Objectives
This is a protocol for a Cochrane Review (intervention). The objectives are as follows:
To assess the benefits and harms of podiatry interventions for preventing falls in older people living in the community.
Background
A 2012 Cochrane review examined the effectiveness and harms of all interventions to prevent falls in older people (aged 60 years and over) living in the community (i.e. in households that do not provide residential health‐related care or rehabilitative services) [1]. The evidence for several of the intervention types included in that review has since been updated in separate, associated reviews of multifactorial and multiple component interventions [2], exercise interventions [3], and environmental interventions [4]. Other Cochrane reviews have also examined interventions to prevent falls in older people in care facilities and hospitals [5, 6, 7]. However, the evidence for podiatry to prevent falls in older people living in the community has not been updated in a Cochrane review since 2012. This update of the podiatry part of the 2012 review follows the methods of that review [1], so is consistent with the methods of the other associated falls prevention reviews [1, 2, 3, 4, 6].
Description of the condition
Falls affect a third of community‐dwelling people over 65 years of age each year [8], and often have serious consequences, such as hip fracture [9], traumatic brain injury [10], or nursing home admission [11], and often result in long‐term reduction in quality of life [12]. Falls in older people are also the leading cause of injury‐related death in this population [13]. Management of fall‐related injuries accounts for up to 1.5% of annual health care expenditure in the USA [14]. As the cause of falls is often multifactorial and involves the interaction of multiple risk factors [15], several interventions to prevent falls have been proposed, including exercise [3], environmental modification [4], psychological interventions [16], and multifactorial or multicomponent interventions including several different intervention approaches [2].
Description of the intervention and how it might work
Podiatry can be defined as the specialist branch of medicine dedicated to the treatment of disorders of the foot and ankle [17]. The scope of practice of podiatry varies around the world due to differences in history, education and government policy, but several interventions are considered to be ‘core’ treatments of the profession. These are: treatment of nails, corns and calluses; provision of foot orthoses or insoles, or both; prescription of foot exercises; and provision or modification, or both, of footwear [18].
These interventions are often administered to older people with balance impairments and an increased risk of falling as part of a multifaceted package [19, 20, 21], or as single interventions [22, 23] for the prevention of falls. These foot and footwear interventions may be delivered by podiatrists or other healthcare professionals; whether the type of healthcare professional who delivers the intervention affects its effectiveness is uncertain [24]. The ability of older people to engage with recommended interventions – and hence their effectiveness – may also be impacted by their cognitive health, mobility and foot pain.
Foot pain affects approximately one in four older people [25]. The strength and range of motion of the foot decreases with age, which impacts mobility and stiffens soft tissue. In turn, the foot becomes more pronated (i.e. turns inward when walking), and structural disorders of the foot, such as hallux valgus (bunions), become more common [26, 27]. This can result in impairments of balance, mobility, functional gait and foot pain, all of which increase the risk of falls [28]. Several studies have reported a higher prevalence of foot problems in older people who fall [29, 30, 31], and a recent systematic review and meta‐analysis confirmed that foot problems – specifically foot pain, hallux valgus and lesser toe deformity – are risk factors for falls [30]. Foot and footwear interventions that address these impairments may be effective in reducing the incidence of falls [32].
Why it is important to do this review
The most recent Cochrane review that evaluated the effectiveness of any intervention to reduce falls in older people in the community was published in 2012 and included a single trial of multifaceted podiatry interventions [1]. Since then, no Cochrane review has updated the evidence for podiatry interventions to prevent falls. The most recent non‐Cochrane systematic review – a meta‐analysis of nine randomised controlled trials – was conducted in 2019 [33], and included both trials that examined podiatry treatment as an intervention (five trials), and multifactorial falls‐prevention trials that included podiatry referrals. However, in the multifactorial trials, it was difficult to determine what the participants actually received from their podiatry referral, and the multifaceted nature of the interventions made it difficult to determine whether the podiatry component was effective.
Objectives
To assess the benefits and harms of podiatry interventions for preventing falls in older people living in the community.
