Abstract
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. 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. 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. 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.
Highlights
From hand splints to knee braces to surgical implants, devices are an important element in the clinical management of osteoarthritis (OA) and of other rheumatic diseases [1,2,3]
We focus on devices intended to treat or prevent OA but given the interest in devices as treatments for localised joint problems in other rheumatic diseases [5], our recommendations have relevance for device testing in rheumatic diseases in general
The findings of this review were presented to the Arthritis Research UK Osteoarthritis and Crystals Disorders Clinical Study Group in January 2014. This group consisted of 30 people including rheumatologists, physiotherapists, podiatrists, engineers, orthopaedists, trialists and patient representatives who have a particular interest in osteoarthritis, many who have carried out device trials
Summary
From hand splints to knee braces to surgical implants, devices are an important element in the clinical management of osteoarthritis (OA) and of other rheumatic diseases [1,2,3]. No guidelines have been presented on the optimal design and conduct of device trials, literature has recurrently highlighted the challenges faced when developing and undertaking these trials [10,11,12]. Such challenges have included: the determination of a sham or placebo comparator, standardisation of dose of the experimental intervention through participant adherence, controlling confounding variables such as activity levels and footwear or clothing which may confound outcomes [1013]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
