Standard Elements in Studies of Adverse Events and Medical Error: the SESAME statement.

Variability and persistent gaps in reporting have been consistently observed across studies evaluating adverse events in healthcare, dating back to the early days of the patient safety movement. Incomplete descriptions-particularly missing details regarding study design, conduct, methodologies and applied definitions-impede interpretation, hinder critical appraisal and limit reproducibility. These deficiencies not only obstruct a shared understanding of findings but also diminish the overall impact such studies may have on patient safety initiatives and policy development. To address these challenges and enhance the quality of reporting, we developed the SESAME (Standard Elements in Studies of Adverse Events and Medical Error) reporting guideline. SESAME is a 44-item checklist designed to support comprehensive and standardised reporting in studies evaluating potential patient harm. The guideline was developed over a 2-year period by an international, multidisciplinary panel through a consensus-driven process aligned with EQUATOR (Enhancing the QUAlity and Transparency Of Health Research Network) standards.