and referral) prior to randomisation
1. Intervention: physiotherapist‐led, group‐based balance training 3 x per wk for 12 wks. Tailored to address risk factors identified at pre‐testing. Home assessment by physiotherapist students. Written recommendations given and discussed. Funding to assist with modifications. Measured and supplied with hip protectors.
2. Control: usual activities but offered intervention after post test
Outcomes 1. Rate of falls
Other outcomes reported but not included in this review
Duration of the study 3 months
Notes Required to attend minimum of 30 sessions
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Twelve subjects were randomly assigned to the experimental group and 11 subjects were assigned to the control group." Insufficient information to permit judgement.
Allocation concealment (selection bias) Unclear risk Quote: "randomly assigned". Insufficient information to permit judgement.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk No information on method of recording falls. Insufficient information to permit judgement.
Incomplete outcome data (attrition bias)
Falls High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Quote: "The number of falls that occurred in both groups during the 12 week intervention was also collected at the end of the intervention." Ascertainment relied on participant recall at the end of the 12 week intervention.

Beyer 2007.

Study characteristics
Methods RCT
Participants Setting: Copenhagen, Denmark
N = 65
Sample: women with a history of a fall identified from hospital records
Age (years): range 70 to 90
Inclusion criteria: community‐dwelling; at a relatively high risk of falls, defined as either ≥ 80 years old or ≥ 65 years with history of a fall in the previous 12 months or a timed up and go test score of at least 15 seconds; home‐dwelling; aged 70 to 90 years; history of a fall requiring treatment in ED but not hospitalisation; able to come to training facility
Exclusion criteria: lower limb fracture in last 6 months; neurological diseases, unable to understand Danish; cognitively impaired (MMSE < 24)
Interventions 1. Supervised group exercise programme (flexibility, lower limb resistance exercise, balance training, stretching), 60 min, 2 x per wk, for 6 months
2. Control: no intervention, but offered intervention after 1 year
Outcomes 1. Number of people falling
Other outcomes reported but not included in this review
Duration of the study 1 year
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "…using the minimization method with the aid of a computer program for randomization"
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Falls were recorded in both allocated groups using the same method (a monthly falls calendar), but no mention of blinding of personnel confirming falls or carrying out data entry. Insufficient information to make a judgement of 'Low risk' or 'High risk'.
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "A falls calendar was sent to every participant on the first day of each month" for 1 year

Bischoff‐Ferrari 2006.

Study characteristics
Methods RCT
Participants Setting: Boston, MA, USA
N = 445
Sample: men and women recruited by direct mailings and presentations (sample frame not given) (55% women)
Age (years): mean 71
Inclusion criteria: aged ≥ 65
Exclusion criteria: current cancer or hyperparathyroidism; kidney stone in last 5 years; renal disease; bilateral hip surgery; bisphosphonate, calcitonin, oestrogen, tamoxifen, or testosterone therapy in past 6 months, or fluoride in past 2 years; femoral neck BMD > 2 SD below the mean for subjects of the same age and sex; dietary calcium intake > 1500 mg/day; laboratory evidence of kidney disease
Interventions 1. Cholecalciferol (700 IU vitamin D) and calcium citrate malate (500 mg elemental calcium) orally, daily at bedtime for 3 years
2. Control: double placebo tablets
Outcomes 1. Rate of falls
2. Number of people falling
3. Number sustaining a fracture
4. Adverse effects
Other outcomes reported but not included in this review
Duration of the study 3 years
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Participants were randomly assigned ..."
Quote: "Random group assignment was performed with stratification according to sex, race and decade of age."
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Low risk Placebo‐controlled medication trial
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls reported by participants who were blind to their group allocation (placebo‐controlled trial)
Blinding of outcome assessment (detection bias)
Fractures Low risk Quote: "... cases of nonvertebral fracture were ascertained by means of interviews and verified with use of hospital records."
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "Participants were asked to send a postcard after every fall, which was then followed by a telephone call from a staff member to assess the circumstances of the fall. In addition, falls were ascertained at every follow‐up visit."

Bischoff‐Ferrari 2010.

Study characteristics
Methods RCT (2 x 2 factorial design)
Participants Setting: hospital centre, Triemli, Switzerland
N = 173
Sample: acute hip fracture (79% women)
Age (years): mean 84 (range 65 to 99)
Inclusion criteria: aged ≥ 65; acute hip fracture; MMSE ≥ 15; creatinine clearance > 15 mL/min; able to walk 3 m before hip fracture
Exclusion criteria: prior hip fracture at same hip; cancer or chemotherapy in last year; severe visual or hearing impairment; kidney stone in past 5 years; hypercalcaemia; primary parathyroidism or sarcoidosis
Interventions 1. Cholecalciferol (vitamin D3) 2000 IU/day (breakfast and bedtime 400 IU cholecalciferol + 500 mg calcium carbonate + 1200 IU cholecalciferol at breakfast) + standard physiotherapy (supervised physiotherapy 30 min/day in acute care)
2. Cholecalciferol 2000 IU/day (breakfast and bedtime 400 IU cholecalciferol + 500 mg calcium carbonate + 1200 IU cholecalciferol at breakfast) + extended physiotherapy (supervised physiotherapy 30 min/day + 30 min/day home programme instruction in acute care + unsupervised home programme for 12 months (standing on 1, 2 legs; Theraband for arms; getting in/out chairs; going up/down stairs))
3. Cholecalciferol 800 IU/day (breakfast and bedtime 400 IU cholecalciferol + 500 mg calcium carbonate + placebo cholecalciferol at breakfast) + standard physiotherapy (as above)
4. Cholecalciferol 800 IU/day (breakfast and bedtime 400 IU cholecalciferol + 500 mg calcium carbonate + placebo cholecalciferol at breakfast) + extended physiotherapy (as above)
Outcomes 1. Rate of falls
2. Number sustaining a hip fracture
3. Adverse effects
Duration of the study 1 year
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Computer‐based randomization was performed by the study statistician"
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement of 'high' or 'low'
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "Randomization for the dosage of cholecalciferol was double‐blinded, whereas randomization for PT was single‐blinded (all study staff except the treating physiotherapist who instructed the home program were blinded to the PT treatment allocation)."
Trial with 4 arms (factorial design) with varying risk of bias. Drug intervention placebo‐controlled (low risk). Although participants and PT aware of which physiotherapy intervention they were receiving the impact of non‐blinding likely to be low or unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Phoned by assessor blind to allocation. Quote: "... all study staff except the treating physiotherapist who instructed the home program were blinded to the PT treatment allocation." "To maintain the blinding of our study staff to the PT group, we assessed adherence to the home program (at least once per wk vs less) only at the 12‐month follow‐up visit or by telephone call."
Blinding of outcome assessment (detection bias)
Fractures Low risk Quote: "Falls, fall‐related injuries, and hospital readmissions were assessed by monthly telephone calls and a patient diary." "All admission records were reviewed by 3 blinded coinvestigators (H.A.B.‐F., A.E., and N.J.M.) to determine the main cause of readmission." Hip fracture data used in this review and these participants would have been hospitalised and therefore confirmed by blinded coinvestigators.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "Falls, fall‐related injuries, and hospital readmissions were assessed by monthly telephone calls and a patient diary. In addition, a telephone hotline was provided to report these events at any time."

Blalock 2010.

Study characteristics
Methods RCT
Participants Setting: North Carolina, USA
N = 186
Sample: recruited through a chain of community pharmacies (71% women)
Age (years): mean 74.8 (SD 6.9)
Inclusion criteria: aged ≥ 65 years; ≥ 1 falls during 12‐month period before study entry; taking ≥ 4 prescription medications; taking ≥ 1 high falls‐risk medication; able to speak and read English
Exclusion criteria: resident of long‐term care facility; cognitively impaired; housebound
Interventions 1. Pharmacist intervention: face‐to‐face consultation with community pharmacist about medication regimen (identifying side effects etc). Pharmacist follow‐up as required; participants' physicians to co‐ordinate any recommended medication changes. Given fall prevention brochure and home safety checklist
2. Control: given fall prevention brochure and home safety checklist
Outcomes 1. Rate of falls
2. Number of people falling
Duration of the study 1 year
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The allocation sequence used for making group assignments was created using a list of random numbers, generated in blocks of 20 to ensure balancing of group assignment over the duration of participant recruitment."
Allocation concealment (selection bias) Unclear risk Quote: "The allocation sequence was concealed from all study personnel except the principal investigator, who had no contact with study participants during the process of data collection or intervention delivery." Insufficient information to permit judgement.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Participants contacted by phone if calendars not returned, or reporting a fall. The only unblinded member of the research group was not involved in data collection (see above).
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "... each participant received a set of twelve 1‐month calendars. They were asked to record each fall they experienced on the calendar for the current month. …asked to return each calendar to study staff at the end of the month. Participants who did not return a calendar by the 10th of the following month were called by study personnel to obtain the required information by phone."

Brown 2002.

Study characteristics
Methods RCT (individually randomised, but 6 clusters containing couples at same address)
Participants Setting: Perth, Western Australia
N = 149
Sample: men and women recruited by press releases in 11 newspapers and information brochures distributed to organisations, GPs, etc (79% women)
Age (years): N = 101 aged 75 to 84, N = 48 aged 85 to 94
Inclusion criteria: age ≥ 75; community‐living; independent in basic ADL; able to walk 20 m without personal assistance
Exclusion criteria: cognitive impairment (MMSE ≤ 24); various conditions, e.g. angina, claudication, cerebrovascular disease, low or high blood pressure, major systemic disease, mental illness
Interventions 1. Exercise intervention to improve cardiovascular endurance, general muscle performance, balance, co‐ordination and flexibility. 60 min, 2 x per wk for 16 wks (32 hours).
2. Social intervention for 13 wks involving presentations of travel slides and videos by participants
3. Control: no intervention
Outcomes 1. Number of participants falling
Duration of the study 14 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomised into one of three groups using a table of random numbers".
Allocation concealment (selection bias) Low risk Randomised into one of 3 groups "by a physiotherapist uninvolved in the study."
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls reported by participants who were aware of their group allocation, but outcome assessors were blinded
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Participants provided details of falls in monthly report sheet returned in reply paid addressed envelopes

Buchner 1997a.

Study characteristics
Methods RCT
Participants Setting: Seattle, USA
N = 105
Sample: random sample of HMO members (FICSIT intervention groups only) (51% women)
Age (years): mean 75
Inclusion criteria: aged 68 to 85; unable to do 8‐step tandem gait test without errors; below 50th percentile in knee extensor strength for height and weight
Exclusion criteria: active cardiovascular, pulmonary, vestibular, and bone disease; positive cardiac stress test; body weight > 180% ideal; major psychiatric illness; active metabolic disease; chronic anaemia; amputation; chronic neurological or muscle disease; inability to walk; dependency in eating, dressing, transfer or bathing; terminal illness; inability to speak English or complete written forms
Interventions Randomised into 7 groups: 6 intervention groups (3 FICSIT trial, 3 MoveIT trial), and 1 control group. Only FICSIT trial and control groups included in this review.
Supervised exercise classes 1 hour, 3 x per wk for 24 to 26 wks followed by unsupervised exercise
1. 6 months endurance training (ET) (stationary cycles) with arms and legs propelling wheel
2. 6 months strength training (ST) classes (using weight machines for resistance exercises for upper and lower body)
3. 6 months ST plus ET
4. Control: usual activity levels but "allowed to exercise after 6 months"
Exercise sessions started with a 10 to 15‐minute warm‐up and ended with a 5 to 10‐minute cool down
Outcomes 1. Rate of falls
2. Number of people falling
3. Number of people with adverse effects
"A priori decision" to report fall outcomes for "any exercise" (all 3 exercise groups combined) compared with control group
Duration of the study Maximum 25 months (median 18 months)
Notes Seattle FICSIT trial. Only 1.3% of original sample randomised. Falls not primary outcome. Other outcomes assessed at end of intervention (6 months) then "control group allowed to exercise after 6 months" (7/30 participants did). Cost analysis reported in primary reference.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised "using a variation of randomly permuted blocks."
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Falls reported by participants who were aware of their group allocation. Quote: "Most study outcomes were measured by blinded examiners..." but unclear whether this applies to personnel carrying out telephone follow‐up of falls.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Falls reported immediately by mail, also monthly postcard return; telephone follow‐up if no postcard received

Bunout 2005.

Study characteristics
Methods RCT
Participants Setting: Chile
N = 298
Sample: men and women (71% women)
Age (years): mean 75 (SD 5)
Inclusion criteria: "elderly subjects" consenting to participate; able to reach community centre
Exclusion criteria: severe disabling condition; cognitive impairment (MMSE < 20)
Interventions 1. Exercise class: 1 hour, 2 x per wk, for 1 year, moderate‐intensity resistance exercise training (functional weight bearing exercises, exercises with TheraBands and walking (see Appendix 2 of supplementary data on journal website for details)
2. Control: no intervention
Outcomes 1. Rate of falls
2. Number of people falling
Other outcomes reported but not included in this review
Duration of the study For the 1 year of intervention
Notes Journal website for supplementary data www.ageing.oupjournals.org. Additional data obtained from author.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised using computer‐generated random number table
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Falls reported at follow‐up clinics by participants who were aware of their group allocation. Blinding of researchers at follow‐up not reported. 
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Unclear risk Interval recall. Falls ascertained at monthly outpatient clinic or by telephone.

Campbell 1997.

Study characteristics
Methods RCT
Participants Setting: Dunedin, New Zealand
N = 233
Sample: women identified from general practice registers
Age (years): mean 84.1 (SD 3.1)
Inclusion criteria: at least 80 years old; community‐living
Exclusion criteria: cognitive impairment; not ambulatory in own residence; already receiving physiotherapy
Interventions Baseline health and physical assessment for both groups.
1. 1‐hour visits by physiotherapist x 4 in first 2 months to prescribe home‐based individualised exercise and walking programme. Exercise, 30 min, 3 x per wk plus walk outside home 3 x per wk. Encouraged to continue for 1 year. Regular phone contact to maintain motivation after first 2 months.
2. Control: social visit by research nurse x 4 in first 2 months. Regular phone contact.
Outcomes 1. Rate of falls
2. Number of people falling
Duration of the study 24 months but 12‐month data used in analyses
Notes Otago Exercise Programme manual can be obtained from www.cdc.gov/HomeandRecreationalSafety/Falls/compendium/1.2_otago.html. Cost‐effectiveness analysis reported (Robertson 2001c).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Allocation schedule developed using computer‐generated numbers
Allocation concealment (selection bias) Low risk Assignment by independent person off site
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers High risk Falls reported by participants who were aware of group allocation. Blinding of adjudicator reported, but researcher making telephone contact was aware of group allocation as she also did social visits (personal communication).
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Falls recorded daily on postcard calendars, mail registration monthly by postcard, telephone follow‐up

Campbell 1999.

