Document Detail


The impact of adherence on sports injury prevention effect estimates in randomised controlled trials: Looking beyond the CONSORT statement.
MedLine Citation:
PMID:  21429793     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Objective: To investigate estimated outcome effects of a sports injury prevention intervention when analysed by means of a per protocol (PP) analysis approach. Design: Randomised controlled trial (RCT) involving 522 athletes who sustained a lateral ankle sprain allocated to either an intervention (received a preventive programme in addition to usual care) or control group who were followed prospectively for one year. Methods: Secondary analysis of data relating to registered ankle sprain recurrences, exposure and adherence to the allocated intervention using a PP analysis approach. Results: Twenty-three percent of the RCT intervention group indicated to have fully adhered with the neuromuscular training programme. A per protocol analysis only considering fully adherent athletes and control athletes, showed a Hazard Ratio of 0.18 (95% CI: 0.07-0.43). Significantly fewer recurrent ankle sprains were found in the fully adherent group compared to the group that was not adherent (relative risk=0.63; 95% CI: 0.43-0.99). Conclusions: A PP analysis on fully adherent athletes versus control group athletes showed that the established intervention effect was over threefold higher compared to an earlier intention-to-treat based analysis approach. This shows that outcomes of intervention studies are heavily biased by adherence to the allocated intervention.
Authors:
Evert A L M Verhagen; Maarten D W Hupperets; Caroline F Finch; Willem van Mechelen
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-3-21
Journal Detail:
Title:  Journal of science and medicine in sport / Sports Medicine Australia     Volume:  -     ISSN:  1878-1861     ISO Abbreviation:  -     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-3-24     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9812598     Medline TA:  J Sci Med Sport     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.
Affiliation:
Department of Public and Occupational Health, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands.
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