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
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
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DOI：
10.1093/rheumatology/kev328
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发表时间：
2016-02-01
期刊：
影响因子：
5.5
通讯作者：
Conaghan, Philip G.
中科院分区：
文献类型：
--
作者：
Felson, David T.;Redmond, Anthony C.;Conaghan, Philip G.
客观的。设计和开展测试 OA 和其他风湿性疾病治疗设备的高质量试验面临着独特的挑战。这些挑战包括确定设备的作用机制和适当的假手术。设备试验的设计比安慰剂对照药物试验更具挑战性。我们的目标是为设计设备试验提出建议。方法。英国关节炎研究中心的一个研究小组由 30 名风湿病学家、物理治疗师、足病医生、工程师、骨科医生、试验人员和患者组成，其中包括许多进行过设备试验的人，他们会面并（使用德尔菲式方法）就设备试验的建议达成共识。结果。设备试验所面临的独特挑战包括确定设备的作用机制，以及因此提供适当的假手术，以提供安慰剂效应而不重复活性设备的作用。如果没有明确的作用机制，建议进行三组试验，包括不治疗组和假定假手术组。对于个体化的器械，需要通用化的适应症和器械的标准化，以便治疗能够通用化。结论。制定了一套关于设备试验的共识建议，为改进试验设计提供了基础，并有望增加风湿病有效治疗设备的数量。
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.