ADAPTACIÓN TRANSCULTURAL Y VALIDACIÓN DE LA CLASIFICACIÓN DE LOS NIVELES DE DAÑO ASOCIADOS A EVENTOS DE SEGURIDAD DEL PACIENTE DEL NHS ENGLAND PARA EL SISTEMA ÚNICO DE SALUD BRASILEÑO (SUS): UN PROTOCOLO DE ESTUDIO
DOI:
https://doi.org/10.56238/sevened2026.019-098Palabras clave:
Seguridad del Paciente, Daño del Paciente, Gestión de Riesgos, Sistema Único de Salud, Comparación TransculturalResumen
La seguridad del paciente constituye una prioridad estratégica de los sistemas de salud, y la clasificación del nivel de daño es información esencial para dimensionar las consecuencias de los incidentes, orientar la priorización institucional y favorecer la comparabilidad de los datos. En Brasil, el campo "grado del daño" del Sistema de Notificaciones para la Vigilancia Sanitaria (Notivisa), alineado con la Clasificación Internacional para la Seguridad del Paciente (CISP), utiliza descriptores amplios y no diferencia, de forma estructurada, el daño físico del psicológico, lo que puede ampliar la variabilidad interpretativa entre profesionales y limitar la comparabilidad de la información. La clasificación de los niveles de daño del NHS England, organismo responsable de la coordinación del Servicio Nacional de Salud (National Health Service, NHS) en Inglaterra, integra el Learn from Patient Safety Events Service (LFPSE), distingue las categorías de daño físico y psicológico y adopta descriptores y criterios de decisión potencialmente útiles para el contexto brasileño. Este manuscrito presenta el protocolo de un estudio metodológico prospectivo dirigido a desarrollar, en portugués brasileño y en el contexto del Sistema Único de Salud brasileño (SUS), una versión adaptada y validada de la clasificación de los niveles de daño asociados a eventos de seguridad del paciente publicada por el NHS England. El estudio se llevará a cabo en etapas secuenciales: traducciones iniciales, síntesis de las traducciones, retrotraducciones, revisión por comité del documento traducido, contextualización normativa y organizacional al SUS, validación de contenido mediante el método Delphi y validación de apariencia con profesionales que podrán utilizar la clasificación en su práctica institucional. No habrá participación directa de pacientes. Se espera producir una versión conceptualmente equivalente al material de origen y compatible con el contexto normativo y organizacional del SUS, preservando la estructura de categorías de daño, niveles de daño, descriptores de los niveles y criterios de decisión, y contribuyendo a una mayor precisión, estandarización y comparabilidad de la información sobre el daño y a respuestas institucionales a incidentes de seguridad del paciente más proporcionadas, transparentes y orientadas al aprendizaje.
Referencias
AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA. Gestão de riscos e investigação de eventos adversos relacionados à assistência à saúde. Brasília, DF: Anvisa, 2025. Disponível em: https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/servicosdesaude/manuais/copy2_of_infecc_qualidade_cad_7_completo_web_20250915_final2.pdf. Acesso em: 4 maio 2026.
AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA. Plano integrado para a gestão sanitária da segurança do paciente em serviços de saúde 2026-2030. Brasília, DF: Anvisa, 2026. Disponível em: https://www.gov.br/anvisa/pt-br/assuntos/servicosdesaude/seguranca-do-paciente/Plano_Integrado_seguranca_do_paciente_2026_2030___FINAL_jan_2026.pdf. Acesso em: 7 jun. 2026.
ALAVI, M.; LE LAGADEC, D.; CLEARY, M. Challenges of cross-cultural validation of clinical assessment measures: a practical introduction. Journal of Advanced Nursing, v. 82, n. 2, p. 941-949, 2026. DOI: 10.1111/jan.16906.
AMERICAN EDUCATIONAL RESEARCH ASSOCIATION; AMERICAN PSYCHOLOGICAL ASSOCIATION; NATIONAL COUNCIL ON MEASUREMENT IN EDUCATION. Standards for educational and psychological testing. Washington, DC: American Educational Research Association, 2014.
BEATON, D. E. et al. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine, v. 25, n. 24, p. 3186-3191, 2000. DOI: 10.1097/00007632-200012150-00014.
BRASIL. Conselho Nacional de Saúde. Resolução nº 466, de 12 de dezembro de 2012. Aprova diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos. Brasília, DF: Conselho Nacional de Saúde, 2012. Disponível em: https://conselho.saude.gov.br/resolucoes/2012/Reso466.pdf. Acesso em: 4 maio 2026.
