In case of an adverse event don’t forget to say sorry
DOI:
https://doi.org/10.23938/ASSN.0031Keywords:
Adverse effects. Patient safety. Disclosure. Ethics.Abstract
Background. Disclosing information to a patient who is a victim of an adverse event (AE) presents some particularities depending on the legal framework in the country where the AE occurred. The aim of this study is to identify the limits and conditions when apologizing to a patient who has suffered an AE.
Methods. A consensus conference involving 26 professionals from different autonomous communities, institutions, and profiles (health, insurance, inspection, academic) with accredited experience in patient safety management systems and criminal law.
Results. Open disclosure should include an apology expressed in neutral terms (showing empathy and regret for what has happened) without the informant being identified as responsible for the damage, blaming third parties, or offering compensation on behalf of the insurance company. The professional who feels most directly involved in the incident is usually the least likely to report it and apologise. The informant profile must conform to the type and severity of the AE. The rules and conditions of liability insurance advise against providing specific information on the amount of compensation.
Conclusions. The apology should be offered in terms of the regulatory framework in force in each country. In Spain, an appropriate response of empathy for the patient is warranted, expressing regret for what happened (apologising), which can facilitate the relationship with the patient, mitigate their mistrust, and reduce the number of disputes.
Downloads
References
DE VRIES EN, RAMRATTAN MA, SMORENBURG SM, GOUMA DJ, BOERMEESTER MA. The incidence and nature of in-hospital adverse events: a systematic review. BMJ Qual Saf 2008; 17: 216-223.
ARANAZ-ANDRÉS JM, AIBAR C, LIMÓN R, MIRA JJ, VITALLER J, AGRA Y et al. A study of the prevalence of adverse events in primary healthcare in Spain. Eur J Public Health 2012; 22: 921-925.
ARANAZ-ANDRÉS JM, AIBAR-REMÓN C, LIMÓN-RAMÍREZ R, AMARILLA A, RESTREPO FR, URROZ O et al. Prevalence of adverse events in the hospitals of five Latin American countries: results of the Iberoamerican study of adverse events (IBEAS). BMJ Qual Saf 2011; 20: 1043-1051.
MONTSERRAT-CAPELLA D, SUÁREZ M, ORTIZ L, MIRA JJ, GAITÁN H, REVEIZ L. On behalf of the AMBEAS Group. Frequency of ambulatory care adverse events in Latin American countries: the AMBEAS/PAHO cohort study. Int J Qual Health Care 2015; 27: 52-59.
ARANAZ-ANDRÉS JM, LIMÓN R, MIRA JJ, AIBAR C, GEA MT, AGRA Y et al. What makes hospitalized patients more vulnerable and increases their risk of experiencing an adverse event? Int J Qual Health Care 2011; 23: 705-711.
LIMÓN-RAMÍREZ R, GARCÍA-RUBIO J, MIRALLES- BUENO JJ, ELEANOR-CANO I, VÉLEZ-MORALES E, DOMÍNGUEZ-ESCOBAR JF et al. Estudio de eventos adversos en sanidad privada. Proyecto Confianza de seguridad del paciente. Rev Calid Asist 2012; 27: 139-145.
LORIMER S, COX A, LANGFORD NJ. A patient's perspective: the impact of adverse drug reactions on patients and their views on reporting. J Clin Pharm Ther 2012; 37: 148-152.
MAZOR KM, GREENE SM, ROBLIN D, LEMAY CA, FIRNENO CL, CALVI J et al. More than words: patients’ views on apology and disclosure when things go wrong in cancer care. Patient Educ Couns 2013; 90: 341-346.
MIRA JJ, CARRILLO I, LORENZO S, FERRÚS L, SILVESTRE C, PÉREZ-PÉREZ P et al. The aftermath of adverse events in Spanish primary care and hospital health professionals. BMC Health Serv Res 2015; 15: 151.
MIRA JJ, LORENZO S; Grupo de Investigación en Segundas Víctimas. Algo no estamos haciendo bien cuando informamos a los/las pacientes tras un evento adverso. Gac Sanit 2015; 29: 370-374.
O'CONNOR E, COATES HM, YARDLEY IE, WU AW. Disclosure of patient safety incidents: a comprehensive review. Int J Qual Health Care 2010; 22: 371-379.
WU AW, MCCAY L, LEVINSON W, LEDEMA R, WALLACE G, BOYLE DJ et al. Disclosing Adverse Events to Patients: International Norms and Trends. J Patient Saf 2017; 13: 43-49.
MASTROIANNI AC, MELLO MM, SOMMER S, HARDY M, GALLAGHER TH. The flaws in state “apology” and “disclosure” laws dilute their intended impact on malpractice suits. Health Aff (Millwood) 2010; 29: 1611-1619.
