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

Abstract

IntroductionMost 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 analysisIn 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 disseminationThis 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.

International study to develop the WOUND‐Q patient‐reported outcome measure for all types of chronic wounds

“…We previously published a protocol paper that described our approach to develop the WOUND‐Q. 25 Our multi‐phase mixed methods approach adheres to published guidelines for the development and translation of a PROM. 26 , 27 , 28 , 29 , 30 In phase 1 (qualitative), an interpretive description qualitative approach was followed, which built on existing clinical and research knowledge.…”

“…We previously published our interview guide. 25 The guide included open‐ended questions that aimed to elicit concepts of interest from patients about outcomes (eg, physical, psychological, and social life) and experiences (eg, information and wound care team) of wound care. As interviews progressed and participants discussed topics not on the interview guide, the guide was revised to include these new concepts for probing in subsequent interviews.…”

“…Table 1 shows the characteristics of the sample. Participants had a range of wound types in different anatomic locations that had lasted from 3 months to 25 shows the saturation table for the conceptual model for codes that were endorsed by 10 or more participants. We generated an item for each code related to themes forming the conceptual framework and developed 16 independently functioning scales.…”

Patient‐reported experience measures are essential to improving quality of care for chronic wounds: An international qualitative study

“…The data used for this study were collected as part of a larger phase I qualitative study to understand patient‐reported quality of life outcomes and health care experiences among patients with chronic wounds (WOUND‐Q) 41 . Results of our quality of life outcomes study have been reported separately 41 . The objective of the current study was to describe patient‐reported experiences and health care processes that impact quality of care for chronic wounds.…”

“…For this study, we used an interpretive description approach, which aims to generate knowledge relevant for a clinical context by building on existing theoretical knowledge, clinical knowledge, and a scientific basis to inform a study 43 . Four experienced qualitative researchers performed semi‐structured interviews in the native language of each patient using a common interview guide (Appendix A) 41 . For patient convenience, interviews were conducted in‐person or by telephone.…”