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Validation of patient global item for quality of life impact on Hidradenitis suppurativa

Kirby, J .S., Hereford, B., Thorlacius, L., Villumsen, B., Ingram, J. R., Garg, A., Butt, M., Esmann, S., King, T., Tan, J. and Jemec, G. B. E. 2021. Validation of patient global item for quality of life impact on Hidradenitis suppurativa. British Journal of Dermatology 184 (4) , pp. 681-687. 10.1111/bjd.19344

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Background Hidradenitis suppurativa (HS) is a chronic inflammatory disease that is not well understood. The HS core outcome set calls for a patient global assessment (PtGA), for which measures are limited. Objectives Our aim is 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 HS patients in Denmark (DK) and the United States (US). Field testing was conducted via a cross‐sectional observational study with adults with HS in the US and DK. The candidate PtGA item, demographic items, and multiple patient‐reported scales including the Hidradenitis Suppurativa Quality of Life (HiSQOL), Dermatology Life Quality Index (DLQI), numerical rating scale (NRS) for pain were concurrently administered to evaluate convergent and known‐groups validity. The scales with a single‐item assessment of change were administered again 24‐72 hours 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 with significant correlations with the HiSQOL score r = 0.79 [95CI: 0.75‐0.82] and DLQI (r = 0.78, [95CI: 0.74‐0.82]). The PtGA displayed known‐groups validity with the DLQI score bands based on significance of an analysis of variance (p<.0001). Good test‐retest reliability was supported by the intraclass correlation coefficient (ICC value = 0.82, [95CI: 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.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Publisher: Wiley
ISSN: 0007-0963
Date of First Compliant Deposit: 16 July 2020
Date of Acceptance: 29 June 2020
Last Modified: 06 Oct 2021 15:45

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