Methods: An Arthritis Research UK study group comprised of 30 persons including rheumatologists, physiotherapists, podiatrists, engineers, orthopedists, 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 which 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 individualised devices, generalisable indications and standardisation of the devices are needed so that treatments can be generalised.
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.
- clinical trials