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REFORM study. cmRCT design workshop 6th July 2012. Sarah Cockayne Research Fellow. Background. Falls and fall related fractures are a serious cause of morbidity and cost to society Some evidence that foot problems & inappropriate footwear may increase the risk of falls

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Reform study

REFORM study

cmRCT design workshop 6th July 2012

Sarah Cockayne Research Fellow


Falls and fall related fractures are a serious cause of morbidity and cost to society

Some evidence that foot problems & inappropriate footwear may increase the risk of falls

Some podiatry treatments may improve balance1 2

Two Cochrane reviews on falls prevention did not identify trials evaluating podiatry interventions 3 4

Only one trial in Australia has evaluated footwear advice and orthotic inserts for falls prevention 5

2009 HTA call for ankle and foot orthoses for older people with balance problems. Study has MREC approval, R&D approval outstanding

Aim of the reform trial
Aim of the REFORM trial

Aim - evaluate the clinical and cost effectiveness of a multifaceted podiatry intervention for falls prevention in the over 70s

Intervention: footwear advice & provision £80 voucher; foot orthoses ; home based foot and ankle exercises; routine podiatry care; falls prevention leaflet

Control group: falls prevention leaflet; usual podiatry and GP care

Primary outcome - rate of falls (falls/person/time)

Secondary outcomes - proportion of fallers and multiple fallers, patient reported time to first fall, fear of falling, activity of daily living, Geriatric Depressions Scale, EQ5D


  • Cohort multiple RCT design

  • Assemble a cohort of 1700 men & women over 70 years

  • Pilot phase

  • Database search

    • Podiatry clinics

    • Search for patients over 70 who have fallen, exclude patients with neuropathy, lower limb amputation, chair/bed bound

Methods 2
Methods 2

  • Potential participants sent a recruitment pack in the post

    • Introduction letter, patient information sheet, background information form (BIF), consent form, decline form and a pre-paid reply envelope

    • Patients who wish to take part return their consent form & BIF

    • Patients who decline return their decline form & BIF

The patient information sheet
The Patient Information Sheet

  • We ask the patient to fill in some questionnaires

  • Explain what happens in the control and intervention groups

  • Explain if they’re not eligible for the trial then

    • we would still like them to take part in the study

    • allow us to follow their health and see if this changes over time

    • send questionnaires to them over a period of 12 months

  • Patients are sent questionnaires and monthly falls calendars at the same time points as those in the trial

  • The whole cohort are followed up together

The patient information sheet 2
The Patient Information Sheet 2

  • Section about being approached to take part in any other studies

    • “If you agree, you may be invited to join other research studies about how to improve balance and reduce the number of falls by researchers in the REFORM team.”

    • “If you do agree to us contacting you about other studies we will keep all personal and anonymised data for a total of 5 years to allow us to do this.”

    • Consent form states:

      • “Researchers from the REFORM team would like to contact men and women who agree to take part in the main REFORM study to see if they would be interested in helping with other related studies. These are entirely optional. If you would not like to be sent information about related studies, please tick this box.”

The r d form
The R&D form

  • Question - How long will personal data be stored or accessed after the study has ended?

    • Over 3 years option selected

    • Personal data of participants who agree to us contacting them again about other related REFORM studies will be stored for up to five years to allow us to contact them again

  • We have the capacity to undertake additional studies

Methods 3
Methods 3

  • YTU will identify all eligible patients in the cohort

    • review the responses from BIF

    • Consenting patients will be sent a baseline questionnaire and falls calendar

    • eligible patients have to complete run-in data collection forms ie falls calendar and a baseline questionnaire

  • The patients will then be entered into the trial but we will prioritise those who have fallen the most

    • Sample size is 890

    • If we identify more than 890 eligible patients we will randomise patients in a 2:1 ratio in favour of the control group

Methods 4
Methods 4

  • Patient notification of group allocation

    • Intervention group – states they will be invited to clinic and sent some questionnaires

    • Control group – states they are allocated to usual care group and will be sent questionnaires

    • Cohort group – states “they have been selected to take part in the cohort study. This means that you will have been sent a falls prevention information sheet which we hope you found helpful. Your GP care will continue as usual. If you are already seeing a podiatrist for treatment which is not related to the study, you will continue to see them as usual. If you are not currently receiving treatment from a podiatrist, then you will not have to attend the podiatry clinic for the study.”

Comments on design
Comments on design

  • HTA

    • Did not comment on the proposed cmRCT design

    • ‘It might be helpful to say more, in a simplified way if possible, about how the very large number of people initially recruited translate into final numbers for the intervention and control group.”

    • Clearer criteria for progression from pilot full trial

    • Asked to justify the components of the complex intervention, or if not consider a factorial design

  • Ethics

    • Did not have any ethical concerns with the design as we submitted

    • Clarification requested on: access to personal details; if depressed people are involved; if patient’s balance assessed; if podiatry clinics had to expertise to assess patients

Potential problems
Potential problems

  • Capacity issues at the YTU

    • Collection of data in the cohort

      • Monthly falls calendar require a telephone reminder one week after they’re due

    • Process the data generated by the cohort

      • We may have to follow up a random sample

  • The study includes a pilot phase

    • Feasibility of recruiting the cohort

    • Pilot, review and refine if necessary recruitment methodology


Balanowski K and Flynn L. Effect of painful keratoses debridement on foot pain, balance and function in older adults. Gait and Posture 2005. 22:302-307

Hijmans J, Geertzen JHB, Dijkstra PU et al. Systematic review of the effects of shoes and other ankle or foot appliances on balance in older people and people with peripheral nervous system disorders. Gait and Posture 2007. 25:316-323.

Gillespie L, Robertson MC, Gillespie WJ et al. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev 2009;2:CD007146.

Cameron I, Murray GR, Gillespie LD et al. Interventions for preventing falls in older people in nursing care facilities and hospitals . Cochrane Database Syst Rev 2010: p. 1:CD005465.

Spink MJ, Menz HB, Fotoohabadi MR et al. Effectiveness of a multifaceted podiatry intervention to prevent falls in community dwelling older people with disabling foot pain: randomised controlled trial. British Medical Journal 2011 342:d3411doi:10.1136/bmj.d3411