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.