David T Felson1, Anthony C Redmond2, Graham J Chapman2, Toby O Smith3, David F Hamilton4, Richard K Jones5, Cathy A Holt6, Michael J Callaghan7, Deborah J Mason8, Philip G Conaghan2. 1. Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester, UK, Clinical Epidemiology Unit, School of Medicine, Boston University, Boston, USA, david.felson@manchester.ac.uk. 2. Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds NIHR Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds. 3. School of Health Sciences, University of East Anglia, Norwich. 4. School of Clinical Sciences, University of Edinburgh, Edinburgh. 5. School of Health Sciences, University of Salford, Lancashire. 6. School of Engineering, Cardiff University and Arthritis Research UK Biomechanics and Bioengineering Centre and. 7. Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester, UK. 8. Cardiff School of Biosciences, Cardiff University, Cardiff, UK.
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.
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.
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