- Title
- The impact of adherence on sports injury prevention effect estimates in randomised controlled trials : Looking beyond the CONSORT statement
- Creator
- Verhagen, Evert; Huuperans, Maarten; Finch, Caroline; van Mechelen, Willem
- Date
- 2011
- Type
- Text; Journal article
- Identifier
- http://researchonline.federation.edu.au/vital/access/HandleResolver/1959.17/56088
- Identifier
- vital:5472
- Identifier
-
https://doi.org/10.1016/j.jsams.2011.02.007
- Identifier
- ISSN:1440-2440
- Abstract
- 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.
- Relation
- Journal of Science and Medicine in Sport Vol. 14, no. 4 (July 2011 2011), p. 287-292; http://purl.org/au-research/grants/nhmrc/565900
- Rights
- © Copyright Agency Limited
- Rights
- This metadata is freely available under a CCO license
- Subject
- CONSORT statement; RCT; Injury prevention; Adherence; 1106 Human Movement and Sports Science; 1117 Public Health and Health Services
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