Study characteristics
Methods RCT (2 x 2 factorial design)
Participants Setting: community. Dunedin, New Zealand
N = 93
Sample: identified from general practice registers (76% women)
Age (years): mean 74.7 (SD 7.2)
Inclusion criteria: at least 65 years old; currently taking a benzodiazepine, any other hypnotic, or any antidepressant or major tranquilliser; ambulatory in own residence; not receiving physiotherapy; thought by GP to benefit from psychotropic medication withdrawal
Exclusion criteria: cognitive impairment
Interventions Baseline assessment
1. Gradual withdrawal of psychotropic medication (placebo substitution) over 14 wk period plus home‐based exercise programme
2. Psychotropic medication withdrawal (placebo substitution) with no exercise programme
3. No change in psychotropic medication plus exercise programme
4. No change in psychotropic medication, no exercise programme
Exercise programme: 1‐hour physiotherapist visits 4 x in first 2 months to prescribe home‐based individualised exercises (muscle strengthening and balance retraining exercises 30 min, 3 x per wk) and walking 2 x per wk
Regular phone contact to maintain motivation
Study capsules created by grinding tablets and packing into gelatin capsules. Capsules containing inert and active ingredients looked and tasted the same.
Outcomes 1. Rate of falls
2. Number of people falling
Duration of the study 44 wks
Notes Only 19% randomised. Psychotropic medications recorded 1 month after completion of study. 8 of the 17 who had taken the placebo for 44 wks had restarted 1 month after end of study. Otago Exercise Programme manual can be obtained from www.cdc.gov/HomeandRecreationalSafety/Falls/compendium/1.2_otago.html. Cost‐effectiveness analysis reported (Robertson 2001d).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Allocation schedule developed using computer‐generated numbers
Allocation concealment (selection bias) Low risk Assignment by independent person off site
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants and personnel blinded to psychotropic medication dose. Although participants and PT aware of which physiotherapy intervention they were receiving this is unlikely to have introduced performance bias.
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls reported by participants who were aware of exercise allocation, but not medication withdrawal. Investigator confirming fall events blind to group allocation.
Incomplete outcome data (attrition bias)
Falls High risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Falls recorded daily on postcard calendars, mail registration monthly by postcard, telephone follow‐up

Campbell 2005.

Study characteristics
Methods RCT (2 x 2 factorial design)
Participants Setting: New Zealand
N = 391
Sample: men and women with severe visual impairment (visual acuity 6/24 or worse) identified in blind register, university and hospital outpatient clinics, and private ophthalmology practice (68% women)
Age (years): mean 83.6 (SD 4.8), range 75 to 96
Inclusion criteria: vision worse than 6/24 in better eye; age ≥ 75 years
Exclusion criteria: unable to walk around home
Interventions 1. Home safety programme
2. Otago Exercise Programme plus vitamin D supplements
3. Both of the above
4. Control: 2 x 1‐hour social visits during the first 6 months of the trial
Outcomes 1. Rate of falls
2. Number of people falling
Duration of the study 1 year
Notes Otago Exercise Programme manual can be obtained from www.cdc.gov/HomeandRecreationalSafety/Falls/compendium/1.2_otago.html. Cost‐effectiveness analysis reported in the primary reference.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers
Allocation concealment (selection bias) Low risk Schedule held by independent person at separate site, telephone access
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls reported by participants who were aware of their group allocation. Phoned by independent assessor blind to allocation. Person classifying fall events also blind to allocation.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Prospective. Falls recorded on daily on monthly pre‐paid postcard calendars, telephone follow‐up

Carpenter 1990.

Study characteristics
Methods RCT (individually randomised, but small number of clusters as husbands allocated to same group)
Participants Setting: Andover, United Kingdom
N = 539
Sample: women and men recruited from patient lists of 2 general medical practices. The sample represents 89.5% of those in the age group in the participating practices (65% women)
Age (years): ≥ 75; 23 men and 49 women > 85
Inclusion criteria: aged ≥ 75; living in Andover area
Exclusion criteria: living in residential care
Interventions 1. Visit by trained volunteers for dependency surveillance using Winchester disability rating scale. The intervention was stratified by degree of disability on the entry evaluation. For those with no disability, the visit was every 6 months; for those with disability, 3 months. Scores compared with previous assessment and referral to GP if score increased by 5 or more.
2. Control: no disability surveillance between initial and final evaluation
Outcomes 1. Rate of falls (in each group in the month before the final interview at 3 years)
Other outcomes reported but not included in this review
Duration of the study 3 years
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised by random number tables
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel no blind to allocated group, but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Recollection of falls in the preceding month was ascertained at final interview in both groups by an assessor. Blinding not described.
Incomplete outcome data (attrition bias)
Falls High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Unclear risk Retrospective recall, but over 1‐month period

Carter 1997.

Study characteristics
Methods RCT
Participants Setting: Hunter Valley, Australia
N = 657
Sample: men and women identified by 37 general practitioners as meeting inclusion criteria (30% women)
Age (years): ≥ 70
Inclusion criteria: aged ≥ 70; able to speak and understand English; community‐dwelling; living independently
Exclusion criteria: psychiatric disturbance affecting comprehension of the aims of the study
Interventions 1. Brief feedback on home safety plus pamphlets on home safety and medication use (low‐intensity intervention)
2. Action plan for home safety plus medication review (high‐intensity intervention)
3. Control: no intervention during study period but intervention after the end of the study period
Outcomes 1. Number of people falling (during previous month at 3, 6, and 12 months)
Duration of the study 1 year
Notes Unpublished study
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number generator
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Self reported falls and blinding of personnel carrying out structured interview at 3, 6, and 12 months not described 
Incomplete outcome data (attrition bias)
Fallers High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk 4‐week retrospective diary used by participants prior to structured interview at 3, 6, and 12 months

Carter 2002.

Study characteristics
Methods RCT
Participants Setting: Vancouver, Canada
N = 93
Subjects: community‐dwelling osteoporotic women
Age (years): mean 69 (SD 3)
Inclusion criteria: aged 65 to 75 years; residents of greater Vancouver; osteoporotic (based on BMD)
Exclusion criteria: < 5 years post menopause; weighed > 130% ideal body weight; other contraindications to exercising; already doing > 8 hours/wk moderate to hard exercise; planning to be out of city > 4 wk during 20 wk programme
Interventions 1. Exercise class (Osteofit) for 40 min, 2 x per wk, for 20 wks in community centres. Classes of 12 per instructor. 8 to 16 strengthening and stretching exercises using Theraband elastic bands and small free weights. Bimonthly social seminar.
2. Control: usual routine activities and bimonthly social seminar separate from intervention group
Outcomes 1. Rate of falls
Other outcomes reported but not included in this review
Duration of the study 20 wks
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised by computer‐generated programme
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Quote: "All data were collected by trained researchers blinded to group assignment." 
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Falls recorded in falls calendars returned monthly

Cerny 1998.

Study characteristics
Methods RCT (individually randomised but some clusters, e.g. couples or 2 ladies where one was dependent on the other for transport)
Participants Setting: California, USA
N = 28
Sample: community‐dwelling "well elderly" (proportion of women not stated)
Age (years): mean 71 (SD 4)
Inclusion criteria: none described
Exclusion criteria: none described
Interventions 1. Exercise programme of progressive resistance, stretching, aerobic and balance exercises, and brisk walking over various terrains for 1.5 hours, 3 x per wk, for 6 months
2. Control: no intervention
Outcomes 1. Number of people falling
Other outcomes reported but not included in this review. Falls a secondary outcome
Duration of the study 6 months
Notes Contact with lead author but no full paper or report prepared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised by coin toss. Individually randomised but some clusters, e.g. couples or 2 ladies where one was dependent on the other for transport (information from author).
Allocation concealment (selection bias) High risk Coin toss on site
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Reported only in abstract. Insufficient information to permit judgement. 
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Assume retrospective recall and 3 and 6 months assessment

Ciaschini 2009.

Study characteristics
Methods RCT
Participants Setting: Algoma District (including Sault Ste Marie), Ontario, Canada
N = 201
Sample: community‐dwelling people at risk of a fall‐related fracture (94% women)
Age (years): mean 72 (SD 8.4)
Inclusion criteria: community‐dwelling; > 55 years old; able to consent; at risk of fracture (non‐pathological fracture in past year with T‐score < 2.0; attended ED with a fall, self referred, or referred by health professional and at high risk of falls (TUG test > 14 sec))
Exclusion criteria: if already receiving therapy for osteoporosis as per Osteoporosis Canada guidelines
Interventions 1. Multifactorial falls risk assessment by nurse + counselling and referral for PT and OT and interventions, plus recommendations for osteoporosis therapy targeting physicians and their patients
2. Control: usual care until 6 months, then same as intervention group
Outcomes 1. Number of people falling
2. Number of sustaining a fracture
Other outcomes reported but not included in this review: primary outcome implementation of appropriate falls risk management by 6 months
Duration of the study 6 months
Notes 12‐month study but 6‐month data used in review analysis as control group participants were offered the intervention after 6 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Eligible patients were randomized using a computer generated randomization scheme under supervision of the study biostatistician, into an immediate intervention protocol (IP) group or to a delayed intervention protocol (DP) group".
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement (see above)
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "The patients, treating physicians and outcomes collectors could not be blinded to the intervention status." but impact of non‐blinding unclear.
Blinding of outcome assessment (detection bias)
Falls and fallers High risk Outcome collection stated not to be blind to allocation
Blinding of outcome assessment (detection bias)
Fractures Low risk Probably low risk as fractures ascertained in both groups from patient records
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "Falls and falls‐related injuries were obtained from electronic medical records as well as patient diaries."
Quote: "the number of falls and fractures as recorded in monthly patient diaries. Followup telephone calls every 3 months were used to obtain this data and completed patient diaries were mailed to the investigators at study end."

Clemson 2004.

Study characteristics
Methods RCT. Randomised in blocks of 4 stratified by sex and number of falls in previous 12 months
Participants Setting: Sydney, Australia
N = 310
Sample: volunteer community‐dwelling men and women recruited by various strategies (74% women)
Age (years): mean 78 (SD 5)
Inclusion criteria: aged ≥ 70; community‐dwelling; fallen in past year or felt themselves to be at risk of falling. Exclusion criteria: dementia (> 3 errors on Short Portable Mental Status Questionnaire); homebound; unable to independently leave home; unable to speak English
Interventions Both groups received baseline assessment at home before randomisation
1. Stepping On programme. Multifaceted small‐group (N = 12) learning environment to encourage self efficacy, behaviour change, and reduce falls using decision‐making theory and a variety of learning strategies. Facilitated by OT. 2 hours per wk, for 7 wks; taught exercises and practised in classes. OT home visit within 6 wks of final programme session; booster session 3 months after final session.
2. Control: at least 2 social visits from student OT with no discussion of falls or fall prevention
Outcomes 1. Rate of falls
2. Number of people falling
Duration of the study 14 months
Notes Details of programme in Appendix A of Clemson 2004: risk appraisal, exercise, moving safely, home hazards, community safety, footwear, vision and falls, vitamin D, hip protectors, medication management, mobility mastery, review and plan
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Randomised by researcher not involved in subject screening or assessment". Method not described.
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Study participants and personnel not blinded, but staff visiting control group instructed not to discuss falls or fall prevention
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk All participants used monthly calendar; telephone contact if not returned in 2 weeks. Blinding of study personnel recording data from the calendars not described. 
Incomplete outcome data (attrition bias)
Falls Unclear risk SeeAppendix 3 for method of assessment. Insufficient information to permit judgement.
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Prospective. Monthly falls postcard calendar.

Clemson 2010.

Study characteristics
Methods RCT
Participants Setting: Sydney, Australia
N = 34
Sample: volunteer community‐dwelling men and women recruited by various strategies (47% women)
Age (years): mean 82 (SD 5.9)
Inclusion criteria: aged > 70 years; ≥ 2 falls or an injurious fall in previous year
Exclusion criteria: cognitive impairment; no conversational English; unable to ambulate independently; resident in nursing home or hostel; unstable or terminal illness that would preclude planned exercises; neurological conditions, e.g. Parkinson's disease
Interventions 1. LiFE (Lifestyle approach to reducing Falls through Exercise) programme (progressive balance and strength training embedded in daily life activities). Taught in 5 home visits + 2 booster visits over 3 months + 2 phone calls. Included evaluation of functional balance and strength, profile of current activities, taught LiFE principles and given safety advice relating to activities, planning of activities, and goal setting.
2. Control: no intervention
Outcomes 1. Rate of falls
2. Number of people falling
Other outcomes reported but not included in this review
Duration of the study 6 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomisation was conducted … using a random numbers table"
Allocation concealment (selection bias) Low risk Quote: "Randomisation was conducted by an investigator not involved in assessment or intervention …" "Once baseline assessments were completed by the research assistant (RA), participants were then allocated in order of completion from the generated lists by the blinded investigator."
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel carrying out the intervention were not blind to allocated groups. Unclear whether this could result in performance bias.
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Quote: "An RA who was not involved in the intervention and masked to the group allocation conducted all assessments. Falls surveillance was by daily calendar, which participants mailed monthly, using pre‐addressed envelopes to the RA. An investigator telephoned any participant who failed to return the calendar or who reported a fall." Unclear whether the investigator carrying out the telephone calls was blind to group allocation.
Incomplete outcome data (attrition bias)
Falls Unclear risk SeeAppendix 3 for method of assessment. Insufficient information to permit judgement.
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "Falls surveillance was by daily calendar, which participants mailed monthly, using pre‐addressed envelopes …"

Close 1999.

Study characteristics
Methods RCT
Participants Setting: London, United Kingdom
N = 397
Sample: community‐dwelling individuals presenting at A&E after a fall (68% women). Admitted patients not recruited until discharge
Age (years): mean 78.2 (SD 7.5)
Inclusion criteria: aged ≥ 65; history of falling
Exclusion criteria: cognitive impairment (AMT < 7) and no regular carer (for informed consent reasons); speaking little or no English; not living locally
Interventions 1. Medical and occupational therapy assessments and interventions
Medical assessment to identify primary cause of fall and other risk factors present (general examination and visual acuity, balance, cognition, affect, medications). Intervention and referral as required. Home visit by occupational therapist (functional assessment and environmental hazards). Advice, equipment, and referrals as required.
2. Control: usual care only
Outcomes 1. Rate of falls
2. Number of people falling
Other outcomes reported but not included in this review
Duration of the study 1 year
Notes Cost analysis reported in Close 2000
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised by random numbers table
Allocation concealment (selection bias) Low risk List held independently of the investigators
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk All participants received falls diary and 4‐monthly postal questionnaire. Blinding of personnel recording the questionnaires not described. 
Blinding of outcome assessment (detection bias)
Fractures Unclear risk Self reported and blinding of personnel recording the questionnaires not described, confirmation of fractures not described
Incomplete outcome data (attrition bias)
Falls High risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "Each participant was given a “falls diary” with 12 monthly sheets to assist with the recall of further falls."
Quote: "Follow‐up was done by postal questionnaire, which was sent to all participants every 4 months for 1 year after the fall. Information about subsequent falls, fall‐related injury, and details of doctor and hospital visits or admissions and degree of function were requested.

Coleman 1999.

Study characteristics
Methods RCT (cluster‐randomised by physician practice)
Participants Setting: HMO members, Washington, USA
N = 169
Sample: community‐dwelling men and women in 9 physician practices in an ambulatory clinic (49% women)
Age (years): mean 77
Inclusion criteria: aged ≥ 65; high risk of being hospitalised or of developing functional decline; community‐dwelling
Exclusion criteria: living in nursing home; terminal illness; moderate to severe dementia or "too ill" (physician's judgement)
Interventions 1. Half‐day Chronic Care Clinics every 3 to 4 months in 5 practices focusing on planning chronic disease management (physician and nurse); reducing polypharmacy and high‐risk medications (pharmacist); patient self management/support group
2. Control: usual care (4 practices)
Outcomes 1. Number of people falling
Duration of the study 24 months (data at 12 months used in analysis)
Notes Cost analysis reported in primary reference
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomized using simple randomization"
Allocation concealment (selection bias) High risk Cluster‐randomised
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls were recorded by participants on a standardised questionnaire at 12 and 24 months. Chart abstraction conducted by a member of the study team and an additional reviewer blinded to study group.  
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Retrospective recall. Quote: "Falls were assessed using a standardized questionnaire" at 12 and 24 months.

Comans 2010.

Study characteristics
Methods RCT
Participants Setting: Metro South Community Rehabilitation Service, Brisbane, Australia
N = 107
Sample: recruited from people referred to Metro South Community Rehabilitation Service from 3 local EDs following presentation for a fall, or from local GPs (66% women)
Age (years): mean 78.9 (SD 7.7)
Inclusion criteria: community‐dwelling; age > 60 years; referred with history of a fall (see above) and/or declining mobility, function, or physical conditioning; able to complete TUG test
Exclusion criteria: living in high‐level care; non‐ambulant; assessed by OP or PT as unable to participate due to cognitive and/or physical function
Interventions 1. Centre‐based (group) intervention: 2 hours, 1 x per wk, for 8 wks. Group exercises (modified Tai Chi warm‐up, balance exercises, indoors walking circuit, lower limb strengthening exercises (30 min); education and discussion group covering falls prevention, promoting physical activity, National Nutritional Guidelines, relaxation, stress management, future planning; upper limb strengthening and functional activities (30 min)
2. Home‐based (individual) intervention: 1 x per wk, for 8 wks. Home visits by Community Rehabilitation Service (CRS) staff 45 to 60 min, 1 to 2 x wk, for 8 wks. Visits include 30 to 45 min personalised exercises and education modules as for the group programme but outdoors walking and ADL, e.g. hanging out washing for upper limb functional activities
Both groups received OT home safety recommendations and a tailored balance‐specific home exercise programme (10 min, 2 x per day)
Outcomes 1. Rate of falls
2. Number of fallers
Other outcomes reported but not included in this review
Duration of the study 6 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A list of computer‐generated random numbers was used to allocate subjects to home or centre‐based treatment
Allocation concealment (selection bias) Low risk Quote: "The randomization sequence was placed into sealed, opaque numbered envelopes by administration staff not connected with research. Following consent, the assessing therapist contacted administration staff who opened the next envelope in the sequence and informed the therapist of the participant's group allocation."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Although participants and personnel carrying out the intervention were not blind to allocated groups this is unlikely to have introduced bias as both groups received a similar intervention, but in different settings
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Quote: "Participants were followed up by monthly telephone contact for falls data and reassessed 6 months after initial randomization again by a blinded assessor."
Incomplete outcome data (attrition bias)
Falls High risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Unclear risk No mention of concurrent recording of falls by participants
Quote: "Falls after the intervention commenced were collected monthly by telephone contact and at interview at the 8‐week and 6‐month follow‐up assessments."

Conroy 2010.

Study characteristics
Methods RCT (multicentre)
Participants Setting: Nottingham and Derbyshire, United Kingdom
N = 364
Sample: community‐dwelling people registered with participating GPs (N = 8) (60% women)
Age (years): mean 78.6 (SD 5.7), range 70 to 101
Inclusion criteria: > 70 years; identified as being at high risk of falling by a postal screening questionnaire
Exclusion criteria: living in care home; receiving end of life care; already receiving a falls prevention programme; unwilling or unable to attend falls prevention programme; unable to provide informed consent
Interventions 1. Screening questionnaire, information leaflets, and invitation to attend the day hospital for multifactorial assessment and any subsequent intervention
2. Control: screening questionnaire, information leaflets, and usual care from primary care service until outcome data collected, then offered day‐hospital intervention
Outcomes 1. Rate of falls
2. Number of people falling
3. Number sustaining a fracture
Duration of the study 1 year
Notes Cost‐effectiveness analysis reported in Irvine 2010
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The randomisation list was computer generated using a random block size to maximise allocation concealment"
Allocation concealment (selection bias) Low risk Quote: "participants were allocated into the intervention or control arm by research assistants using an internet based randomization service"
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "Owing to the nature of the intervention, it was not possible to blind participants or researchers to allocation" but impact of non‐blinding unclear.
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Outcome assessor stated to be blinded. Quote: "Participants will be contacted via telephone by the "blinded" assessor at the end of each month to encourage return of the diary." (protocol paper)
Blinding of outcome assessment (detection bias)
Fractures Unclear risk Not completely clear that fractures were recorded in diaries in the same way as falls but seems to be the case. Quote: "Participants will be asked to record falls in the diary, along with the outcome (saw GP, phoned ambulance, sent to hospital, injuries)." Contacted by "blinded" assessor but no confirmation of fractures from medical records.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "… ascertained using prospective, participant‐completed monthly falls diaries, mailed to the research team at the end of every month."

Cornillon 2002.

Study characteristics
Methods RCT
Participants Setting: St Étienne, France
N = 303
Subjects: community‐dwelling and independent in ADL (83% women)
Age (years): mean 71
Inclusion criteria: aged over 65; living at home; ADL independent; consented
Exclusion criteria: cognitively impaired (MMSE < 20); obvious disorder of walking or balance
Interventions 1. Information on fall risk, and balance and sensory training in groups of 10 to 16. One session per wk, for 8 wks. Session started with foot and ankle warm‐up (walking on tip toe and on heels etc), walking following verbal orders, walking bare foot on different surfaces, standing on one leg with eyes open and shut, practising getting up from the floor
2. Control: normal activities
Outcomes 1. Rate of falls
2. Number of people falling
Duration of the study 1 year
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised by random number tables
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Falls recorded on 6‐monthly falls calendars. No telephone contact described. Blinding of study personnel recording data from the calendars not described. 
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Prospective. Falls recorded on 6 monthly falls calendars.

Cumming 1999.

Study characteristics
Methods RCT (randomised consent design)
Participants Setting: Sydney, Australia
N = 530
Sample: community‐dwelling people recruited in hospital wards, clinics, and day care centres (57% women)
Age (years): mean 77 (SD 7.2)
Inclusion criteria: aged ≥ 65; community‐dwelling within study area
Exclusion criteria: cognitively impaired and not living with someone who could give informed consent and report falls; if OT home visit already planned
Interventions 1. One home visit by experienced OT assessing environmental hazards (standardised form) and supervision of home modifications Telephone follow‐up after 2 wks
2. Control: usual care
Outcomes 1. Rate of falls
2. Number of people falling
Duration of the study 1 year
Notes Cost‐effectiveness analysis reported in Salkeld 2000
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Stratified block randomisation using random numbers table
Allocation concealment (selection bias) Low risk Randomised off site by person not involved in recruitment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls self reported by participants. Quote: "Subjects who had not returned a calendar within 10 days of the end of the month were telephoned and asked about falls in the previous month. If one or more falls were reported, a telephone‐administered questionnaire was used to elicit details of each fall". Quote: "Follow‐up interviews were blind to group allocation"
Incomplete outcome data (attrition bias)
Falls Unclear risk SeeAppendix 3 for method of assessment. Insufficient information to permit judgement.
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Prospective. Falls ascertained using monthly falls calendar.

Cumming 2007.

Study characteristics
Methods RCT
Participants Setting: Sydney, Australia
N = 616
Sample: men and women from outpatient aged care services, some volunteers recruited by advertisement (68% women)
Age (years): mean 80.6 (SD 6)
Inclusion criteria: age 70 and older; living independently in the community; no cataract surgery or new eye glass prescription in previous 3 months; participant or care giver able to complete monthly falls calendar
Exclusion criteria: none noted
Interventions 1. Vision tests and eye examinations. Dispensing of new spectacles if required. Referral for expedited ophthalmology treatment if appropriate occular pathology identified. Mobility training and canes if required.
2. Control: usual care
Outcomes 1. Rate of falls
2. Number of people falling
3. Number sustaining a fracture
Duration of the study 1 year
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Low risk Randomised off site by person not involved in recruitment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk All participants used monthly falls diary, with telephone contact if not returned in 2 weeks. Blinding of study personnel recording data from the calendars not described. 
Blinding of outcome assessment (detection bias)
Fractures High risk Fractures were self reported by participants who were aware of their group allocation, and not confirmed by the results of radiological examination or from primary care case records
Incomplete outcome data (attrition bias)
Falls Unclear risk SeeAppendix 3 for method of assessment. Insufficient information to permit judgement.
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "Ascertainment of falls involved a self‐report falls calendar ... Subjects were asked to record on each day an "N" if they did not fall and an "F" if they had a fall. If a fall occurred, the subject completed an additional postcard about fall‐related injuries (including fractures)".

Dangour 2011.

Study characteristics
Methods RCT (cluster‐randomised by health centre, 2 x 2 factorial design)
Participants Setting: Santiago, Chile
N = 2799. N = 28 clusters; N = 20 clusters only for fallers and fractures
Sample: randomly sampled households in health centre catchment areas and health centre registries (68% women)
Age (years): range 65 to 68
Inclusion criteria (clusters): health centres with > 400 residents aged 65 to 67.9 years in low‐middle economic status municipalities
Exclusion criteria (individuals): unable to walk unaided; seeking medical advice for unplanned 3 kg weight loss over 3 months; planning to move house within 3 months; already enrolled in national Programme of Complementary Feeding for the Older Population (PACAM) or consuming PACAM programme supplements; scoring ≥ 6 on Pfeffer screen (poor cognitive function)
Interventions 1. Nutritional supplements (50 g daily of a vegetable powdered food and 50 g daily of a powdered low‐lactose milk based drink)
2. Physical activity classes (1 hour supervised group training sessions, 2 x per wk, encouraged to walk to sessions)
3. Nutritional supplements + physical activity classes
4. Control: no intervention
Outcomes 1. Number of people falling
Other outcomes reported but not included in this review
Primary outcomes were pneumonia and walking capacity
Duration of the study 24 months
Notes Cost analysis reported in primary reference.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The center names (clusters) were put into a hat. The four treatment arms (nutritional supplementation, nutritional supplementation+physical activity, physical activity, control) were randomly numbered 1–4. As each name was drawn out of the hat by a member of the study team, it was assigned to the next treatment number until each arm contained five clusters."
Allocation concealment (selection bias) High risk In the Methods section, page 3, the following paragraph came after the paragraph about random sequence generation in item 1 above: "Participants were recruited from May to December 2005.", implying recruitment took place after health centres were randomised to the 4 groups. There was no mention of active blinding of research team members recruiting participants.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers High risk Although assessors of the primary outcomes (pneumonia, physical function) were blind to group allocation, this was not mentioned, therefore assumed not to apply, for secondary outcomes (included fallers and fractures)
Blinding of outcome assessment (detection bias)
Fractures High risk Self reported fractures, not confirmed by the results of radiological examination or from primary care case records
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Participant recall for falls was at 12 and 24 months. For secondary outcomes including "self‐reported incidence of falls" ... "Participants in the original 20 clusters were re‐interviewed after 12 and 24 mo for outcome data."

Dapp 2011.

Study characteristics
Methods RCT (cluster‐randomised by household if more than one person per household)
Participants Setting: 14 general practices, Hamburg, Germany
N = 2580
Sample: registered with participating practices (63% women)
Age (years): mean 71.8 (SD 7.6)
Inclusion criteria: aged ≥ 60
Exclusion criteria: need for human help or nursing care; cognitive impairment; terminal disease
Interventions 1. High‐risk appraisal with GP feedback. Patients chose reinforcement with group sessions or home visits
2. Control: usual care
Outcomes 1. Number of fallers
Duration of the study 1 year
Notes Health promotion rather than fall prevention specifically
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "computer generated allocation sequence"
Allocation concealment (selection bias) Low risk Quote: "randomly allocated to intervention and control groups by the independent study centre"
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Questionnaire completed independently by participant at home, and then "All data were double entered by staff blinded for subject allocation."
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Retrospective recall at 12 months

Davis 2011a.

