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

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 neuromuscu..