title: Designing a placebo device: involving service users in clinical trial design.
abstract: BACKGROUND
  Service users are increasingly involved in the design of clinical trials and in product and device development. Service user involvement in placebo development is crucial to a credible and acceptable placebo for clinical trials, but such involvement has not yet been reported.
  
  
  OBJECTIVE
  To enhance the design of a future clinical trial of hand splints for thumb-base osteoarthritis (OA), service users were involved in splint selection and design of a placebo splint. This article describes and reflects on this process.
  
  
  METHODS
  Two fora of service users were convened in 2011. Service users who had been prescribed a thumb splint for thumb-base OA were approached about involvement by Occupational Therapy (OT) practitioners.
  A total of eight service users took part in the fora. Service users discussed their experience of OA and their own splints and then tried a variety of alternative splints. Through this they identified the active features of splints alongside acceptable and unacceptable design features. Service users focused on wearability and support with or without immobilization. Fora discussed whether a placebo group ('arm') was an acceptable feature of a future trial, and service users developed a potential design for a placebo splint.
  
  
  CONCLUSIONS
  This is the first project that to involve service users in placebo design. Service users are increasingly involved in product and device design and are ideally placed to identify features to make a placebo credible yet lacking key active ingredients. The future trial will include research into its acceptability.
authors: Musculoskeletal Research Unit, School of Clinical Sciences, Southmead Hospital, University of Bristol, Bristol, UK.
authors: Rachael
authors: R
authors: Gooberman-Hill
authors: Clare
authors: C
authors: Jinks
authors: Sofia Barbosa
authors: SB
authors: Bouças
authors: Kelly
authors: K
authors: Hislop
authors: Krysia S
authors: KS
authors: Dziedzic
authors: Carol
authors: C
authors: Rhodes
authors: Amanda
authors: A
authors: Burston
authors: Jo
authors: J
authors: Adams
mesh_terms: D000368:Aged; D004867:Equipment Design / Q000379:methods*; D005260:Female; D006225:Hand; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000628:therapy*; D010358:Patient Participation / Q000379:methods*; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000295:instrumentation* / Q000379:methods; D013165:Splints; D013933:Thumb
chemical_list: D010919:Placebos
keywords: device design; hand; osteoarthritis; placebo; service user involvement; splint