Authors of APA journal articles who call a clinical trial a "randomized controlled trial" (RCT) are now required to meet the basic standards and principles outlined in the Consolidated Standards of Reporting Trials (CONSORT) guidelines as part of an effort to improve clarity, accuracy and fairness in the reporting of research methodology. The guidelines, developed by a group of scientists and editors in 1996, aim to standardize depictions of RCTs to help researchers, health-care providers, policy-makers and the public clearly interpret and determine the integrity of the study results.
The CONSORT statement, available at www.consort-statement.org, provides guidelines for reporting on the study's findings and includes a 22-item checklist that significantly overlaps with many aspects of existing APA style. In particular, the CONSORT guidelines enhance specification of the initial subject pool, the final study sample and the selection and dropout that occurred from the beginning to the end of the study.
APA's Publications and Communications (P&C) Board adopted the principles of the guidelines in April 2003 for purposes of defining RCTs, joining other leading medical journals and international editorial groups, such as The Lancet and the Journal of the American Medical Association.
The move was important to improve the communication between the scientific researcher and the reader in understanding scientific results, says P&C chair Mark Appelbaum, PhD, a psychology professor and the associate vice chancellor of undergraduate education at the University of California, San Diego.
"Using the CONSORT guidelines, readers will be able to very quickly and in an organized way understand exactly what happened in a randomized clinical trial," Appelbaum says. For example, the guidelines allow readers to analyze the study's sample size and statistical methods.
Most notably, the guidelines help readers judge the reliability and relevance of a study's findings by clearly spelling out the population examined and to which findings are relevant, says Gary R. VandenBos, PhD, APA's executive director of publications and communications. Studies have found CONSORT guidelines help improve readers' RCT interpretation, minimize biased conclusions and guide decision-making about a patient's treatment and national public health policies.
"In many ways, the CONSORT guidelines are a natural outcome of 50 years of psychotherapy research and 25 years of meta-analyses from the available literature around the effectiveness of a host of clinical procedures--in health and mental health," VandenBos says.
In keeping with the movement to improve the reporting of studies in APA journals, the P&C has begun examining the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) guidelines and will be discussing them with the Council of Editors in 2005. The TREND guidelines would be consistent with the CONSORT guidelines in making the study's methodology more clearly stated, but would provide a checklist for the reporting of nonrandomized studies.