The SESAME Checklist and the accompanying SESAME Elaboration and Explanation (E&E) manuscripts were jointly, simultaneously published as open access in three journals in September 2026. Citations and links are below. Also included below is an evaluation of existing reporting guidelines conducted to explore the extent to which key items were already covered in related checklists. When citing the SESAME guideline, please use one of these citations below for the Checklist.
Checklist
Griffey RT, Stockwell DC, Adler LM, Ancona R, Classen D, Schneider RM, Rutjes AW, Carpenter CR, Unbeck M; SESAME Development Team. Standard Elements in Studies of Adverse Events and Medical Error: the SESAME statement. J Patient Saf. 2026 Sep 11. doi: 10.1097/PTS.0000000000001583. Epub ahead of print. PMID: 42725443.
Griffey RT, Unbeck M, Stockwell DC, Adler LM, Ancona R, Classen D, Schneider RM, Rutjes AWS, Carpenter CR; SESAME Development Team. Standard Elements in Studies of Adverse Events and Medical Error: the SESAME statement. BMJ Qual Saf. 2026 Jan 23:bmjqs-2025-019458. doi: 10.1136/bmjqs-2025-019458. Epub ahead of print. PMID: 41577438.
Griffey, R. T., Stockwell, D. C., Adler, L. M., Ancona, R., Classen, D., Schneider, R. M., Rutjes, A. W., Carpenter, C. R., Unbeck, M., & (2026). Standard Elements in Studies of Adverse Events and Medical Error: the SESAME statement. Pediatric Quality & Safety, 11(5), e931. https://doi.org/10.1097/pq9.0000000000000931
Standard Elements in Studies of Adverse Events and Medical Error: the SESAME statement
This article introduces the SESAME (Standard Elements in Studies of Adverse Events and Medical Error) Statement, a new reporting guideline designed to improve the transparency, consistency, and reproducibility of research focused on adverse events, near-misses, and medical errors. Developed by an international, multidisciplinary group, the statement responds to long-standing problems in patient safety research, including inconsistent definitions of harm, variable methods for identifying and characterizing events, and poor reporting of causation, preventability, and reliability. The authors outline the rationale for SESAME, describe its development process in alignment with EQUATOR Network standards, and present a structured checklist of core reporting elements applicable across diverse study designs. By standardizing how adverse events and medical errors are defined, detected, and reported, the SESAME Statement aims to enable more meaningful comparisons across studies, strengthen systematic reviews and meta-analyses, and ultimately support more effective patient safety improvement efforts.
Explanation and Elaboration
Griffey RT, Stockwell DC, Adler LM, The SESAME Development Team, et al
Standard Elements in Studies of Adverse Events and Medical Error: the SESAME statement
BMJ Quality & Safety. Published Online First: 23 January 2026. doi: 10.1136/bmjqs-2025-019458
Griffey, R. T., Adler, L. M., Stockwell, D. C., Hibbert, P. D., Klein, D. O., Schwendimann, R., Auerbach, A. D., Ancona, R., Schneider, R. M., Classen, D., Carpenter, C. R., Rutjes, A. W. S., Unbeck, M., , Auerbach, A., Bates, D., Brooke, B., Carson-Stevens, A., Dorrill, R. A., … Winterstein, A. (2026). Standard Elements in Studies of Adverse Events and Medical Error (SESAME): explanation and elaboration. Pediatric Quality & Safety, 11(5), e930. https://doi.org/10.1097/pq9.0000000000000930
Griffey, R. T., Adler, L. M., Stockwell, D. C., Hibbert, P. D., Klein, D. O., Schwendimann, R., Auerbach, A. D., Ancona, R., Schneider, R. M., Classen, D., Carpenter, C. R., Rutjes, A. W. S., Unbeck, M., , Adler, L., Auerbach, A., Bates, D., Brooke, B., Carson-Stevens, A., … Winterstein, A. (2026). Standard Elements in Studies of Adverse Events and Medical Error (SESAME): explanation and elaboration. Journal of Patient Safety. https://doi.org/10.1097/PTS.0000000000001584
Standard Elements in Studies of Adverse Events and Medical Error (SESAME): explanation and elaboration
This explanation and elaboration companion to the SESAME statement walks through each item in the 44-item checklist, clarifying what authors should report in studies of adverse events and medical error and why each element matters. For every item, the paper explains the rationale, highlights how incomplete reporting can limit interpretation and reproducibility, and illustrates best practice with examples drawn from the literature. The result is a practical guide to using SESAME in real studies, helping researchers report study design, setting, population, event definitions, reviewer methods, quality assurance, and analysis in a more transparent and consistent way.
Needs assessment manuscript: Problem with the existing reporting standards for adverse event and medical error research.
Carpenter CR, Griffey RT, Rutjes AWS, Unbeck M, Adler LM, Stockwell DC, Classen D; SESAME Statement Development Team. The problem with the existing reporting standards for adverse event and medical error research. BMJ Qual Saf. 2025 Mar 19;34(4):273-278. doi: 10.1136/bmjqs-2024-017491. PMID: 39933922; PMCID: PMC12802381.
Problem with the existing reporting standards for adverse event and medical error research.
This BMJ Quality & Safety article argues that current research reporting guidelines inadequately support studies focused on adverse events, near-misses, and medical errors, leading to inconsistent methods, poor transparency, and limited comparability across patient safety research. After reviewing 12 relevant EQUATOR Network reporting guidelines, we show that none comprehensively address eight core elements they identify as essential for high-quality adverse event reporting—such as clear definitions of harm, standards for causation and preventability, reviewer training, fidelity to detection methods, and reliability of data abstraction. Many guidelines include none or only a few of these elements, confirming a major gap in existing standards. To address this, the authors describe the rationale and conceptual framework for the developing Standard Elements in Studies of Adverse Events and Medical Error (SESAME) guideline, which aims to improve transparency, reproducibility, and interpretability across diverse study designs and ultimately strengthen the evidence base for patient safety improvement.
Conceptual Flow Diagram for Retrospective Studies
The conceptual framework outlines the key elements that should be reported in retrospective studies of adverse events and medical error to improve transparency and comparability. Investigators should clearly describe their data sources, review scope, reviewer selection and training, and the methods used to determine whether an event was caused by healthcare, reached the patient, and resulted in non-harm, harm, or an adverse event. They should also report how events are classified by type and severity, whether preventability was assessed and by what criteria, and the degree of interrater reliability. If artificial intelligence is used, authors should further specify the training data, algorithms, and whether the system is being used descriptively or predictively.