Adherence to published standards of reporting: a comparison of placebo-controlled trials published in English or German.

Abstract

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. To identify deficiencies in the quality of reporting of placebo-controlled randomized trials published in German or English. 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. High reporting quality, defined as adherence to published standards and measured by an 18-item scale based on 2 standard guidelines. 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. There is room for improvement in the reporting of placebo-controlled randomized trials for both English and German reports.