New policy on reports of randomized clinical trials.

Abstract

An important goal of the Annals of Behavioral Medicine (ABM) is to publish the most credible and objective evaluations of behavioral interventions. Unfortunately, some excellent behavioral studies have been discounted by reviewers because the research was not reported in sufficient detail for evaluation by researchers and practitioners. The Consolidated Standards of Reporting Trials (CONSORT; www.consort-statement.org) is a checklist that was designed by medical researchers to facilitate the reporting and review of clinical trials (1). As noted in a previous editorial (2), many medical journals (e.g., Journal of the American Medical Association, New England Journal of Medicine, and the Annals of Internal Medicine) have already adopted this checklist, requiring that authors and reviewers attend to uniform standards for reporting and reviewing clinical trials. ABM has joined these other journals in endorsing CONSORT. Reports of clinical trials submitted to ABM are distributed to reviewers with the CONSORT checklist for detailed evaluation. In 2001, the Society of Behavioral Medicine established an Evidence-Based Behavioral Medicine (EBBM) Committee. One of the first tasks of the committee was to highlight this checklist through brief example (3) and through detailed explication. The committee statement was published in Volume 26, Issue 3 of the Annals. The article includes the modified CONSORT checklist itself (see p. 163), an explanation of the application of these checklist items to behavioral medicine trials, and recommendations for additional behavioral medicine-specific items. It is expected that such tools will help guide our efforts to create a sturdy evidence base for subsequent evidence-based behavioral medicine review. Authors of randomized clinical trials submitted to ABM should review the article by the Evidence-Based Behavioral Medicine Committee (4). The CONSORT guidelines can help guide authors through the manuscript development process. The checklist (page 163) informs authors of the components that evidence-based reviewers will be looking for. All articles should include a figure that describes the flow of participants through each stage of their research. This helps the reader understand the number of participants that were randomly assigned, the number that received the intended treatment, the number completing the study protocol, and the number analyzed. The figure is given on page 167 of the committee article. We recognize that developing a manuscript using these guidelines will be extra work for some authors. However, we believe that enforcement of these guidelines will significantly improve the quality of reports on behavioral interventions. Ultimately, the credibility of our fields depends on the scientific rigor of our research. Systematic detailed reporting will improve communication and advance the field.