Methods
This review is part of a suite of Cochrane reviews on falls prevention. It updates the subsection of interventions classified as 'podiatry interventions' in the Gillespie 2012 Cochrane review “Interventions for preventing falls in older people living in the community” [1]. This review will follow the methods of the original 2012 Gillespie review [1]. Other intervention categories from the original 2012 review have been updated recently [2, 3, 4], as well as allied reviews that cover people living in care facilities and hospitals [5, 6, 7]. This review will retain consistency of inclusion criteria and methods, including search strategies, study selection criteria, data extraction and synthesis methods with this group of associated reviews.
We will follow the Methodological Expectations for Cochrane Intervention Reviews when conducting the review [34], and PRISMA 2020 for the reporting [35]. We will describe any deviations to the protocol within the review supplementary materials under 'Differences between the protocol and review'.
Criteria for considering studies for this review
Types of studies
We will consider all trials, including quasi‐randomised trials (such as those allocated by alternation), cluster‐randomised and cross‐over trials for inclusion.
Types of participants
We will include trials:
of podiatry interventions to prevent falls in older people of either sex in the community;
that specify an inclusion criterion of 60 years of age or over, or younger participants if the mean age minus one standard deviation (SD) exceeds 60 years;
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, retirement villages, or sheltered housing. Trials with mixed populations (community and higher dependency places of residence) will be eligible for inclusion if data are provided for subgroups based on setting, or the numbers in higher dependency residences are very few and balanced in the comparison groups. We will also include trials that recruit participants in hospital if the majority were discharged to the community, where the majority of the intervention was delivered and falls recorded.
We will exclude trials:
that recruit participants with specific conditions (e.g. post‐stroke, Parkinson’s disease, visual impairment or diabetic neuropathy) as interventions to prevent falls in these populations have been addressed in separate reviews [36, 37, 38, 39], and the foot‐ and footwear‐related interventions implemented for them are often unique to these particular conditions;
that were conducted in care facilities, as these have been included in a separate Cochrane review "Interventions for preventing falls in older people in care facilities" [6].
Types of interventions
We will include:
any podiatry intervention designed to reduce falls in older people, typically administered by a podiatrist, including: routine podiatry care (i.e. toenail debridement, scalpel reduction of corns and calluses); foot orthoses or insoles; footwear advice or provision; exercise programmes specific to the foot and ankle; or any other podiatry‐specific intervention;
comparators, which can be any other intervention, usual care (e.g. general physical activity or multifactorial interventions) or placebo;
any dose, frequency or time frame of intervention delivery.
We will exclude:
surgical trials, as surgical interventions are not performed routinely to prevent falls specifically;
multifactorial trials, or trials of multiple‐component interventions where a podiatry referral or intervention is delivered as part of a combination of two or more different categories of intervention.
Outcome measures
We will only include:
trials that report raw data or statistics relating to the rate or number of falls, or number of participants sustaining at least one fall during follow‐up ('fallers'), consistent with the associated Cochrane falls prevention reviews [2, 3, 4]. Trials that report only those participants who had more than one fall will be included.
We will exclude trials that:
report only specific types of fall (e.g. injurious falls, bedside falls), as these represent only a subset of all falls;
focus on intermediate outcomes such as improved balance or strength, or fear of falling, but do not report falls;
record falls as a potential adverse event of the intervention: this review aims to synthesise the evidence from interventions intended to prevent falls, so we will exclude trials that record falls as a potential adverse event of interventions that are not primarily intended to prevent falls, as these would not provide appropriate evidence. In addition, pooling such trials with those of falls prevention interventions may mask the effects of interventions specifically designed to reduce falls.
Critical outcomes
Rate of falls (falls per unit of person‐time that falls were monitored)
Number of fallers (risk of falling)
Important outcomes
Risk of fracture (number of participants sustaining fall‐related fractures)
Risk of falls requiring hospital admission (number of people who experienced one or more falls that resulted in hospital admission)
Risk of falls requiring medical attention (number of people who experienced one or more falls that required medical attention)
Health‐related quality of life measured using a validated scale, e.g. EQ‐5D or similar
Adverse events (or complications of the interventions, e.g. pain)
Economic outcomes (economic evaluations or costs) assessed using the Drummond scale [40].
We will record intervention adherence data where these are available for use in the interpretation of trial and review findings.