Study characteristics
Methods RCT
Participants Setting: Vancouver, Canada
N = 155
Sample: community‐dwelling women
Age (years): mean 70 (range 65 to 75)
Inclusion criteria: aged 65 to 75; cognitively intact; visual acuity 20/40 or better
Exclusion criteria: resistance training in the last 6 months; medical condition for which exercise is contraindicated; neurogenerative disease; taking cholinesterase inhibitors; depression; on hormone replacement therapy during previous 12 months
Interventions 1. Resistance training classes, 1 x per wk
2. Resistance training classes, 2 x per wk
3. Control: balance and tone classes, 2 x per wk
Outcomes 1. Rate of falls
Duration of the study 1 year
Notes Cost‐effectiveness analysis and cost utility analysis reported in primary reference
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The randomization sequence was generated by http://www.randomization.com"
Allocation concealment (selection bias) Low risk Quote: "The randomization sequence … was concealed until interventions were assigned. This sequence was held independently and remotely by the research coordinator"
Blinding of participants and personnel (performance bias)
All outcomes Low risk Not possible to blind participants or personnel but both groups received an exercise intervention so unlikely to introduce bias
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Quote: "The assessors were blinded to the participants' assignments"
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "We used monthly fall diary calendars to track all falls for each participant during the 12‐month study period."

Davison 2005.

Study characteristics
Methods RCT
Participants Setting: A&E, Newcastle, United Kingdom
N = 313
Sample: people presenting at A&E with a fall or fall‐related injury (72% women)
Age (years): mean 77 (SD 7)
Inclusion criteria: age > 65 years, presenting at A&E with a fall or fall‐related injury; history of at least 1 additional fall in previous year; community‐dwelling
Exclusion criteria: cognitively impaired (MMSE < 24); > 1 previous episode of syncope; immobile; live > 15 miles away from A&E; registered blind; aphasic; clear medical explanation for their fall, e.g. acute myocardial infarction, stroke, epilepsy; enrolled in another study
Interventions 1. Multifactorial post‐fall assessment and intervention. Hospital‐based medical assessment and intervention: fall history and examination including medications, vision, cardiovascular assessment, laboratory blood tests, ECG. Home‐based physiotherapist assessment and intervention: gait, balance, assistive devices, footwear. Home‐based OT home hazard assessment and interventions.
2. Control: usual care
Outcomes 1. Rate of falls
2. Number of people falling
Duration of the study 1 year
Notes Only 1 participant in residential/nursing care. More detailed description of intervention on journal website (www.ageing.oupjournals.org)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised by computer‐generated block randomisation
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk All participants used monthly falls diaries. Quote: "These data were processed by a researcher blinded to randomisation and otherwise unconnected with the study."
Blinding of outcome assessment (detection bias)
Fractures Low risk Quote: "Secondary outcome measures [including fractures] were recorded with interviewer‐led questionnaires ... The interviewer was blind to randomisation". "Hospital records were checked retrospectively at 1 year for all participants."
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Prospective. Falls data collected using fall diaries returned 4‐weekly.

Day 2002.

Study characteristics
Methods RCT (factorial design)
Participants Setting: Melbourne, Australia
N = 1107
Sample: community‐dwelling men and women identified from electoral roll (60% women)
Age (years): mean 76.1 (SD 5.0)
Inclusion criteria: aged ≥ 70; community‐dwelling and able to make modifications; expected to remain in area for 2 years (except for short absences); have approval of family physician
Exclusion criteria: undertaken regular to moderate exercise with a balance component in previous 2 months; unable to walk 10 to 20 m without rest or help or having angina; severe respiratory or cardiac disease; psychiatric illness prohibiting participation; dysphasia; recent major home modifications; education and language adjusted score > 4 on the short portable mental status questionnaire
Interventions 1. Exercise: 1 hour class per wk for 15 wks, plus daily home exercises. Designed by physiotherapist to improve flexibility, leg strength, and balance (or less demanding routine depending on subject's capability).
2. Home hazard management: home assessed by "trained assessor", hazards removed or modified by participants or City of Whitehorse's home maintenance programme. Staff visited home, provided quote for work including free labour and materials up to AUD 100.
3. Vision improvement: assessed at baseline using dual visual acuity chart. Referred to usual eye care provider, general practitioner, or local optometrist if not already receiving treatment for identified impairment.
4. (1) + (2)
5. (1) + (3)
6. (3) + (2)
7. (1) + (2) + (3)
8. No intervention. Received brochure on eye care for over 40‐year olds.
Outcomes 1. Rate of falls
2. Number of people falling
Duration of the study 18 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised by "adaptive biased coin" technique, to ensure balanced group numbers
Allocation concealment (selection bias) Low risk Computer‐generated by an independent third party contacted by telephone
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk All participants used monthly falls diary, with telephone contact from a researcher blinded to group allocation if not returned in 5 days
Incomplete outcome data (attrition bias)
Falls Unclear risk Insufficient information to permit judgement. SeeAppendix 3 for method of assessment.
Incomplete outcome data (attrition bias)
Fallers Unclear risk Insufficient information to permit judgement. SeeAppendix 3 for method of assessment.
Risk of bias in recall of falls Low risk Falls reported using monthly postcard to record daily falls. Telephone follow‐up if calendar not returned within 5 working days of the end of each month, or reporting a fall.

De Vries 2010.

Study characteristics
Methods RCT
Participants Setting: Amsterdam, the Netherlands
N = 217
Sample: people consulting ED or family physician after a fall (71% women)
Age (years): mean 79.8 (SD 7.35)
Inclusion criteria: aged ≥ 65 years; living independently or in assisted living facility; living near University Medical Center; history of fall in previous 3 months
Exclusion criteria: unable sign informed consent or provide a fall history; cognitive impairment (MMSE < 24); fall due to traffic or occupational accident; living in nursing home; acute pathology requiring long‐term rehabilitation, e.g. stroke
Interventions 1. Multidisciplinary assessment in geriatric outpatient clinic and individually tailored treatment in collaboration with patient's GP e.g. withdrawal of psychotropic drugs, balance and strength exercises, home hazard reduction, referral to specialists
2. Control: usual care
Outcomes 1. Number of people falling
2. Number sustaining a fracture
Other outcomes reported but not included in this review
Duration of the study 1 year
Notes Cost‐effectiveness analysis and cost utility analysis reported in Peeters 2011
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "computer‐generated random sequence"
Allocation concealment (selection bias) Low risk Quote: "…opaque envelopes are numbered and filled with group names. When a participant is designated to the high‐risk group, the interviewer, who is unaware of the content, opens the envelope with the lowest number." (from protocol paper)
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "Participants, intervention caregivers, and interviewers could not be blinded to group assignment." but impact of non‐blinding unclear.
Blinding of outcome assessment (detection bias)
Falls and fallers High risk Not completely clear but study personnel stated to be non‐blinded, and falls self reported
Blinding of outcome assessment (detection bias)
Fractures High risk Quote: "By their response to a questionnaire sent 11⁄2 years after the first home visit, participants were asked to indicate whether they had sustained a fracture since the first home visit." Study personnel non‐blinded, and no confirmation of fractures from medical records.
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "For 1 year, the participants recorded each week whether they had fallen."
"Once per 3 months the participants return a calendar sheet by mail. When no sheet is received, or when the sheet is completed incorrectly, we inquire by telephone whether, and if yes, when the participant has fallen in the past 3 months."

Dhesi 2004.

Study characteristics
Methods RCT
Participants Setting: United Kingdom
N = 139
Sample: patients attending a falls clinic (78% women)
Age (years): mean 76.8 (SD 6.2)
Inclusion criteria: aged ≥ 65; community‐dwelling; fallen in previous 8 wks; normal bone chemistry; 25 OHD ≤ 12 µg/litre
Exclusion criteria: AMT < 7/10; taking vitamin D or calcium supplements; history of chronic renal failure, alcohol abuse, conditions or medications likely to impair postural stability or vitamin D metabolism
Interventions 1. One intramuscular injection (2 ml) of 600,000 IU ergocalciferol
2. Control: one placebo injection of 2 ml normal saline
Outcomes 1. Rate of falls
2. Number of people falling
Duration of the study 6 months
Notes Flowchart in Figure 1 shows N = 139 randomised with 70 in intervention group, but Table 1 (baseline characteristics) shows N = 138 randomised with 69 in intervention group
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised in blocks of 20, by computer program
Allocation concealment (selection bias) Low risk Randomised independently of the investigators
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, placebo‐controlled study
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk All participants used a 6‐month falls diary which was reviewed with the patient by blinded trialist
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Falls recorded in falls diary which was reviewed at follow‐up assessment

Di Monaco 2008.

Study characteristics
Methods Quasi‐randomised trial (alternation)
Participants Setting: Torino, Italy
N = 119
Sample: women in hospital after a fall‐related hip fracture
Age (years): mean 80 (SD 6.6)
Inclusion criteria: history of fall‐related hip fracture; returning to same dwelling in the community; aged ≥ 60 years
Exclusion criteria: not living in Turin; MMSE < 23
Interventions 1. Multidisciplinary fall prevention programme during hospital stay plus single home visit by OT (median 20 days post discharge); assessed hazards, gave advice on modifying home environment, behaviour changes and use of assistive devices
2. Control: as above but no home visit
Outcomes 1. Rate of falls
2. Number of people falling
Duration of the study 6 months
Notes Intervention commences in hospital but designed to prevent falls in the community
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "...119 women were allocated to intervention or control groups alternately."
Allocation concealment (selection bias) High risk Randomised by alternation. No concealment.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers High risk Falls data were collected at home visit at 6 months by same OTs that carried out the interventions, i.e. not blind to intervention group
Incomplete outcome data (attrition bias)
Falls High risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Unclear risk Quote: "During their stay in hospital, all the women were asked to record falls occurring after discharge, and to report them at a home visit by an occupational therapist scheduled for approximately 6 months after discharge. During this home visit, the occupational therapist asked the women in detail about falls occurring after discharge from hospital."

Dukas 2004.

Study characteristics
Methods RCT
Participants Setting: Basel, Switzerland
N = 378.
Sample: volunteers recruited from long‐term cohort study, and newspaper advertisements (52% women)
Age (years): mean 75 (SD 4.2)
Inclusion criteria: aged over 70; mobile; independent lifestyle
Exclusion criteria: primary hyperparathyroidism; polyarthritis or inability to walk; calcium supplementation > 500 mg/day; vitamin D intake > 200 IU/day, active kidney stone disease; history of hypercalcuria, cancer or other incurable diseases; dementia, elective surgery planned within next 3 months; severe renal insufficiency; fracture or stroke within last 3 months
Interventions 1. Alfacalcidol (Alpha D3 TEVA) 1 µg/day for 36 wks
2. Placebo daily for 36 wks
Outcomes 1. Number of people falling
2. Adverse effects
Other outcomes reported but not included in this review
Duration of the study 9 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised using "numbered containers"; numbered and blinded by independent statistical group
Allocation concealment (selection bias) Low risk Numbered and blinded by independent statistical group
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, placebo‐controlled study
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Subjects (blind to intervention group) asked to record falls in a diary and to telephone within 48 hours of a fall. Questionnaire about incidence of falls at clinic visits (4 wks, 12 wks, and every 12 wks subsequently to 36 wks) and "All investigators and staff conducting the study remained blinded throughout the treatment period."
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Unclear risk Subjects asked to record falls in a diary and to telephone within 48 hours of a fall. Also questionnaire about incidence of falls at clinic visits (4 wks, 12 wks, and every 12 wks subsequently to 36 wks).

Elley 2008.

Study characteristics
Methods RCT
Participants Setting: Hutt Valley, New Zealand
N = 312
Sample: patients from 19 primary care practices (69% women)
Age (years): mean 80.8 (SD 5)
Inclusion criteria: aged ≥ 75 (> 50 years for Maori and Pacific people), fallen in last year, living independently
Exclusion criteria: unable to understand study information and consent processes, unstable or progressive medical condition, severe physical disability, dementia (< 7 on Abbreviated Mental Test Score)
Interventions 1. Community‐based nurse assessment of falls and fracture risk factors, home hazards, referral to appropriate community interventions, and strength and balance exercise programme
2. Control: usual care and social visits
Outcomes 1. Rate of falls
2. Number of people falling
Duration of the study 1 year
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "computer randomisation"
Allocation concealment (selection bias) Low risk Quote: "independent researcher at a distant site"
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Partipants recorded falls prospectively using postcard calendars, completed daily and mailed monthly. Follow‐up telephone calls were by blinded research staff.  
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "Postcard calendars completed daily and posted monthly".

Fabacher 1994.

Study characteristics
Methods RCT
Participants Setting: California, USA
N = 254
Sample: men and women aged over 70 years and eligible for veterans medical care. Identified from voter registration lists and membership lists of service organisations (2% women)
Age (years): mean 73 years
Inclusion criteria: aged ≥ 70; not receiving health care at Veterans Administration Medical Centre
Exclusion criteria: known terminal disease, dementia
Interventions 1. Home visit by health professional to screen for medical, functional, and psychosocial problems, followed by a letter for participants to show to their personal physician. Targeted recommendations for individual disease states, preventive health practices
2. Control: follow‐up telephone calls for outcome data only
Outcomes 1. Number of people falling
Other outcomes reported but not included in this review
Duration of the study 1 year
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomly assigned ... using randomly generated assignment cards in sealed envelopes". Judged to be unclear.
Allocation concealment (selection bias) Unclear risk Quote: "randomly assigned ... using randomly generated assignment cards in sealed envelopes". Judged to be unclear.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers High risk Intervention group data collected on a structured interview form at 4‐monthly face to face visits. Control group received only 4‐monthly telephone interviews. 
Incomplete outcome data (attrition bias)
Fallers High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Falls identified at 4‐monthly intervals, by structured interview for active arm and by telephone for controls

Faes 2011.

Study characteristics
Methods RCT (cluster‐randomised in pairs: participant + caregiver)
Participants Settting: Arnhem and Nijmegan, the Netherlands
N = 33 pairs
Sample: patients recruited from 3 geriatric outpatient clinics (70% women)
Age (years): mean 78.3 (SD 7)
Inclusion criteria: fallen in previous 6 months; able to walk 15 m independently (with or without walking aid); had a primary informal caregiver; community‐dwelling; life expectancy > 1 year; frail (≥ 2 frailty indicators)
Exclusion criteria: awaiting nursing home admission; MMSE < 15
Interventions 1. Psychological teaching and training + physical training in small groups. 10 x 2 h sessions 2 x per wk + booster session 6 wks later. Caregivers trained in autonomy boosting strategies, and being co‐therapist at home
2. Control: usual care
Outcomes 1. Rate of falls
2. Number of people falling
Other outcomes reported but not included in this review
Duration of the study 7 months
Notes Trial terminated due to "Extremely difficult recruitment. Preliminary analysis showed no effect of the intervention." Target sample 160 people plus their carer (N = 320)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Treatment allocation…was based on a minimization algorithm that balanced for the minimization factors"
Allocation concealment (selection bias) Low risk Quote: "allocation, carried out by an independent statistician"
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Quote: "Nonresponders were contacted over the telephone so that the fall history for the missing calendar weeks and underlying reasons for their lack of response could be assessed" "The assessors (M.F.R. and M.C.F.) were blinded."
Incomplete outcome data (attrition bias)
Falls High risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "Falls were registered daily using a preaddressed, reply‐paid 2‐weekly fall registration calendar throughout the whole course of the trial."

