Background: Hidradenitis suppurativa (HS) is a chronic inflammatory disease. The HS core outcome set calls for a patient global assessment (PtGA). Objectives: To assess the validity, reliability and responsiveness of a candidate single-item PtGA for HS-specific health-related quality of life (HRQoL). Methods: Cognitive debriefing interviews were conducted with patients with HS in Denmark and the USA. A cross-sectional observational study was done with adults with HS in the USA and Denmark. Candidate PtGA item, demographic items and multiple patient-reported scales – the Hidradenitis Suppurativa Quality of Life (HiSQOL), Dermatology Life Quality Index (DLQI) and numerical rating scale (NRS) for pain – were concurrently administered to evaluate convergent and known-groups validity. Scales with a single-item assessment of change were readministered 24–72 h later, to evaluate reliability and responsiveness. Results: After cognitive debriefing, the candidate PtGA for HS-specific HRQoL was finalized with five response levels. Convergent validity of the PtGA was supported by significant correlations with HiSQOL score [r = 0·79, 95% confidence interval (CI) 0·75–0·82] and DLQI (r = 0·78, 95% CI 0·74–0·82). The PtGA displayed known-groups validity with DLQI score bands based on significance of an anova (P < 0·001). Good test–retest reliability was supported by the intraclass correlation coefficient (0·82, 95% CI 0·78–0·85) for those who reported stable HS. Responsiveness was assessed by differences in PtGA score against a patient-reported assessment of change, which showed significant differences towards improvement. Conclusions: The single-item PtGA exhibits reliability, validity and responsiveness in assessing HS-specific HRQoL in HS, making it a good provisional tool for HS clinical research.
|Original language||English (US)|
|Number of pages||7|
|Journal||British Journal of Dermatology|
|State||Published - Apr 2021|
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