How different countries respond to adverse events whilst patients' rights are protected.

Patient safety is high on the policy agenda internationally. Learning from safety incidents is a core component in achieving the important goal of increasing patient safety. This study explores the legal frameworks in the countries to promote reporting, disclosure, and supporting healthcare professionals (HCPs) involved in safety incidents. A cross-sectional online survey was conducted to ascertain an overview of the legal frameworks at national level, as well as relevant policies. ERNST (The European Researchers' Network Working on Second Victims) group peer-reviewed data collected from countries was performed to validate information. Information from 27 countries was collected and analyzed, giving a response rate of 60%. A reporting system for patient safety incidents was in place in 85.2% (N = 23) of countries surveyed, though few (37%, N = 10) were focused on systems-learning. In about half of the countries (48.1%, N = 13) open disclosure depends on the initiative of HCPs. The tort liability system was common in most countries. No-fault compensation schemes and alternative forms of redress were less common. Support for HCPs involved in patient safety incidents was extremely limited, with just 11.1% (N = 3) of participating countries reporting that supports were available in all healthcare institutions. Despite progress in the patient safety movement worldwide, the findings suggest that there are considerable differences in the approach to the reporting and disclosure of patient safety incidents. Additionally, models of compensation vary limiting patients' access to redress. Finally, the results highlight the need for comprehensive support for HCPs involved in safety incidents.

Percepción del médico como segunda víctima tras un error durante la práctica clínica / Physician's perception as second victim after an error during clinical practice

No disponible

The Impact of Incident Disclosure Behaviors on Medical Malpractice Claims.

OBJECTIVES: To provide preliminary estimates of incident disclosure behaviors on medical malpractice claims. METHODS: We conducted a descriptive analysis of data on medical malpractice claims obtained from the Controlled Risk Insurance Company and Risk Management Foundation of Harvard Medical Institutions (Cambridge, Massachusetts) between 2012 and 2013 (n = 434). The characteristics of disclosure and apology after medical errors were analyzed. RESULTS: Of 434 medical malpractice claims, 4.6% (n = 20) medical errors had been disclosed to the patient at the time of the error, and 5.9% (n = 26) had been followed by disclosure and apology. The highest number of disclosed injuries occurred in 2011 (23.9%; n = 11) and 2012 (34.8%; n = 16). There was no incremental increase during the financial years studied (2012-2013). The mean age of informed patients was 52.96 years, 58.7 % of the patients were female, and 52.2% were inpatients. Of the disclosed errors, 26.1% led to an adverse reaction, and 17.4% were fatal. The cause of disclosed medical error was improper surgical performance in 17.4% (95% confidence interval, 6.4-28.4). Disclosed medical errors were classified as medium severity in 67.4%. No apology statement was issued in 54.5% of medical errors classified as high severity. CONCLUSIONS: At the health-care centers studied, when a claim followed a medical error, providers infrequently disclosed medical errors or apologized to the patient or relatives. Most of the medical errors followed by disclosure and apology were classified as being of high and medium severity. No changes were detected in the volume of lawsuits over time.

El papel de la formación universitaria para conseguir la Salud en Todas las Políticas / The role of university education in achieving Health in All Policies

No disponible

Eleven-year descriptive analysis of closed court verdicts on medical errors in Spain and Massachusetts.

OBJECTIVES: To evaluate and compare the characteristics of court verdicts on medical errors allegedly harming patients in Spain and Massachusetts from 2002 to 2012. DESIGN, SETTING AND PARTICIPANTS: We reviewed 1041 closed court verdicts obtained from data on litigation in the Thomson Reuters Aranzadi Westlaw databases in Spain (Europe), and 370 closed court verdicts obtained from the Controlled Risk and Risk Management Foundation of Harvard Medical Institutions (CRICO/RMF) in Massachusetts (USA). We included closed court verdicts on medical errors. The definition of medical errors was based on that of the Institute of Medicine (USA). We excluded any agreements between parties before a judgement. RESULTS: Medical errors were involved in 25.9% of court verdicts in Spain and in 74% of those in Massachusetts. The most frequent cause of medical errors was a diagnosis-related problem (25.1%; 95% CI 20.7% to 31.1% in Spain; 35%; 95% CI 29.4% to 40.7% in Massachusetts). The proportion of medical errors classified as high severity was 34% higher in Spain than in Massachusetts (p=0.001). The most frequent factors contributing to medical errors in Spain were surgical and medical treatment (p=0.001). In Spain, 98.5% of medical errors resulted in compensation awards compared with only 6.9% in Massachusetts. CONCLUSIONS: This study reveals wide differences in litigation rates and the award of indemnity payments in Spain and Massachusetts; however, common features of both locations are the high rates of diagnosis-related problems and the long time interval until resolution.

