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Health-related quality of life in patients with diabetic foot ulceration: study protocol for adaptation and validation of patient-reported outcome measurements (PROMs) in Dutch-speaking patients
  1. Wahid Rezaie1,
  2. Flora Lusendi2,
  3. Kris Doggen2,
  4. Giovanni Matricali3,
  5. Frank Nobels4
  1. 1 Orthopaedics & Trauma, Multidisciplinary Diabetic Foot Clinic, Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium
  2. 2 Health Services Research Unit, Belgian Scientific Institute of Public Health, Brussel, Belgium
  3. 3 Multidisciplinary Diabetic Foot Clinic, KU Leuven Hospital, Leuven, Belgium
  4. 4 Multidisciplinary Diabetic Foot Clinic, Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium
  1. Correspondence to Dr Wahid Rezaie; wrezaie{at}me.com

Abstract

Introduction Diabetic foot ulceration (DFU) is a common late-stage complication of diabetes with a large impact on health status and quality of life. Patient-reported outcome measures (PROMs) provide a standardised method of obtaining patients’ views on their well-being. The DFU Scale Short Form (DFS-SF) is a validated disease-specific PROM for measuring health-related quality of life among DFU patients. The Lower Extremity Functional Scale (LEFS) is another PROM that can be used to measure physical functioning in patients with lower extremity disorders. The LEFS is not yet validated for DFU. Both instruments are not validated in the Dutch language. The purpose of this study is to culturally adapt and validate the DFS-SF and LEFS questionnaires for Belgian Dutch-speaking patients with DFU.

Methods and analysis This study will be conducted as a monocentre observational cohort study in DFU patients presenting at a hospital-based multidisciplinary diabetic foot clinic. Data will be collected from the medical electronic files and from DFS-SF, LEFS and five-level EuroQol five-dimension questionnaires that will be presented to the patients at defined time points. Reproducibility, internal consistency, floor and ceiling effects, construct validity and responsiveness will be assessed for the DFS-SF and LEFS.

Ethics and dissemination The study protocol has been approved by the Medical Ethics Committee of Onze-Lieve-Vrouw Hospital (Aalst, Belgium). The results of the study will be disseminated through peer-reviewed publications and conference presentations.

  • patient-reported outcome measures
  • diabetic foot ulcer
  • DFS-SF
  • LEFS
  • Dutch
  • validity

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors WR and FN developed the study. WR was a principal investigator. WR, FL, KD, GM and FN were involved in writing the study protocol. WR, FL, KD, GM and FN will be involved in assessment of outcomes. FL and KD will perform statistical analysis of the study data. WR and FN drafted the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval The trial will be conducted in compliance with the principles of the Declaration of Helsinki (2013), the principles of GCP and in accordance with all applicable regulatory requirements. This protocol and related documents were approved by the Medical Ethics Committee of OLV Aalst (Belgian registration number B126201836509).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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