- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07750028
Catalan Translation and Psychometric Validation of the QuickDASH (QuickDASH-CAT)
2. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
100
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ana Scott-Tennent De Rivas, MD
- Telefonnummer: +34650574958
- E-post: dra.anascotttennent@gmail.com
Studiesteder
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Barcelona
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Sabadell, Barcelona, Spania, 08208
- Parc Taulí Hospital Univesritari
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Ta kontakt med:
- Ana Scott-Tennent De Rivas, MD
- Telefonnummer: 0034-650574958
- E-post: dra.anascotttennent@gmail.com
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Underetterforsker:
- Francesc Mercano Fernandez, MD
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Underetterforsker:
- Jaume Camara Cabrera, PHD
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Underetterforsker:
- Nona Poy, MD
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Underetterforsker:
- Roger Rojas Sayol, MD
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Underetterforsker:
- Joan Miquel Noguera, PHD
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Hovedetterforsker:
- Ana Scott-Tennent De Rivas, MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Cross-cultural adaptation and psychometric validation of the Catalan QuickDASH
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ana Scott-Tennent De Rivas, MD, Institut d'Investigació i Innovació Parc Taulí (I3PT)
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. desember 2026
Primær fullføring (Antatt)
1. februar 2027
Studiet fullført (Antatt)
1. mars 2027
Datoer for studieregistrering
Først innsendt
2. august 2026
Først innsendt som oppfylte QC-kriteriene
2. august 2026
Først lagt ut (Faktiske)
6. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- QuickDASH-CAT-2026
- CEIm: 2026.036-50 (Annet stipend/finansieringsnummer: FESSH PROM)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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