Designing a placebo device: involving service users in clinical trial design
Designing a placebo device: involving service users in clinical trial design
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 wear- ability 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.
Gooberman Hill, Rachael
7464450e-287b-4f00-bc64-21a3fcba88a6
Jinks, Claire
42e74784-76fa-4d77-956a-ad6269ad535e
Barbosa Boucas, Sofia
7503352f-ee90-403a-9275-62c43899d954
Hislop, Kelly
4489bd0e-403e-4636-baf9-606762504ce4
Dziedzic, Krysia
b2fe3d66-6300-4bb8-8a9f-e895fa102603
Rhodes, Carol
1c1db2e0-9e30-48eb-98d4-5becf9511671
Burston, Amanda
84d2b18e-97ef-4cf4-87f1-0d4112c23bfa
Adams, Jo
6e38b8bb-9467-4585-86e4-14062b02bcba
Gooberman Hill, Rachael
7464450e-287b-4f00-bc64-21a3fcba88a6
Jinks, Claire
42e74784-76fa-4d77-956a-ad6269ad535e
Barbosa Boucas, Sofia
7503352f-ee90-403a-9275-62c43899d954
Hislop, Kelly
4489bd0e-403e-4636-baf9-606762504ce4
Dziedzic, Krysia
b2fe3d66-6300-4bb8-8a9f-e895fa102603
Rhodes, Carol
1c1db2e0-9e30-48eb-98d4-5becf9511671
Burston, Amanda
84d2b18e-97ef-4cf4-87f1-0d4112c23bfa
Adams, Jo
6e38b8bb-9467-4585-86e4-14062b02bcba
Gooberman Hill, Rachael, Jinks, Claire, Barbosa Boucas, Sofia, Hislop, Kelly, Dziedzic, Krysia, Rhodes, Carol, Burston, Amanda and Adams, Jo
(2013)
Designing a placebo device: involving service users in clinical trial design.
Health Expectations.
(doi:10.1111/hex.12043).
(In Press)
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.
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 wear- ability 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.
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Accepted/In Press date: 14 January 2013
Organisations:
Physical & Rehabilitation Health
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Local EPrints ID: 347421
URI: http://eprints.soton.ac.uk/id/eprint/347421
ISSN: 1369-6513
PURE UUID: 37c10692-52d3-4b44-ade6-16003e91b9db
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Date deposited: 22 Jan 2013 12:57
Last modified: 15 Mar 2024 02:49
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Contributors
Author:
Rachael Gooberman Hill
Author:
Claire Jinks
Author:
Sofia Barbosa Boucas
Author:
Kelly Hislop
Author:
Krysia Dziedzic
Author:
Carol Rhodes
Author:
Amanda Burston
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