Any trials we identify that do not report data for the overall rate or number of falls, but that indicate this would be measured in a trial record or protocol will be listed in the excluded studies and highlighted in the Discussion. We will also make contact with authors of trial reports with missing data to obtain relevant data, but will exclude those trials if no data are obtained.
Timing of outcome measurements
For all outcomes, we will prioritise the utilisation of long‐term data (i.e. 12 months or longer), where it is available. For trials with outcomes measured at multiple time points, we will use the time point closest to 12 months in the main analysis. We will include separate, shorter‐term analyses for trials with final follow‐up less than 12 months after randomisation. To maximise the use of available information from trials with multiple follow‐up points, we will use the longest follow‐up in the main analysis, but also report outcomes at additional follow‐up time points.
Search methods for identification of studies
Electronic searches
(See Supplementary material 1 for details.)
This review will update the podiatry interventions in the original Gillespie 2012 Cochrane review [1]. To avoid research waste through duplication of effort, we will augment the included trials in Gillespie 2012 with the relevant trials (up to 2018) included in the non‐Cochrane review by Wylie, which was published in 2019 [33], and had a broader scope than our review. We will supplement these approaches with database searches from July 2018 onwards of:
Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies (CRS‐Web);
Ovid MEDLINE ALL;
Embase;
CINAHL Plus;
ongoing trial registers via the World Health Organization's ICTRP Search Portal and ClinicalTrials.gov.
We will base the search strategy for 2018 onwards on that in the Gillespie 2012 Cochrane review [1], and incorporate the podiatry‐specific search strategy from the Wylie 2019 non‐Cochrane systematic review [33]. We will not apply any language restrictions.
In MEDLINE (OvidSP), we will combine subject‐specific search terms for falls and older people with the sensitivity‐ and precision‐maximising version of the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE [41]. We will modify this strategy for use in CENTRAL, Embase, and CINAHL.
Searching other resources
To identify additional trials and citations we will:
check reference lists of newly included trial articles and further trials;
contact researchers in the field;
check included studies lists in recent, relevant systematic reviews;
search MEDLINE (and other databases if necessary) for the latest version of the citations for trials included from the Gillespie 2012 Cochrane review [1], and the Wylie 2019 non‐Cochrane review [33], and examine any relevant retraction statements and errata associated with included trials.
Data collection and analysis
We will carry out data collection and analysis according to methods in the Cochrane Handbook for Systematic Reviews of Interventions [42]. In line with Cochrane policy, review authors will not assess any trials with which they have been involved for eligibility for inclusion, or assessment of risk of bias, or be involved in data extraction of those trials.
Selection of studies
From existing systematic reviews
Two review authors (HBM or CS and SD) will screen all included trials in the non‐Cochrane Wylie 2019 review to identify trials that are not included in Gillespie 2012. We will consider trials from both reviews for inclusion in this review, and confirm their eligibility through full‐text review [1, 33].
From database searches
If our searches identify more than 500 potentially relevant citations after duplicate removal, we will use the RCT classifier and Cochrane Crowd to identify RCTs through Screen4Me [41]. After this process has been conducted, we will screen all remaining abstracts independently to identify potentially relevant trials for full review using Covidence [43], by means of the title, abstract, or descriptors. Two review authors (HBM or CS and SMD) will independently assess the full text of potentially eligible trials for inclusion using Covidence [43]. Disagreement will be resolved by discussion and consensus or adjudication by a third author (CS), where necessary. We will contact trial authors for additional information, if necessary, to assess the eligibility of their studies. Review authors will not determine the eligibility of their own trials.
Data extraction and management
To avoid research waste through duplication of effort, where appropriate, one review author (SMD) will extract data from the non‐Cochrane Wiley 2019 review that utilised duplicate data extraction [33], and will confirm the accuracy and completeness of data extraction by checking the full‐text of the included trials. Independently, pairs of review authors (HBM or CS and SMD) will extract data from additional newly identified trials using a pretested data extraction form or Covidence [43]. Details of data extraction items are provided in Supplementary material 2. We will link multiple reports of the same trial as a single trial in Covidence, and evidence from all reports will be reviewed when we undertake data extraction. Where possible, where data are unclear, we will contact the trial authors for clarification. Disagreement will be resolved by discussion and consensus or third‐party adjudication (CS) when necessary.
