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. 2020 Mar 25;10(3):e032332.
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)

Anne Klassen  1 , Emiel Lwg van Haren  2 , Karen Cross  3 , Kenneth L Fan  4 , Chris Gibbons  5 , Maarten M Hoogbergen  2 , Natasha M Longmire  1 , Lotte Poulsen  6 , Jens Ahm Sorensen  7 , Lee Squitieri  8 , Elena Tsangaris  5 , Tert C van Alphen  2 , Anne-Margreet van Dishoeck  9 , Dali Vasilic  9 , Andrea L Pusic  10
Affiliations

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

Anne Klassen et al. BMJ Open. .

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.

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Conflict of interest statement

Competing interests: The WOUND-Q will be owned by Memorial Sloan-Kettering Cancer Center. Drs ALP and AK are codevelopers of other Q-Portfolio instruments and receive a share of any license revenue on the inventor sharing policies of the institutions that own them.

Figures

Figure 1
Figure 1
Flow diagram illustrating the multiphase mixed methods approach to the development of the WOUND-Q. QUAN, quantitative study component; QUAL, qualitative study component. Image reproduced from Wong Riff et al.
Figure 2
Figure 2
Translation and cultural adaption steps for the WOUND-Q. Image reproduced from van Alphen et al. QUAN, quantitative study component; QUAL, qualitative study component.
See this image and copyright information in PMC

References

    1. Martinengo L, Olsson M, Bajpai R, et al. . Prevalence of chronic wounds in the general population: systematic review and meta-analysis of observational studies. Ann Epidemiol 2019;29:8–15. 10.1016/j.annepidem.2018.10.005 - DOI - PubMed
    1. Nussbaum SR, Carter MJ, Fife CE, et al. . An economic evaluation of the impact, cost, and Medicare policy implications of chronic nonhealing wounds. Value Health 2018;21:27–32. 10.1016/j.jval.2017.07.007 - DOI - PubMed
    1. Guest JF, Ayoub N, McIlwraith T, et al. . Health economic burden that wounds impose on the National health service in the UK. BMJ Open 2015;5:e009283 10.1136/bmjopen-2015-009283 - DOI - PMC - PubMed
    1. Cochrane Wounds Cochrane Ireland and Cochrane UK symposium 2020. Available: https://wounds.cochrane.org/ [Accessed May 2019].
    1. Smith F, Dryburgh N, Donaldson J, et al. . Debridement for surgical wounds. Cochrane Database Syst Rev 2013;9:CD006214 10.1002/14651858.CD006214.pub4 - DOI - PMC - PubMed

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