Khanna Dinesh, Greene George J, Perschon Chelsea Rose, Jamali Marzieh, Steen Virginia, Medsger Thomas, Singh Gurkirpal, Cella David
Division of Rheumatology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Scleroderma Program, University of Michigan, Ann Arbor, MI, USA.
J Scleroderma Relat Disord. 2025 Jun 3:23971983251334162. doi: 10.1177/23971983251334162.
Systemic sclerosis (scleroderma) is associated with functional disability and poor quality of life. Patient-reported outcome measures provide valuable insights into patients' experiences, symptoms, and perceptions of their health. The Health Assessment Questionnaire-Disability Index (HAQ-DI) and the Scleroderma Health Assessment Questionnaire (S-HAQ) are widely used patient-reported outcome measures in scleroderma research and clinical care. However, there is lack of data to (a) ensure and document patients with systemic sclerosis understand the concepts contained in these measure and (b) demonstrate face, item, and content validity for these items and measures.
We conducted cognitive debriefing of the S-HAQ in patients with diffuse cutaneous systemc sclerosis (dcSSc). The S-HAQ includes the HAQ-DI, a 20-item questionnaire that assesses functional ability for performing day-to-day activities, four systemic sclerosis-specific items that assess scleroderma symptoms, and one item on overall scleroderma-related limitations.
The total sample of patients with dcSSc (N = 20) had a mean age of 57.6 years and average disease duration of 3.4 years. For the HAQ-DI, the participants understood the concepts and the items were clear. In addition, majority (60%-100%) of participants reported using aids and devices to perform activities of daily living and/or utilizing assistance from another person. The systemic sclerosis-specific items of the S-HAQ were relevant to participants but required revisions to item wording and response options, including a change from the visual analog scales to numerical rating scales.
The HAQ-DI and S-HAQ systemic sclerosis-specific items demonstrated content and item validity, respectively. Several minor modifications were made to the S-HAQ instructions, item wording, and rating scales.
系统性硬化症（硬皮病）与功能残疾和生活质量差相关。患者报告的结局指标能为患者的经历、症状及对自身健康的认知提供有价值的见解。健康评估问卷残疾指数（HAQ-DI）和硬皮病健康评估问卷（S-HAQ）是硬皮病研究和临床护理中广泛使用的患者报告结局指标。然而，缺乏数据来（a）确保并记录系统性硬化症患者理解这些指标中包含的概念，以及（b）证明这些条目和指标的表面效度、条目效度和内容效度。
我们对弥漫性皮肤系统性硬化症（dcSSc）患者进行了S-HAQ的认知访谈。S-HAQ包括HAQ-DI，这是一份20项问卷，评估进行日常活动的功能能力，四项硬皮病特异性条目评估硬皮病症状，以及一项关于硬皮病相关总体限制的条目。
dcSSc患者的总样本（N = 20）平均年龄为57.6岁，平均病程为3.4年。对于HAQ-DI，参与者理解其中的概念且条目清晰。此外，大多数（60%-100%）参与者报告在进行日常生活活动时使用辅助器具和设备及/或接受他人帮助。S-HAQ的硬皮病特异性条目与参与者相关，但需要对条目措辞和回答选项进行修订，包括从视觉模拟量表改为数字评定量表。
HAQ-DI和S-HAQ的硬皮病特异性条目分别证明了内容效度和条目效度。对S-HAQ的说明、条目措辞和评定量表进行了一些小的修改。