Risk of bias assessment in included studies
Pairs of review authors (HBM or CS and SMD) will independently assess the risk of bias on the basis of the effect of assignment to the interventions at baseline, regardless of whether the interventions are received as intended (i.e. 'intention‐to‐treat') for each included trial. We will use the Cochrane risk‐of‐bias tool for randomised trials (RoB2) [44], and consider the following domains:
bias arising from the randomisation process;
bias due to deviations from the intended interventions;
bias due to missing outcome data;
bias in the measurement of the outcome; and
bias in the selection of the reported result [45].
We will assess risk of bias for the following outcomes for the main comparison of multifaceted podiatry in comparison to control and also for single interventions in comparison to control:
rate of falls;
risk of falling;
risk of fracture;
risk of falls requiring hospital admission;
health‐related quality of life;
adverse events; and
economic outcomes (cost‐effectiveness).
For any cross‐over trials, we will use the cross‐over trial extension tool for RoB2 [46]. For any cluster‐randomised trials, we will consider the participants as those in whom the outcomes are measured, and we will use the variant for cluster‐randomised trials [47]. Additional detail on assessment of risk of bias is provided in Supplementary material 3.
Assessors will rate the risk of bias as 'low', 'some concerns' or 'high risk' for each domain, and make an overall risk of bias judgement based on the signalling questions and algorithms in the appropriate RoB2 crib sheet, using the RoB 2 Excel tool (available at www.riskofbias.info). Judging a result to be at a particular level of risk of bias for an individual domain implies that the result has an overall risk of bias at least that severe. Assessors will not be blinded to trial authors or source institutions. Disagreement will be resolved by consensus, or by third party adjudication.
We will conduct sensitivity analyses according to trial quality, excluding trials at high risk of bias as described under Sensitivity analysis.
Measures of treatment effect
We will report the treatment effect for rate of falls as a rate ratio (RaR) and 95% confidence interval (CI). We will report a risk ratio (RR) and 95% CI for the dichotomous outcomes of risk of falling (number of fallers); risk of fracture; risk of falls requiring hospital admission; and risk of falls requiring medical attention. For continuous outcomes, such as health‐related quality of life, we will present the mean difference (MD) with 95% CI where the same outcome measure is used, or standardised mean difference (SMD) with 95% CI when outcomes are measured using different scales. We will use final values in preference to change scores.
Critical outcomes
Rate of falls
The rate of falls is the total number of falls per unit of person‐time for which falls are monitored (e.g. falls per person‐year). The rate ratio compares the rate of falls in any two groups during each trial. We will use a rate ratio (for example, incidence rate ratio or hazard ratio for all falls) and 95% CI if these are reported in the paper. If both adjusted and unadjusted rate ratios are reported, we will use the unadjusted estimate, unless the adjustment is for clustering. If a rate ratio is not reported, but appropriate raw data are available, we will use Microsoft Excel to calculate a rate ratio and 95% CI [48]. To do this, we will use the reported rate of falls (falls per person‐year) in each group and the total number of falls for participants contributing data, or calculate the rate of falls in each group from the total number of falls and the total length of time for which falls were monitored (in person‐years) for participants contributing data. In cases where data are only available for people who completed the trial, or where the trial authors state there were no losses to follow‐up, we will assume that these participants had been followed up for the maximum possible period. Where there are no falls in one arm of a trial, and a low total number of falls or participants, or both, we will not be able to determine the rate of falls. We will not pool such data, although we consider that the omission of these data from the pooled analysis is unlikely to change any estimate of effect. We will explore the likely effect of this through sensitivity analyses.
Risk of falling
For number of fallers, the risk ratio compares the number of people who fell once or more (fallers) in the intervention and control arms of each trial. We will use a reported estimate of risk (hazard ratio for first fall, risk ratio (relative risk), or odds ratio if the incidence of fallers in the control arm is ≤ 3%) and 95% CI, if available. If both adjusted and unadjusted estimates are reported, we will use the unadjusted estimate, unless the adjustment is for clustering. If an odds ratio is reported, or there is no effect estimate and 95% CI, where appropriate raw data are available, we will calculate a risk ratio and 95% CI using the csi command in Stata [49], or in Review Manager [50]. For the calculations, we will use the number of participants contributing data in each group if this is known; if this is not reported, we will use the number randomised to each group.
