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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; Holt, CA; Callaghan, MJ; Mason, DJ; Conaghan, PG

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 Thumbnail


Authors

DT Felson

AC Redmond

GJ Chapman

T Smith

DF Hamilton

CA Holt

MJ Callaghan

DJ Mason

PG Conaghan



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.

Citation

Felson, D., Redmond, A., Chapman, G., Smith, T., Hamilton, D., Jones, R., …Conaghan, P. (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), 320-326. https://doi.org/10.1093/rheumatology/kev328

Journal Article Type Article
Acceptance Date Aug 5, 2015
Online Publication Date Sep 10, 2015
Publication Date Feb 1, 2016
Deposit Date Oct 22, 2015
Publicly Available Date Aug 5, 2016
Journal Rheumatology
Print ISSN 1462-0324
Electronic ISSN 1462-0332
Publisher Oxford University Press
Volume 55
Issue 2
Pages 320-326
DOI https://doi.org/10.1093/rheumatology/kev328
Publisher URL http://dx.doi.org/10.1093/rheumatology/kev328
Related Public URLs http://rheumatology.oxfordjournals.org/

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