[Evaluation and Improvement of the Informed Consent Documents in 9 Hospitals, Spain]. / Evaluación y mejora de la calidad de los documentos de consentimiento informado en nueve hospitales del servicio murciano de salud.

BACKGROUND: Informed consent forms are very important in the process of medical information. The aim of this study was to assess the changes in the formal quality levels of these documents, as a result of corrective measures implemented after the first evaluation. METHODS: Complete cycle of evaluation and quality improvement, with 4 assessments between the years 2007 and 2013. They were assessed 19 criteria in 3,045 documents belonging to 9 hospitals of Murcian Health Service. In the first evaluation the universe was studied and in the others a random sample. From the results of the first assessment corrective measures were implemented. To evaluate its effectiveness the percentage of non-observances per criteria was obtained, calculating the percentage of relative improvement between the first and the last evaluation. To assess the variability among hospitals the high-low ratio in the average number of defects per document was obtained. RESULTS: The percent of improvement achieved was 40.8%. This ranged from 94% in the name of the centre to 17.6% in the relevant consequences, being statistically significant in 16 of the 19 criteria. The average number of defects per document decreased from 7.6 to 4.5, with a high-low ratio among hospitals of 8.33. CONCLUSIONS: The improvement achieved in the quality of informed consent documents is related to the effectiveness of corrective measures implemented.

Evaluación y mejora de la calidad de los documentos de consentimiento informado en nueve hospitales del servicio murciano de salud / Evaluation and Improvement of the Informed Consent Documents in 9 Hospitals, Spain

Fundamentos: Los documentos de consentimiento informado tienen gran importancia en el proceso de información médica. El objetivo de este trabajo fue evaluar los cambios producidos en los niveles de calidad formal de estos documentos como consecuencia de las medidas correctoras puestas en marcha tras la primera evaluación. Métodos: Ciclo completo de evaluación y mejora de la calidad con 4 evaluaciones entre los años 2007 y 2013. Se valoraron 19 criterios en 3.045 documentos pertenecientes a 9 hospitales del Servicio Murciano de Salud. En la primera evaluación se estudiaron todos los documentos y en las restantes una muestra aleatoria. A partir de los resultados de la primera evaluación se pusieron en marcha medidas correctoras. Para valorar su efectividad se calculó el porcentaje de incumplimiento de los criterios y el porcentaje de mejora relativa entre la primera y la última evaluación Para valorar la variabilidad se obtuvo la razón de variación entre hospitales en el promedio de defectos por documento. Resultados: La mejora alcanzada fue del 40,8%. Esta oscilaba entre el 94% en el nombre del centro y el 17,6% en las consecuencias relevantes, siendo las diferencias encontradas en 16 de los 19 criterios estadísticamente significativas. El promedio de defectos por documento descendió de 7,6 a 4,5 con una razón de variación entre hospitales de 8,33. Conclusiones: La mejora alcanzada en la calidad de los documentos de consentimiento informado está relacionada con la efectividad de las medidas correctoras puestas en marcha (AU)

Background: Informed consent forms are very important in the process of medical information. The aim of this study was to assess the changes in the formal quality levels of these documents, as a result of corrective measures implemented after the first evaluation. Methods: Complete cycle of evaluation and quality improvement, with 4 assessments between the years 2007 and 2013. They were assessed 19 criteria in 3,045 documents belonging to 9 hospitals of Murcian Health Service. In the first evaluation the universe was studied and in the others a random sample. From the results of the first assessment corrective measures were implemented. To evaluate its effectiveness the percentage of non-observances per criteria was obtained, calculating the percentage of relative improvement between the first and the last evaluation. To assess the variability among hospitals the high-low ratio in the average number of defects per document was obtained. Results: The percent of improvement achieved was 40.8%. This ranged from 94% in the name of the centre to 17.6% in the relevant consequences, being statistically significant in 16 of the 19 criteria. The average number of defects per document decreased from 7.6 to 4.5, with a high-low ratio among hospitals of 8.33. Conclusions: The improvement achieved in the quality of informed consent documents is related to the effectiveness of corrective measures implemented (AU)

Assessment of protocols for surgical-site preparation in a regional network of hospitals.

