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Adherence to published standards of reporting: a comparison of placebo-controlled trials published in English or
1Department of Social and Preventive Medicine, University of Berne, Switzerland. junker@ispm.unibe.ch
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.