Análisis de las barreras y oportunidades legales-éticas de la comunicación y disculpa de errores asistenciales en España / Analysis of barriers and legal-ethical opportunities for disclosure and apology for medical errors in Spain

Objetivo: Identificar las oportunidades y las barreras legales-éticas sobre la comunicación y disculpa del error médico en España. Método: Estudio transversal a 46 expertos/as en derecho sanitario-bioética. Resultados: 39 (84,7%) respondieron que siempre deberían comunicarse los eventos y 38 (82,6%) se mostraron a favor de una disculpa. Treinta expertos/as (65,2%) declararon que si se realizaba una comunicación de errores, esta no devengaría responsabilidad profesional. Se identificó como oportunidad la mejora de la confianza médico/a-paciente, y como barrera principal, el miedo a las consecuencias de la comunicación. Discusión: existe un consenso sobre la falta de responsabilidad derivada de una comunicación-disculpa y la necesidad de iniciar un programa de comunicación a través del soporte a los/las médicos/as (AU)

Objective: To identify opportunities for disclosing information on medical errors in Spain and issuing an apology, as well as legal-ethical barriers. Method: A cross-sectional study was conducted through a questionnaire sent to health law and bioethics experts (n=46). Results: A total of 39 experts (84.7%) responded that health providers should always disclose adverse events and 38 experts (82.6%) were in favour of issuing an apology. Thirty experts (65.2%) reported that disclosure of errors would not lead to professional liability. The main opportunity for increasing disclosure was by enhancing trust in the physician-patient relationship and the main barrier was fear of the outcomes of disclosing medical errors. Conclusions: There is a broad agreement on the lack of liability following disclosure/apology on adverse events and the need to develop a strategy for disclosure among support for physicians (AU)

A retrospective review of medical errors adjudicated in court between 2002 and 2012 in Spain.

OBJECTIVES: This paper describes verdicts in court involving injury-producing medical errors in Spain. DESIGN, SETTING AND PARTICIPANTS: A descriptive analysis of 1041 closed court verdicts from Spain between January 2002 and December 2012. It was determined whether a medical error had occurred, and among those with medical error (n = 270), characteristics and results of litigation were analyzed. Data on litigation were obtained from the Thomson Reuters Aranzadi Westlaw databases. MAIN OUTCOME MEASURES: All verdicts involving health system were reviewed and classified according to the presence of medical error. Among those, contributory factors, medical specialty involved, health impact (death, disability and severity) and results of litigation (resolution, time to verdict and economic compensations) were described. RESULTS: Medical errors were involved in 25.9% of court verdicts. The cause of medical error was a diagnosis-related problem in 25.1% and surgical treatment in 22.2%, and Obstetrics-Gynecology was the most frequent involved specialty (21%). Most of them were of high severity (59.4%), one-third (32%) caused death. The average time interval between the occurrence of the error and the verdict was 7.8 years. The average indemnity payment was €239 505.24; the highest was psychiatry (€7 585 075.86) and the lowest was Emergency Medicine (€69 871.19). CONCLUSIONS: This study indicates that in Spain medical errors are common among verdicts involving the health system, most of them causing high-severity adverse outcomes. The interval between the medical error and the verdict is excessive, and there is a wide range of economic compensation.

[Analysis of barriers and legal-ethical opportunities for disclosure and apology for medical errors in Spain]. / Análisis de las barreras y oportunidades legales-éticas de la comunicación y disculpa de errores asistenciales en España.

OBJECTIVE: To identify opportunities for disclosing information on medical errors in Spain and issuing an apology, as well as legal-ethical barriers. METHOD: A cross-sectional study was conducted through a questionnaire sent to health law and bioethics experts (n=46). RESULTS: A total of 39 experts (84.7%) responded that health providers should always disclose adverse events and 38 experts (82.6%) were in favour of issuing an apology. Thirty experts (65.2%) reported that disclosure of errors would not lead to professional liability. The main opportunity for increasing disclosure was by enhancing trust in the physician-patient relationship and the main barrier was fear of the outcomes of disclosing medical errors. CONCLUSIONS: There is a broad agreement on the lack of liability following disclosure/apology on adverse events and the need to develop a strategy for disclosure among support for physicians.

