Analysis of the safety culture in a Cardiology Unit managed by processes

La cultura sobre seguridad se perfila como uno de los requisitos para evitar la aparición de efectos adversos, sin embargo no se ha estudiado en el ámbito de la cardiología. El objetivo es evaluar la cultura de seguridad en una unidad de cardiología que tiene implantado y certificado un sistema integrado de gestión de calidad y riesgos para la seguridad del paciente. Método: Se realizó un estudio observacional trasversal en 2 años consecutivos utilizando la encuesta Hospital Survey on Patient Safety Culture de la «Agency for Healthcare Research and Quality» en su versión española (42 ítems agrupados en 12 dimensiones) sobre todo el personal. Se comparó el porcentaje de respuestas positivas de cada dimensión en 2014 y 2015, así como con los datos a nivel nacional y en EE. UU., siguiendo las recomendaciones establecidas. Resultados: La valoración global, sobre un máximo de 5, fue de 4.5 en 2014 y de 4.7 en 2015. Identificamos 7 dimensiones como fortaleza. Las peor valoradas fueron: Dotación de personal, Apoyo de la gerencia y Trabajo en equipo entre unidades. La comparación mostró superioridad en todas las dimensiones a nivel nacional, y en 8 respecto a los datos del registro americano. Conclusiones: La cultura de seguridad en una unidad de cardiología con un sistema integrado de gestión de calidad y riesgos y seguridad del paciente es elevada, superior a la nacional en todas sus dimensiones y en la mayoría de ellas respecto al registro de EE. UU.The safety culture is one of the requirements to prevent the occurrence of adverse effects, however has not been studied in the field of cardiology. The objective is to evaluate the safety culture in a cardiology unit has implemented and certified an integrated quality and risk management for patient safety system. Methods: A transversal observational study was made in 2 consecutive years using the survey “Hospital Survey on Patient Safety Culture” of the “Agency for Healthcare Research and Quality” in its Spanish version (42 items grouped into 12 dimensions) in all staff. The percentage of positive responses in each dimension in 2014 and 2015 were compared, as well as national data and United States data, following the established rules. Results: The overall assessment of a possible 5, was 4.5 in 2014 and 4.7 in 2015. We identified seven dimensions as a fortress. The worst rated were: staffing, management support and teamwork between units. The comparison showed superiority in all dimensions respect to national data, and 8 respect to American data. Conclusions: The safety culture in a Cardiology Unit with an integrated quality and risk management and patient safety system is high, higher than the national in all its dimensions and in most of them respect to the United States

Long-term prognostic impact of anticoagulation on patients with atrial fibrillation undergoing hemodialysis

Introducción y objetivos: La evidencia de la eficacia y seguridad de la anticoagulación oral con dicumarínicos en pacientes en hemodiálisis con fibrilación auricular (FA) es controvertida. El objetivo de nuestro estudio es evaluar las implicaciones a nivel pronóstico a largo plazo de la anticoagulación con dicumarínicos en una cohorte de pacientes con FA no valvular en programa de hemodiálisis debido a insuficiencia renal terminal. Métodos: Estudio observacional retrospectivo con inclusión consecutiva de 74 pacientes en hemodiálisis con FA. El periodo de inclusión fue de enero de 2005 a octubre de 2016. Las variables principales fueron mortalidad por todas las causas, reingresos no programados y sangrados. Resultados: La edad media fue de 75 ± 10 años; el 66,2% fueron hombres y 43 pacientes (58,1%) recibieron acenocumarol. Durante una mediana de seguimiento de 2,40 años (IQR = 0,88-4,15), el acenocumarol no demostró beneficio en supervivencia [HR = 0,76, IC 95% (0,35-1,66), p = 0,494]. Sin embargo, los pacientes anticoagulados presentaron más riesgo de hospitalizaciones cardiovasculares recurrentes [IRR = 3,94, IC 95% (1,06-14,69), p = 0,041]. Hubo una tendencia a un aumento de hospitalizaciones repetidas de causa isquémica en los pacientes anticoagulados [IRR = 5,80, IC 95% (0,86-39,0), p = 0,071]. Se observó una tendencia estadística hacia un mayor riesgo de sangrados totales recurrentes en los anticoagulados [IRR = 4,43, IC 95% (0,94-20,81), p = 0,059]. Conclusiones: En el presente estudio, la anticoagulación oral con acenocumarol en pacientes en hemodiálisis con FA no supuso un aumento de la supervivencia, y sin embargo, se asoció con un mayor riesgo de hospitalizaciones de causa cardiovascular y una tendencia a mayor riesgo de sangrados totales.Introduction and objectives: Evidence for the efficacy and safety of oral anticoagulation with dicumarines in patients with atrial fibrillation (AF) on hemodialysis is controversial. The aim of our study is to evaluate the long-term prognostic implications of anticoagulation with dicumarines in a cohort of patients with non-valvular AF on a hemodialysis program due to end-stage renal disease. Methods: Retrospective, observational study with consecutive inclusion of 74 patients with AF on hemodialysis. The inclusion period was from January 2005 to October 2016. The primary variables were all-cause mortality, non-scheduled readmissions and bleeding during follow-up. Results: Mean age was 75 ± 10 years; 66.2% were men and 43 patients (58.1%) received acenocoumarol. During a median follow-up of 2.40 years (IQR = 0.88-4.15), acenocoumarol showed no survival benefit [HR = 0.76, 95% CI (0.35-1.66), p = 0.494]. However, anticoagulated patients were at increased risk of recurrent cardiovascular hospitalizations [IRR = 3.94, 95% CI (1.06-14.69), p = 0.041]. There was a trend towards an increase in repeated hospitalizations of ischemic cause in anticoagulated patients [IRR = 5.80, 95% CI (0.86-39.0), p = 0.071]. There was a statistical trend towards a higher risk of recurrent total bleeding in patients treated with acenocoumarol [IRR = 4.43, 95% CI (0.94-20.81), p = 0.059]. Conclusions: In this study, oral anticoagulation with acenocoumarol in patients with AF on hemodialysis did not increase survival. However, it was associated with an increased risk of hospitalizations of cardiovascular causes and a tendency to an increased risk of total bleeding

Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials

An amendment to this paper has been published and can be accessed via the original article

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal