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Identifying placebo responders and predictors of response in osteoarthritis: a protocol for individual patient data meta-analysis

Fu, Yu; Persson, Monica S.M.; Bhattacharya, Archan; Goh, Siew-Li; Stocks, Joanne; van Middelkoop, Marienke; Bierma-Zeinstra, Sita M.A.; Walsh, David; Doherty, Michael; Zhang, Weiya

Authors

Yu Fu

Monica S.M. Persson

Archan Bhattacharya

Siew-Li Goh

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Dr JOANNE STOCKS JOANNE.STOCKS@NOTTINGHAM.AC.UK
Assistant Professor in Sports Andexercise Medicine

Marienke van Middelkoop

Sita M.A. Bierma-Zeinstra

DAVID WALSH david.walsh@nottingham.ac.uk
Professor of Rheumatology

Michael Doherty



Abstract

Background: The management of osteoarthritis (OA) is unsatisfactory, as most treatments are not clinically effective over placebo and most drugs have considerable side effects. On average, 75 % of the analgesic effect from OA treatments in clinical trials can be attributed to a placebo response, and this response varies greatly from patient to patient. This individual patient data (IPD) meta-analysis aims to identify placebo responders and the potential determinants of the placebo response in OA.
Methods: This study is undertaken in conjunction with the OA Trial Bank, an ongoing international consortium aiming to collect IPD from randomised controlled trials (RCTs) for all treatments of OA. RCTs for each treatment of OA have been systematically searched for, and authors of the relevant trials have been contacted to request the IPD. We will use the IPD of placebo-controlled RCTs held by the OA Trial Bank for this project. The IPD in placebo groups will be used to investigate the placebo response according to the minimum clinically important difference (MCID) threshold (e.g. 20 % pain reduction). Responders to placebo will be compared with non-responders to identify predictors of response. The quality of the trials will be assessed and potential determinants will be examined using multilevel logistic regression analyses.
Discussion: This study explores the varying magnitude of the placebo response and the proportion of participants that experience a clinically important placebo effect in OA RCTs. Potential determinants of the placebo response will also be investigated. These determinants may be useful for future studies as it may allow participants to be stratified into groups based on their likely response to placebo. The results of this study may also be useful for pharmaceutical companies, who could improve the design of their studies in order to separate the specific treatment from the non-specific contextual (i.e. placebo) effects.

Citation

Fu, Y., Persson, M. S., Bhattacharya, A., Goh, S., Stocks, J., van Middelkoop, M., …Zhang, W. (2016). Identifying placebo responders and predictors of response in osteoarthritis: a protocol for individual patient data meta-analysis. Systematic Reviews, 5(1), https://doi.org/10.1186/s13643-016-0362-x

Journal Article Type Article
Acceptance Date Oct 21, 2016
Online Publication Date Oct 28, 2016
Publication Date Oct 28, 2016
Deposit Date Jan 18, 2017
Publicly Available Date Jan 18, 2017
Journal Systematic Reviews
Electronic ISSN 2046-4053
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 5
Issue 1
Article Number 183
DOI https://doi.org/10.1186/s13643-016-0362-x
Keywords Osteoarthritis, Placebo response, Individual patient data meta-analysis
Public URL http://eprints.nottingham.ac.uk/id/eprint/39933
Publisher URL http://systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-016-0362-x
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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