Designing a placebo device: involving service users in clinical trial design. (14th January 2013)

• Record Type: Journal Article
• Authors: Gooberman‐Hill, Rachael; Jinks, Clare; Bouças, Sofia Barbosa; Hislop, Kelly; Dziedzic, Krysia S.; Rhodes, Carol; Burston, Amanda; Adams, Jo
• Is Part Of: Health expectations. Volume 16:Number 4(2013:Dec.)
• Page Start: e100
• Page End: e110
• Publication Date: 2013-01-14
• Subjects: Medical policy -- Periodicals; Public health -- Periodicals; Health planning -- Periodicals; 362.105
• DOI: 10.1111/hex.12043
• Languages: English
• ISSNs: 1369-6513

Abstract

<abstract abstract-type="main" xml:lang="en" id="hex12043-abs-0001"> <title>Abstract</title> <sec id="hex12043-sec-0001" sec-type="section"> <title>Background</title> <p>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.</p> </sec> <sec id="hex12043-sec-0002" sec-type="section"> <title>Aims</title> <p>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.</p> </sec> <sec id="hex12043-sec-0003" sec-type="section"> <title>Design</title> <p>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.</p> </sec> <sec id="hex12043-sec-0004" sec-type="section"> <title>Content of the fora</title> <p>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.</p> </sec> <sec id="hex12043-sec-0005" sec-type="section"> <title>Conclusion and discussion</title> <p>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.</p> </sec> </abstract>