The impact of adherence on sports injury prevention effect estimates in randomised controlled trials: looking beyond the CONSORT statement.

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.