Important outcomes
Adverse events
Where reported, we will record adverse events or complications of the intervention and calculate risk ratios.
Economic outcomes
We will note the results from any economic evaluations (cost‐effectiveness analysis, cost‐utility analysis) incorporated in the included trials. We will also extract data about the type of resource use reported (e.g. delivering the intervention, hospital admissions, medication use) and the cost of the items for each group from each trial that reports a cost analysis, cost description or analytic model. We will assess economic evaluations using the Drummond scale [40].
Unit of analysis issues
For cluster‐randomised trials, we will perform adjustments for clustering if this has not been done in the published reports [51]. We will use an intracluster correlation coefficient (ICC) of 0.01 from a cluster trial of older people in primary care, as reported in Smeeth 2002 [52].
Where appropriate, for trials with multiple intervention groups, we will combine the groups or include only one pair‐wise comparison (intervention versus control) in any analysis to avoid the same group of participants being included twice. For trials with multiple intervention groups included in the same meta‐analysis (e.g. in a subgroup analysis examining different types of intervention), where the reported rate or risk ratio is used for the meta‐analysis, we will adjust the standard errors by an appropriate inflation factor according to Rűcker's methods described for approximation [53], and divide the number of control participants (in the forest plot for display purposes only) between different comparisons by the number of intervention groups in the same analysis to avoid double‐counting them. For example, for a three‐arm trial, with 100 participants in the control group, 100 participants in intervention arm A, and 100 participants in intervention arm B, the standard errors of the falls rate or risk ratios in the intervention A versus control and intervention B versus control comparisons would be inflated by 22% and the number of control participants would be displayed as 50 in both comparisons.
For trials that do not report falls that occur within the intervention delivery period, we will not pool outcome data with other trials in the main analysis, but will explore their impact in a sensitivity analysis. We will not include outcomes collected at different time points in the same trial in the same analysis.
If cross‐over trials are reported as having been analysed in parallel (for example, all measurements from intervention "A" periods and all measurements from intervention "B" periods), the incorporation of these data into meta‐analysis gives rise to unit‐of‐analysis error, so this method of synthesis will not be undertaken. Instead, if reported, we will include data from the first period only in meta‐analysis. If data are not reported separately for the first cross‐over period, we will report the results in tabular form and not pool them [51].
Dealing with missing data
We will attempt to contact trial authors to obtain missing data where necessary. We will use only the data available in our analyses; we will not impute missing data.
Reporting bias assessment
We will construct funnel plots for analyses that contain more than 10 trials in order to explore the possibility of small study effects or publication and other reporting biases. If a considerable number of small trials contribute to an analysis, we will conduct a sensitivity analysis and exclude trials with fewer than 20 participants in each arm. We will assess asymmetry in funnel plots by visual inspection; we will conduct no formal statistical analysis on them.
Synthesis methods
We will group the results of included trials and compile forest plots for the rate of falls, risk of falling and risk of fracture using the generic inverse variance method in Review Manager [50]. This method will enable pooling of the adjusted and unadjusted treatment effect estimates (rate ratios or risk ratios) that are reported in the papers, or we will calculate from data presented in the paper. We will pool results using a random‐effects model, since we expect there will be clinical diversity. We will use the Restricted Maximum Likelihood estimator to estimate between‐trial variance. We will use the Hartung‐Knapp‐Sidik‐Jonkman method to calculate a CI for the meta‐analysis effect estimate when there are at least three trials, and the estimate of heterogeneity is greater than zero. In other scenarios (i.e. in pooled analyses of two trials, or where the estimate of heterogeneity is equal to zero), we will use the Wald‐type method. We will conduct a sensitivity analysis examining the effect of using a fixed‐effect model in cases where there is little clinical diversity or the estimate of heterogeneity is equal to zero.
We will examine the descriptions of interventions used in individual trials and categorise the interventions accordingly. We will pool the results of single interventions if the trials contain comparable interventions and participant characteristics. We will pool the results of multifaceted interventions separately. Where it is inappropriate to pool data based on heterogeneity of intervention and participant characteristics, we will present trial data in the analyses or tables for illustrative purposes and report these in the text.
