Recommendations for the conduct of efficacy trials of treatment devices for osteoarthritis : a report from a working group of the Arthritis Research UK Osteoarthritis and Crystal Diseases Clinical Studies Group

Felson, DT, Redmond, AC, Chapman, GJ, Smith, T, Hamilton, DF, Jones, R ORCID: https://orcid.org/0000-0001-5242-185X, Holt, CA, Callaghan, MJ, Mason, DJ and Conaghan, PG 2016, 'Recommendations for the conduct of efficacy trials of treatment devices for osteoarthritis : a report from a working group of the Arthritis Research UK Osteoarthritis and Crystal Diseases Clinical Studies Group' , Rheumatology, 55 (2) , pp. 320-326.

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Abstract

Objective. There are unique challenges to designing and carrying out high-quality trials testing therapeutic devices in OA and other rheumatic diseases. Such challenges include determining the mechanisms of action of the device and the appropriate sham. Design of device trials is more challenging than that of placebo-controlled drug trials. Our aim was to develop recommendations for designing device trials. Methods. An Arthritis Research UK study group comprised of 30 rheumatologists, physiotherapists, podiatrists, engineers, orthopaedists, trialists and patients, including many who have carried out device trials, met and (using a Delphi-styled approach) came to consensus on recommendations for device trials. Results. Challenges unique to device trials include defining the mechanism of action of the device and, therefore, the appropriate sham that provides a placebo effect without duplicating the action of the active device. Should there be no clear-cut mechanism of action, a three-arm trial including a no-treatment arm and one with presumed sham action was recommended. For individualized devices, generalizable indications and standardization of the devices are needed so that treatments can be generalized. Conclusion. A consensus set of recommendations for device trials was developed, providing a basis for improved trial design, and hopefully improvement in the number of effective therapeutic devices for rheumatic diseases.

Item Type:	Article
Schools:	Schools > School of Health and Society > Centre for Health Sciences Research
Journal or Publication Title:	Rheumatology
Publisher:	Oxford University Press
ISSN:	1462-0324
Related URLs:	Publication
Funders:	Arthritis Research UK
Depositing User:	Prof Richard Jones
Date Deposited:	22 Oct 2015 15:56
Last Modified:	06 Nov 2019 11:30
URI:	http://usir.salford.ac.uk/id/eprint/36869

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