Department of Dermatology, Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA.
Penn State College of Medicine, Hershey, PA, USA.
Br J Dermatol. 2021 Apr;184(4):681-687. doi: 10.1111/bjd.19344. Epub 2020 Sep 3.
Hidradenitis suppurativa (HS) is a chronic inflammatory disease. The HS core outcome set calls for a patient global assessment (PtGA).
To assess the validity, reliability and responsiveness of a candidate single-item PtGA for HS-specific health-related quality of life (HRQoL).
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.
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.
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.
化脓性汗腺炎（HS）是一种慢性炎症性疾病。HS 核心结局集呼吁进行患者总体评估（PtGA）。
评估用于 HS 特异性健康相关生活质量（HRQoL）的单一项目 PtGA 的有效性、可靠性和反应性。
在丹麦和美国对 HS 患者进行认知访谈。在美国和丹麦进行了一项横断面观察性研究，纳入成年 HS 患者。同时评估候选 PtGA 项目、人口统计学项目和多个患者报告量表——化脓性汗腺炎生活质量（HiSQOL）、皮肤病生活质量指数（DLQI）和疼痛数字评定量表（NRS）——以评估收敛效度和已知组别的有效性。对具有单一项目变化评估的量表在 24-72 小时后进行重测，以评估可靠性和反应性。
经过认知访谈，最终确定了用于 HS 特异性 HRQoL 的候选 PtGA，共 5 个反应水平。PtGA 与 HiSQOL 评分呈显著相关（r=0.79，95%置信区间 [CI] 0.75-0.82），与 DLQI 评分呈显著相关（r=0.78，95% CI 0.74-0.82），支持了其收敛效度。PtGA 与基于方差分析显著差异的 DLQI 评分组间存在已知组别的有效性（P<0.001）。对于报告 HS 稳定的患者，组内相关系数（0.82，95% CI 0.78-0.85）支持了良好的测试重测可靠性。PtGA 评分对患者报告的变化评估的差异评估了其反应性，表明朝着改善方向有显著差异。
单一项目 PtGA 在评估 HS 特异性 HRQoL 方面具有可靠性、有效性和反应性，是 HS 临床研究的良好临时工具。
