ABSTRACT
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
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Surveys and Questionnaires/standards , Translations , Quality of Life , Wounds and Injuries/physiopathology , Prospective Studies , Reproducibility of Results , Spain , Chronic DiseaseABSTRACT
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.
Subject(s)
Quality of Life , Translations , Aged , Factor Analysis, Statistical , Female , Humans , Spain , Surveys and QuestionnairesABSTRACT
OBJECTIVE: To document the efficacy of a combined therapeutic strategy in achieving rapid wound healing in patients with long-standing ulcers. MATERIALS AND METHODS: Outpatients with hard-to-heal venous leg ulcers were included in an interventional, prospective, single-arm, mono-centre study and treated with autologous punch grafting, TLC-NOSF dressing and multi-type compression therapy. The primary outcome was the percentage of healed wounds by week 12. Secondary outcomes included time-to-reach wound closure, wound area reduction, treatment acceptability and safety. RESULTS: From November 2018 to October 2019, 42 patients with 51 ulcers were included (23 males, 70.6±40.8 years old, with multiple comorbidities). Despite poor wound healing prognosis at baseline (47% of recurrent ulcers, with a mean duration of 15 months and a mean area of 12.6cm2), wound healing was achieved in 47 ulcers (92%) after a mean period of treatment of 25±13 days. A relative wound area reduction>75% was also reached in three additional ulcers by the last evaluation visit. No adverse event related to the procedure was reported throughout the study period. The associated treatment were very well tolerated and accepted by the patients. CONCLUSIONS: The evaluated procedure induced fast re-epithelisation of the treated ulcers. Based on our experience, this simple and successful reparative strategy may be considered as an interesting option in the treatment of venous leg ulcers of poor prognosis.