Sibeoni J, Dunogué B, Dupont A, Haiddar D, Benmostefa N, Falissard B, Mouthon L, Révah-Levy A, Verneuil L
Service Universitaire de Psychiatrie de l'Adolescent, Argenteuil Hospital Centre, Argenteuil, France.
ECSTRRA Team, UMR-1153, Inserm, Université de Paris, F-75010, Paris, France.
Br J Dermatol. 2022 Jan;186(1):96-105. doi: 10.1111/bjd.20688. Epub 2021 Oct 21.
Hand involvement in systemic sclerosis (SSc) is at the core of the disease, with a substantial impact on both functional aspects and quality of life. There is no patient-reported outcome (PRO) scale globally assessing hand involvement in SSc.
To develop and validate a PRO scale, the Hand scleroDerma lived Experience (HAnDE) scale, to assess the lived experience of hand involvement in patients with SSc.
This was an exploratory sequential mixed-methods study with two phases: (i) PRO development through an inductive process to analyse the structure of lived experience, involving 21 patients with SSc; and (ii) PRO validation by assessing the psychometric properties of the scale among 105 patients with SSc.
Phase 1 enabled us to generate the 18-item provisional scale. From Phase 2, the mean (SD) total score of the scale was 29·16 (16·15). The item reduction process retained 16 items with five levels of answers (range 0-64). Internal consistency of the 16-item version was excellent (Cronbach's alpha = 0·946). Construct validity was very good, principal component analysis pointing towards a unidimensional instrument, with one factor explaining 56% of the variance, and concurrent validity being confirmed: Cochin Hand Function Scale r = 0·66; Health Assessment Questionnaire - Disability index r = 0·58; Hospital Anxiety and Depression Scale, anxiety r = 0·51, depression r = 0·4; Mouth Handicap in Systemic Sclerosis scale r = 0·61; 36-Item Short Form Health Survey, physical component r = -0·48, mental component r = -0·46; and Kapandji score r = -0·46. The correlations were statistically significant (P < 0·05).
We propose, for future trials and clinical practice in SSc, a new PRO, the HAnDE scale, that assesses all the dimensions - functional, aesthetic, relational, existential and emotional - of the lived experience of hand involvement in SSc.
手部受累在系统性硬化症（SSc）中处于疾病的核心位置，对功能方面和生活质量均有重大影响。目前尚无全球通用的患者报告结局（PRO）量表来全面评估SSc患者的手部受累情况。
开发并验证一种PRO量表，即手部硬皮病生活体验（HAnDE）量表，以评估SSc患者手部受累的生活体验。
这是一项探索性序贯混合方法研究，分为两个阶段：（i）通过归纳过程进行PRO开发，以分析生活体验的结构，涉及21例SSc患者；（ii）通过评估105例SSc患者中该量表的心理测量特性来进行PRO验证。
第一阶段使我们生成了包含18个条目的初步量表。在第二阶段，该量表的平均（标准差）总分是29.16（16.15）。条目缩减过程保留了16个条目，有五个答案级别（范围0 - 64）。16条目版本的内部一致性极佳（Cronbach's α = 0.946）。结构效度非常好，主成分分析表明该量表为单维工具，一个因子解释了56%的方差，同时效度得到确认：科钦手部功能量表r = 0.66；健康评估问卷 - 残疾指数r = 0.58；医院焦虑抑郁量表，焦虑r = 0.51，抑郁r = 0.4；系统性硬化症口腔功能障碍量表r = 0.61；36条目简明健康调查，身体成分r = -0.48，心理成分r = -0.46；以及卡潘迪评分r = -0.46。这些相关性具有统计学意义（P < 0.05）。
我们建议，在未来SSc的试验和临床实践中，采用一种新的PRO量表，即HAnDE量表，该量表可评估SSc患者手部受累生活体验的所有维度——功能、美观、人际关系、生存及情感维度。