BRASIL. Lei nº 13.709, de 14 de agosto de 2018. Lei Geral de Proteção de Dados Pessoais (LGPD). Brasília, DF: Presidência da República, 2018. Disponível em: https://www.planalto.gov.br/ccivil_03/_ato2015-2018/2018/lei/l13709.htm. Acesso em: 4 maio 2026.
BRASIL. Lei nº 15.378, de 6 de abril de 2026. Institui o Estatuto dos Direitos do Paciente. Diário Oficial da União: seção 1, Brasília, DF, 7 abr. 2026a. Disponível em: https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=07/04/2026&jornal=515&pagina=1&totalArquivos=213. Acesso em: 4 maio 2026.
BRASIL. Ministério da Saúde. Portaria GM/MS nº 11.527, de 9 de junho de 2026. Institui a Política Nacional de Qualidade e Segurança do Paciente. Diário Oficial da União: seção 1, Brasília, DF, 10 jun. 2026b. Disponível em: https://www.in.gov.br/web/dou/-/portaria-gm/ms-n-11.527-de-9-de-junho-de-2026-711400715. Acesso em: 10 jun. 2026.
BRASIL. Ministério da Saúde. Portaria nº 529, de 1º de abril de 2013. Institui o Programa Nacional de Segurança do Paciente (PNSP). Brasília, DF: Ministério da Saúde, 2013. Disponível em: https://bvsms.saude.gov.br/bvs/saudelegis/gm/2013/prt0529_01_04_2013.html. Acesso em: 4 maio 2026.
CARE QUALITY COMMISSION. Regulation 20: Duty of candour. London: Care Quality Commission, 2025. Disponível em: https://www.cqc.org.uk/guidance-regulation/providers/regulations-service-providers-and-managers/health-social-care-act/regulation-20. Acesso em: 7 jun. 2026.
CASTRO, M. C. et al. Brazil’s unified health system: the first 30 years and prospects for the future. The Lancet, v. 394, n. 10195, p. 345-356, 2019. DOI: 10.1016/S0140-6736(19)31243-7.
CENTER FOR OPEN SCIENCE. Open Science Framework. Charlottesville: Center for Open Science, [s.d.]. Disponível em: https://osf.io/. Acesso em: 6 jun. 2026.
COOPER, J. et al. Classification of patient-safety incidents in primary care. Bulletin of the World Health Organization, v. 96, n. 7, p. 498-505, 2018. DOI: 10.2471/BLT.17.199802.
CROMPTON, A. et al. How can specialist investigation agencies inform system-wide learning for patient safety? A qualitative study of perspectives on the early years of the English Healthcare Safety Investigation Branch. Journal of Health Services Research & Policy, v. 30, n. 1, p. 31-39, 2025. DOI: 10.1177/13558196241291816.
DREISMANN, L. et al. Invisible harm in patient safety: a framework and definition for preventable psychological harm in cancer care. BMJ Open Quality, v. 14, e003466, 2025. DOI: 10.1136/bmjoq-2025-003466.
DYER, C. New NHS safety watchdog aims to promote openness and avoid “blame culture”. BMJ, j4306, 2017. DOI: 10.1136/bmj.j4306.
FAUSTINO, T. N. et al. National Patient Safety Program in Brazil: incidents reported between 2014 and 2017. Journal of Patient Safety, v. 17, n. 8, p. e1202-e1208, 2021. DOI: 10.1097/PTS.0000000000000496.
GOEKCIMEN, K. et al. Addressing patient safety hazards using critical incident reporting in hospitals: a systematic review. Journal of Patient Safety, 2022. DOI: 10.1097/PTS.0000000000001072.
GOLDMAN, J. et al. Integrating equity into incident reporting and patient concerns systems: a critical interpretive synthesis. BMJ Quality & Safety, v. 35, n. 1, p. 64-74, 2026. DOI: 10.1136/bmjqs-2025-019118.
GUILLEMIN, F.; BOMBARDIER, C.; BEATON, D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. Journal of Clinical Epidemiology, v. 46, n. 12, p. 1417-1432, 1993. DOI: 10.1016/0895-4356(93)90142-N.
HALLAM, K. P-159 Better together: Patient Safety Incident Response Framework (PSIRF) through a collaborative approach. BMJ Supportive & Palliative Care, p. A69.2-A69, 2023. DOI: 10.1136/spcare-2023-HUNC.180.
