Are large clinical trials in orthopaedic trauma justified?

ABSTRACT: BACKGROUND:The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. METHODS:The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study. RESULTS:The pilot study analysis of 89 patients and initial incremental enrolme

SUBMITTER: Sprague S 

PROVIDER: S-EPMC5909275 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature