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Problem with the existing reporting standards for adverse event and medical error research
Mayo Clinic, Rochester, New York, USA, US.
Washington University School of Medicine, St. Louis, Missouri, USA, US.
University of Modena and Reggio Emilia, Modena, Italy, IT; UniCamillus-Saint Camillus International University of Health and Medical Sciences, Rome, Italy, IT.
Dalarna University, School of Health and Welfare, Caring Science/Nursing. Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm.ORCID iD: 0000-0002-5090-0352
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2025 (English)In: BMJ Quality and Safety, ISSN 2044-5415, E-ISSN 2044-5423, Vol. 34, no 4, p. 273-278Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2025. Vol. 34, no 4, p. 273-278
Keywords [en]
Adverse events, epidemiology and detection, Chart review methodologies, Health services research, Outcome Assessment, Health Care, Patient Safety
National Category
Clinical Medicine Health Sciences
Identifiers
URN: urn:nbn:se:du-50218DOI: 10.1136/bmjqs-2024-017491ISI: 001500477900009PubMedID: 39933922Scopus ID: 2-s2.0-85218153645OAI: oai:DiVA.org:du-50218DiVA, id: diva2:1939102
Available from: 2025-02-20 Created: 2025-02-20 Last updated: 2025-10-09Bibliographically approved

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Unbeck, Maria

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