Clinical trials in general surgical journals: Are methods better reported?

Background. Reports of clinical trials often lack adequate describtions of their design and analysis. Thus readers cannot properly assess the strength of the findings and are limited in their ability to draw their own conclus ions. A review of 6 surgical journals in 1984 revealed that the frequency o f reporting II basic elements of design and analysis in clinical trials was only 59%. This study attempted to identify areas that still need improveme nt. Methods. Eligible studies published from July 1995 through June 1996 includ ed all reports of comparative clinical trials on human subjects that were p rospective and had at least 2 treatment arms. A total of 68 articles publis hed in 6 general surgery journals were reviewed. The frequency that the pre viously identified II basic elements of design and analysis were reported w as determined. Results. Seventy-four percent of all items were reported accurately (a 15% increase from the previous study), 4% were reported ambiguously, and 23% we re not reported; improvement was seen in every journal. The reporting of el igibility criteria and statistical power improved the most. For 3 items, re porting was still not adequate; 32% of reports provided information about s tatistical power, 40% about the method of randomization, and 49% about whet her the person assessing outcomes was blind to the treatment assignment. Conclusions. Improvements have been made in reporting surgical clinical tri als, but in general methodologic questions poorly answered in the 1980s con tinue to be answered poorly in the 1990s. Editors of surgical journals are urged to provide authors with guidelines on how to report clinical trial de sign and analysis.