Dejar de hacer lo que no hay que hacer / Ceasing to do what shouldn't be done

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[In case of an adverse event don´t forget to say sorry]. / Si ocurrió un evento adverso piense en decir "lo siento".

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.

[Proposals for the study of the second victim phenomenon in Spanish Primary Care Centres and Hospitals]. / Propuestas para el estudio del fenómeno de las segundas víctimas en España en atención primaria y hospitales.

OBJECTIVE: To identify the Spanish studies conducted since 2014 on second victims. Its main objective was to identify a global response to the second victim problem, assessing the impact of adverse events (AE) on caregivers and developing of a set of tools to reduce their impact. METHOD: Descriptive studies in which a sample of managers and safety coordinators from Hospitals and Primary Care were surveyed to determine the activities being carried out as regards second victims, as well as a sample of health professionals to describe their experience as a second victims. Qualitative studies are included to design a guide of recommended actions following an AE, an online awareness program on this phenomenon, an application (app) with activities on safety that are the responsibility of the managers, and a web tool for the analysis of AEs. RESULTS: A total of 1,493 professionals (managers, safety coordinators and caregivers) from eight Spanish regions participated. The guide of recommendations, the online program, and the developed applications are accessible on the website: www.segundasvictimas.es, which has received more than 2,500 visits in one year. DISCUSSION: Study results represent a starting point in the study of the second victim phenomenon in Spain. The tools developed raise the awareness of the medical healthcare community about this problem, and provide professionals with basic skills to manage the impact of AEs.

Propuestas para el estudio del fenómeno de las segundas víctimas en España en atención primaria y hospitales / Proposals for the study of the second victim phenomenon in Spanish primary care centres and hospitals

Objetivo. Identificar los enfoques metodológicos y avances de un conjunto de estudios que se han realizado en España desde 2014 en la línea de investigación sobre segundas víctimas, mediante la evaluación del impacto de los eventos adversos (EA) en los profesionales sanitarios. Elaborar un conjunto de herramientas de ayuda para reducir su impacto. Método. Estudio descriptivo en el que se encuestó a directivos y coordinadores de seguridad de hospitales y atención primaria para conocer qué actividades se estaban llevando a cabo en materia de segundas víctimas, y a profesionales asistenciales para describir su posible experiencia como segundas víctimas, junto a estudios cualitativos para diseñar una guía de acciones recomendadas tras un EA, un programa online de sensibilización sobre este fenómeno, una app con actividades en seguridad responsabilidad de los directivos y una herramienta web para el análisis de los EA. Resultados. Participaron 1.493 profesionales (directivos, coordinadores de seguridad y personal asistencial) de 8 comunidades autónomas. La guía de recomendaciones, el programa online y las aplicaciones desarrolladas se encuentran accesibles en el sitio web: www.segundasvictimas.es, que recibió más de 2.500 visitas en un año. Discusión. Los resultados del estudio representan un punto de partida en el estudio del fenómeno de las segundas víctimas en España. Las herramientas desarrolladas sensibilizan a la comunidad sanitaria acerca de esta problemática y dotan a los profesionales de habilidades para gestionar el impacto de los EA (AU)

Objective. To identify the Spanish studies conducted since 2014 on second victims. Its main objective was to identify a global response to the second victim problem, assessing the impact of adverse events (AE) on caregivers and developing of a set of tools to reduce their impact. Method. Descriptive studies in which a sample of managers and safety coordinators from Hospitals and Primary Care were surveyed to determine the activities being carried out as regards second victims, as well as a sample of health professionals to describe their experience as a second victims. Qualitative studies are included to design a guide of recommended actions following an AE, an online awareness program on this phenomenon, an application (app) with activities on safety that are the responsibility of the managers, and a web tool for the analysis of AEs. Results. A total of 1,493 professionals (managers, safety coordinators and caregivers) from eight Spanish regions participated. The guide of recommendations, the online program, and the developed applications are accessible on the website: www.segundasvictimas.es, which has received more than 2,500 visits in one year. Discussion. Study results represent a starting point in the study of the second victim phenomenon in Spain. The tools developed raise the awareness of the medical healthcare community about this problem, and provide professionals with basic skills to manage the impact of AEs (AU)