Perspectiva de los estudiantes de Enfermería sobre la comunicación y disculpa de los eventos adversos a los pacientes: estudio descriptivo / Perspective of nursing students on the communication and apologies to patients for adverse events: A descriptive study

OBJETIVO: Describir el abordaje de la comunicación y la disculpa ante un evento adverso desde los estudiantes de enfermería. MÉTODO: Estudio descriptivo de la comunicación y disculpa de eventos adversos por estudiantes en los cursos académicos 2011-12 y 2012-13. Debate grupal y redacción de un mensaje escrito dirigido al paciente lesionado en el que se abordaban los hechos ocurridos durante su estancia hospitalaria. Se analizaron cada una de las comunicaciones realizadas mediante el empleo de un check-list ad hocdonde se identificaron ítems relacionados con la comunicación y disculpa de eventos adversos. RESULTADOS: Los 126 estudiantes de enfermería participantes elaboraron 21 comunicaciones escritas. En el 81% de las comunicaciones se relataron los hechos constitutivos de los eventos adversos acaecidos y el 47,1% se inclinó por una comunicación abreviada de los hechos sin detallar cada uno de los eventos detectados. Solo en el 9,5% de las comunicaciones escritas se reprodujeron fielmente los hechos al paciente. El 33,3% se disculpó de los errores cometidos y el 47,6% requirió que la comunicación fuera firmada por la gerencia del centro. El 100% de los estudiantes optó por no informar de los profesionales de la salud que habían intervenido en los hechos causantes de los eventos adversos. CONCLUSIONES: Se evidencia cierto temor en el reconocimiento a explicar los errores asistenciales en referencia a cómo y quién. Es necesario impulsar herramientas en los futuros profesionales de enfermería para hacer frente a una comunicación abierta y honesta, así como a la disculpa de los errores

OBJECTIVE: To describe nurse attitudes toward depression, using a standardized questionnaire and to evaluate how a training workshop can modify or influence these attitudes. METHODS: A prospective study based on the application of the Depression Attitude Questionnaire, before and six months after, participating in a training day on the nursing role in the management of depression in Primary Care. The sample consisted of 40 Primary Care nurses from 10 health centers in the province of Tarragona. RESULTS: Nurses are in a neutral position when considering the management of depressed patients as a difficult task, or to feel comfortable in this task, but there is a high degree of acceptance of the claim that the time spent caring for depressed patients is rewarding. In general, there was little significant difference in the mean scores for the different items of the Depression Attitude Questionnaire, before and six months, after the training intervention. CONCLUSIONS: The attitude towards the management of depression in Primary Care and to the role that nurses can play in this task is generally favorable. Fruitful training and organizational initiatives can be established in order to define and structure the nursing role in the management of depression in Primary Care

Errores asistenciales y las leyes de la disculpa, ¿las necesitamos? / Medical errors and the apology laws, do we need them?

No disponible

Información al paciente a través del consentimiento informado / Information to patient through an informed consent

No disponible

Respuesta: Defecto de información en las reclamaciones por responsabilidad profesional médica / Reply: Lack of information in medical liability claims

No disponible

[Perspective of nursing students on the communication and apologies to patients for adverse events: a descriptive study]. / Perspectiva de los estudiantes de Enfermería sobre la comunicación y disculpa de los eventos adversos a los pacientes: estudio descriptivo.

OBJECTIVES: To describe the approach to the communication and blame of an adverse by nursing students. METHOD: A descriptive study on disclosure and apologies for adverse events by nursing students in the academic years 2011-12 and 2012-13. The study included group discussion and drafting a written communication to the injured patient about adverse events during hospitalization. An ad hoc checklist was used and an analysis was performed on items related to the disclosure and apologies issues. RESULTS: A total of 126 nursing students were involved, and they created 21 written The facts about adverse events were reported in 81% of written communications, and 47.1% chose an abbreviated disclosure of the facts with no detailed explanation of adverse events. The facts were accurately reproduced in only 9.5% of written communications to the patients. One third (33.3%) apologized for the mistakes, and 47.6% required that the communication was signed by the Management. All (100%) of the nursing students chose not to report the health professionals who had participated during the events. CONCLUSIONS: There is a fear to acknowledge errors within health centers. It is recommended that tools are developed for these future nursing professionals to make an open and honest disclosure of adverse events, as well as the apologies for them.