Fiatarone 1997.

Study characteristics
Methods RCT
Participants Setting: USA
N = 34
Sample: frail older people (94% women)
Age (years): mean 82 (SD 1)
Inclusion criteria: community‐dwelling older people; moderate to severe functional impairment
Exclusion criteria: none given
Interventions 1. High‐intensity progressive resistance training exercises in own home (3 day/wk for 16 wks). 2 weeks instruction and then weekly phone calls. 11 different upper and lower limb exercises with arm and leg weights
2. Control: wait list control. Weekly phone calls
Outcomes 1. "Frequency of falls" but probably means fallers
Other outcomes reported but not included in this review
Duration of the study 16 wks (duration of intervention)
Notes Abstract only
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomisation not described
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
Fallers Unclear risk SeeAppendix 3 for method of assessment. Insufficient information to permit judgement.
Risk of bias in recall of falls Unclear risk Interval recall. Falls identified weekly by phone call.

Foss 2006.

Study characteristics
Methods RCT
Participants Setting: Nottingham, United Kingdom
N = 239
Sample: women referred to ophthalmology outpatient clinic
Age (years): median 79.5 (range 70 to 92)
Inclusion criteria: over 70 years of age; following successful cataract operation and with operable second cataract
Exclusion criteria: having complex cataracts; visual field defects or severe comorbid eye disease affecting visual acuity; memory problems preventing completion of questionnaires or reliable recall of falls
Interventions 1. Small incision cataract surgery with insertion of intraocular lens under local anaesthetic
2. Control: waiting list
Outcomes 1. Rate of falls
2. Number of people falling
3. Number sustaining a fracture
Duration of the study 1 year
Notes Cost utility analysis reported in Sach 2010
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "lists prepared from random numbers in variably sized permuted blocks to maintain approximate equality in the size of the groups".
Allocation concealment (selection bias) Low risk Sequentially numbered, opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers High risk Falls were noted on diary by participants who were aware of their group allocation, and the data collected at 3 and 9 months by telephone and at 4 and 6 months at interview. These assessments were "not masked to allocation."
Blinding of outcome assessment (detection bias)
Fractures High risk Fractures were noted on diary by participants who were aware of their group allocation, and the data collected at 3 and 9 months by telephone and at 4 and 6 months at interview. These assessments were "not masked to allocation." No mention of confirmation by radiological examination reports or from primary care case records.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Prospective. Falls recorded on daily diary. Data collected by phone at 3 and 9 months, and by interview at 6 and 12 months.

Fox 2010.

Study characteristics
Methods RCT (individually randomised, but small number of clusters as husbands allocated to same group)
Participants Setting: Humboldt County and San Diego County, California, USA
N = 552
Sample: new and existing 'Preventive Health Care for the Aging' (PHCA) clients (67% women)
Age (years): mean 76.9 (SD 6.8)
Inclusion criteria: ≥ 65 years; no plans to move within 1 year; speaking English, Spanish, Cantonese or Vietnamese
Exclusion criteria: serious cognitive impairment; medical disorders that would affect participation
Interventions 1. Usual PHCA care (community‐based health promotion programme) + multifactorial fall prevention programme targeting 10 risk factors: fall risk factor assessment by public health nurse followed by education and written care plan with fall prevention goals; referral to individually tailored physical activity programmes. 50% received a home hazard assessment.
2. Control: usual PHCA care
Outcomes 1. Number of people falling
Duration of the study 1 year
Notes Only adjusted odds ratio reported. No raw data. Mean number of falls (SD) reported, but only by quarter year.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "computer‐generated list of random numbers"
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk Neither clinicians nor participants blinded
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Not stated whether assessors were blind to randomised group
Incomplete outcome data (attrition bias)
Fallers Unclear risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Unclear risk Quote: "Clients in both the treatment and control groups were given calendars to record falls and fall‐related physician visits"
Quote: "We measured fall frequency at 3‐month intervals using a form developed for this project. We asked clients questions regarding the occurrence of falls in the previous quarter ..."

Gallagher 1996.

Study characteristics
Methods RCT
Participants Setting: Victoria, British Columbia, Canada
N = 100
Sample: community‐dwelling volunteers (80% women)
Age (years): mean 74.6
Inclusion criteria: aged ≥ 60; fallen in previous 3 months
Exclusion criteria: none described
Interventions 1. 2 risk assessment interviews of 45 min each. One counselling interview of 60 min showing video and booklet and results of risk assessment
2. Control: baseline interview and follow‐up only. No intervention
Outcomes 1. Rate of falls
Other outcomes reported but not included in this review
Duration of the study 6 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomisation not described
Allocation concealment (selection bias) Unclear risk Method of randomisation not described
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Participants completed a calendar daily and returned it every 2 weeks; a telephone interview was then conducted. At final interview at 6 months, the interviewer was not blinded.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Calendar postcards completed and returned every 2 weeks for 6 months. Telephone follow‐up of reported falls.

Gallagher 2001.

Study characteristics
Methods RCT
Participants Setting: presumed community, Omaha, USA
N = 489
Sample: mailing lists used to contact women aged 65 to 77 years in Omaha and surrounding district
Age (years): mean 71 (SD 4), range 65 to 77
Inclusion criteria: 65 to 77 years; not osteoporotic (femoral neck density in normal range for age)
Exclusion criteria: severe chronic illness; primary hyperparathyroidism or active renal stone disease; on certain medications in last 6 months, e.g. bisphosphonates, anticonvulsants, oestrogen, fluoride, thiazide diuretics
Interventions 1. Calcitriol (Rocaltrol) 0.25 µg twice daily for 3 years
2. HRT/ERT (conjugate estrogens (Premarin) 0.625 mg daily + medroxyprogesterone (Provera) 2.5 mg daily
3. Calcitriol plus HRT/ERT as above
4. Control: placebo
(ERT given to hysterectomised women N = 290, i.e. not given progestin)
All groups advised to increase dietary calcium if daily intake < 500 mg/day and to decrease dietary calcium if intake > 1000 mg/day
Outcomes 1. Rate of falls
2. Number of people falling
3. Number sustaining a fracture
4. Number of people with adverse effects
Other outcomes reported but not included in this review
Duration of the study 3 years
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Simple randomisation", stratified on presence or absence of uterus. No further details.
Allocation concealment (selection bias) Unclear risk Quote: "randomly assigned". No methods described.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, placebo‐controlled study
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Data on falls and fractures were collected by questionnaire at interview at intervals over 36 months. Participants and assessors both blinded.
Blinding of outcome assessment (detection bias)
Fractures Low risk Data on falls and fractures were collected by questionnaire at interview at intervals over 36 months. Quote: "All fractures were confirmed from x‐ray reports."
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Falls retrospectively monitored by interview questionnaire at 6 weeks, 3 months, and‐6 monthly thereafter

Gill 2008.

Study characteristics
Methods RCT
Participants Setting: Ontario, Canada
N = 241
Sample: male Canadian veterans of WWII and Korean War living in south‐west Ontario
Age (years): mean 81 (SD 3.8)
Inclusion criteria: living independently in the community; able to understand and respond to questionnaire; at least 1 modifiable risk factor for falling identified by initial screening questionnaire
Interventions Initial postal risk factor screening questionnaire to all potential participants
1. Specialised geriatric services group: comprehensive geriatric assessment by geriatrician or PT with individual recommendations for fall risk factor reduction
2. Family physician group: participants sent letter summarising risk factors reported in questionnaire. Similar letter sent to participant's family physician. Treatment left to discretion of family physician
Outcomes 1. Number of fallers
Duration of the study 1 year
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Randomized". No description of sequence generation.
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Falls reported by participants who were aware of their group allocation. Unclear whether staff who confirmed falls by telephone were blinded. 
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Monthly falls calendars returned for 1 year. Telephone follow‐up if calendar not returned or falls reported.

Grahn Kronhed 2009.

Study characteristics
Methods RCT
Participants Setting: Linköping, Sweden
N = 73
Sample: women with osteoporosis identified from Linköping Hospital, Osteoporosis Unit files
Age (years): mean 71.4, range 60 to 81
Inclusion criteria: BMD measured within previous 9 months and T‐score ≤ ‐2.5 SD
Exclusion criteria: enrolled in a pharmacological RCT; requiring indoor walking aids; cognitively impaired (MMSE < 20); severe heart disease, malignancy, recent arthroplasty, unhealed fractures; unable to understand Swedish
Interventions 1. Group exercise programme (60 min, 2 x per wk, for 4 months) supervised by PT
2. Control: no intervention. Instructed not to change exercise routines for 1 year
Outcomes 1. Mean number of falls (no SD reported)
2. Number sustaining a fracture
Other outcomes reported but not included in this review
Duration of the study 1 year
Notes No participants sustained a fracture during follow‐up
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Method not described but assume it was truly random given that "An independent statistical unit randomized the participants ..."
Allocation concealment (selection bias) Low risk Quote: "An independent statistical unit randomized the participants..."
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Quote: "… participants were followed‐up concerning … falls … for 1 year by the independent statistical unit." Probably blind to allocated group or at least unlikely to introduce bias.
Blinding of outcome assessment (detection bias)
Fractures High risk Appear to be participant‐reported fractures with no description of confirmation
Incomplete outcome data (attrition bias)
Falls Unclear risk SeeAppendix 3 for method of assessment. Insufficient information to permit judgement.
Risk of bias in recall of falls Low risk Quote: "... participants reported number of falls each week for the 1‐year study period"

Grant 2005.

Study characteristics
Methods RCT (multicentre, 2 x 2 factorial design)
Participants Setting: United Kingdom
N = 5292
Sample: 21 centres in England and Scotland (85% women)
Age (years): mean 77 (SD 6)
Inclusion criteria: aged ≥ 70; recent fracture caused by a fall
Exclusion criteria: bed or chair bound prior to fracture; abbreviated mental test score 6 or less; cancer likely to metastasise to bone within previous 10 years; fracture associated with pre‐existing bone abnormality; known hypercalcaemia; renal stone in last 10 years; life expectancy < 6 mo; known to be leaving the UK; taking > 200 IU (5 µg) vitamin D or > 500 mg calcium supplements daily; had fluoride, calcitonin, tibolone, HRT, selective oestrogen receptor modulators or any vitamin D metabolite (such as calcitriol) in the last 5 years; vitamin D by injection in preceding year
Interventions 2 tablets daily with meals for 2 years. Tablets delivered every 4 months by post. Randomised to tablets containing a total of either:
1. 800 IU (20 µg) vitamin D3 plus placebo calcium
2. 800 IU vitamin D3 + 1000 mg calcium
3. 1000 mg elemental calcium (calcium carbonate) plus placebo vitamin D
4. Double placebo
Outcomes 1. Number of people falling
2. Number sustaining a fracture
3. Number of people with adverse effects
Duration of the study 60 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated, centralised randomisation, stratified by centre
Allocation concealment (selection bias) Low risk Centralised randomisation
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, placebo‐controlled study
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Data from falls window periods throughout the study collected by self report ‐ both participants and assessors were blinded to allocation
Blinding of outcome assessment (detection bias)
Fractures Low risk Fracture data from participants in all groups were confirmed by the checking of patient records by blinded assessors
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Unclear risk Interval recall. Falls ascertained in 4‐monthly postal questionnaire ("Have you fallen during the last week") with telephone follow‐up if required, also from hospital and GP staff annotating notes

Gray‐Donald 1995.

Study characteristics
Methods RCT
Participants Setting: Quebec, Canada
N = 50
Subjects: recruited from people receiving long‐term home help services (71% women)
Age (years): mean 77.5 (SD 8)
Inclusion criteria: aged over 60; requiring community services; elevated risk of under‐nutrition (excessive weight loss or BMI < 24 kg/m2)
Exclusion criteria: alcoholic; terminal illness
Interventions 1. 12 wk intervention of high energy nutrient dense supplements provided by dietitian. Two 235 ml cans/day (1045 to 1480 kj per can) for 12 wks.
2. Control: visits only (encouragement and suggestions about improving diets)
Outcomes 1. Number of people falling
Duration of the study 12 wks
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomisation not described. Stratified by gender and nutritional risk criteria.
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Fall events ascertained at each of two 6‐weekly interviews. Blinding of assessors not reported.
Incomplete outcome data (attrition bias)
Fallers High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Retrospectively monitored at 6 and 12 weeks

Greenspan 2005.

Study characteristics
Methods RCT (2 x 2 factorial design)
Participants Setting: Boston, USA
N = 373
Sample: women identified from newspaper advertisements, targeted mailings, presentations to seniors groups, and physician referrals
Age (years): mean 71.3 (SD 5.2)
Inclusion criteria: community‐dwelling women including women with hysterectomy; aged 65 and older
Exclusion criteria: illness that could affect bone mineral metabolism; current use of medications known to alter bone mineral metabolism; known contraindication to HRT use
Interventions 1. HRT/ERT plus placebo alendronate
2. HRT/ERT plus alendronate
3. Alendronate plus placebo HRT/ERT
4. Placebo HRT/ERT plus placebo alendronate
All participants received calcium and vitamin D supplementation throughout the study
(ERT given to hysterectomised women, i.e. not given progestin)
Outcomes 1. Number of people falling
Falls a secondary outcome of study. Other outcomes reported but not included in this review
Duration of the study 3 years
Notes In the 2005 report the data presented are for all women receiving HRT. This includes women who received HRT + alendronate. Although there is no evidence of an interaction between these agents which might plausibly affect falls, this cannot be absolutely ruled out. Therefore in this review we have taken a conservative approach, and not used data the group who received HRT + alendronate.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer random number generation
Allocation concealment (selection bias) Low risk Sequentially numbered, opaque, sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, placebo‐controlled study
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Participants in both groups and assessors blinded to treatment group
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Interval recall, but at 6 months and 1 year

Haines 2009.

