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. 2025 Mar 19;34(4):273-278.
doi: 10.1136/bmjqs-2024-017491.

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

Christopher R Carpenter  1 , Richard T Griffey  2 , Anne W S Rutjes  3   4 , Maria Unbeck  5   6 , Lee M Adler  7 , David C Stockwell  8 , David Classen  9   10 ; SESAME Statement Development Team
Collaborators, Affiliations

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

Christopher R Carpenter et al. BMJ Qual Saf. .

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.

Keywords: Adverse events, epidemiology and detection; Chart review methodologies; Health services research; Outcome Assessment, Health Care; Patient Safety.

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Conflict of interest statement

Competing interests: CRC is the Deputy Editor-in-Chief of Academic Emergency Medicine, Associate Editor, Annals of Internal Medicine’s ACP Journal Club, and Associate Editor, Journal of the American Geriatrics Society. CRC serves on the American College of Emergency Physicians Clinical Policy Committee and the American Board of Emergency Medicine, as an MyEMCert Editor. DCS is the Chief Clinical Officer, Emeritus & Chair, Clinical Advisory Council of Pascal Metrics, a federally certified Patient Safety Organization. RTG is supported by grant 1 R01 HS027811-01 from the Agency for Healthcare Research and Quality (AHRQ). The contents of this work are solely the responsibility of the authors and do not necessarily represent the official view of the AHRQ.

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