The problem with the existing reporting standards for adverse event and medical error research.

Abstract

The Enhancing the Quality and Transparency of Health Research (EQUATOR) Network indexes over 600 reporting guidelines designed to improve the reproducibility of manuscripts across medical fields and study designs. Although several such reporting guidelines touch on adverse events that may occur in the context of a study, there is a large body of research whose primary focus is on adverse events, near-misses and medical errors that do not currently have a dedicated reporting guideline to help set reporting standards and facilitate comparisons across studies. As part of the process prescribed by EQUATOR for developing such a reporting guideline, we performed a needs assessment, evaluating whether existing standards address key features of a proposed reporting guideline in development, entitled Standard Elements in Studies of Adverse Events and Medical Error (SESAME). We evaluated 12 EQUATOR reporting guidelines for the presence of eight key features of SESAME. Five of the 12 failed to include any of these key features. None of the remaining seven incorporated more than four of the eight SESAME key components, confirming the need for a dedicated reporting guideline for studies of adverse events and medical errors.