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

A Brazilian Portuguese instrument for assessing patient engagement in patient safety has completed cross-cultural adaptation and content validation, providing healthcare organizations with a new self-assessment tool. In the methodological study, 97.9% of the instrument’s items were judged equivalent by all evaluators, while most items achieved acceptable results across a Content Validity Index of 99.6% and inter-rater agreement of 99.0% for comprehensiveness, clarity and relevance. The researchers described the evidence as supporting the tool’s feasibility and applicability in Brazilian healthcare organizations and similar institutional settings, while recommending broader psychometric evaluation before wider conclusions are drawn.

The instrument is adapted from the Patient Engagement in Patient Safety within Canadian Healthcare Organizations tool, which was developed to self-assess patient engagement in safety at the systemic level within healthcare organizations. The study did not test whether the tool improves safety outcomes or whether engagement causes reductions in harm. Instead, it examined whether a Canadian organizational assessment could be translated and adapted for use in Brazil without losing equivalence, and whether the resulting content was understandable, relevant and comprehensive for the intended setting.

This distinction places the work within measurement development rather than an evaluation of clinical effectiveness. Cross-cultural adaptation was completed in six stages: preparation, translation, back-translation, pre-test, review and documentation. The pre-test involved nine health organizations.

Equivalences between versions were evaluated using a coefficient of agreement, and items receiving agreement below 90% were discussed until consensus was reached. At the end of this process, 97.9% of the items were considered equivalent by 100% of the evaluators. These figures describe the assessment of equivalence during adaptation; they do not establish the instrument’s repeatability, measurement structure or relationship with safety indicators in routine use.

The second phase used a two-round Delphi technique to assess content validity. A committee of seven experts, including a partner patient, rated the adapted instrument in terms of comprehensiveness, clarity and relevance. Most items met acceptable Content Validity Index and inter-rater agreement values, reported for the study as 99.6% and 99.0%, respectively.

Items with unsatisfactory results were modified, reassessed and, after approval by all experts, incorporated into the finalized instrument. After completion of the adaptation and validation process, the instrument was finalized and made available for use in Brazil. The authors concluded that it provides evidence of cross-cultural adaptation and content validity, as well as preliminary evidence of feasibility and applicability for assessing patient engagement in patient safety within Brazilian healthcare organizations.

Larger and more diverse samples are therefore needed to expand psychometric evaluation and strengthen the evidence for broader use. The study was published as open access in BMC Health Services Research .

Subject of Research: Cross-cultural adaptation and content validation of a Brazilian patient-safety engagement instrument for healthcare organizations

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

Article References: Sousa, M. R. G. D., Freitas, J. S. D., Lima, J. C. D., Silva, K. D. C., Pomey, M. P., Aho-glele, U., & Silva, A. E. B. D. C. (2026). First Brazilian instrument for assessing patient engagement in patient safety: a cross-cultural adaptation and content validation study. BMC Health Services Research. https://doi.org/10.1186/s12913-026-15377-2

Image Credits: AI Generated

DOI: 10.1186/s12913-026-15377-2

Keywords: patient safety, patient engagement, Brazil, cross-cultural adaptation, content validity, healthcare organizations, measurement development, patient partner, Delphi technique, organizational assessment, First, Brazilian