RESUMO
ANTECEDENTES Y OBJETIVOS: El Wound-QoL es un cuestionario validado para medir la calidad de vida en pacientes con heridas crónicas, que fue desarrollado originalmente para su uso en alemán. El objetivo de este estudio fue traducir el cuestionario Wound-QoL para su uso en la práctica clínica y estudios de investigación en España, así como validar esta versión. MATERIALES Y MÉTODOS: Se realizaron dos traducciones independientes del Wound-QoL, directa e inversa, a partir de la versión original en alemán, seguidas de un consenso de expertos sobre las versiones resultantes. Después de su perfeccionamiento se realizó un estudio piloto y posteriormente el estudio de validación. RESULTADOS: Se incluyó un total de 115 pacientes. La edad media fue de 69,5 (DE 14,5) años, y el 60,0% eran mujeres. La versión española del Wound-QoL mostró una excelente consistencia interna (índice alfa de Cronbach > 0,8 en todas las escalas). El análisis factorial dio como resultado las mismas escalas que la versión original. Se objetivaron características satisfactorias de la distribución de la puntuación global y de las subescalas. La validez de constructo y la validez convergente con otros resultados (calidad de vida genérica, tasa de curación) fueron satisfactorias. La gran mayoría de los pacientes consideraron que el cuestionario era una herramienta sencilla y factible. El tiempo medio necesario para completar el cuestionario fue de 5 minutos. El 99,1% de los participantes consideraron que las preguntas eran fáciles de entender y el 94,7% declaró que personal. CONCLUSIONES: La versión española del Wound-QoL muestra una excelente validez en la práctica clínica. Por lo tanto, puede ser recomendada para su uso tanto en la rutina clínica como en los ensayos
BACKGROUND AND AIMS: The Wound-QoL is a validated and feasible questionnaire for measuring disease-specific health-related quality of life in chronic wounds, originally developed for use in German. The objective of this study was to translate the Wound-QoL for use in clinical care and in clinical trials in Spain and to validate this version. MATERIALS AND METHODS: Two independent fourth- and back translations of the Wound-QoL from the original German version were conducted, followed by an expert consensus of the resulting versions. After refinement, the final tool was piloted in N = 10 patients and then used in the validation study. RESULTS: A total of 115 patients were recruited. Mean age was 69.5 (SD 14.5) years, 60.0% were female. The Spanish version of Wound-QoL showed high internal consistency (Cronbach's alpha > 0.8 in all scales). Factor analysis resulted in the same scales as the original version. There were satisfactory distribution characteristics of the global score and the subscales. Construct validity and convergent validity with other outcomes (generic QoL, healing rate) were satisfactory. The vast majority of patients considered the Wound-QoL a simple and feasible tool. Mean time needed for completing the questionnaire was 5 minutes. Overall, 99.1% of the participants found it easy to understand the questions and 94.7% stated that the questionnaire suits the personal situation. CONCLUSIONS. The Spanish version of the Wound-QoL shows good validity in clinical practice. It can be recommended for use in clinical routine and trials
Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Inquéritos e Questionários/normas , Traduções , Qualidade de Vida , Ferimentos e Lesões/fisiopatologia , Estudos Prospectivos , Reprodutibilidade dos Testes , Espanha , Doença CrônicaRESUMO
BACKGROUND AND AIMS: The Wound-QoL is a validated and feasible questionnaire for measuring disease-specific health-related quality of life in chronic wounds, originally developed for use in German. The objective of this study was to translate the Wound-QoL for use in clinical care and in clinical trials in Spain and to validate this version. MATERIALS AND METHODS: Two independent fourth- and back translations of the Wound-QoL from the original German version were conducted, followed by an expert consensus of the resulting versions. After refinement, the final tool was piloted in N=10 patients and then used in the validation study. RESULTS: A total of 115 patients were recruited. Mean age was 69.5 (SD 14.5) years, 60.0% were female. The Spanish version of Wound-QoL showed high internal consistency (Cronbach's alpha>0.8 in all scales). Factor analysis resulted in the same scales as the original version. There were satisfactory distribution characteristics of the global score and the subscales. Construct validity and convergent validity with other outcomes (generic QoL, healing rate) were satisfactory. The vast majority of patients considered the Wound-QoL a simple and feasible tool. Mean time needed for completing the questionnaire was 5minutes. Overall, 99.1% of the participants found it easy to understand the questions and 94.7% stated that the questionnaire suits the personal situation. CONCLUSIONS: The Spanish version of the Wound-QoL shows good validity in clinical practice. It can be recommended for use in clinical routine and trials.
Assuntos
Qualidade de Vida , Traduções , Idoso , Análise Fatorial , Feminino , Humanos , Espanha , Inquéritos e QuestionáriosRESUMO
Los sistemas de gestión de calidad (SGC) son herramientas que sirven para estructurar, controlar y mejorar las actividades habituales que se desarrollan en una organización o servicio. La norma ISO 9001:2015 es una norma reconocida internacionalmente que proporciona los recursos necesarios para ayudar a una organización a mejorar su rendimiento, basándose en el principio de planificar-hacer-controlar-actuar, con el fin de obtener una mejora continua. En sanidad es una herramienta clave para la gestión de los servicios ofrecidos a los pacientes. La certificación de calidad ISO permite demostrar el cumplimiento de dicha norma, de acuerdo a unos estándares de calidad establecidos. El proceso de implantación de un SGC siguiendo esta norma debe seguir varias fases, que culminan con la realización de una auditoría externa que, una vez superada, permite obtener la certificación de calidad ISO 9001:2015. En este artículo se describen los pasos a seguir para obtener dicha certificación en un Servicio de Dermatología
Quality management systems (QMS) are tools that serve to structure, control and improve the usual activities that take place in an organization or service.The ISO 9001:2015 is an internationally recognized standard, which provides the necessary resources to help an organization to improve its performance, based on the principle of plan-do-control-act, in order to obtain continuous improvement. In the field of health, it is an essential tool for the management of the services offered to patients. The ISO quality certification allows to demonstrate compliance, according to established quality standards. The process of implementing a QMS follows several phases that culminate with the completion of an external audit, which once passed, allows obtaining the quality certification ISO 9001:2015. This article describes the steps to follow to obtain this certification in a Dermatology Service
Assuntos
Humanos , Qualidade da Assistência à Saúde/normas , 34002 , Dermatologia/normas , 51924 , CertificaçãoRESUMO
Quality management systems (QMS) are tools that serve to structure, control and improve the usual activities that take place in an organization or service. The ISO 9001:2015 is an internationally recognized standard, which provides the necessary resources to help an organization to improve its performance, based on the principle of plan-do-control-act, in order to obtain continuous improvement. In the field of health, it is an essential tool for the management of the services offered to patients. The ISO quality certification allows to demonstrate compliance, according to established quality standards. The process of implementing a QMS follows several phases that culminate with the completion of an external audit, which once passed, allows obtaining the quality certification ISO 9001:2015. This article describes the steps to follow to obtain this certification in a Dermatology Service.
Assuntos
Dermatologia/normas , Departamentos Hospitalares/normas , Gestão da Qualidade Total/normas , Melhoria de Qualidade , EspanhaRESUMO
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