HASSON, F.; KEENEY, S.; MCKENNA, H. Research guidelines for the Delphi survey technique. Journal of Advanced Nursing, v. 32, n. 4, p. 1008-1015, 2000. DOI: 10.1046/j.1365-2648.2000.t01-1-01567.x.
HERDMAN, M.; FOX-RUSHBY, J.; BADIA, X. A model of equivalence in the cultural adaptation of HRQoL instruments: the universalist approach. Quality of Life Research, v. 7, n. 4, p. 323-335, 1998. DOI: 10.1023/A:1008846618880.
IACOBUCCI, G. NHS will focus on investigating serious incidents with the best learning opportunities. BMJ, l4514, 2019. DOI: 10.1136/bmj.l4514.
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. ISO 31000:2018: risk management: guidelines. Geneva: International Organization for Standardization, 2018.
JÜNGER, S. et al. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: recommendations based on a methodological systematic review. Palliative Medicine, v. 31, n. 8, p. 684-706, 2017. DOI: 10.1177/0269216317690685.
KUMAH, A. Poor quality care in healthcare settings: an overlooked epidemic. Frontiers in Public Health, v. 13, 1504172, 2025. DOI: 10.3389/fpubh.2025.1504172.
LIMA JÚNIOR, A. J. D. et al. Ocorrência e evitabilidade de eventos adversos em hospitais: estudo retrospectivo. Revista Brasileira de Enfermagem, v. 76, e20220025, 2023. DOI: 10.1590/0034-7167-2022-0025pt.
LOUCH, G. et al. How were patient safety incidents responded to, investigated, and learned from within the English National Health Service before the implementation of the Patient Safety Incident Response Framework? A rapid review. Journal of Patient Safety, v. 21, n. 1, p. e42-e55, 2025. DOI: 10.1097/PTS.0000000000001349.
LYNN, M. R. Determination and quantification of content validity. Nursing Research, v. 35, n. 6, p. 382-386, 1986.
MACRAE, C. Investigating for improvement? Five strategies to ensure national patient safety investigations improve patient safety. Journal of the Royal Society of Medicine, v. 112, n. 9, p. 365-369, 2019. DOI: 10.1177/0141076819848114.
MAIA, C. S. et al. Notificações de eventos adversos relacionados com a assistência à saúde que levaram a óbitos no Brasil, 2014-2016. Epidemiologia e Serviços de Saúde, v. 27, e2017320, 2018. DOI: 10.5123/S1679-49742018000200004.
MASSUDA, A. et al. Sustentabilidade e resiliência do Sistema Único de Saúde. [S. l.]: Partnership for Health System Sustainability and Resilience, 2023. Disponível em: https://www3.weforum.org/docs/WEF_Report_PHSSR_Brazil_Portuguese_2023.pdf. Acesso em: 13 jun. 2026.
MAYBERRY, J. F.; FARRUKH, A. The NHS’s new police force. Medico-Legal Journal, v. 94, n. 1, p. 17-19, 2026. DOI: 10.1177/00258172251344745.
MCDONALD, T. B. et al. Responding to patient safety incidents: the “seven pillars”. BMJ Quality & Safety, v. 19, e11, 2010. DOI: 10.1136/qshc.2008.031633.
MELLO, L. R. G. et al. Instrumento brasileiro para investigação de eventos adversos na saúde: estudo de validação. Acta Paulista de Enfermagem, v. 37, eAPE001125, 2024. DOI: 10.37689/acta-ape/2024AO00011255.
MENDES, W. et al. The application of Iberoamerican study of adverse events (IBEAS) methodology in Brazilian hospitals. International Journal for Quality in Health Care, v. 30, n. 6, p. 480-485, 2018. DOI: 10.1093/intqhc/mzy055.
MESINIOTI, P. et al. Closing investigations: the role of national policy in shaping structural, organisational and relational constraints on learning from patient safety incidents. Safety Science, v. 192, 106999, 2025. DOI: 10.1016/j.ssci.2025.106999.
NHS ENGLAND. Patient Safety Incident Response Framework. London: NHS England, 2022. Disponível em: https://www.england.nhs.uk/long-read/patient-safety-incident-response-framework/#links-to-other-processes. Acesso em: 11 jun. 2026.
NHS ENGLAND. Policy guidance on recording patient safety events and levels of harm. London: NHS England, 2023. Disponível em: https://www.england.nhs.uk/long-read/policy-guidance-on-recording-patient-safety-events-and-levels-of-harm/. Acesso em: 4 maio 2026.
