Impact of quality items on study outcome. Treatment in acute lateral ankle sprains.

Objective: This study investigates the influence of different aspects of methodologic quality on the conclusions of a systematic review concerning treatments of acute lateral ankle sprain. Method: A data set of a systematic review of 44 trials was used, of which 22 trials could be included in this study. Quality assessment of the individual studies was performed using the Delphi list. We calculated effect sizes of the main outcome measure in each study in order to evaluate the relationship between overall quality scores and outcome. Next, we investigated the impact of design attributes on pooled effect sizes by subgroup analysis. Results: The quality of most studies (82%) was low; only 4 of 22 trials were of high quality. Studies with proper randomization and blinding procedure produce a slightly higher (not statistically significant) effect estimate compared to the other studies. Conclusion: Previous research has suggested that methodologically poorly designed studies tend to over-estimate the effect estimate. Our study does not confirm these conclusions