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  • Title: The impact of adherence on sports injury prevention effect estimates in randomised controlled trials: looking beyond the CONSORT statement.
    Author: Verhagen EA, Hupperets MD, Finch CF, van Mechelen W.
    Journal: J Sci Med Sport; 2011 Jul; 14(4):287-92. PubMed ID: 21429793.
    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.
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