Designing a placebo device: involving service users in clinical trial design
Article first published online: 14 JAN 2013
© 2013 John Wiley & Sons Ltd
Volume 16, Issue 4, pages e100–e110, December 2013
How to Cite
Gooberman-Hill, R., Jinks, C., Bouças, S. B., Hislop, K., Dziedzic, K. S., Rhodes, C., Burston, A. and Adams, J. (2013), Designing a placebo device: involving service users in clinical trial design. Health Expectations, 16: e100–e110. doi: 10.1111/hex.12043
- Issue published online: 18 NOV 2013
- Article first published online: 14 JAN 2013
- Manuscript Accepted: 10 DEC 2012
- Arthritis Research UK. Grant Number: 19400
- device design;
- service user involvement;
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.
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.
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.