Association of BRCA1 germline mutations in young onset triple-negative breast cancer (TNBC)

BACKGROUND: BRCA1-associated breast cancers have been associated to a triple-negative phenotype. The prevalence of BRCA1 germline mutations in young onset TNBC based on informativeness of family history has not been reported. PATIENTS AND METHODS: From January 2008 to May 2009 were collected blood and tumor samples from patients with TNBC younger than 50 years and without a family history of breast and ovarian cancer in first- and second-degree relatives. Analysis of BRCA1 germline mutations was made. Age at diagnosis and informativeness of family history (presence of female in first- and second-degree relatives alive until age 45) was collected in all cases. Immunohistochemistry of basal-like features was performed centrally in all available tumors. RESULTS: Seven pathogenic mutations were detected in 92 patients (7.6 %), two of them in patients younger than 35 years (28.6 %) (Fisher's exact test, p = 0.631). Three non-classified variants were detected (3.2 %). Family history was informative in two patients with a pathogenic mutation (28.6 %) and not informative in five (71.4 %) (Fisher's exact test, p = 0.121). Of the seven patients with a pathogenic mutation, four had a basal-like phenotype. CONCLUSION: Patients with apparently sporadic TNBC younger than 50 years and a non-informative family history are candidates for germline genetic testing of BRCA1 (AU)

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Association of BRCA1 germline mutations in young onset triple-negative breast cancer (TNBC).

BACKGROUND: BRCA1-associated breast cancers have been associated to a triple-negative phenotype. The prevalence of BRCA1 germline mutations in young onset TNBC based on informativeness of family history has not been reported. PATIENTS AND METHODS: From January 2008 to May 2009 were collected blood and tumor samples from patients with TNBC younger than 50 years and without a family history of breast and ovarian cancer in first- and second-degree relatives. Analysis of BRCA1 germline mutations was made. Age at diagnosis and informativeness of family history (presence of female in first- and second-degree relatives alive until age 45) was collected in all cases. Immunohistochemistry of basal-like features was performed centrally in all available tumors. RESULTS: Seven pathogenic mutations were detected in 92 patients (7.6 %), two of them in patients younger than 35 years (28.6 %) (Fisher's exact test, p = 0.631). Three non-classified variants were detected (3.2 %). Family history was informative in two patients with a pathogenic mutation (28.6 %) and not informative in five (71.4 %) (Fisher's exact test, p = 0.121). Of the seven patients with a pathogenic mutation, four had a basal-like phenotype. CONCLUSION: Patients with apparently sporadic TNBC younger than 50 years and a non-informative family history are candidates for germline genetic testing of BRCA1.

[Benign positional vertigo, an armchair for diagnosis and for treatment: description and significance]. / Vertige positionnel paroxystique bénin, un fauteuil au service du diagnostic et du traitement: description et intérêt.

OBJECTIVES: The benign positional vertigo is a very frequent pathology. It requires to establish the diagnosis, to fixe the head in some positions to get various nystagmus which are observed directly or by video-nystagmoscopy or analyzed by video-nystagmography. PURPOSE: To describe the diagnostic and therapeutical interests of a special armchair, now available, whose characteristics are to be able to swivel around two axes of vertical and horizontal rotations, the patient being completely interdependent of the armchair. It thus makes it possible to place the patient's head in position wished with a high degree of accuracy and facility. METHODS: After a short description of the characteristics of armchairs classically used, the authors describe in detail this new armchair Its geometrical characteristics are reported and its capacities, like its mode of use: fixing of the patient with armchair then mobilization of the unit "armchair-patient" and setting in position of the head at the point of the space desired by the ENT. RESULTS: The authors report the main advantages of this armchair. It allows a great accuracy of movement given to the semicircular canals, a possible mobilization with an amplitude until there ever reached, a significant reduction of the proprioceptive entries of patient, a perfect safety of the examination, a possible mobilization of obese or arthritic patients and, finally, a very increased comfort for the patient himself. Finally future technological developments possible are brought back. CONCLUSION: Thanks to the use of the armchair of mechanical assistance, the diagnosis and treatment of benign positional vertigo appear more certain, more precise and more practical at the same time for the medical doctor and the patients. A multicentric study is in process to show its interest in this pathology.

[Evaluation of the clinical practice of Informed Consent in clinical trials]. / Evaluación de la práctica clínica del Consentimiento Informado en los ensayos clínicos.

On the basis of existing publications it would seem legitimate to assume that in a clinical test (CT) the difficulties inherent in the process of researcher-participant communication are in practice greater than desired. Similarly, the hypothesis is adopted that difficulties exist in the formal legibility of the documents of Informed Consent. We present the results of a transversal study made of a random sample (n=160) of the CTs approved by the Ethical Committee of Clinical Research (CEIC) of Navarra during the years 1995-1999. The results found were: in 69.7% of the cases the researcher filed the documents corresponding to the CT, the Informed Consent appears signed by the researcher in 56.6% of the CTs, and in more than 83% of the cases the written information shows shortcomings in legibility, which confirms the correctness of the hypothesis and permits the detection of areas where improvements need to be developed.

Evaluación de la práctica clínica del Consentimiento Informado en los ensayos clínicos / Evaluation of the clinical practice of Informed Consent in clinical trials

Sobre la base de las publicaciones existentes parece lícito suponer que en un ensayo clínico (EC), las dificultades inherentes al proceso de comunicación investigador-participante son en la práctica mayores que las deseadas. Se asume asimismo la hipótesis de que existen deficiencias en la legibilidad formal de los documentos de consentimiento informado. Se presentan los resultados de un estudio transversal realizado en una muestra aleatoria (n= 160) de los EC aprobados por el CEIC de Navarra durante los años 1995-1999. Los resultados encontrados (en el 69,7% de los casos el investigador archiva la documentación correspondiente al EC, el CI aparece firmado por el investigador en el 56,6% de los EC, y en más del 83% de los casos la información escrita presenta una deficiente legibilidad) confirman la bondad de la hipótesis y detectan áreas de mejora a desarrollar (AU)

On the basis of existing publications it would seem legitimate to assume that in a clinical test (CT) the difficulties inherent in the process of researcher-participant communication are in practice greater than desired. Similarly, the hypothesis is adopted that difficulties exist in the formal legibility of the documents of Informed Consent. We present the results of a transversal study made of a random sample (n=160) of the CTs approved by the Ethical Committee of Clinical Research (CEIC) of Navarra during the years 1995-1999. The results found were: in 69.7% of the cases the researcher filed the documents corresponding to the CT, the Informed Consent appears signed by the researcher in 56.6% of the CTs, and in more than 83% of the cases the written information shows shortcomings in legibility, which confirms the correctness of the hypothesis and permits the detection of areas where improvements need to be developed (AU)

Estudio de brotes nosocomiales / Study of nocosomial outbreaks

Se revisan los pasos básicos de la investigación de brotes (determinación de la naturaleza y gravedad de la epidemia, definición de caso, confirmación y búsqueda de casos, establecimiento de la tasa basal, epidemiología descriptiva y análisis de la misma, medidas de control, información y seguimiento).Se pone de manifiesto la necesidad de que cualquier estudio de brotes se realice en el contexto de un equipo multidisciplinar del que formarán parte, cuando menos, un epidemiólogo ( que coordinará las actuaciones), un microbiólogo y un clínico. Este trabajo coordinado posibilita el éxito de la investigación y la posterior adopción de medidas de prevención y control que permitan romper la cadena de transmisión en sus puntos críticos. (AU)

