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    A qualitative investigation of the relevance of skin irritation and self-confidence bolt-ons and their conceptual overlap with the EQ-5D in patients with psoriasis

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    Objectives A number of bolt-ons have been proposed for the EQ-5D, including two psoriasis-specific bolt-ons, skin irritation and self-confidence. The study investigates and compares the relevance and comprehensiveness of these psoriasis-specific bolt-ons and the EQ-5D-5L and explores the potential conceptual overlaps between the existing five dimensions and the two bolt-ons. Methods Psoriasis patients were purposively sampled according to age and gender. Semi-structured interviews, where participants were asked to complete the EQ-5D-5L and the bolt-ons while thinking aloud, were conducted. Probes were used to investigate the thought processes of patients regarding the dimensions, wording, recall period and relevant concepts not captured by the EQ-5D-5L and bolt-ons. Data were analysed thematically. A focus group was used to confirm the findings. Results Overall, 16 patients completed the interviews. Sixteen and fifteen patients considered skin irritation and self-confidence relevant areas to describe psoriasis problems. Three patients considered itching a form of discomfort, and thus, pointed out a potential overlap between pain/discomfort and skin irritation. Twelve patients reported overall 10 general health- or psoriasis-related concepts that are not captured by the EQ-5D-5L, including itching, social relationships and sex life. Eleven patients reported that the recall period of the EQ-5D-5L might be subject to bias because of the daily or within-day fluctuations of their symptoms. Conclusions The skin irritation and self-confidence bolt-ons contribute to improve content validity of the EQ-5D-5L in patients with psoriasis. The qualitative approach taken in this study expands the existing methodological framework for the development and testing validity of bolt-ons for the EQ-5D
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