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Methodologic issues in clinical trials for prevention or risk reduction in Osteoarthritis

Record type: Article

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.

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Citation

Jordan, J.M., Sowers, M.F., Messier, S.P., Bradley, J., Arangio, G., Katz, J.N., Losina, E., Rovati, L., Batchell, N., Cooper, C., Spector, T., Zhang, W., Gardiner, J. and Wahba, M. (2011) Methodologic issues in clinical trials for prevention or risk reduction in Osteoarthritis Osteoarthritis and Cartilage, 19, (5), pp. 500-508. (doi:10.1016/j.joca.2010.10.031). (PMID:21396470).

More information

Published date: May 2011
Keywords: prevention, clinical trial, obesity, injury, osteoarthritis

Identifiers

Local EPrints ID: 187991
URI: http://eprints.soton.ac.uk/id/eprint/187991
ISSN: 1063-4584
PURE UUID: 17831a92-168c-43da-90c6-c03fb492cb1f

Catalogue record

Date deposited: 19 May 2011 12:43
Last modified: 18 Jul 2017 11:43

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Contributors

Author: J.M. Jordan
Author: M.F. Sowers
Author: S.P. Messier
Author: J. Bradley
Author: G. Arangio
Author: J.N. Katz
Author: E. Losina
Author: L. Rovati
Author: N. Batchell
Author: C. Cooper
Author: T. Spector
Author: W. Zhang
Author: J. Gardiner
Author: M. Wahba

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