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| The impact of adherence on sports injury prevention effect estimates in randomised controlled trials: looking beyond the CONSORT statement [with consumer summary] |
| Verhagen EALM, Hupperets MDW, Finch CF, van Mechelen W |
| Journal of Science and Medicine in Sport 2011 Jul;14(4):287-292 |
| clinical trial |
| 4/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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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 to 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 to 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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