AIMS: Cutaneous lupus erythematosus (CLE) causes various skin manifestations. Painful skin lesions, dyspigmentation, scarring, itch, hair loss, and photosensitivity negatively impact quality of life of patients with CLE. A literature review, a social listening study, and a qualitative interview study explored key symptoms and their impact on patients with CLE and potentially relevant patient-reported outcome measures (PROMs) comprehensively covering CLE symptoms and impacts. Three candidate PROMs used in CLE were identified in the literature review, and the Skindex 29 ? 3 was determined to be the most appropriate for further investigation. We report on the cognitive debriefing interviews (CDIs) conducted in patients with CLE to assess the relevance, comprehensibility and completeness of the Skindex 29 ? 3 for this population.
METHODS: Twenty adults in the United States diagnosed with moderate or severe CLE (subacute and discoid subtypes) reviewed the Skindex 29 ? 3 during individual interviews. A semistructured interview guide was developed to guide the CDIs. Study participants were asked to ‘‘think aloud,’’ describing their thought processes as they read and responded to the items dditionally, interviewers explored participant interpretations of the instructions, item content, and response options with probe questions and asked about any important missing concepts. The interview data were evaluated using thematic analysis.
RESULTS: The only change made to the Skindex 29 ? 3 based on participant feedback was decreasing the recall period from 4 weeks to 7 days. The instructions, items, and response options were reported to be clear and were interpreted as intended. The items were determined to be relevant, understandable and comprehensive by most participants; no missing concepts were noted. The relevance of the CLE-specific items assessing photosensitivity was endorsed by all participants. Hair loss was not relevant for all participants but was an important CLE symptom for those who experienced it.
CONCLUSION: This study confirms the Skindex 29 ? 3 to be a relevant and appropriate PROM for use in studies of CLE treatment as it includes items specific to CLE, such as hair loss and photosensitivity, and the remaining items developed to assess common skin condition symptoms and impacts were all relevant for patients with CLE.
