title: Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial).
abstract: BACKGROUND
  Falls 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.
  
  
  METHODS
  Pragmatic 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.
  
  
  RESULTS
  In 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.
  
  
  CONCLUSIONS
  There was a small reduction in falls. The intervention may be cost-effective.
  
  
  BACKGROUND
  ISRCTN ISRCTN68240461.
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
authors.forename: Sarah
authors.initials: S
authors.lastname: Cockayne
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
authors.forename: Joy
authors.initials: J
authors.lastname: Adamson
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
authors.forename: Arabella
authors.initials: A
authors.lastname: Clarke
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
authors.forename: Belen
authors.initials: B
authors.lastname: Corbacho
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
authors.forename: Caroline
authors.initials: C
authors.lastname: Fairhurst
authors.affiliation: NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, United Kingdom.
authors.forename: Lorraine
authors.initials: L
authors.lastname: Green
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
authors.forename: Catherine E
authors.initials: CE
authors.lastname: Hewitt
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
authors.forename: Kate
authors.initials: K
authors.lastname: Hicks
authors.affiliation: NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, United Kingdom.
authors.forename: Anne-Maree
authors.initials: AM
authors.lastname: Kenan
authors.affiliation: Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Kadoorie Critical Care Research Centre, John Radcliffe Hospital, University of Oxford, Oxford, United Kingdom.
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Lamb
authors.affiliation: National University of Ireland, Galway, Republic of Ireland.
authors.forename: Caroline
authors.initials: C
authors.lastname: McIntosh
authors.affiliation: School of Allied Health, College of Science, Health and Engineering, La Trobe University, Bundoora, Victoria, Australia.
authors.forename: Hylton B
authors.initials: HB
authors.lastname: Menz
authors.affiliation: NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, United Kingdom.
authors.forename: Anthony C
authors.initials: AC
authors.lastname: Redmond
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
authors.forename: Zoe
authors.initials: Z
authors.lastname: Richardson
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
authors.forename: Sara
authors.initials: S
authors.lastname: Rodgers
authors.affiliation: Podiatry Services, Sheffield Teaching Hospitals NHS Foundation Trust, Jordanthorpe Health Centre, Sheffield, United Kingdom.
authors.forename: Wesley
authors.initials: W
authors.lastname: Vernon
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
authors.forename: Judith
authors.initials: J
authors.lastname: Watson
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom.
authors.forename: David J
authors.identifier: http://orcid.org/0000-0002-1667-4275
authors.initials: DJ
authors.lastname: Torgerson
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008297:Male; D011032:Podiatry