title: Recommendations for the conduct of efficacy trials of treatment devices for osteoarthritis: a report from a working group of the Arthritis Research UK Osteoarthritis and Crystal Diseases Clinical Studies Group.
abstract: OBJECTIVE
  There are unique challenges to designing and carrying out high-quality trials testing therapeutic devices in OA and other rheumatic diseases. Such challenges include determining the mechanisms of action of the device and the appropriate sham. Design of device trials is more challenging than that of placebo-controlled drug trials. Our aim was to develop recommendations for designing device trials.
  
  
  METHODS
  An Arthritis Research UK study group comprised of 30 rheumatologists, physiotherapists, podiatrists, engineers, orthopaedists, trialists and patients, including many who have carried out device trials, met and (using a Delphi-styled approach) came to consensus on recommendations for device trials.
  
  
  RESULTS
  Challenges unique to device trials include defining the mechanism of action of the device and, therefore, the appropriate sham that provides a placebo effect without duplicating the action of the active device. Should there be no clear-cut mechanism of action, a three-arm trial including a no-treatment arm and one with presumed sham action was recommended. For individualized devices, generalizable indications and standardization of the devices are needed so that treatments can be generalized.
  
  
  CONCLUSIONS
  A consensus set of recommendations for device trials was developed, providing a basis for improved trial design, and hopefully improvement in the number of effective therapeutic devices for rheumatic diseases.
authors.affiliation: Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester, UK, Clinical Epidemiology Unit, School of Medicine, Boston University, Boston, USA, david.felson@manchester.ac.uk.
authors.forename: David T
authors.initials: DT
authors.lastname: Felson
authors.affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds NIHR Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds.
authors.forename: Anthony C
authors.initials: AC
authors.lastname: Redmond
authors.affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds NIHR Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds.
authors.forename: Graham J
authors.initials: GJ
authors.lastname: Chapman
authors.affiliation: School of Health Sciences, University of East Anglia, Norwich.
authors.forename: Toby O
authors.initials: TO
authors.lastname: Smith
authors.affiliation: School of Clinical Sciences, University of Edinburgh, Edinburgh.
authors.forename: David F
authors.initials: DF
authors.lastname: Hamilton
authors.affiliation: School of Health Sciences, University of Salford, Lancashire.
authors.forename: Richard K
authors.initials: RK
authors.lastname: Jones
authors.affiliation: School of Engineering, Cardiff University and Arthritis Research UK Biomechanics and Bioengineering Centre and.
authors.forename: Cathy A
authors.initials: CA
authors.lastname: Holt
authors.affiliation: Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester, UK.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Callaghan
authors.affiliation: Cardiff School of Biosciences, Cardiff University, Cardiff, UK.
authors.forename: Deborah J
authors.initials: DJ
authors.lastname: Mason
authors.affiliation: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds NIHR Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds.
authors.forename: Philip G
authors.initials: PG
authors.lastname: Conaghan
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D032921:Consensus; D006801:Humans; D019637:Orthopedic Procedures / Q000379:methods / Q000592:standards*; D020370:Osteoarthritis, Knee / Q000628:therapy*; D006113:United Kingdom
keywords: brace; clinical trials; devices; efficacy; orthoses; osteoarthritis; recommendations