LOREN DJ, GARBUTT J, DUNAGAN WC, BOMMARITO KM, EBERS AG, LEVINSON W et al. Risk managers, physicians, and disclosure of harmful medical errores. Jt Comm J Qual Patient Saf 2010; 36: 101-108.
The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. No. 2936. Regulation 20.
Agence Régionale de Santé d’île-de-France. La médiation medicale: en établissements de santé. Guide de bonnes pratiques 2012-2013. Agence Régionale de Santé d’île-de-France; 2013.
WHITE AA, GALLAGHER TH. Medical error and disclosure. Handb Clin Neurol 2013; 118: 107-117.
European Commission, Directorate-General Health and Consumers. Eurobarometer. Patient safety and quality of care. Special Eurobarometer 411. 2014. Disponible en: http://ec.europa.eu/health/patient_safety/eurobarometers/ebs_411_en.htm.
Australian Commission on Safety and Quality in Health Care (ACAQHC). Australian Open Disclosure Framework. Sydney: ACSQHC; 2013.
Communication and Optimal Resolution (CANDOR). May 2016. Agency for Healthcare Research and Quality, Rockville, MD. Disponible en: http://www.ahrq.gov/professionals/quality-patient-safety/patient-safety-resources/resources/candor/index.html.
MARTÍN-DELGADO MC, FERNÁNDEZ-MAILLO M, BAÑERES-AMELLA J, CAMPILLO-ARTERO C, CABRÉ-PERICAS L, ANGLÉS-COLL R et al. Conferencia de consenso sobre información de eventos adversos a pacientes y familiares. Rev Calid Asist 2013; 28: 381-389.
GIRALDO P, CORBELLA J, RODRIGO C, COMAS M, SALA M, CASTELLS X. Análisis de las barreras y oportunidades legales-éticas de la comunicación y disculpa de errores asistenciales en España. Gac Sanit 2016; 30: 117-120.
ROMEO-CASABONA CM, URRUELA A, LIBANO A. Establecimiento de un sistema nacional de notificación y registro de incidentes y eventos adversos: aspectos legales. Tensiones y posibles conflictos de lege lata. Informe Técnico. Madrid: Ministerio Sanidad y Consumo; 2007.
ROMEO-CASABONA CM, URRUELA A. El establecimiento de un sistema nacional de notificación y registro de incidentes y eventos adversos en el sector sanitario: aspectos legales. Madrid: Agencia de Calidad del Sistema Nacional de Salud Ministerio de Sanidad y Política Social; 2009.
Disclosure Working Group. Canadian disclosure guidelines: being open and honest with patients and families. Edmonton, AB: Canadian Patient Safety Institute; 2011.
TYSALL A, DUFFY A. Open Disclosure: National Guidelines: Communicating with service users and their families following adverse events in healthcare. Ireland: Health Service Executive and State Claims Agency; 2013.
Sistema Español de Notificación en Seguridad en Anestesia y Reanimación (SENSAR). Recomendaciones para la respuesta institucional a un evento adverso. Rev Esp Anestesiol Reanim 2015; 62: e5-e16.
STUDDERT DM, PIPER D, IEDEMA R. Legal aspects of open disclosure II: attitudes of health professionals – findings from a national survey. Med J Aust 2010; 193: 351-355.
BIRKS Y, HARRISON R, BOSANQUET K, HALL J, HARDEN M, ENTWISTLE V et al. An exploration of the implementation of open disclosure of adverse events in the UK: a scoping review and qualitative exploration. Health Serv Deliv Res 2014; 2.
WATSON BM, ANGUS D, GORE L, FARMER J. Communication in open disclosure conversations about adverse events in hospitals. Language & Communication 2015; 41: 57-70.
CARRILLO I, FERRÚS L, SILVESTRE C, PÉREZ-PÉREZ P, TORIJANO ML, IGLESIAS-ALONSO F et al. Propuestas para el estudio del fenómeno de las segundas víctimas en España en atención primaria y hospitales. Rev Calid Asist 2016; 31: 3-10.
MIRA JJ, LORENZO S, CARRILLO I, FERRÚS L, PÉREZ-PÉREZ P, IGLESIAS F et al. Interventions in health organisations to reduce the impact of adverse events in second and third victims. BMC Health Serv Res 2015; 15: 341.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2017 Anales del Sistema Sanitario de Navarra

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.
La revista Anales del Sistema Sanitario de Navarra es publicada por el Departamento de Salud del Gobierno de Navarra (España), quien conserva los derechos patrimoniales (copyright ) sobre el artículo publicado y favorece y permite la difusión del mismo bajo licencia Creative Commons Reconocimiento-CompartirIgual 4.0 Internacional (CC BY-SA 4.0). Esta licencia permite copiar, usar, difundir, transmitir y exponer públicamente el artículo, siempre que siempre que se cite la autoría y la publicación inicial en Anales del Sistema Sanitario de Navarra, y se distinga la existencia de esta licencia de uso.


