Identifying health-related quality of life concepts to inform the development of the WOUND-Q

Objective: The impact of hard-to-heal wounds extends beyond traditional clinical metrics, negatively affecting a patient s healthrelated quality of life (HRQoL). Yet treatment outcomes are seldom measured from the patient s perspective. The purpose of the present study was to perform in-depth qualitative interviews with patients diagnosed with varying types of hard-to-heal wounds to identify outcomes important to them. Method: Participants were recruited from wound care clinics in Canada, Denmark, the Netherlands and the US, and were included if they had a hard-to-heal wound (i.e., lasting ?3 months), were aged ?18 years, and fluent in English, Dutch or Danish. Qualitative interviews took place between January 2016 and March 2017. An interpretive description qualitative approach guided the data analysis. Interviews were audio-recorded, transcribed and coded line-by-line. Codes were categorised into top-level domains and themes that formed the final conceptual framework. Results: We performed 60 in-depth interviews with patients with a range of wound types in different anatomic locations that had lasted from three months to 25 years. Participants described outcomes that related to three top-level domains and 13 major themes: wound (characteristics, healing); HRQoL (physical, psychological, social); and treatment (cleaning, compression stocking, debridement, dressing, hyperbaric oxygen, medication, suction device, surgery). Conclusion: The conceptual framework developed as part of this study represents the outcome domains that mattered the most to the patients with hard-to-heal wounds. Interview quotes were used to generate items that formed the WOUND-Q scales, a patient-reported outcome measure for patients with hard-to-heal wounds. Declaration of interest: Phase I of this study was funded by a research grant received from the Plastic Surgery Foundation, US. The authors have no financial interest to declare in relation to the content of this article. The Article Processing Charge was paid from the Plastic Surgery Foundation grant. AP and AFK are co-developers of the Q-Portfolio instruments (https://qportfolio.org) and receive a share of any licence revenue on the inventor sharing policies of the institutions that own them. The remaining authors have no conflicts of interest to declare.