Document Detail


Designing a placebo device: involving service users in clinical trial design.
MedLine Citation:
PMID:  23311756     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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. AIMS: 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. DESIGN: 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. CONTENT OF THE FORA: 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. CONCLUSION AND DISCUSSION: 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:
Rachael Gooberman-Hill; Clare Jinks; Sofia Barbosa Boucsas; Kelly Hislop; Krysia S Dziedzic; Carol Rhodes; Amanda Burston; Jo Adams
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-14
Journal Detail:
Title:  Health expectations : an international journal of public participation in health care and health policy     Volume:  -     ISSN:  1369-7625     ISO Abbreviation:  Health Expect     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9815926     Medline TA:  Health Expect     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2013 Blackwell Publishing Ltd.
Affiliation:
Musculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Southmead Hospital, Bristol, UK.
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