Methodologic issues in clinical trials for prevention or risk reduction in osteoarthritis.
Publication/Presentation Date
5-1-2011
Abstract
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 co-morbidities, 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.
Volume
19
Issue
5
First Page
500
Last Page
508
ISSN
1522-9653
Published In/Presented At
Jordan, J. M., Sowers, M. F., Messier, S. P., Bradley, J., Arangio, G., Katz, J. N., Losina, E., Rovati, L., Bachtell, N., Cooper, C., Spector, T., Zhang, W., Gardiner, J., & Wahba, M. (2011). Methodologic issues in clinical trials for prevention or risk reduction in osteoarthritis. Osteoarthritis and cartilage, 19(5), 500–508. https://doi.org/10.1016/j.joca.2010.10.031
Disciplines
Medicine and Health Sciences
PubMedID
21396470
Department(s)
Department of Surgery
Document Type
Article