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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

Lookup NU author(s): Professor Fraser Birrell, Dr Elspeth Wise

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Abstract

© The Author 2015.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.

Publication metadata

Author(s): Felson DT, Redmond AC, Chapman GJ, Smith TO, Hamilton DF, Jones RK, Holt CA, Callaghan MJ, Mason DJ, Conaghan PG, Adams J, Arden NK, Birrell F, Cumming J, Corp N, Halstead J, Hurley M, Kingsbury SR, Martin K, Nuki G, O'Neill T, Reilly K, Robinson N, Roddy E, Simpson H, Thomas C, Thomas E, Watt FE, Wilkinson J, Wise E

Publication type: Article

Publication status: Published

Journal: Rheumatology (United Kingdom)

Year: 2015

Volume: 55

Issue: 2

Pages: 320-326

Online publication date: 10/09/2015

Acceptance date: 01/01/1900

ISSN (print): 1462-0324

ISSN (electronic): 1462-0332

Publisher: Oxford University Press

URL: http://doi.org/10.1093/rheumatology/kev328

DOI: 10.1093/rheumatology/kev328

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