Impacto económico de los eventos adversos en los hospitales españoles a partir del Conjunto Mínimo Básico de Datos / Assessing the economic impact of adverse events in Spanish hospitals by using administrative data

Objetivo Evaluar la incidencia y los costes de los eventos adversos presentes en el Conjunto Mínimo Básico de Datos (CMBD) en los hospitales españoles en el período 2008-2010.MétodoEstudio retrospectivo que estima el coste incremental por episodio, según la presencia de eventos adversos. El coste se obtiene de la Red Española de Costes Hospitalarios (RECH), creada a partir de los registros de costes por paciente basados en actividades y CMBD. Los eventos adversos se han identificado mediante Indicadores de Seguridad del Paciente (validados en el Sistema Sanitario español) de la Agency of Healthcare Research and Quality, junto a indicadores del proyecto europeo EuroDRG. Resultados Se incluyen 245.320 episodios, con un coste de 1.308.791.871 Euros. Aproximadamente 17.000 episodios (6,8%) sufrieron un evento adverso, lo que representa un 16,2% del coste total. Los eventos adversos, ajustados por el Grupo Relacionado por el Diagnóstico, añaden un coste incremental medio que oscila entre 5.260 Euros y 11.905 Euros. Seis de los diez eventos adversos con mayor coste incremental son posteriores a intervenciones quirúrgicas. El coste incremental total de los eventos adversos es de 88.268.906Euros, un 6,7% adicional del total del gasto sanitario. Conclusiones Valorando su impacto, los eventos adversos representan relevantes costes que pueden revertirse en mejora de la calidad y la seguridad del sistema de salud (AU)

Objective To evaluate the incidence and costs of adverse events registered in an administrative dataset in Spanish hospitals from 2008 to 2010.MethodsA retrospective study was carried out that estimated the incremental cost per episode, depending on the presence of adverse events. Costs were obtained from the database of the Spanish Network of Hospital Costs. This database contains data from 12 hospitals that have costs per patient records based on activities and clinical records. Adverse events were identified through the Patient Safety Indicators (validated in the Spanish Health System) created by the Agency for Healthcare Research and Quality together with indicators of the EuroDRG European project. Results This study included 245,320 episodes with a total cost of 1,308,791,871 Euros. Approximately 17,000 patients (6.8%) experienced an adverse event, representing 16.2% of the total cost. Adverse events, adjusted by diagnosis-related groups, added a mean incremental cost of between Euros 5,260 and Euros11,905. Six of the 10 adverse events with the highest incremental cost were related to surgical interventions. The total incremental cost of adverse events was Euros 88,268,906, amounting to an additional 6.7% of total health expenditure. Conclusions Assessment of the impact of adverse events revealed that these episodes represent significant costs that could be reduced by improving the quality and safety of the Spanish Health System (AU)

[Assessing the economic impact of adverse events in Spanish hospitals by using administrative data]. / Impacto económico de los eventos adversos en los hospitales españoles a partir del Conjunto Mínimo Básico de Datos.

OBJECTIVE: To evaluate the incidence and costs of adverse events registered in an administrative dataset in Spanish hospitals from 2008 to 2010. METHODS: A retrospective study was carried out that estimated the incremental cost per episode, depending on the presence of adverse events. Costs were obtained from the database of the Spanish Network of Hospital Costs. This database contains data from 12 hospitals that have costs per patient records based on activities and clinical records. Adverse events were identified through the Patient Safety Indicators (validated in the Spanish Health System) created by the Agency for Healthcare Research and Quality together with indicators of the EuroDRG European project. RESULTS: This study included 245,320 episodes with a total cost of 1,308,791,871€. Approximately 17,000 patients (6.8%) experienced an adverse event, representing 16.2% of the total cost. Adverse events, adjusted by diagnosis-related groups, added a mean incremental cost of between €5,260 and €11,905. Six of the 10 adverse events with the highest incremental cost were related to surgical interventions. The total incremental cost of adverse events was € 88,268,906, amounting to an additional 6.7% of total health expenditure. CONCLUSIONS: Assessment of the impact of adverse events revealed that these episodes represent significant costs that could be reduced by improving the quality and safety of the Spanish Health System.

Responsabilidad sanitaria de la notificación de acontecimientos adversos: ¿puede estar tranquilo el profesional que notifica? / Responsibility for reporting adverse events: can notifying health professional be assured?

No disponible