title: An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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)).
  
  
  
  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.
  
  
  
  International Standard Randomised Controlled Trials Number registry, ISRCTN68240461 . Registered on 01 July 2011.
authors.affiliation: Department of Health Sciences, York Trials Unit, University of York, York, YO10 5DD, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Cockayne
authors.affiliation: Department of Health Sciences, York Trials Unit, University of York, York, YO10 5DD, UK.
authors.forename: Caroline
authors.initials: C
authors.lastname: Fairhurst
authors.affiliation: Department of Health Sciences, York Trials Unit, University of York, York, YO10 5DD, UK.
authors.forename: Joy
authors.initials: J
authors.lastname: Adamson
authors.affiliation: Department of Health Sciences, York Trials Unit, University of York, York, YO10 5DD, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Hewitt
authors.affiliation: Podiatry Services, Harrogate and District NHS Foundation Trust, Harrogate District Hospital, Lancaster Park Road, Harrogate, UK.
authors.forename: Robin
authors.initials: R
authors.lastname: Hull
authors.affiliation: Department of Health Sciences, York Trials Unit, University of York, York, YO10 5DD, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Hicks
authors.affiliation: NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, UK.|Leeds Institute of Rheumatology and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
authors.forename: Anne-Maree
authors.initials: AM
authors.lastname: Keenan
authors.affiliation: Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Kadoorie Critical Care Research Centre, John Radcliffe Hospital, University of Oxford, Oxford, UK.
authors.forename: Sarah E
authors.initials: SE
authors.lastname: Lamb
authors.affiliation: NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, UK.|Leeds Institute of Rheumatology and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
authors.forename: Lorraine
authors.initials: L
authors.lastname: Green
authors.affiliation: School of Health Sciences, Áras Moyola, National University of Ireland, Galway, Ireland.
authors.forename: Caroline
authors.initials: C
authors.lastname: McIntosh
authors.affiliation: Lower Extremity and Gait Studies Program, Faculty of Health Sciences, La Trobe University, Bundoora, 3086, Victoria, Australia.
authors.forename: Hylton B
authors.initials: HB
authors.lastname: Menz
authors.affiliation: NIHR Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Leeds, UK.|Leeds Institute of Rheumatology and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
authors.forename: Anthony C
authors.initials: AC
authors.lastname: Redmond
authors.affiliation: Department of Health Sciences, York Trials Unit, University of York, York, YO10 5DD, UK.
authors.forename: Sara
authors.initials: S
authors.lastname: Rodgers
authors.affiliation: Department of Health Sciences, York Trials Unit, University of York, York, YO10 5DD, UK.
authors.forename: David J
authors.initials: DJ
authors.lastname: Torgerson
authors.affiliation: The School of Human & Health Sciences, Division of Podiatry, University of Huddersfield, Huddersfield, UK.
authors.forename: Wesley
authors.initials: W
authors.lastname: Vernon
authors.affiliation: Department of Health Sciences, York Trials Unit, University of York, York, YO10 5DD, UK.
authors.forename: Judith
authors.initials: J
authors.lastname: Watson
authors.affiliation: Department of Health Sciences and the Hull York Medical School, University of York, York, YO10 5DD, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Knapp
authors.affiliation: 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, Oxford Road, Manchester, M13 9PL, UK. jo.rick@manchester.ac.uk.
authors.forename: Jo
authors.identifier: 0000-0002-4659-8111
authors.initials: J
authors.lastname: Rick
authors.affiliation: 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, Oxford Road, Manchester, M13 9PL, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Bower
authors.affiliation: Pragmatic Clinical Trials Unit (PCTU), Centre for Primary Care and Public Health, Blizard Institute, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.
authors.forename: Sandra
authors.initials: S
authors.lastname: Eldridge
authors.affiliation: Pragmatic Clinical Trials Unit (PCTU), Centre for Primary Care and Public Health, Blizard Institute, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.
authors.forename: Vichithranie W
authors.initials: VW
authors.lastname: Madurasinghe
authors.affiliation: Department of Public Health and Primary Care, University of Cambridge, Institute of Public Health, Forvie Site, Robinson Way, Cambridge, CB2 0SR, UK.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Graffy
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D000368:Aged; D000369:Aged, 80 and over; D032882:Comprehension; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D016017:Odds Ratio; D010353:Patient Education as Topic; D018579:Patient Selection; D011032:Podiatry / Q000379:methods*; D035842:Research Subjects / Q000523:psychology*; D018401:Sample Size; D006113:United Kingdom
keywords: Patient information; Randomised controlled trial; Recruitment; Retention