OIKONOMOU, E. et al. Patient safety regulation in the NHS: mapping the regulatory landscape of healthcare. BMJ Open, v. 9, e028663, 2019. DOI: 10.1136/bmjopen-2018-028663.
OTTOSEN, M. J. et al. Long-term impacts faced by patients and families after harmful healthcare events. Journal of Patient Safety, v. 17, n. 8, p. e1145-e1151, 2021. DOI: 10.1097/PTS.0000000000000451.
PAIM, J. et al. The Brazilian health system: history, advances, and challenges. The Lancet, v. 377, n. 9779, p. 1778-1797, 2011. DOI: 10.1016/S0140-6736(11)60054-8.
PANAGIOTI, M. et al. Prevalence, severity, and nature of preventable patient harm across medical care settings: systematic review and meta-analysis. BMJ, v. 366, l4185, 2019. DOI: 10.1136/bmj.l4185.
PFEIFFER, Y. et al. Identifying hazards for psychological harm in cancer care using incident reports: searching for the invisible. International Journal for Quality in Health Care, v. 37, mzaf099, 2025. DOI: 10.1093/intqhc/mzaf099.
POLIT, D. F.; BECK, C. T. The content validity index: are you sure you know what’s being reported? Critique and recommendations. Research in Nursing & Health, v. 29, n. 5, p. 489-497, 2006. DOI: 10.1002/nur.20147.
POLIT, D. F.; BECK, C. T.; OWEN, S. V. Is the CVI an acceptable indicator of content validity? Appraisal and recommendations. Research in Nursing & Health, v. 30, n. 4, p. 459-467, 2007. DOI: 10.1002/nur.20199.
QUICK, O. Duties of candour in healthcare: the truth, the whole truth, and nothing but the truth? Medical Law Review, v. 30, n. 2, p. 324-352, 2022. DOI: 10.1093/medlaw/fwac004.
SILVA, Z. P. da et al. Perfil sociodemográfico e padrão de utilização dos serviços de saúde do Sistema Único de Saúde (SUS), 2003-2008. Ciência & Saúde Coletiva, v. 16, n. 9, p. 3807-3816, 2011. DOI: 10.1590/S1413-81232011001000016.
SOUSA, V. D.; ROJJANASRIRAT, W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. Journal of Evaluation in Clinical Practice, v. 17, n. 2, p. 268-274, 2011. DOI: 10.1111/j.1365-2753.2010.01434.x.
TERWEE, C. B. et al. COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Quality of Life Research, v. 27, n. 5, p. 1159-1170, 2018. DOI: 10.1007/s11136-018-1829-0.
VILLAR, V. C. F. L.; MARTINS, M.; RABELLO, E. T. Incidentes e eventos adversos de segurança do paciente notificados pelos cidadãos no Brasil: estudo descritivo, 2014-2018. Epidemiologia e Serviços de Saúde, v. 30, n. 4, e2021005, 2021. DOI: 10.1590/s1679-49742021000400007.
WEAVER, S.; STEWART, K.; KAY, L. Systems-based investigation of patient safety incidents. Future Healthcare Journal, v. 8, n. 3, p. e593-e597, 2021. DOI: 10.7861/fhj.2021-0147.
WILD, D. et al. Principles of good practice for the translation and cultural adaptation process for Patient-Reported Outcomes (PRO) measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value in Health, v. 8, n. 2, p. 94-104, 2005. DOI: 10.1111/j.1524-4733.2005.04054.x.
WORLD HEALTH ORGANIZATION. Conceptual framework for the International Classification for Patient Safety: version 1.1: final technical report January 2009. Geneva: World Health Organization, 2010.
WORLD HEALTH ORGANIZATION. Global patient safety action plan 2021-2030: towards eliminating avoidable harm in health care. Geneva: World Health Organization, 2021.
WORLD HEALTH ORGANIZATION. Global patient safety report 2024. Geneva: World Health Organization, 2024. Disponível em: https://www.who.int/publications/i/item/9789240095458. Acesso em: 7 jun. 2026.
YE, X. et al. Cross-cultural adaptation of an implementation science glossary into simplified Chinese: study protocol. Frontiers in Health Services, v. 6, 1799760, 2026. DOI: 10.3389/frhs.2026.1799760.
YUSOFF, M. S. B. ABC of content validation and content validity index calculation. Education in Medicine Journal, v. 11, n. 2, p. 49-54, 2019. DOI: 10.21315/eimj2019.11.2.6.
Descargas
Publicado
Número
Sección
Licencia

Esta obra está bajo una licencia internacional Creative Commons Atribución-NoComercial 4.0.