Standard Elements in Studies of Adverse Events and Medical Error (SESAME): explanation and elaboration

Studies that evaluate adverse events and medical error often suffer from incomplete and inadequate reporting, which affects the interpretability and reproducibility of their findings. To address this, we developed the 44-item Standard Elements in Studies of Adverse Event or Medical Error (SESAME) checklist using a rigorous process following the recommendations of the Enhancing the QUAlity and Transparency Of health Research Network. The aim of this manuscript is to explain the scope and aim of the checklist by providing a detailed explanation of each item in the SESAME checklist, illustrated by examples from selected studies of adverse events and medical error.

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Publication Details

Journal
Journal of Patient Safety
Published
2026-09-11
DOI
https://doi.org/10.1097/pts.0000000000001584
Primary Topic
Patient Safety and Medication Errors
Type
article
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Standard Elements in Studies of Adverse Events and Medical Error (SESAME): explanation and elaboration

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Journal of Patient Safety
Patient Safety and Medication Errors
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Standard Elements in Studies of Adverse Events and Medical Error (SESAME): explanation and elaboration

Dorthe O. Klein, Ryan M. Schneider, Richard T. Griffey, René Schwendimann, Anne WS Rutjes, Peter Damian Hibbert, David C. Stockwell, Maria Unbeck, Christopher R. Carpenter, Lee Adler, David Classen, Rachel Ancona, Andrew D. Auerbach, The SESAME Development Team
article en

Abstract

Studies that evaluate adverse events and medical error often suffer from incomplete and inadequate reporting, which affects the interpretability and reproducibility of their findings. To address this, we developed the 44-item Standard Elements in Studies of Adverse Event or Medical Error (SESAME) checklist using a rigorous process following the recommendations of the Enhancing the QUAlity and Transparency Of health Research Network. The aim of this manuscript is to explain the scope and aim of the checklist by providing a detailed explanation of each item in the SESAME checklist, illustrated by examples from selected studies of adverse events and medical error.

Journal of Patient Safety
Dalarna University (SE), Mayo Clinic (US), Johns Hopkins University (US), University of California, San Francisco (US), University of Basel (CH), Washington University in St. Louis (US), University of Utah (US), Johns Hopkins Medicine (US), Maastricht University Medical Centre (NL), Karolinska Institutet (SE), Maastricht University (NL), Photometrics (United States) (US), Saint Camillus International University of Health and Medical Sciences (IT), Department of Health (TW), Cancer Institute of Florida (US), University of San Francisco (US), Macquarie University (AU)
Gender equality
Openalex Percentile: Top 7%
Patient Safety and Medication Errors
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