ABSTRACT
A clinical trial cannot be adequately interpreted without information about the methods used in the design of the study and the analysis of the results. To determine the frequency of reporting what we consider 11 important aspects of design and analysis, we surveyed all 67 clinical trials published in the New England Journal of Medicine, the Lancet, and the British Medical Journal from July through December 1979 and in the Journal of the American Medical Association from July 1979 through June 1980. Of the 11 items in the 67 trials published in all four journals, 56 percent were clearly reported, 10 percent were ambiguously mentioned, and 34 percent were not reported at all.
At least 80 percent of the 67 trials reported information about statistical analyses, statistical methods used, and random allocation of subjects, yet only 19 percent reported the method of randomization. Loss to follow-up was discussed in 79 percent of the articles, treatment complications in 64 percent, and admission of subjects before allocation in 57 percent, but eligibility criteria for admission to the trial appeared in only 37 percent. Although information about whether patients were blind to treatment was given in 55 percent, information about whether there was blind assessment of outcome was reported in only 30 percent. The statistical power of the trial to detect treatment effects was discussed in only 12 percent of the articles.
The clinical trials published in the New England Journal of Medicine reported 71 percent of the 11 items, those in the Journal of the American Medical Association 63 percent, those in the British Medical Journal 52 percent, and those in the Lancet 46 percent These rates are significantly different (P<0.001). We recommend that editors improve the reporting of clinical trials by giving authors a list of the important items to be reported.
