An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial
Sarah Cockayne,
Caroline Fairhurst,
Joy Adamson,
Catherine Hewitt,
Robin Hull,
Kate Hicks,
Anne-Maree Keenan,
Sarah E. Lamb,
Lorraine Green,
Caroline McIntosh,
Hylton B. Menz,
Anthony C. Redmond,
Sara Rodgers,
David J. Torgerson,
Wesley Vernon,
Judith Watson,
Peter Knapp,
Jo Rick,
Peter Bower,
Sandra Eldridge,
Vichithranie W. Madurasinghe,
Jonathan Graffy
Affiliations
Sarah Cockayne
Department of Health Sciences, York Trials Unit, University of York
Caroline Fairhurst
Department of Health Sciences, York Trials Unit, University of York
Joy Adamson
Department of Health Sciences, York Trials Unit, University of York
Catherine Hewitt
Department of Health Sciences, York Trials Unit, University of York
Robin Hull
Podiatry Services, Harrogate and District NHS Foundation Trust, Harrogate District Hospital
Kate Hicks
Department of Health Sciences, York Trials Unit, University of York
Anne-Maree Keenan
NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital
Sarah E. Lamb
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Kadoorie Critical Care Research Centre, John Radcliffe Hospital, University of Oxford
Lorraine Green
NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital
Caroline McIntosh
School of Health Sciences, Áras Moyola, National University of Ireland
Hylton B. Menz
Lower Extremity and Gait Studies Program, Faculty of Health Sciences, La Trobe University
Anthony C. Redmond
NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital
Sara Rodgers
Department of Health Sciences, York Trials Unit, University of York
David J. Torgerson
Department of Health Sciences, York Trials Unit, University of York
Wesley Vernon
The School of Human & Health Sciences, Division of Podiatry, University of Huddersfield
Judith Watson
Department of Health Sciences, York Trials Unit, University of York
Peter Knapp
Department of Health Sciences and the Hull York Medical School, University of York
Jo Rick
Medical Research Council North West Hub for Trials Methodology Research, National Institute of Health Research (NIHR) School for Primary Care Research, Manchester Academic Health Science Centre, Centre for Primary Care, University of Manchester
Peter Bower
Medical Research Council North West Hub for Trials Methodology Research, National Institute of Health Research (NIHR) School for Primary Care Research, Manchester Academic Health Science Centre, Centre for Primary Care, University of Manchester
Sandra Eldridge
Pragmatic Clinical Trials Unit (PCTU), Centre for Primary Care and Public Health, Blizard Institute
Vichithranie W. Madurasinghe
Pragmatic Clinical Trials Unit (PCTU), Centre for Primary Care and Public Health, Blizard Institute
Jonathan Graffy
Department of Public Health and Primary Care, University of Cambridge, Institute of Public Health
Abstract Background Randomised controlled trials are generally regarded as the ‘gold standard’ experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial. Methods A three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial. Results Six thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77–1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71–1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65–1.31, p = 0.65)). Conclusions This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study. Trial registration International Standard Randomised Controlled Trials Number registry, ISRCTN68240461 . Registered on 01 July 2011.
