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

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

prevention, clinical trial, obesity, injury, osteoarthritis
1063-4584
500-508
Jordan, J.M.
e6208733-af45-48af-949a-660e9d32db42
Sowers, M.F.
ac9e306e-0247-4626-8086-924e67024266
Messier, S.P.
5527f2a1-f64a-4c4c-9ae7-823bea2d367d
Bradley, J.
7abc0060-2a06-425b-824b-1612430e7049
Arangio, G.
5aec5bfc-e2ea-46cc-b715-81509a458e29
Katz, J.N.
1ba163a2-8fb9-4ae1-b560-f4b36b8ac2de
Losina, E.
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Rovati, L.
0beee2d0-acd4-4e4c-b6d0-9b4fc0639d5c
Batchell, N.
825febfa-90ad-42e9-8889-50a4bc053ce0
Cooper, C.
e05f5612-b493-4273-9b71-9e0ce32bdad6
Spector, T.
1fd13fc5-08aa-44c9-b920-c41e925e79d6
Zhang, W.
1c80d4f2-4ba8-41f6-85a6-a76a4d65dc9b
Gardiner, J.
cc34d117-0d33-45cc-b502-40aea9c6027e
Wahba, M.
cc0c0a7c-1dda-47a0-abb1-97ce0485efe6
Jordan, J.M.
e6208733-af45-48af-949a-660e9d32db42
Sowers, M.F.
ac9e306e-0247-4626-8086-924e67024266
Messier, S.P.
5527f2a1-f64a-4c4c-9ae7-823bea2d367d
Bradley, J.
7abc0060-2a06-425b-824b-1612430e7049
Arangio, G.
5aec5bfc-e2ea-46cc-b715-81509a458e29
Katz, J.N.
1ba163a2-8fb9-4ae1-b560-f4b36b8ac2de
Losina, E.
9e979600-32a8-4577-a763-c671ccf40045
Rovati, L.
0beee2d0-acd4-4e4c-b6d0-9b4fc0639d5c
Batchell, N.
825febfa-90ad-42e9-8889-50a4bc053ce0
Cooper, C.
e05f5612-b493-4273-9b71-9e0ce32bdad6
Spector, T.
1fd13fc5-08aa-44c9-b920-c41e925e79d6
Zhang, W.
1c80d4f2-4ba8-41f6-85a6-a76a4d65dc9b
Gardiner, J.
cc34d117-0d33-45cc-b502-40aea9c6027e
Wahba, M.
cc0c0a7c-1dda-47a0-abb1-97ce0485efe6

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), 500-508. (doi:10.1016/j.joca.2010.10.031). (PMID:21396470)

Record type: Article

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.

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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
ORCID for C. Cooper: ORCID iD orcid.org/0000-0003-3510-0709

Catalogue record

Date deposited: 19 May 2011 12:43
Last modified: 18 Mar 2024 02:45

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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 ORCID iD
Author: T. Spector
Author: W. Zhang
Author: J. Gardiner
Author: M. Wahba

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