Study characteristics
Methods RCT
Participants Setting: Brisbane, Australia
N = 53
Sample: patients in geriatric rehabilitation, medical, or surgical units in Princess Alexandra Hospital (60% women)
Age (years): mean 80.7 (SD 7.7)
Inclusion criteria: aged > 65 years; gait instability or walking with a mobility aid; discharged from hospital to a community‐dwelling
Exclusion criteria: unstable severe cardiac disease; cognitive impairment; aggressive behaviour; restricted weight‐bearing status; referred for post‐discharge community rehabilitation services
Interventions 1. 'Kitchen Table Exercise Program': DVD and workbook. Progressive lower limb strength and balance exercises, 3 to 7 x per wk. DVD player provided if required. At least 1 home visit from project PT, then telephone contact weekly for 8 wks from first home visit, then 18 wks without active encouragement
2. Control: no exercise intervention
Outcomes 1. Rate of falls
2. Number of people falling
3. Number sustaining a fracture
Other outcomes reported but not included in this review
Duration of the study 6 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The random allocation sequence was generated by an investigator (TH) using a computerized random number generator."
Allocation concealment (selection bias) Low risk Quote: "This sequence was entered into sealed, consecutively numbered, opaque envelopes. Each envelope corresponding to the participants study number (allocated in the order in which participants consented to participate in the study) was opened following completion of the baseline assessment. The envelopes containing the allocation sequence were secured within a locked office."
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and personnel not blind to intervention, and falls were self reported
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Quote: "All participants received monthly follow‐up phone calls from the blinded outcome assessor."
Blinding of outcome assessment (detection bias)
Fractures High risk The only evidence for fractures was from self reports from participants
Incomplete outcome data (attrition bias)
Falls Unclear risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "Participants in both group were provided with a log for recording falls and details surrounding them." "All participants received monthly follow‐up phone calls from the blinded outcome assessor."

Haran 2010.

Study characteristics
Methods RCT
Participants Setting: Sydney and Illawarra regions, New South Wales, Australia
N = 606
Sample: sample from electoral roll; residents of retirement villages; outpatients and inpatients discharged from rehabilitation and orthopaedic ward; responders to advertising etc (65% women)
Age (years): mean 80 (SD 6.6)
Inclusion criteria: community‐dwelling; at a relatively high risk of falls (≥ 80 years, or 65 to 79 and TUG test ≥ 15 sec and/or ≥ 1 fall in past 12 mo); using bifocal, trifocal, or progressive lens glasses ≥ 3 x per wk when walking outdoors; reviewed by an optometrist or ophthalmologist in previous 24 months; "quite or very confident" that they could comply with the study recommendations
Exclusion criteria: using single lens distance glasses; residing in high‐care residential facility; cognitive impairment (MMSE < 24); severe visual impairment (MET < 16 dB); insufficient English language skills; ophthalmic surgery planned in the next 12 months; unstable medical condition
Interventions 1. Optometrist examination; prescribed single lens distance glasses for use in most walking or standing activities and given advice on use of their glasses
2. Control: used their multifocal glasses in their usual manner (no advice)
All participants received an optometry assessment and updated multifocal glasses (if required) at baseline
Outcomes 1. Rate of falls
2. Number of people falling
3. Number sustaining fall‐related fractures
Other outcomes reported but not included in this review
Duration of the study 13 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Each stratum was randomly allocated in permuted blocks of 10 generated externally (by JS)" a professor of statistics
Allocation concealment (selection bias) Low risk Quote: "by using sequentially numbered opaque sealed envelopes containing group assignment"
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Both groups received an intervention, i.e. an optometrist examination and updated multifocal lens prescription if required. The intervention group were prescribed a pair of single lens distance glasses and advice.
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Monthly calendars and follow‐up telephone calls as required. Research personnel who received the calendars and made the calls were blinded to group allocation.
Blinding of outcome assessment (detection bias)
Fractures High risk Injurious falls were defined as those that resulted in fractures, dislocations, and organ and soft tissue trauma. These were collected as self report from the monthly calendars and telephone calls and not verified from primary source.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Daily diaries returned monthly with a follow‐up phone call if not returned

Harari 2008.

Study characteristics
Methods RCT (cluster‐randomised by household if more than 1 person per household)
Participants Setting: London, United Kingdom
N = 2503
Sample: patients in 3 computerised group practices (26 GPs) (55% women)
Age (years): mean 74 (SD 6.2)
Inclusion criteria: aged ≥ 65; registered with participating group practice
Exclusion criteria: needing human assistance with basic ADL; living in a nursing/residential home; dementia; terminal disease; non‐English speaking
Interventions 1. Participants sent Health Risk Appraisal for Older Persons (HRA‐O) questionnaire; feedback (20 to 35 page report) from GP on modifying risk, personalised preventive health checklist, sources of support including local exercise schemes etc. Advised to discuss issues with GP or practice nurse; reminder card sent to non‐responders 6 months later. HRA‐O and feedback documented in patient record
2. Control: usual care
Outcomes No useable data. Obtained number of multiple fallers from author.
Other outcomes reported but not included in this review
Duration of the study 1 year
Notes Initially 4 practices, 3 randomised to participate in trial and 1 to act as a control. Patients within the participating practices randomised to intervention or control group. 1 centre from an international multicentre study (PRO‐AGE) (see Dapp 2011a for other centre recording falls)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomisations were computer generated at an independent centre."
Allocation concealment (selection bias) Low risk Quote: "Randomisations were computer generated at an independent centre." Although people living in the same household were allocated to the same group (so this could not be concealed) this should not have introduced bias given that the randomisation took place at an independent centre.
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and GPs not blind to allocated group. Patients were individually randomised in each practice which could mean there is a risk of contamination as GPs treating both intervention and control participants were given training, and additionally those not in the intervention group could have sought health advice elsewhere.
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Participants and health practitioners not blind to group allocation, but does not mention whether person abstracting data from the questionnaire was blind to allocation
Incomplete outcome data (attrition bias)
Fallers Unclear risk SeeAppendix 3 for method of assessment. Insufficient information to permit judgement.
Risk of bias in recall of falls High risk No concurrent recording of falls. Quote: "... at the one year follow‐up, as a secondary outcome, we asked people about falls in the previous year." (personal communication).

Harwood 2004.

Study characteristics
Methods RCT
Participants Setting: Nottingham, United Kingdom
N = 150
Sample: women admitted to orthogeriatric rehabilitation ward within 7 days of surgery for hip fracture
Age (years): mean 81.2, range 67 to 92
Inclusion criteria: recent surgery for hip fracture; previous community residence; previous independence in ADL
Exclusion criteria: previously institutionalised; disease or medication known to affect bone metabolism; < 7 on 10‐point mental state score
Interventions 1. Single injection of vitamin D2 (ergocalciferol) 300,000 units
2. Single injection of vitamin D2 (ergocalciferol) 300,000 units plus oral calcium carbonate (Calcichew) 1 tablet x 2/day (1 g elemental calcium daily)
3. Oral vitamin D3 + calcium carbonate (Calceos) 1 tablet x 2/day (cholecalciferol 800 units/day + calcium 1 g/day)
4. Control: no treatment
Outcomes 1. Number of people falling
2. Number sustaining a fracture
3. Number of people with adverse effects
Other outcomes reported but not included in this review
Duration of the study 1 year
Notes Recruited in hospital but meets the inclusion criteria as participants were all community‐dwelling and intervention was designed to prevent falls in the community
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised to 4 groups by computer‐generated random number lists
Allocation concealment (selection bias) Unclear risk Quote: "using sealed, opaque, envelopes"
Blinding of participants and personnel (performance bias)
All outcomes High risk No placebo was used; participants aware of whether they were receiving medication or no treatment
Blinding of outcome assessment (detection bias)
Falls and fallers High risk Falls reported at intervals by participants to researchers who were aware of their group allocation
Blinding of outcome assessment (detection bias)
Fractures High risk Fractures reported by participants to researchers who were aware of their group allocation. Fracture reports were not verified.
Incomplete outcome data (attrition bias)
Fallers High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Falls not recorded in diaries. Presume falls and fractures ascertained at dedicated clinic at 3, 6 and 12 months.

Harwood 2005.

Study characteristics
Methods RCT
Participants Setting: Nottingham, United Kingdom
N = 306
Sample: women referred to 1 of 3 consultant ophthalmologists (or optometrist‐led cataract clinic)
Age (years): median 78.5, range 70 to 95
Inclusion criteria: women; aged > 70 years; with cataract; no previous ocular surgery
Exclusion criteria: cataract not suitable for surgery by phacoemulsification; severe refraction error in 2nd eye; visual field deficits; severe co‐morbid eye disease affecting visual acuity; registrable partially sighted as a result of cataract; memory problems
Interventions 1. Expedited cataract surgery (target within 1 month)
2. Routine waiting list for surgery (within 13 months) plus up‐to‐date spectacle prescription
Outcomes 1. Rate of falls
2. Number of people falling
3. Number sustaining a fracture
Other outcomes reported but not included in this review
Duration of the study 1 year
Notes Cost‐effectiveness analysis and cost utility analysis reported in Sach 2007
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random numbers in variably sized permuted blocks. Quote: "Block randomised consecutively to groups."
Allocation concealment (selection bias) Low risk Sequentially numbered, opaque, sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers High risk All participants used falls diaries. Neither assessors nor participants were blinded. 
Blinding of outcome assessment (detection bias)
Fractures Unclear risk Neither assessors nor participants were blinded. Unclear whether fracture were confirmed.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Prospective. Falls recorded in diaries, telephoned at 3 and 9 months, interviewed at 6 and 12 months for data.

Hauer 2001.

Study characteristics
Methods RCT
Participants Setting: Germany
N = 57
Sample: women recruited at the end of ward rehabilitation in a geriatric hospital
Age (years): mean 82 (SD 4.8), range 75 to 90
Inclusion criteria: ≥ 75 years; fall(s) as reason for admission to hospital or recent history of injurious fall leading to medical treatment; residing within study community
Exclusion criteria: acute neurological impairment; severe cardiovascular disease; unstable chronic or terminal illness; major depression; severe cognitive impairment; musculoskeletal impairment preventing participation in training regimen; falls known to be due to a single, identifiable disease, e.g. stroke or hypoglycaemia
Interventions 1. Exercise: group lower‐extremity progressive resistance training and progressive functional balance training, 90 min, 3 x per wk, for 12 wks
2. Control: "motor placebo", i.e. flexibility, calisthenics, ball games, and memory tasks while seated, 60 min, 3 x per wk, for 12 wks
Both groups also received identical physiotherapy (25 min, 2 x per wk)
Outcomes 1. Number of people falling
Duration of the study 6 months after intervention
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stratified randomisation
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Low risk Control group received "placebo activities" and both groups received identical physiotherapy sessions
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls reported by participants but control group received "placebo activities". Assessor was blinded. 
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Prospective. Daily diaries collected every 2 weeks.

Helbostad 2004.

Study characteristics
Methods RCT
Participants Setting: 6 local districts in Trondheim, Norway
N = 77
Sample: volunteers recruited through newspapers and invitations from health workers (81% women)
Age (years): mean 81 (SD 4.5)
Inclusion criteria: aged ≥ 75; fallen in last year; using walking aid indoor or outdoor
Exclusion criteria: exercising 1 or more times weekly; terminal illness; cognitive impairment (MMSE < 22); recent stroke; unable to tolerate exercise
Interventions 1. Combined training: home visit by physical therapist for assessment; group classes, 5 to 8 people (individually tailored progressive resistance exercises, functional balance training) 1 h, 2 x per wk, for 12 wks + home exercises as below (2)
2. Home training: 4 non‐progressive exercises (functional balance and strength exercises) 2 x daily, for 12 wks + 3 group meetings
Outcomes 1. Rate of falls
2. Number of people falling
Duration of the study 1 year
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomised into one of two exercise programs"
Allocation concealment (selection bias) Low risk Randomised by independent research office using sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes Low risk Cluster‐randomised trial comparing 2 types of exercise intervention. Low risk of performance bias.
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls reported by participants but both groups received an exercise intervention. Assessors blind to subjects' assignment.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Monthly falls diary (pre‐paid post card), telephone call if no response or fall reported

Hendriks 2008.

Study characteristics
Methods RCT with economic evaluation
Participants Setting: Maastricht, The Netherlands
N = 333
Sample: people who have visited an ED or a GP because of a fall (68% women)
Age (years): mean 74.8 (SD 6.4)
Inclusion criteria: ≥ 65 years; community‐dwelling; history of a fall requiring visit to ED or GP; living in Maastricht area
Exclusion criteria: not able to speak or understand Dutch; unable to complete questionnaires or interviews by telephone; cognitive impairment (< 4 on AMT4); long‐term admission to hospital or other institution (> 4 wks from date of inclusion); permanently bedridden; fully dependent on a wheelchair
Interventions 1. Multifactorial intervention: detailed assessment by geriatrician, rehabilitation physician, geriatric nurse; recommendations and indications for referral sent to participants' GPs. GPs could then take action if they agreed with the recommendations and/or referrals. Home assessment by OT; recommendations sent to participants and their GPs, and direct referral to social or community services for provision of technical aids and adaptations or additional support.
2. Control: usual care
Outcomes 1. Number of people falling
Duration of the study 1 year
Notes Cost analysis reported in primary reference
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Randomisation was achieved by means of computerised alternative allocation and performed by an external agency".
Allocation concealment (selection bias) Unclear risk Quote: "Randomisation was achieved by means of computerised alternative allocation and performed by an external agency".
Blinding of participants and personnel (performance bias)
All outcomes High risk GPs received copy of notes made for intervention group participants. Although GPs may have been unaware which participants were in the control group this may have influenced treatment that they prescribed to control participants, especially as the trialists "placed no restrictions on co‐interventions". 
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls reported by participants who were aware of their group allocation. Quote: "To ensure blinding during data collection, measurements by phone were contracted out to an independent call centre ..., whose operators were unaware of group allocation."
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Quote: "Participants recorded their falls continuously on a fall calendar during twelve months after baseline. They were contacted monthly by telephone by an independent call centre (MEMIC) to report the falls noted on the calendar".

Hill 2000.

