Methodologic issues in clinical trials for prevention or risk reduction in osteoarthritis
Methodologic issues in clinical trials for prevention or risk reduction in osteoarthritis
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DOI：
10.1016/j.joca.2010.10.031
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发表时间：
2011-05-01
影响因子：
7
通讯作者：
Wahba, M.
中科院分区：
文献类型：
--
作者：
Jordan, J. M.;Sowers, M. F.;Wahba, M.
OA预防试验的设计和执行存在方法学问题，这些问题与旨在影响流行疾病的试验不同。疾病定义及其精确和敏感的测量，高风险人群的识别，干预的性质（药物，营养品，行为）及其对其他器官系统的潜在多效性影响是至关重要的。由于预防性试验可能会延长，因此密切关注伴随的生活变化和合并症、依从性和参与者在试验中的保留是至关重要的，因为认识到“预防性误解”和“行为去抑制”可能会影响试验显示所研究干预措施效果的能力。这些潜在的陷阱都不会妨碍成功和科学严谨的过程和结果。随着技术改进测量和预测OA过程及其临床后果的手段，将越来越有可能筛选个体的高风险表型，将临床因素与来自成像，遗传，代谢和其他生物标志物的信息相结合，并影响这种高风险状况，以避免或延迟OA结构和病理学。(C)2011年由Elsevier Ltd代表国际骨关节炎研究学会出版。
The design and execution of prevention trials for OA have methodological issues that are distinct from trials designed to impact prevalent disease. Disease definitions and their precise and sensitive measurement, identification of high-risk populations, the nature of the intervention (pharmaceutical, nutraceutical, behavioral) and its potential pleiotropic impacts on other organ systems are critical to consider. Because prevention trials may be prolonged, close attention to concomitant life changes and comorbidities, adherence and participant retention in the trial is of primary importance, as is recognition of the potential for "preventive misconception" and "behavioral disinhibition" to affect the ability of the trial to show an effect of the intervention under study. None of these potential pitfalls precludes a successful and scientifically rigorous process and outcome. As technology improves the means to measure and predict the OA process and its clinical consequences, it will be increasingly possible to screen individuals for high-risk phenotypes, combining clinical factors with information from imaging, genetic, metabolic and other biomarkers and to impact this high-risk condition to avoid or delay OA both structurally and symptomatically. (C) 2011 Published by Elsevier Ltd on behalf of Osteoarthritis Research Society International.