If the number of participants in each arm of a trial is not known, we will not pool the results with the outcomes of other trials, but will explore the impact of this in a sensitivity analysis. If trials exclude a period of the intervention follow‐up from the measurement of falls outcomes, we will not pool the results with other trials, and will examine the impact of this in a sensitivity analysis.
Economic outcomes reported in the included trials will be presented in tabulated form with a brief commentary in the text.
Investigation of heterogeneity and subgroup analysis
If there are enough data, we will conduct subgroup analyses based on trial level data (e.g. enrolment criteria or baseline characteristics, or both, or intervention descriptions) to explore:
differences between different intervention types according to the TIDieR and Profane taxonomies [54, 55] (e.g. advice only versus provision of footwear with or without advice);
participant cognitive status (cognitively impaired versus cognitively intact or mixed populations);
mobility (impaired versus non‐impaired or mixed mobility);
participant foot pain (presence of pain versus absence of pain or mixed population); and
professional delivering the intervention (podiatrists versus non‐podiatrists).
We will use the random‐effects model to pool data in all subgroup analyses and test for subgroup differences that may be due to the high risk of false‐positive results which can occur when comparing subgroups with a fixed‐effect model [56]. We will use the test for subgroup differences available in Review Manager to determine whether there is evidence for a difference in treatment effect between subgroups [50].
Sensitivity analysis
Where there is considered to be significant statistical heterogeneity for one measure of falls outcomes but not the other (e.g. for rate of falls but not risk of falling), we will perform sensitivity analyses to determine the likely effects of using random‐effects versus fixed‐effect meta‐analyses. If there is observed asymmetry in the funnel plots, we will conduct sensitivity analyses for interventions with a considerable number of small trials, and exclude trials with 20 or fewer participants in each arm of the trial to explore the possibility of small‐trial effects. We will conduct sensitivity analyses where trials included in a meta‐analysis report zero falls in the intervention arm, adding one fall in the intervention arm to examine the likely effect of omitting the trial(s) from the analysis. If the number of participants in each arm of the trial is not known, we will explore the impact of excluding such trials by conducting a sensitivity analysis assuming an equal number of randomised participants in each arm of the trial. If trials exclude the intervention period from the falls outcomes, we will explore the impact of excluding such trials by including them in a sensitivity analysis. We will conduct sensitivity analyses according to trial quality, excluding trials at high risk of bias in the key domains likely to have an impact in the context of this review, that is:
bias arising due to the randomisation process;
bias due to deviations from intended interventions (other than due to lack of blinding as this is unlikely to be feasible);
bias arising due to missing outcome data; or
bias in measurement of the outcome to inform the rating for the domain of risk of bias or study limitations, or both.
Certainty of the evidence assessment
For the main comparisons, we will use the GRADE approach to assess the certainty of evidence for each outcome reported in the summary of findings table [57]. Two review authors (HBM, or CS and SD) will perform GRADE assessment independently and disagreement will be resolved by discussion, or by adjudication with a third review author. The certainty rating of 'high' is reserved for a body of evidence based on randomised controlled trials. We will downgrade the certainty rating to 'moderate', 'low' or 'very low' depending on the presence and extent of five factors:
study limitations;
inconsistency of effect;
imprecision;
indirectness; and
publication bias.
The risk of bias assessment will be informed by sensitivity analyses in which we excluded trials that are at high risk of bias in key domains.
We will GRADE only the cost‐effectiveness outcome data for economic outcomes, as other economic outcomes (e.g. costs) do not provide information about the relative benefit of the alternative interventions. Review authors will not conduct GRADE assessments or adjudicate for comparisons that include trials on which they have worked.
We will prepare a summary of findings table for the main comparison of multifaceted podiatry in comparison to usual care. We will prioritise long‐term follow‐up time points of 12 months or longer and present the following outcomes:
rate of falls;
risk of falling;
risk of fracture;
risk of falls requiring hospital admission;
health‐related quality of life;
adverse events; and
economic outcomes (cost‐effectiveness).
Equity considerations
A formal equity‐related assessment will not form part of this review, although some equity considerations related to the PROGRESS‐Plus characteristics of the trials will be considered within the Discussion [58]. For example, if all trials were conducted in middle‐to‐high income countries, there may be equity issues that relate to implementation and access to interventions determined by place of residence and socioeconomic status, or the complexity and cost of the intervention.
