First Brazilian instrument for assessing patient engagement in patient safety: a cross-cultural adaptation and content validation study

Abstract Background Patient safety is highlighted as a global health challenge, requiring changes and the implementation of initiatives to minimize risks, prevent care failures, and avoid harm to patients. Patient engagement has been one of the most recommended strategies for improving the quality and safety of care. To understand and monitor this practice, the Patient Engagement in Patient Safety within Canadian Healthcare Organizations tool was developed to self-assess the nature of patient engagement in patient safety at the systemic level in healthcare organizations. To enable research on this topic in Brazilian health organizations, the objective of this study was to produce a cross–culturally adapted Brazilian Portuguese version of this instrument, with content validation, for use in Brazil. Methods This was a methodological study developed in two phases. The first consisted of the cross–cultural adaptation of the instrument to Portuguese and followed six stages: preparation, translation, back–translation, pre–test with nine health organizations, review, and documentation. Equivalences were analyzed using the coefficient of agreement. The second phase involved content validation using the Delphi technique, with a committee of experts (n = 7), including partner patient, in two sequential rounds, measuring the Content Validity Index (CVI) and inter–rater agreement (IRA). Results In the cross–cultural adaptation, 97.9% of the items were considered equivalent by 100% of the evaluators. Items with agreement below 90% were discussed until consensus was reached. In the content validation, most items had acceptable CVI (99.6%) and IRA (99.0%) in terms of comprehensiveness, clarity, and relevance. Items with unsatisfactory values were modified, reassessed, and, after approval by all experts, the instrument was finalized and made available for use in Brazil. Conclusions The instrument demonstrated evidence of cross-cultural adaptation and content validity, as well as feasibility and applicability for assessing patient engagement in patient safety within Brazilian healthcare organizations and similar institutional settings. Further studies involving larger and more diverse samples are recommended to expand psychometric evaluation and strengthen the evidence supporting its broader use.