title: Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial: experiences from the ProFHER trial.
abstract: OBJECTIVE
  A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults.
  
  
  METHODS
  These processes included the development of a patient information leaflet on self-care during sling immobilisation, the development of a basic treatment physiotherapy protocol that received input and endorsement by specialist physiotherapists providing patient care, and establishing an expectation for the provision of home exercises. Specially designed forms were also developed to facilitate reliable reporting of the physiotherapy care that patients received.
  
  
  RESULTS
  All three initiatives were successfully implemented, alongside the measures to optimise the documentation of physiotherapy. Thus, all participating sites that recruited patients provided the sling immobilisation leaflet, all adhered to the physiotherapy protocol and all provided home exercises. There was exemplary completion of the physiotherapy forms that often reflected a complex patient care pathway. These data demonstrated equal and high access to and implementation of physiotherapy between groups, including the performance of home exercises.
  
  
  CONCLUSIONS
  In order to increase the validity and relevance of the evidence from trials of surgical interventions and meet international reporting standards, careful attention to study design, conduct and reporting of the intrinsic rehabilitation components is required. The involvement of rehabilitation specialists is crucial to achieving this. Cite this article: Bone Joint Res 2014;3:335-40.
authors.affiliation: Health and Social Care Institute, School of Health and Social Care, Teesside University, Middlesbrough TS1 3BA, UK.
authors.forename: H H G
authors.initials: HH
authors.lastname: Handoll
authors.affiliation: James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Road, Middlesbrough TS4 3BW, UK.
authors.forename: L
authors.initials: L
authors.lastname: Goodchild
authors.affiliation: York Trials Unit, Lower Ground Floor, ARRC Building, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.
authors.forename: S D
authors.initials: SD
authors.lastname: Brealey
authors.affiliation: Health and Social Care Institute, School of Health and Social Care, Teesside University, Middlesbrough TS1 3BA, UK.
authors.forename: N C A
authors.initials: NC
authors.lastname: Hanchard
authors.affiliation: York Trials Unit, Lower Ground Floor, ARRC Building, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.
authors.forename: L
authors.initials: L
authors.lastname: Jefferson
authors.affiliation: York Trials Unit, Lower Ground Floor, ARRC Building, Department of Health Sciences, University of York, Heslington, York YO10 5DD, UK.
authors.forename: A
authors.initials: A
authors.lastname: Keding
authors.affiliation: James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Road, Middlesbrough TS4 3BW, UK.
authors.forename: A
authors.initials: A
authors.lastname: Rangan
keywords: Surgery; Rehabilitation; Pragmatic randomised controlled trials; Shoulder fracture; Research design