- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07750028
Catalan Translation and Psychometric Validation of the QuickDASH (QuickDASH-CAT)
2 de agosto de 2026 actualizado por: Ana Scott-Tennent, Corporacion Parc Tauli
Translation, Cross-cultural Adaptation and Psychometric Validation of the Catalan Version of the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH-CAT)
Patient-reported outcome measures (PROMs) are essential tools for assessing upper extremity disability from the patient's perspective and are increasingly incorporated into routine clinical practice and research.
The Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) is one of the most widely used PROMs in upper limb surgery worldwide.
Although the questionnaire has been translated and validated into multiple languages, no officially translated and psychometrically validated Catalan version is currently available.
The aim of this study is to translate, cross-culturally adapt and psychometrically validate the Catalan version of the QuickDASH according to internationally accepted recommendations for PROM translation and validation.
The project consists of two sequential phases.
Phase I comprises forward translation, synthesis, back-translation, expert committee review and cognitive debriefing.
Phase II consists of a prospective observational psychometric validation study in Catalan-speaking adults with upper extremity disorders.
The resulting instrument is expected to become the official Catalan version of the QuickDASH for use in clinical practice and research.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
Patient-reported outcome measures (PROMs) have become an essential component of modern healthcare by providing standardized assessment of symptoms, disability and treatment outcomes directly from the patient's perspective.
Their routine use has increased considerably during the last decade owing to recommendations from international scientific societies and their incorporation into both clinical research and routine outcome assessment.
The Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) is among the most frequently used PROMs for evaluating upper extremity disability.
Compared with the original 30-item DASH questionnaire, the abbreviated 11-item QuickDASH maintains excellent psychometric performance while substantially reducing respondent burden, facilitating its use in everyday clinical practice.
Despite the widespread use of Catalan within the healthcare system in Catalonia, no officially translated and psychometrically validated Catalan version of the QuickDASH is currently available.
Consequently, clinicians and researchers frequently rely on Spanish versions that may not fully reflect linguistic and cultural characteristics specific to Catalan-speaking populations.
The primary objective of this study is to produce an officially translated, culturally adapted and psychometrically validated Catalan version of the QuickDASH following internationally accepted methodology and the recommendations established by the Institute for Work & Health (IWH), copyright holder of the DASH and QuickDASH questionnaires.
The translation process will include two independent forward translations, synthesis of both versions, two independent back-translations, multidisciplinary expert committee review and cognitive debriefing in Catalan-speaking patients.
Once the final Catalan version has been established, a prospective observational validation study will evaluate its psychometric properties in approximately 100 adult patients presenting with upper extremity disorders at Parc Taulí Hospital Universitari.
Psychometric evaluation will include assessment of internal consistency, test-retest reliability, construct validity, measurement error, responsiveness and floor and ceiling effects according to internationally accepted standards for PROM validation studies.
The availability of an officially validated Catalan QuickDASH is expected to facilitate standardized outcome assessment in Catalan-speaking populations, improve comparability between international studies and promote the incorporation of patient-reported outcomes into routine clinical practice.
Tipo de estudio
De observación
Inscripción (Estimado)
100
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ana Scott-Tennent De Rivas, MD
- Número de teléfono: +34650574958
- Correo electrónico: dra.anascotttennent@gmail.com
Ubicaciones de estudio
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Barcelona
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Sabadell, Barcelona, España, 08208
- Parc Taulí Hospital Univesritari
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Contacto:
- Ana Scott-Tennent De Rivas, MD
- Número de teléfono: 0034-650574958
- Correo electrónico: dra.anascotttennent@gmail.com
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Sub-Investigador:
- Francesc Mercano Fernandez, MD
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Sub-Investigador:
- Jaume Camara Cabrera, PHD
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Sub-Investigador:
- Nona Poy, MD
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Sub-Investigador:
- Roger Rojas Sayol, MD
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Sub-Investigador:
- Joan Miquel Noguera, PHD
-
Investigador principal:
- Ana Scott-Tennent De Rivas, MD
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Adult Catalan-speaking patients (18 years or older) presenting with an upper extremity musculoskeletal disorder (acute or chronic) at the outpatient upper extremity clinic of Parc Taulí Hospital Universitari (Sabadell, Spain), able to read and understand written Catalan and to provide written informed consent
Descripción
Inclusion Criteria:
- Age 18 years or older. Native or fluent Catalan speaker. Diagnosis of an upper extremity musculoskeletal disorder requiring assessment using the QuickDASH questionnaire. Able to read and understand written Catalan. Able and willing to provide written informed consent. Able to complete the questionnaire independently.
Exclusion Criteria:
- Cognitive impairment preventing questionnaire completion. Severe neurological or psychiatric disorders interfering with questionnaire interpretation. Inability to read or understand Catalan. Refusal or inability to provide written informed consent. Any other condition that, in the opinion of the investigator, could compromise participation or interpretation of questionnaire results.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Catalan QuickDASH Validation Cohort
Adult Catalan-speaking patients presenting with upper extremity disorders who will complete the Catalan version of the QuickDASH as part of the psychometric validation study.
Participants will undergo questionnaire assessment at baseline and a subgroup will complete a second assessment for evaluation of test-retest reliability according to the study protocol.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cross-cultural adaptation and psychometric validation of the Catalan QuickDASH
Periodo de tiempo: Baseline and completion of the translation and validation process (approximately 12 months).
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Successful translation, cross-cultural adaptation and psychometric validation of the Catalan version of the Quick Disabilities of the Arm, Shoulder and Hand questionnaire following internationally accepted recommendations, including cognitive debriefing and expert committee review.
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Baseline and completion of the translation and validation process (approximately 12 months).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Ana Scott-Tennent De Rivas, MD, Institut d'Investigació i Innovació Parc Taulí (I3PT)
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C. Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. J Hand Ther. 2001 Apr-Jun;14(2):128-46.
- Mokkink LB, et al. COSMIN Study Design Checklist for Patient-reported Outcome Measurement Instruments. 2019.
- Institute for Work & Health. Guidelines for the Translation and Cross-Cultural Adaptation of the DASH & QuickDASH Outcome Measures. Toronto: Institute for Work & Health; 2007.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de diciembre de 2026
Finalización primaria (Estimado)
1 de febrero de 2027
Finalización del estudio (Estimado)
1 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
2 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de agosto de 2026
Publicado por primera vez (Actual)
6 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- QuickDASH-CAT-2026
- CEIm: 2026.036-50 (Otro número de subvención/financiamiento: FESSH PROM)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be publicly shared.
Requests for access to anonymized data may be considered by the Principal Investigator and the sponsor on reasonable request, in accordance with institutional policies, ethical approval and applicable data protection regulations.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .