International mixed methods study protocol to develop a patient-reported outcome measure for all types of chronic wounds (the WOUND-Q)

Anne Klassen; Emiel Lwg van Haren; Karen Cross; Kenneth L Fan; Chris Gibbons; Maarten M Hoogbergen; Natasha M Longmire; Lotte Poulsen; Jens Ahm Sorensen; Lee Squitieri; Elena Tsangaris; Tert C van Alphen; Anne-Margreet van Dishoeck; Dali Vasilic; Andrea L Pusic

doi:10.1136/bmjopen-2019-032332

International mixed methods study protocol to develop a patient-reported outcome measure for all types of chronic wounds (the WOUND-Q)

BMJ Open. 2020 Mar 25;10(3):e032332. doi: 10.1136/bmjopen-2019-032332.

Authors

Affiliations

¹ Pediatrics, McMaster University, Hamilton, Ontario, Canada.
² Plastic and Reconstructive Surgery, Catharina Ziekenhuis, Eindhoven, The Netherlands.
³ Plastic Surgery, St Michael's Hospital, Toronto, Ontario, Canada.
⁴ Plastic and Reconstructive Surgery, MedStar Georgetown University Hospital, Washington, DC, USA.
⁵ Department of Surgery, Patient Reported Outcome, Value, and Experience (PROVE) Center, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts, USA.
⁶ Department of Plastic Surgery, University of Southern Denmark, Odense, Denmark.
⁷ Department of Plastic Surgery, Odense University Hospital, Odense, Denmark.
⁸ Division of Plastic and Reconstructive Surgery, University of Southern California, Los Angeles, California, USA.
⁹ Plastic and Reconstructive Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.
¹⁰ Department of Surgery, Patient Reported Outcome, Value, and Experience (PROVE) Center, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts, USA apusic@bwh.harvard.edu.

Abstract

Introduction: Most patient-reported outcome measures (PROM) for chronic wounds are specific to a single wound type (eg, pressure ulcer) or part of the body. A barrier to outcome assessment in wound care and research is the lack of a rigorously designed PROM that can be used across wound types and locations. This mixed method study describes the protocol for an international collaboration to develop and validate a new PROM called the WOUND-Q for adults with chronic wounds.

Methods and analysis: In phase I, the qualitative approach of interpretive description is used to elicit concepts important to people with wounds regarding outcome. Participants from Canada, Denmark, the Netherlands, and the USA are aged 18 years and older and have a wound that has lasted 3 months or longer. Interviews are digitally recorded, transcribed and coded. A conceptual framework and preliminary item pool are developed from the qualitative dataset. Draft scales are formed to cover important themes in the conceptual framework. These scales are refined using feedback from people with chronic wounds and wound care experts. After refinement, the scales are translated into Danish and Dutch, following rigorous methods, to prepare for an international field-test study. In phase II, data are collected in Canada, Denmark, the Netherlands, and the USA. An international sample of people with a large variety of chronic wounds complete the WOUND-Q. Rasch Measurement Theory analysis is used to identify the best subset of items to retain for each scale and to examine reliability and validity.

Ethics and dissemination: This study is coordinated at Brigham and Women's Hospital (Boston, USA). Ethics board approval was received at each participating site for both study phases. Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.

Keywords: patient-reported outcome; plastic and reconstructive surgery; psychometrics; quality of life; rasch; wound management.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Chronic Disease / psychology
Chronic Disease / therapy
Humans
Patient Reported Outcome Measures*
Pressure Ulcer* / psychology
Pressure Ulcer* / therapy
Psychometrics
Quality of Life
Wounds and Injuries* / psychology
Wounds and Injuries* / therapy