The impact of adherence on sports injury prevention effect estimates in randomised controlled trials : looking beyond the CONSORT statement
Deutscher übersetzter Titel: | Die Auswirkungen des Einbezugs von Schätzungen des Präventionseffekts bei Sportverletzungen in randomisierten kontrollierten Studien : Ausblick über die CONSORT-Stellungnahme |
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Autor: | Verhagen, Evert A.L.M.; Hupperets, Maarten D.W.; Finch, Caroline F.; Mechelen, Willem van |
Erschienen in: | Journal of science and medicine in sport |
Veröffentlicht: | 14 (2011), 4, S. 287-292, Lit. |
Format: | Literatur (SPOLIT) |
Publikationstyp: | Zeitschriftenartikel |
Medienart: | Gedruckte Ressource |
Sprache: | Englisch |
ISSN: | 1440-2440, 1878-1861 |
DOI: | 10.1016/j.jsams.2011.02.007 |
Schlagworte: | |
Online Zugang: | |
Erfassungsnummer: | PU201110008605 |
Quelle: | BISp |
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. Verf.-Referat