Consumer involvement
Findings from the review will be discussed with a consumer panel to inform the interpretation.
Supporting Information
Supplementary materials are available with the online version of this article: 10.1002/14651858.CD016193.
Supplementary materials are published alongside the article and contain additional data and information that support or enhance the article. Supplementary materials may not be subject to the same editorial scrutiny as the content of the article and Cochrane has not copyedited, typeset or proofread these materials. The material in these sections has been supplied by the author(s) for publication under a Licence for Publication and the author(s) are solely responsible for the material. Cochrane accordingly gives no representations or warranties of any kind in relation to, and accepts no liability for any reliance on or use of, such material.
Supplementary material 1 Search strategies
Supplementary material 2 Data extraction and management
Supplementary material 3 Risk of bias 2 (RoB2) assessment details
New
Additional information
Acknowledgements
The authors would like to thank Dr Gavin Wylie of the University of Dundee, who conducted the 2019 review of podiatry interventions that will be utilised for study identification and data extraction in this review, and who provided the search strategy used in that review. The authors acknowledge that this protocol was developed as part of ongoing collaborative efforts within Cochrane Rehabilitation, Functioning, and Disability.
Editorial and peer‐reviewer contributions
The following people conducted the editorial process for this article:
Sign‐off Editor (final editorial decision): Neil O’Connell, Brunel University of London;
Managing Editor (selected peer reviewers, provided editorial guidance to authors, edited the article): Leanne Jones, Central Editorial Service;
Editorial Assistant (conducted editorial policy checks, collated peer reviewer comments and supported editorial team): Joshua Alba Guinoo, Central Editorial Service;
Copy Editor (copy editing and production): Elizabeth Royle, Central Production Service;
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Peer‐reviewers (provided comments and recommended an editorial decision):
Angela Evans, Adjunct Associate Professor, La Trobe University (clinical/content review);
Brian Duncan (patient and public review);
Tom Patterson, Cochrane Evidence Production and Methods Directorate (methods review);
Steve McDonald, Cochrane Australia (search review).
Contributions of authors
HBM contributed to conception of the protocol, project administration, drafting the protocol, critical review and editing.
SMD contributed to conception of the protocol, project administration, drafting the protocol, critical review and editing.
SEL contributed to conception of the protocol and critical review.
CS contributed to conception of the protocol, acquisition of funding, critical review and editing.
Declarations of interest
HBM: I am a co‐author of two trials that may be eligible for inclusion. I will not be involved in any decisions in relation to these studies around study eligibility, data extraction, risk of bias assessments, or performing GRADE assessments of the studies.
SMD: Employed by Flinders University as Senior Research Fellow to conduct reviews related to falls and fractures, which are funded by the Australian NHMRC‐funded Centre for Research Excellence Prevention of Falls Injuries CRE. Executive committee member of the Australian and New Zealand Falls Prevention Society.
SEL: No commercial or non‐commercial conflicts of interest relevant to this review.
CS: Receives royalties for a coauthored book on falls. CS is an editor for the Cochrane Database of Systematic Reviews but was not involved in the editorial process for this manuscript.
Sources of support
Internal sources
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The University of Sydney, Australia
Administration, computing, and library services (CS)
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La Trobe University, Australia
Administration, computing, and library services (HBM)
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Flinders University, Australia
Administration, computing, and library services (SMD)
External sources
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Centre of Research Excellence for Prevention of Falls Injuries (funded by the Australian National Health and Medical Research Council), Australia, Australia
Salary support (SMD)
Registration and protocol
Cochrane approved the proposal for this review in February 2024.
Data, code and other materials
Data sharing is not applicable to this article as it is a protocol, so no datasets were generated or analysed.
Disclosure of artificial intelligence use
Artificial intelligence was not used in the development of this protocol.
Notes
Published notes in RevMan are for editor use only. Authors should leave this section blank.
References
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Supplementary material 1 Search strategies
Supplementary material 2 Data extraction and management
Supplementary material 3 Risk of bias 2 (RoB2) assessment details
Data Availability Statement
Data sharing is not applicable to this article as it is a protocol, so no datasets were generated or analysed.
