CROSS-CULTURAL ADAPTATION AND VALIDATION OF THE NHS ENGLAND CLASSIFICATION OF LEVELS OF HARM ASSOCIATED WITH PATIENT SAFETY EVENTS FOR THE BRAZILIAN UNIFIED HEALTH SYSTEM (SUS): A STUDY PROTOCOL

Abstract

Patient safety is a strategic priority for health systems, and the classification of the level of harm is essential information for gauging the consequences of incidents, guiding institutional prioritization, and supporting data comparability. In Brazil, the "degree of harm" field of the Health Surveillance Notification System (Notivisa), aligned with the International Classification for Patient Safety (ICPS), uses broad descriptors and does not structurally differentiate physical from psychological harm, which may increase interpretive variability among professionals and limit the comparability of the information. The levels-of-harm classification of NHS England, the body responsible for coordinating the National Health Service (NHS) in England, is part of the Learn from Patient Safety Events Service (LFPSE), distinguishes the categories of physical and psychological harm, and adopts descriptors and decision criteria potentially useful for the Brazilian context. This manuscript presents the protocol of a prospective methodological study aimed at developing, in Brazilian Portuguese and within the Brazilian Unified Health System (SUS), an adapted and validated version of the classification of levels of harm associated with patient safety events published by NHS England. The study will be conducted in sequential stages: initial translations, synthesis of the translations, back-translations, committee review of the translated document, normative and organizational contextualization to the SUS, content validation using the Delphi method, and face validation with professionals who may use the classification in their institutional practice. There will be no direct patient involvement. The study is expected to produce a version conceptually equivalent to the source material and compatible with the normative and organizational context of the SUS, preserving the structure of harm categories, levels of harm, level descriptors, and decision criteria, and contributing to greater precision, standardization, and comparability of harm-related information and to more proportionate, transparent, and learning-oriented institutional responses to patient safety events.