Study characteristics
Methods RCT
Participants Setting: Staffordshire, United Kingdom
N = 78
Sample: people referred to falls assessment clinic (73% women) 
Age (years): mean 78.5
Inclusion criteria: history of recurrent falls referred to falls clinic
Exclusion criteria: cognitive impairment
Interventions 1. Supervised group balance exercise and individualised fall prevention advice. Daily exercise, 2 x per wk
2. Control: standard fall prevention advice
Outcomes 1. Rate of falls
Duration of the study 6 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomisation not described
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient detail for judgement
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Falls reported by participants who were aware of their group allocation. Unclear whether assessors collecting data were.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Recall at end of study period (6 months)

Hogan 2001.

Study characteristics
Methods RCT
Participants Setting: Calgary, Canada
N = 163
Sample: high‐risk community‐dwelling men and women (72% women)
Age (years): mean 77.6 (SD 6.8)
Inclusion criteria: aged ≥ 65; fallen in previous 3 months; community‐dwelling; ambulatory (with or without aid); mentally intact (able to give consent)
Exclusion criteria: qualifying fall resulted in lower extremity fracture, resulted from vigorous or high‐risk activities, because of syncope or acute stroke, or while undergoing active treatment in hospital
Interventions 1. One in‐home assessment by a geriatric specialist (doctor, nurse, physiotherapist, or OT) lasting 1 to 2 hours. Intrinsic and environmental risk factors assessed. Multidisciplinary case conference (20 min). Recommendations sent to patients and patients' doctor for implementation. Subjects referred to exercise class if problems with balance or gait and not already attending an exercise programme. Given instructions about exercises to do at home
2. Control: 1 home visit by recreational therapist
Outcomes 1. Rate of falls
2. Number of people falling
3. Number of fractures (not number of people sustaining a fracture)
Duration of the study 1 year
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated. Stratified by number of falls in previous year: 1 or > 1.
Allocation concealment (selection bias) Unclear risk Sequence concealed in locked cabinet prior to randomisation
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls reported by participants who were aware of their group allocation. Quote: "The RA (research assistant) remained blinded throughout the study as to each subject's group assignment."
Blinding of outcome assessment (detection bias)
Fractures Unclear risk No mention of whether fractures reported were confirmed
Incomplete outcome data (attrition bias)
Falls Unclear risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Unclear risk Falls recorded on monthly calenders (47.8% returned). Also retrospective recall at 3, 6 months (at visit), and 12 months (by phone).

Hornbrook 1994.

Study characteristics
Methods RCT (cluster‐randomised by household)
Participants Setting: USA
N = 3182 (N = 2509 households)
Sample: independently living members of HMO recruited by mail (62% women)
Age (years): mean 73 (SD 6)
Inclusion criteria: aged over 65; ambulatory; living within 20 miles of investigation site; consenting
Exclusion criteria: blind; deaf; institutionalised; housebound; non‐English speaking; severely mentally ill; terminally ill; unwilling to travel to research centre
Interventions 1. Home visit, safety inspection (prior to randomisation), hazards booklet, repair advice, fall prevention classes (addressing environmental, behavioural, and physical risk factors), financial and technical assistance
2. Control: home visit, safety inspection (prior to randomisation), hazards booklet
Outcomes 1. Rate of falls
2. Number of people falling
3. Number sustaining a fracture
Duration of the study 23 months
Notes Cost description reported in primary reference.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomly assigned"
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls self reported by postcard, which prompted telephone interview. Quote: "Fall interviewers were blind to group assignment and did not include anyone who had interacted with participants during intervention sessions."
Blinding of outcome assessment (detection bias)
Fractures Unclear risk Quote: "Fall interviewers were blind to group assignment and did not include anyone who had interacted with participants during intervention sessions." but "Fracture falls and hospitalised falls defined based on participant report" and not confirmed by the results of radiological examination or from primary care case records.
Incomplete outcome data (attrition bias)
Falls Unclear risk SeeAppendix 3 for method of assessment. Insufficient information to permit judgement.
Incomplete outcome data (attrition bias)
Fallers Unclear risk SeeAppendix 3 for method of assessment. Insufficient information to permit judgement.
Risk of bias in recall of falls Low risk Prospective. Returned a postcard after each fall. Also recorded falls on monthly diaries, and received quarterly mail/telephone contacts.

Huang 2004.

Study characteristics
Methods RCT
Participants Setting: Hsin‐Chu County, Northwest Taiwan
N = 120
Sample: persons in registered households (46% women)
Age (years): mean 72 (SD 5.7)
Inclusion criteria: aged ≥ 65; community‐dwelling; cognitively intact
Exclusion criteria: none stated
Interventions 1. 3 home visits over 4 months (HV1, HV2, and HV3) by a nurse
HV1: risk assessment (medications and environmental hazards)
HV2: 2 months later: standard fall prevention brochure plus individualised verbal teaching and brochure relating to fall risk factors identified at HV1
HV3: assessment and collection of falls data
2. Control: HV1: risk assessment
HV2: standard fall prevention brochure
HV3: assessment and collection of falls data
Outcomes 1. Number of people falling
Other outcomes reported but not included in this review
Duration of the study 4 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomisation not described. Quote: "In applying cluster sampling, half of the sample was randomly assigned to the experimental group, and the other half as the comparison group".
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants may have been unaware of which group they were in but personnel not blind to allocated group. Impact of non‐blinding unclear.
Blinding of outcome assessment (detection bias)
Falls and fallers High risk Falls self reported. Researcher who carried out the intervention also collected "Falls Record Checklist" at second and third home visits.
Incomplete outcome data (attrition bias)
Fallers High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Prospective. Self reported falls recorded on a Falls Record Checklist for the 2 months after the intervention visit.

Huang 2005.

Study characteristics
Methods RCT
Participants Setting: hospital, northern Taiwan
N = 141
Sample: people in hospital with a fall‐related hip fracture (69% women)
Age (years): mean 77 (SD 7.6)
Inclusion criteria: in hospital with fall‐related hip fracture; aged ≥ 65; discharged within medical centre catchment area
Exclusion criteria: cognitively impaired; too ill (comorbidities, unable to communicate or in intensive care unit)
Interventions 1. Discharge planning intervention by masters‐level gerontological nurse, from hospital admission until 3 months after discharge (first visit within 48 hours of admission, seen every 48 hours while in hospital, 1 home visit 3 to 7 days after discharge, available by phone 8am ‐ 8pm 7 days/wk, phoned participant or care‐giver once a week). Nurse created individualised discharge plan and facilitated set up of home‐care services etc. Participants provided with brochures on self care for hip fracture patients and fall prevention (environmental safety and medication issues). Nurse provided direct care and education on correct use of assistive devices, assessed rehabilitation needs, and collaborated with physicians to modify therapies.
2. Control: usual discharge planning also by nurses, but not specialists. No brochures, written discharge summaries, home visits, or phone calls.
Outcomes 1. Number of people falling
Other outcomes reported but not included in this review
Duration of the study 3 months
Notes Majority were community‐dwelling as states "the majority of older people with hip fracture who are discharged from hospital are at home..." Intervention included a home visit. 91% living with family.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomly assigned using a computer‐generated table
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk The discharge planning in the intervention group was conducted by a full‐time geriatric nurse. Discharge planning in the control group was conducted by general nurses. Impact of non‐blinding of participants and personnel unclear.
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Falls reported by participants who would have some knowledge of their group allocation. Research assistant stated to be blinded on page 1194, but on page 1295 to have conducted the allocation to groups. Unclear whether same research assistant carried out assessments.
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Unclear risk Falls data collected using falls diary. Appear to have been interviewed at 2 weeks and 3 months. No mention of diaries being returned by post.

Huang 2010.

Study characteristics
Methods RCT (cluster‐randomised by village). Not analysed as factorial design
Participants Setting: Taipei, Taiwan
N = 261 (N = 4 villages)
Sample: people registered as living in 4 randomly selected villages (48% women after loss to follow‐up)
Age (years): mean 71.5 (SD 0.64) in people not lost to follow‐up
Inclusion criteria: aged > 65 years; living in a non‐organised community of Taiwan
Exclusion criteria: immobile; living outside registered living area
Interventions 1. Education: 5 group teaching sessions over 5 months (medications, nutrition, environment (inside and outside), footwear) plus discussion
2. Tai Chi Chuan: 13 simple movements, 40 min, 3 x per wk for 20 wks
3. Tai Chi Chuan + education
4. Control
Outcomes 1. Number of people falling
Duration of the study 5 months and 18 months
Notes Reported results not adjusted for clustering. Raw data at 5 months used in the review and adjusted for clustering. No raw data for 18 months so not possible to adjust for clustering.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The three intervention groups and one control group were then assigned randomly to one each of the four selected villages."
Allocation concealment (selection bias) High risk Individual participant recruitment was undertaken after group allocation of the 4 villages. There was no mention of active blinding of research team members recruiting participants.
Blinding of participants and personnel (performance bias)
All outcomes High risk Interventions (Tai Chi, education classes) were such that it was not possible to blind either participants or those delivering the interventions
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
Fallers High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Unclear risk No mention of how falls were monitored

Huang 2011.

Study characteristics
Methods RCT
Participants Setting: Yi‐Lan county, Taiwan
N = 186
Sample: randomly selected sample of registered households in Yi‐Lan county (59% women)
Age (years): not stated
Inclusion criteria: aged ≥ 60; community‐dwelling; able to communicate in Mandarin or Taiwanese
Exclusion criteria: cognitively impaired; artificial leg or leg brace; unstable health problems or terminally ill
Interventions 1. Cognitive behavioural intervention: 60 to 90 min 1 x per wk for 8 wks, in groups of 8 to 12. Promoting view that fall risk and fear of falling is controllable
2. Cognitive behavioural intervention + intense Tai Chi: as above plus Tai Chi 60 min, 5 x per wk for 8 wks, in groups of 10 to 16
3. Control: no intervention
Outcomes 1. Rate of falls
2. Number of people falling
Other outcomes not included in this review
Duration of the study 5 months (3‐month follow‐up after intervention completed)
Notes Fear of falling the primary outcome
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The first author used a computer‐developed random table to randomly assign patients to three intervention groups … "
Allocation concealment (selection bias) Low risk Quote: "Allocation was concealed from the recruiting RA"
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and personnel not blind to allocation and self reported falls
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Quote: "Participants in all three groups were assessed in their homes for outcomes at baseline, 2 months, and 5 months by an RA blinded to their group allocation." Outcomes include falls.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Unclear risk Quote: "Participants in all three groups were assessed in their homes for outcomes (see below) at baseline, 2 months, and 5 months by an RA blinded to their group allocation." "Number of falls was recorded using the Falls Record Checklist (Huang & Acton 2004), which has a calendar for participants to circle dates when a fall occurred." Unclear whether falls were recorded concurrently or retrospectively at 2‐month and 5‐month assessments. No regular telephone follow‐up described.

Iwamoto 2009.

Study characteristics
Methods RCT
Participants Setting: Tokyo, Japan
N = 68
Sample: volunteer patients from Department of Orthopaedic Surgery (2 hospitals) and Orthopaedic Clinics (3) (90% women)
Age (years): mean 76.4 (SD 5.6), range 66 to 88
Inclusion criteria: aged > 50 years; fully ambulatory; able to complete physical assessments
Exclusion criteria: using walking aids; severe kyphosis due to osteoporotic vertebral fractures; acute illness; severe cardiovascular disease
Interventions 1. Exercise: supervised daily exercise programme, in clinic or hospital: 30 min, 3 x per wk for 20 wks
2. Control: no exercise
Outcomes 1. Rate of falls
2. Number of people falling
3. Number sustaining a fracture
Duration of the study 5 months
Notes Place of residence not specified, i.e. not specifically community‐dwelling, but not preventing falls in hospital or specifically in an institution
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The subjects were randomly divided into two groups ..."
Allocation concealment (selection bias) Unclear risk Quote: "The subjects were randomly divided into two groups ..."
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and personnel not blinded to allocation and falls were self reported. Control group received no intervention but were aware of study aims.
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias)
Fractures High risk Fractures appear to be self reported with no confirmation from medical records
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment. Insufficient information to permit judgement.
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Quote: "The incidence of fall and fracture … was assessed 2.5 and 5 months after the start of the trial. In particular, information regarding falls and fractures was obtained every week by directly asking the participants."
No mention of diaries or calendars. Retrospective recall. Possibly only the intervention group were asked every week (at class) and remainder at 2.5 and 5 months.

Jitapunkul 1998.

Study characteristics
Methods RCT
Participants Setting: Thailand
N = 160
Sample: people recruited from a sample for a previous study (65% women)
Age (years): mean 75.6 (SD 5.8)
Inclusion criteria: aged ≥ 70; living at home
Exclusion criteria: none stated
Interventions 1. Home visit from non‐professional personnel with structured questionnaire. 3‐monthly visits for 3 years. Referred to nurse/geriatrician (community‐based) if Barthel ADL index and/or Chula ADL index declined ≥ 2 points, or ≥ 1 fall in previous 3 months. Nurse/geriatrician would visit, assess, educate, prescribe drugs/aids, provide rehabilitation programme, make referrals
2. Control: no intervention. Visit at the end of 3 years
Outcomes 1. Number of people falling
Duration of the study Falls measured at the end of 3 years. Falls during previous 3 months only.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "... divided into case group (n = 80) and control group (n = 80) at random." Insufficient information to permit judgement.
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers High risk Falls reported by participants who were aware of their group allocation to personnel who were aware of group allocation. Possible bias. Intervention group provided falls data every 3 months for 3 years, but control group received only 1 visit in which falls data were collected.
Incomplete outcome data (attrition bias)
Fallers High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Retrospective, and different methods used in the 2 groups. Intervention group provided falls data every 3 months for 3 years, but falls data for control group only collected at exit assessment at 3 years, and data for preceding 3 months only.

Kamide 2009.

