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The problem with…
The problem with the existing reporting standards for adverse event and medical error research
  1. Christopher R Carpenter1,
  2. Richard T Griffey2,
  3. Anne W S Rutjes3,4,
  4. Maria Unbeck5,6,
  5. Lee M Adler7,
  6. David C Stockwell8,
  7. David Classen9,10
  8. SESAME Statement Development Team
    1. 1 Department of Emergency Medicine, Mayo Clinic, Rochester, New York, USA
    2. 2 Department of Emergency Medicine, Washington University School of Medicine, St. Louis, Missouri, USA
    3. 3 Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy
    4. 4 Departmental Faculty of Medicine, UniCamillus-Saint Camillus International University of Health and Medical Sciences, Rome, Italy
    5. 5 School of Health and Welfare, Dalarna University, Falun, Sweden
    6. 6 Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden
    7. 7 Office of Clinical Effectiveness, Safety and Innovation AdventHealth, Orlando, Florida, USA
    8. 8 Anesthesiology and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland, USA
    9. 9 School of Medicine, University of Utah, Salt Lake City, Utah, USA
    10. 10 PascalMetrics, Washington, DC, USA
    1. Correspondence to Dr Christopher R Carpenter; carpenter.christopher@mayo.edu

    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.

    • Health services research
    • Chart review methodologies
    • Outcome Assessment, Health Care
    • Patient Safety
    • Adverse events, epidemiology and detection

    https://doi.org/10.1136/bmjqs-2024-017491

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      Footnotes

      • X @SAEMEBM

      • Correction notice This article has been corrected since it was first published online. The details of the SESAME Statement Development Team have been updated.

      • Collaborators SESAME Statement Development Team: Rachel Ancona (Washington University); Andrew Auerbach (University of California, San Francisco); David Bates (Harvard Medical School); Benjamin Brooke (University of Utah); Andrew Carson-Stevens (Cardiff University, UK); Ruth Ann Dorrill (HMS Office of the Inspector General); Tejal Gandhi (Press Ganey); Peter Hibbert (Macquarie University, Australia); Dorthe Klein (Maastricht University Medical Centre+, The Netherlands); Edmund SH Kwok (University of Otttawa, Canada); Patricia McGaffigan (Institute for Healthcare Improvement); Kenneth A Michaelson (Ann & Robert Lurie Children’s Hospital); M Hassan Murad (Mayo Clinic); Sarah Musy (University of Basel, Switzerland); Maria Panagioti (University of Manchester, UK); Lucy Schulson (Boston University); Ryan Schneider (Washington University); Rene Schwendimann (University of Basel, Switzerland); Sue Sheridan (Patients for Patient Safety); Michael Simon (University of Basel, Switzerland); Hardeep Singh (Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine); Eric J Thomas (McGovern Medical School at the University of Texas Health Science Center Houston); A G Winterstein (University of Florda).

      • Contributors CRC is the guarantor. CRC and RG conceived and designed the study. CRC acquired and analysed the data. CRC, RG, AR, MU, LMA, DCS and DC interpreted the data. CRC drafted the manuscript. CRC, RG, AR, MU, LMA, DCS and DC critically revised the manuscript for important intellectual content. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

      • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

      • 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.

      • Provenance and peer review Not commissioned; externally peer-reviewed.