Reporting the study populations of clinical trials - Clear transmission orstatic on the line?

In contrast to attempts that have been made to measure the clarity of repor ting of the methods of clinical trials in journal articles, we report here an attempt to measure the accuracy of methods reporting. We focus in this a rticle on eligibility criteria as a test case for the reporting of clinical trial methods. We examined the reporting of eligibility criteria in the pr otocol, methods paper (if applicable), journal article, and Clinical Alert for articles appearing in print between January 1988 and September 1994 for which a Clinical Alert had been issued. Eligibility criteria were further classified into five categories in order to examine the content of informat ion loss, if any. On average, 82% of protocol eligibility criteria were rep orted in methods papers. Journal articles and Clinical Alerts fared somewha t worse: 63% of criteria were reported in journal articles, 19% in Clinical Alerts. In all three categories of medical communication, the reporting of criteria that defined the study disease tended to be complete; reporting o f criteria relating to trial precision, patient safety, legal and ethical c oncerns, and administrative considerations, was not complete. We found that criteria for clinical trial eligibility are frequently under-reported in m edical communications. Moreover, some of the criteria omitted are of consid erable clinical importance. We suggest that in the design phase of clinical trials, proposed eligibility criteria be scrutinized closely. Those criter ia that survive this scrutiny and that have clinical import must be reporte d upon fully and accurately when communicating trial results. (C) 2000 Else vier Science Inc. All rights reserved.