Adherence to Published Standards of Reporting

CONTEXT: Although standards of reporting randomized controlled trials are well established internationally, essential study elements continue to be omitted, which hampers interpretation and systematic review of randomized controlled trials. OBJECTIVE: To identify deficiencies in the quality of reporting of placebo-controlled randomized trials published in German or English. DESIGN: Observational study comparing 32 German- and 89 English-language reports of placebo-controlled trials with parallel design, published by the same group of authors between 1985 and 1994. MAIN OUTCOME MEASURE: High reporting quality, defined as adherence to published standards and measured by an 18-item scale based on 2 standard guidelines. RESULTS: The mean quality score was 8.4 (SD, 3.0; range, 1-16) of 18. The difference of the mean quality scores between English-language reports compared with German-language reports was small (0.27; 95% confidence interval, -0.97 to 1.52). More articles reported clinical aspects than trial methods or statistics. CONCLUSION: There is room for improvement in the reporting of placebo-controlled randomized trials for both English and German reports.