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Vol. 36. Issue 4.
Pages 231-239 (July - August 2021)
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Vol. 36. Issue 4.
Pages 231-239 (July - August 2021)
Original Article
DOI: 10.1016/j.jhqr.2021.03.007
The Study on Safety in Hospitals in the Region of Madrid (ESHMAD) design: Screening and analysis of incidents and adverse events
Diseño del Estudio sobre la Seguridad de los Pacientes en Hospitales de la Comunidad de Madrid (ESHMAD): metodología del cribado y análisis de incidentes y eventos adversos
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J.L. Valencia-Martína,b, J. Martin-Delgadoc,d, A. Pardo-Hernándeze,f, J. Vicente-Guijarrob,g,
Corresponding author
jorge.vicente@salud.madrid.org

Corresponding author.
, J. Requena-Pucheh,i, J.M. Aranaz Andrésb,g,j, ESHMAD Director Group, external advisers 1
a Servicio de Medicina Preventiva y Salud Pública, Hospital Universitario Virgen del Rocío, 41013 Sevilla, Spain
b Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), 28034 Madrid, Spain
c Atenea Research Group, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO), 46035 Valencia, Spain
d Health Services & Policy Research Group, University of Exeter, EX1 2LU Exeter, United Kingdom
e Subdirección General de Calidad Asistencial y Cooperación Sanitaria, Consejería de Sanidad de la Comunidad de Madrid, 28013 Madrid, Spain
f Departamento de Especialidades Médicas y Salud Pública, Universidad Rey Juan Carlos, 28933, Madrid, Spain
g Servicio de Medicina Preventiva y Salud Pública, Hospital Universitario Ramón y Cajal, IRYCIS, 28034 Madrid, Spain
h Hospital General Universitario de Elda, 03600 Alicante, Spain
i Departamento de Salud Pública, Historia de la Ciencia y Ginecología, Universidad Miguel Hernández de Elche, 03202 Elche, Alicante, Spain
j CIBER Epidemiología y Salud Pública (CIBERESP), Spain
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Table 1. Independent variables collected in the study.
Table 2. Characteristics of enrolled hospitals.
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Abstract
Background

A Study related to Safety in Hospitals in the Region of Madrid (ESHMAD) was carried out in order to determine the prevalence, magnitude and characteristics of adverse events in public hospitals. This work aims to define a useful methodology for the multicenter study of adverse events in the Region of Madrid, to set out the preliminary results of the hospital enrollment and to establish a model of a strategy of training of trainers for its implementation.

Methods

ESHMAD was a multicenter, double phase study for the estimation of adverse events and incidents prevalence across the Region of Madrid. First phase comprehended a 1-day cross-sectional prevalence study, in which it was collected, through a screening guide, information about admission, patient characteristics, intrinsic and extrinsic risk factors, and the possibility of an adverse event or incident had happened during the hospitalization. Second phase was a retrospective nested cohort study, in which it was used a Modular Review Form for reviewing the positive screenings of the first phase, identifying in each possible adverse event or incident the classification of the patient safety event, clinical onset, root, and associated causes and factors, impact, and preventability. A pilot study was performed in an Internal Medicine Unit of a tertiary hospital.

Results

34 public hospitals participated, belonging to 6 healthcare categories and with more than 10,000 hospitalisations aggregate capacity. 72 coordinators were enrolled in the strategy of training of trainers, which was performed through five on-site training workshops. In the pilot study, 45.2% patients were identified with at least one positive event of the screening. Of them, 48.1% (25 positive events) were identified as truly AE, with a result of 0.29 EA per analyzed patient.

Conclusions

The ESHMAD protocol allows to estimate the prevalence of adverse events, and the strategy of training of trainers facilitated the spread of the research methodology among the participants.

Keywords:
Patient safety
Cross-sectional studies
Hospital records
Prevalence
Research design
Resumen
Introducción

El Estudio sobre la Seguridad de los Pacientes en Hospitales de la Comunidad de Madrid (ESHMAD), fue desarrollado para estimar la prevalencia, magnitud y características de los eventos adversos en hospitales públicos. Este trabajo pretende definir una metodología útil para el estudio multicéntrico de eventos adversos en hospitales de la Comunidad de Madrid, exponer resultados preliminares sobre el conjunto de los hospitales reclutados y establecer un modelo de estrategia de preparación de formadores para su implementación.

Métodos

ESHMAD fue realizado como un estudio multicéntrico de doble fase para estimar la prevalencia de eventos adversos e incidentes de seguridad. La primera fase consistió en un corte transversal en el que se recopiló, a través de una guía de cribado, información del ingreso, características del paciente, factores de riesgo intrínsecos y extrínsecos, y la posibilidad de que haya ocurrido un incidente o evento adverso durante la estancia. La segunda fase fue un estudio retrospectivo de cohorte anidada en el que se utilizó un formulario de Revisión Modular para los cribados positivos, identificando en cada posible incidente o evento adverso el tipo de evento de seguridad del paciente, características clínicas, causas, factores asociados, impacto y evitabilidad. Se realizó un estudio piloto en una Unidad de Medicina Interna de un hospital de tercer nivel.

Resultados

Participaron 34 hospitales públicos, pertenecientes a seis niveles asistenciales y con una capacidad conjunta mayor de 10.000 pacientes ingresados. Se reclutaron 72 coordinadores para la estrategia de preparación de formadores. En el estudio piloto, un 45,2% de los pacientes presentaron al menos un ítem durante el cribado. De ellos, el 48,1% se consideraron verdaderos eventos adversos, con un resultado de 0,29 eventos adversos por paciente.

Conclusiones

El protocolo ESHMAD permite estimar la prevalencia de eventos adversos y la estrategia de preparación de formadores facilita la difusión de la metodología del proyecto entre los participantes.

Palabras clave:
Seguridad del paciente
Estudios transversales
Registros de hospitales
Prevalencia
Proyectos de investigación

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