Supplementary Material for: Development of HiSQOL: A Hidradenitis Suppurativa-Specific Quality of Life Instrument

<b><i>Background:</i></b> Hidradenitis suppurativa (HS) is a chronic and painful skin disease. In addition, HS lesions may be associated with pus and odour, potentially leading to significant stigma and, consequently, greatly affected quality of life (QOL). QOL is a multidimensional construct, which can be measured in various ways. However, generic or dermatologic QOL measures may not capture changes in QOL particularly affected in HS. Accordingly, patients and experts included in the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC) agreed that future clinical HS trials should measure HS-specific QOL. <b><i>Objectives:</i></b> To develop an HS-specific QOL instrument (HiSQOL, Hidradenitis Suppurativa Quality of life). <b><i>Method:</i></b> The initial phases of the questionnaire development, described in this study, included item generation by patient interviews, development of a pilot questionnaire, questionnaire refinement, and pilot testing. <b><i>Results:</i></b> For item generation, 21 patients were interviewed individually or in focus groups. Analysis of the interviews identified 105 candidate items and, next, a pilot questionnaire was developed. Finally, item reduction and two rounds of pilot testing resulted in a 23-item questionnaire representing physical, psychological, and social QOL dimensions. <b><i>Conclusions:</i></b> We have comprehensively explored on HS’s possible effect on the QOL of the affected individuals and identified a 23-item HS-specific QOL questionnaire. The questionnaire proved to be feasible, acceptable, and comprehensible in the second round of pilot testing. With HiSQOL, researchers can measure HS-specific QOL in future clinical trials, potentially enabling them to discover more effective treatment options. It is envisaged, that after thorough validation in a trial setting, a streamlined version of HISQOL may also become available for clinical use in daily practice.

**背景：** 化脓性汗腺炎（Hidradenitis suppurativa, HS）是一种慢性疼痛性皮肤疾病。HS皮损可伴随脓液与异味，极易引发严重的病耻感，进而大幅降低患者的生活质量（quality of life, QOL）。生活质量是多维度的概念，可通过多种方式进行评估。然而，通用或皮肤病学专用生活质量量表往往无法精准捕捉HS患者特有的生活质量受损情况。因此，纳入化脓性汗腺炎核心结局国际协作组（HIdradenitis SuppuraTiva cORe outcomes set International Collaboration, HISTORIC）的患者与专家一致认为，未来HS临床试验应采用针对HS的专属生活质量评估工具。
**研究目标：** 开发一款针对HS的专属生活质量评估工具（HiSQOL，即Hidradenitis Suppurativa Quality of Life，化脓性汗腺炎生活质量量表）。
**研究方法：** 本研究中的问卷开发初始阶段包括：通过患者访谈生成条目、构建预试验问卷、优化问卷内容，以及开展预试验测试。
**研究结果：** 在条目生成阶段，研究团队对21名患者进行了一对一访谈或焦点小组讨论。对访谈内容的分析共筛选出105个候选条目，随后构建了预试验问卷。最终，通过条目精简与两轮预试验测试，形成了涵盖生理、心理与社会生活质量维度的23条目问卷。
**研究结论：** 本研究全面探讨了HS对患者生活质量的潜在影响，并开发出一款包含23个条目的HS专属生活质量问卷。在第二轮预试验测试中，该问卷展现出良好的可行性、可接受性与易懂性。借助HiSQOL，研究人员可在未来的HS临床试验中精准评估患者的专属生活质量，助力发掘更有效的治疗方案。研究预计，在经过临床试验场景下的全面验证后，精简版的HiSQOL也可应用于日常临床实践。