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Reporting Standards and the Transparency of Trials
“Nobody sets out to write a bad paper,” said Curtis L. Meinert, PhD, professor of epidemiology and biostatistics at the Johns Hopkins School of Hygiene and Public Health in Baltimore. Yet far too many reports of clinical trials have lacked so much vital information that they are virtually unusable as guides for treating patients or planning policy. “There is a lack of detail in published reports that is due partly to authors and partly to editors,” said Meinert.
To bridge the gap between what a trial should report and what is actually published, a small group of researchers, epidemiologists, statisticians (including Meinert), and journal editors have met over the past 7 years to develop the Consolidated Standards of Reporting Trials (CONSORT), a set of guidelines that include a checklist and a model flow diagram, to help biomedical researchers report the results of randomized, controlled clinical trials fully and accurately. The first version of CONSORT appeared in 1996, and a major revision, which was completed in fall 2000, will soon be published. A detailed explanatory article giving the rationale for each item included in the reporting checklist and the empiric evidence that supports the importance of that item will accompany the revised CONSORT statement.
The Need for Uniformity
“I felt for a long time that the medical literature was intimidating—a daunting pile of information which medical practitioners had a hard time using,” commented Edward J. Huth, MD, editor emeritus of Annals. According to Huth, MEDLINE, the familiar on-line bibliographic database of the U.S. National Library of Medicine (NLM), was designed more for researchers than for clinicians. “Practitioners want accurate, reliable, synoptic information—review articles by knowledgeable people,” he stated.
Authors preparing such review articles, however, must draw on the published results of many clinical trials. To avoid comparing apples and oranges, some uniformity in trial …