Surgical-site infection is a preventable adverse event. Implementation of good practices for correct surgical-site preparation can contribute to lessen this safety problem. The objective of this study was to describe the presence and quality of protocols on surgical-site preparation in the Murcia (Spain) regional network of public hospitals. The indicator "existence of protocol for surgical-site preparation" was assessed, as well as the formal quality (expected attributes) and contents (compared to current evidence-based recommendations) of existing documents. Seven of the nine hospitals have a protocol for surgical-site preparation. Opportunities to improve have been identified in relation to the protocols' formal quality and contents. Recommendations related to skin asepsis are incomplete and those related to hair removal contradict existing evidence. Most hospitals have protocols for surgical-site preparation; however, there is great room for improvement, in relation to their expected attributes and to the inclusion of evidence-based recommendations.

Assessment of protocols for surgical-site preparation in a regional network of hospitals / Avaliação da normatização da preparação pré-cirúrgica em uma rede regional de hospitais / Evaluación de la normalización de la preparación prequirúrgica en una red regional de hospitales

Surgical-site infection is a preventable adverse event. Implementation of good practices for correct surgical-site preparation can contribute to lessen this safety problem. The objective of this study was to describe the presence and quality of protocols on surgical-site preparation in the Murcia (Spain) regional network of public hospitals. The indicator "existence of protocol for surgical-site preparation" was assessed, as well as the formal quality (expected attributes) and contents (compared to current evidence-based recommendations) of existing documents. Seven of the nine hospitals have a protocol for surgical-site preparation. Opportunities to improve have been identified in relation to the protocols' formal quality and contents. Recommendations related to skin asepsis are incomplete and those related to hair removal contradict existing evidence. Most hospitals have protocols for surgical-site preparation; however, there is great room for improvement, in relation to their expected attributes and to the inclusion of evidence-based recommendations.

A infecção do sítio cirúrgico é evento adverso, possível de prevenir mediante a implementação de boas práticas de preparação pré-cirúrgica. Este estudo teve por objetivo descrever a existência e qualidade da protocolização da preparação pré-cirúrgica em uma rede regional de hospitais públicos de Múrcia, Espanha. Avaliou-se o indicador Existência de protocolo/norma de preparação pré-cirúrgica, analisando-se a qualidade formal (atributos) e de conteúdo (presença de recomendações baseadas em evidência) dos documentos existentes. Sete (de nove) hospitais comprovaram que tinham protocolos de preparação pré-cirúrgica. Identificaram-se oportunidades de melhoria da qualidade formal e de conteúdo dos protocolos. As recomendações sobre assepsia estavam incompletas na maioria dos documentos, e aquelas de eliminação do pelo mostraram-se contrárias à evidência. A preparação pré-cirúrgica está protocolizada na maioria dos hospitais, mas a qualidade dos protocolos é deficiente, assim como a padronização das práticas baseadas em evidência.

La infección del sitio quirúrgico es un evento adverso prevenible mediante la implementación de buenas prácticas de preparación prequirúrgica. El objetivo del presente estudio fue describir la existencia y calidad de protocolización de la preparación prequirúrgica en la red regional de hospitales públicos de Murcia (España). Se evaluó el indicador "Existencia de protocolo/norma de preparación prequirúrgica", analizando la calidad formal (atributos) y de contenido (presencia de recomendaciones basadas en evidencia) de los documentos existentes. Siete (de nueve) hospitales acreditaron tener protocolos de preparación prequirúrgica. Existen oportunidades de mejora en la calidad formal y de contenido. Las recomendaciones sobre asepsia son incompletas en la mayoría de los documentos, y las de eliminación del vello contrarias a la evidencia. La preparación prequirúrgica está protocolizada en la mayoría de hospitales, pero la calidad de los protocolos es deficiente, así como la normalización de prácticas basadas en evidencia.