Study characteristics
Methods RCT
Participants Setting: Kanagawa, Japan
N = 57
Sample: women registered at an employment agency for older people (see Notes)
Age (years): mean 71 (SD 3.6)
Inclusion criteria: aged ≥ 65 years; community‐dwelling; independently mobile; no restriction on physical activities
Exclusion criteria: cerebrovascular, cardiopulmonary, neuromuscular, liver, or kidney disease; hyperparathyroidism; unstable diabetes mellitus or hypertension; fracture of spine or lower limbs; taking prednisolone; exercising regularly
Interventions 1. Home‐based exercise at least 3 days/wk for 24 wks. Initial 1‐hour educational session plus 1‐hour exercise instruction by PT. Exercise: stretching, moderate intensity lower‐limb strength training, balance training, impact training. No home visits but telephone or mail contact monthly.
2. Control: usual activities. Telephone or mail contact from PT every 3 months
Outcomes 1. Number of people falling
Duration of the study Falls data for previous 6 months collected retrospectively at the end of 12 months follow‐up
Notes Employment agency providing light work or volunteer activities for older people and encouraging social activities
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The random assignment procedure was performed using random numbers generated by a computer program ..."
Allocation concealment (selection bias) Unclear risk Quote: "The subjects were randomly assigned to either the home‐based exercise group or the control group". Insufficient information to permit judgement.
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and therapists aware of group allocation with potential for performance bias. Intervention group: "the therapist contacted each subject by telephone or mail every month to maintain their motivation." Control group: "The subjects who were assigned to the control group were instructed to continue with their usual daily activities, with no restrictions on their exercise activities. A therapist contacted them every 3 months by telephone or mail."
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Quote: "Functional capacity, physical function, and bone mineral density were assessed in all subjects in both groups before and after the 6‐month intervention. The staff performing the assessments were blinded to each subject's group assignment. Falls were also assessed before and after the 12‐month followup."
Incomplete outcome data (attrition bias)
Falls Unclear risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Quote: "Falls were also assessed before and after the 12‐month followup." No concurrent recording described. No mention of frequent telephone monitoring.

Kärkkäinen 2010.

Study characteristics
Methods RCT
Participants Setting: Kuopio, Finland
N = 3432
Sample: women from the OSTPRE (Osteoporosis Risk Factor and Prevention Study) cohort
Age (years): mean 67.3 (SD 1.8)
Inclusion criteria: aged 65 or older at end of November 2002; living in the Kuopio province area
Exclusion criteria: not belonging to OSTPRE bone densitometry sample
Interventions 1. Cholecalciferol 800 IU + calcium carbonate 1000 mg daily
2. Control: no supplementation
Outcomes 1. Rate of falls
2. Number of fallers
3. Number sustaining a fracture
4. Number with adverse effects
Duration of the study 3 years
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was performed with SPSS ... statistical software without any blocking or stratification."
Allocation concealment (selection bias) Unclear risk Quote: "… randomized into intervention (n = 1718) and control (n = 1714) groups by an based on simple randomization. " "The subjects were informed by letter to which group they were randomized. The letter contained information concerning the trial and the prescription for the intervention." Unclear whether person sending letter was blind to allocation.
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "OSTPRE‐FPS was conducted as an open‐label trial and neither placebo control nor blinding was applied."
Blinding of outcome assessment (detection bias)
Falls and fallers High risk Quote: "OSTPRE‐FPS was an open trial and neither placebo control nor blinding was applied."
Blinding of outcome assessment (detection bias)
Fractures Low risk Period of recall differed between the randomly selected subgroup and the remaining sample. Quote: "However, the average time of phone contacts was similar in both groups."
Quote: "All self‐reported fractures were validated using medical records or radiologic reports. Only fractures with radiologic confirmation were regarded as valid fractures, with the exception of rib fractures, for which a physician's clinical diagnosis was regarded as valid."
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Retrospective recall over a long period of time with no concurrent recording described. Period of recall differed between the randomly selected subgroup and the remaining sample. Quote: "However, the average time of phone contacts was similar in both groups."
Quote: "The participants in the subsample were telephoned at 4‐month intervals to record the incidence and circumstances of falls ... " "The rest of the trial population was interviewed by phone once a year between January and April during the trial."

Kemmler 2010.

Study characteristics
Methods RCT
Participants Setting: Erlangen‐Nuremberg area, Germany
N = 246
Sample: women members of Siemens Health Insurance living in Erlangen‐Nuremberg area
Age (years): mean 69 (SD 4)
Inclusion criteria: aged ≥ 65; community‐dwelling; consenting
Exclusion criteria: diseases affecting bone metabolism or fall risk; medication affecting bone metabolism or fall risk; history of profound coronary heart diseases (stroke, cardiac events), acute or chronic inflammatory diseases, or secondary osteoporosis; participation in exercise studies during previous 2 years; very low physical capacity (< 50 W during ergometry)
Interventions 1. Intervention: progressive high‐intensity exercise programme (group classes in gymnasium 60 min, 2 x per wk): warm up, static and dynamic balance training, functional gymnastics, isometric strength training, and stretching for trunk, hip, and thigh, and upper body exercises using elastic belts + progressive home training sessions (20 min, 2 x per wk) emphasising strength and flexibility. 
2. Control: low to moderate intensity (low frequency) "Wellness programme" (not progressive) (1 hour, 1 x per wk for 10 wks then 10 wk rest): relaxation, games/interaction, general co‐ordination, endurance, balance, dances, body sensitivity, muscle strength, breathing, and flexibility
Outcomes 1. Rate of falls
2. Number of people falling
3. Number of fractures (not number of people with fracture)
Other outcomes reported but not included in this review
Duration of the study 18 months
Notes Cost analysis in primary reference
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "computer‐generated block randomization"
Allocation concealment (selection bias) Low risk Quote: "Computer‐generated block randomization stratified for age performed by an independent statistician." "The allocation sequence and group assignment were performed by the Institute of Biometry and Epidemiology. Participants were enrolled by the Institute of Medical Physics."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "The study was blinded for the outcome assessors and participants ..." "To blind the participants, the control group performed a program that focused on well‐being and was designed not to cause physical adaptations"  "The effectiveness of the blinding in the control group was proven in structured interviews conducted by the primary investigators at the end of the 18 months"
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls reported by participants who were aware of their group allocation. Outcome assessors were blind to allocation.
Blinding of outcome assessment (detection bias)
Fractures Unclear risk Quote: "The study was blinded for the outcome assessors". No report of radiological confirmation of fractures.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Unclear risk SeeAppendix 3 for method of assessment. Insufficient information to permit judgement
Risk of bias in recall of falls Low risk Quote: "Injurious falls and overall fractures were monitored daily with the use of fall calendars compiled by the participants. Outcome assessors contacted subjects who fell and nonresponders monthly by telephone."

Kenny 2001.

Study characteristics
Methods RCT
Participants Setting: Cardiovascular Investigation Unit, Newcastle, United Kingdom
N = 175
Sample: individuals presenting at A&E with non‐accidental fall (59% women)
Age (years): mean 73 (SD 10)
Inclusion criteria: aged ≥ 50; history of a non‐accidental fall; diagnosed as having cardioinhibitory CSH
Exclusion criteria: cognitive impairment; medical explanation of fall within 10 days of presentation; blind; lived > 15 miles from A&E; had contraindication to CSM; receiving medications known to cause a hypersensitive response to CSM
Interventions 1. Pacemaker (rate drop response physiologic dual‐chamber pacemaker: Thera RDR, Medtronic, Minneapolis, Minnesota)
2. Control: no pacemaker
Outcomes 1. Rate of falls
2. Number sustaining a fracture
Other outcomes reported but not included in this review
Duration of the study 1 year after randomisation
Notes Out of 3384 A&E attendees with non‐accidental falls, 257 were diagnosed as having carotid sinus hypersensitivity. 175 of these were randomised, i.e. 5% of non‐accidental falls.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Randomised ... block randomisation; in blocks of eight". Method of sequence generation not described.
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Unclear risk Falls reported by participants who were aware of their group allocation. Blinding of assessment personnel not mentioned in report. Insufficient evidence to make judgement. 
Blinding of outcome assessment (detection bias)
Fractures Unclear risk Insufficient information in the report to permit judgement
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Prospective. Falls recorded daily on self completion diary cards which were returned at the end of each week for 1 year.

Kingston 2001.

Study characteristics
Methods RCT
Participants Setting: A&E, Staffordshire, United Kingdom
N = 109
Sample: community‐dwelling women attending A&E with a fall
Age (years): mean 71.9
Inclusion criteria: female; aged 65 to 79; history of a fall; discharged directly to own home
Exclusion criteria: admitted from A&E to hospital or any form of institutional care
Interventions 1. Rapid Health Visitor intervention within 5 working days of index fall: pain control and medication, how to get up after a fall, education about risk factors (environmental and drugs, alcohol etc), advice on diet and exercise to strengthen muscles and joints.
2. Control: usual post fall treatment, i.e. letter to GP from A&E detailing the clinical event, any interventions carried out in hospital and recommendations about follow‐up
Outcomes 1. Number of people falling
Falls not primary outcome of study. Other outcomes reported but not included in this review
Duration of the study 12 wks
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomly allocated"
Allocation concealment (selection bias) Unclear risk Quote: "randomly allocated". Insufficient information to permit judgement.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Quote: "Both groups ... were assessed by face‐to‐face interview with an independent researcher at baseline ..." and "... by the same researcher 12 weeks after the fall"
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Quote: "Falls were recorded at week twelve assessment" (information from author)

Korpelainen 2006.

Study characteristics
Methods RCT
Participants Setting: Oulu, Finland
N = 160
Sample: birth cohort of women
Age (years): mean 73 (SD 1.2)
Inclusion criteria: hip BMD > 2 less than the reference value
Exclusion criteria: "medical reasons"; use of a walking aid other than a stick; bilateral total hip joint replacement; unstable chronic illness; malignancy; medication known to affect bone density; severe cognitive impairment; involvement in other interventions
Interventions 1. Supervised exercise programme (physiotherapist led). Mixed home and supervised group programme plus twice yearly seminars on nutrition, health, medical treatment and fall prevention
2. Control: twice yearly seminars on nutrition, health, medical treatment, and fall prevention
Outcomes 1. Rate of falls
2. Number sustaining a fracture
Duration of the study 30 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Each participant received sequentially, according to the original identification numbers, the next random assignment in the computer list".
Allocation concealment (selection bias) Low risk The randomisation was "provided by a technical assistant not involved in the conduction of the trial."
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls reported by participants who were aware of their group allocation. Assessors blind to allocation.
Blinding of outcome assessment (detection bias)
Fractures Low risk Fractures reported by participants who were aware of their group allocation. Assessors blind to allocation. Quote: "In the event of a need for medical treatment, the self reported information was checked from the medical records." 
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk 3‐monthly retrospective recall

Lannin 2007.

Study characteristics
Methods RCT
Participants Setting: Sydney, Australia
N = 10
Sample: patients admitted to a rehabilitation facility and referred to OT (80% women)
Age (years): mean 81 (SD 7)
Inclusion criteria: mild or no cognitive impairment; community‐dwelling (non institutional); aged 65 or older; no medical contraindications that would require strict adherence to equipment recommendations
Exclusion criteria: none
Interventions 1. Best practice occupational therapy home visit intervention
2. Control: standard practice in‐hospital assessment and education
Outcomes 1. Number of people falling
Duration of the study 3 months
Notes Pilot study
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Allocation schedule computer‐generated
Allocation concealment (selection bias) Low risk Quote: "Concealed in opaque, consecutively numbered envelopes by a person not involved in the study."
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants and personnel not blind to allocated group but impact of non‐blinding unclear
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls reported by participants who were aware of their group allocation. Quote: "The assessor was blinded to group allocation."
Incomplete outcome data (attrition bias)
Fallers High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Unclear risk Interval recall. Falls ascertained by assessor at home visit at 2 weeks, and 1, 2 and 3 months after discharge.

Latham 2003.

Study characteristics
Methods RCT (factorial design)
Participants Setting: 5 hospitals in Auckland, New Zealand and Sydney, Australia
N = 243
Sample: frail older people recently discharged from hospital (53% women)
Age (years): mean 79
Inclusion criteria: aged ≥ 65, considered frail (one or more health problems, e.g. dependency in an ADL, prolonged bed rest, impaired mobility, or a recent fall); no clear indication or contraindication to either of the study treatments
Exclusion criteria: poor prognosis and unlikely to survive 6 months; severe cognitive impairment; physical limitations that would limit adherence to exercise programme; unstable cardiac status; large ulcers around ankles that would preclude use of ankle weights; living outside hospitals' geographical zone; not fluent in English
Interventions 1. Exercise: quadriceps exercises using adjustable ankle cuff weights 3 x per wk for 10 wks. First 2 sessions in hospital, remainder at home. Monitored weekly by physiotherapist: alternating home visit with telephone calls.
2. "Attention" control: frequency matched telephone calls and home visits from research physical therapist including general enquiry about recovery, general advice on problems, support
3. Vitamin D: single oral dose of six 1.25 mg calciferol (300,000 IU)
4. Vitamin D control: placebo tablets
Outcomes 1. Rate of falls
2. Number of people falling
3. Number of people with adverse effects from exercise (not vitamin D)
Other outcomes reported but not included in this review
Duration of the study 6 months
Notes Detailed description of exercise regimen given in paper
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Study biostatistician‐generated random sequence. Block randomisation technique.
Allocation concealment (selection bias) Low risk Computerised centralised randomisation scheme
Blinding of participants and personnel (performance bias)
All outcomes Low risk Trial with 4 arms with varying risk of bias (factorial design). 2 arms double‐blind, placebo‐controlled (low risk) and 2 arms exercise and attention control with matched frequency of visits where impact of non‐blinding likely to be low or unclear.
Blinding of outcome assessment (detection bias)
Falls and fallers Low risk Falls reported by participants who were blinded to group allocation (placebo‐controlled arms) and assessor blind to group allocation. Falls reported by participants who were aware of their group allocation (exercise and exercise control arms) but assessor blind to group allocation.
Incomplete outcome data (attrition bias)
Falls Low risk SeeAppendix 3 for method of assessment
Incomplete outcome data (attrition bias)
Fallers Low risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls Low risk Prospective. Falls recorded in fall diary with weekly reminders for first 10 weeks. Nurses examined fall diaries and sought further details about each fall at 3 and 6‐month visits. Reminder phone call between visits.

Li 2005.

Study characteristics
Methods RCT
Participants Setting: Legacy Health System, Portland, Oregon, USA
N = 256
Sample: people enrolled in health maintenance organisation (70% women)
Age (years): mean 77.5 (SD 5), range 70 to 92
Inclusion criteria: age ≥ 70; physician clearance to participate; inactive (no moderate to strenuous activity in last 3 months); walks independently
Exclusion criteria: chronic medical problems that would limit participation; cognitive impairment
Interventions 1. Exercise intervention: Tai Chi 1 hour, 3 x per wk for 26 wks
2. Control: low‐level stretching 1 hour, 3 x per wk for 26 wks
Outcomes 1. Rate of falls
2. Number of people falling
Other outcomes reported but not included in this review
Duration of the study 1 year
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selectio