Programa de minimización de riesgos biológicos asociados a la infraestructura hospitalaria: funciones, actividades, responsabilidades / Program for minimising biological risks associated with hospital infrastructure: functions, activities, responsibilities

Los objetivos de este artículo son identificar y describir los gérmenes que con más frecuencia generan infecciones nosocomiales en cuyo mecanismo de transmisión están implicadas instalaciones hospitalarias; establecer las instalaciones críticas del hospital para prevenir la aparición de estas infecciones hospitalarias, indicar las medidas de mantenimiento, vigilancia y control recomendadas en la evidencia disponible y finalmente, proponer unas pautas de actuación sobre las instalaciones hospitalarias implicadas ante la aparición de casos. Los gérmenes que con más frecuencia generan infecciones nosocomiales en relación con la infraestructura hospitalaria son Aspergillus(A), Legionella(L), y M. Tuberculosis (Mt). Las principales áreas críticas en los hospitales son las instalaciones de aire acondicionado y ventilación de habitaciones de pacientes inmunocomprometidos (UVI, transplantes) o pacientes contagiosos (tuberculosis activa), los quirófanos, y la red de abastecimiento de agua. Se recuerdan las actuaciones de limpieza, mantenimiento, vigilancia y control y se propone la elaboración de un plan de actuación coordinado en cada hospital entre los servicios implicados en este proceso: Servicio de Obras y Mantenimiento, Unidad de Limpieza, Servicio de Medicina Preventiva y Gestión de Calidad, y Servicio de Microbiología liderado por la dirección de cada centro (AU)

Control de la infección en el personal sanitario II: Enfermedades vehiculadas por vía aérea. Enfermedades producidas por gérmenes emergentes / Control of infection in health personnel II: immunisation. Diseases carried by the air. Diseases caused by emergent germs

El control medio ambiental para la prevención de las enfermedades transmitidas a través del aire presenta dificultades importantes en el medio hospitalario. Se revisan las medidas generales de control susceptibles de utilización, así como las específicas en razón del mecanismo de transmisión específico ( transmisión aérea o por gotitas).Dada la trascendencia y repercusión de la tuberculosis en el personal sanitario se detallan las actuaciones principales a realizar para su prevención y control. (AU)

[Minor abnormalities of the internal ear. Radioclinical correlations]. / Malformations mineures de l'oreille interne. Corrélations radio-cliniques.

Moderately severe cochleovestibular disorders of often late onset may arise from minor dysplasias of the internal ear. Diagnosis of these bone dysplasias is radiologic. The problem that arises is that of the indications for radiotomography of the internal ear, insofar as on the one hand no certain radioclinical equivalence exists, and on the other hand this radiologic examination is of greater diagnostic than therapeutic value.

[Bacteria seen in acute otitis media in children hospitalised for infectious diseases]. / Recensement des bactéries trouvées lors d'otites moyennes aiguës chez des enfants hospitalisés pour maladie infectieuse.

The authors draw the following conclusion on the basis of 85 cases of children hospitalised for infectious diseases : -amongst childhood infectious diseases, measles between the ages of 7 and 14 is most commonly associated with complications in the form of otitis (50 as against 19 other diseases). -Staphylococcus aureus was the dominant organism in measles otitis, but in addition to a particular affinity of this organism for measles, it is also necessary to bear in mind contamination by hospital flora, amongst which staphylococci are especially representative, in view of the late development of the otitis and the multiresistance of staphylococci isolated after the 4th day of admission. -Bacteria seen in other exanthematous fevers were more varied but if there is not rapid cure of the otitis, the generally sensitive flora is replaced by a multiresistant hospital flora, once again dominated by staphylococcus aureus and Gram negative bacilli. - The role played by such flora was seen to occur particularly on the 4th day of hospitalization, implying a twofold increase in the period of hospitalisation when compared with cases where paracentesis was performed before this time.