Evidence map›Paper›PMID 28107372›Full record

Trial reportPloS one2017

Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial).

Sarah Cockayne, Joy Adamson, Arabella Clarke, Belen Corbacho, Caroline Fairhurst, Lorraine Green, Catherine E Hewitt, Kate Hicks, Anne-Maree Kenan, Sarah E Lamb and 9 more

Abstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Update of the fracture risk prediction tool FRAX: a systematic review of potential cohorts and analysis plan.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Sarah CockayneYork Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
Joy AdamsonYork Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
Arabella ClarkeYork Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
Belen CorbachoYork Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
Caroline FairhurstYork Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
Lorraine GreenNIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, United Kingdom.
Catherine E HewittYork Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
Kate HicksYork Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
Anne-Maree KenanNIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, United Kingdom.
Sarah E LambNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Kadoorie Critical Care Research Centre, John Radcliffe Hospital, University of Oxford, Oxford, United Kingdom.
Caroline McIntoshNational University of Ireland, Galway, Republic of Ireland.
Hylton B MenzSchool of Allied Health, College of Science, Health and Engineering, La Trobe University, Bundoora, Victoria, Australia.
Anthony C RedmondNIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, United Kingdom.
Zoe RichardsonYork Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
Sara RodgersYork Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
Wesley VernonPodiatry Services, Sheffield Teaching Hospitals NHS Foundation Trust, Jordanthorpe Health Centre, Sheffield, United Kingdom.
Judith WatsonYork Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
David J TorgersonYork Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.ORCID http://orcid.org/0000-0002-1667-4275
REFORM study

Funding

Department of Health 09/77/01Department of Health PDA/03/07/047
6 · The paper itself

Abstract

backgroundFalls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention.

designPragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness.

resultsIn the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained.

conclusionThere was a small reduction in falls. The intervention may be cost-effective.

trial registrationISRCTN ISRCTN68240461.

Indexed as

PodiatryAccidental FallsAgedAged, 80 and overCohort StudiesFemaleHumansMale

Identifiers

PMID28107372
PMCPMC5249075

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.