From the Department of Experimental and Clinical Medicine, and Department of Public Health, University of Florence; Department of Geriatric Medicine, Division of Rheumatology Azienda Ospedaliero-Universitaria Careggi (AOUC), Florence, Italy; the Centre for Rheumatology and Connective Tissue Diseases, University College London (UCL), Division of Medicine, London, UK; Rheumatology and Rehabilitation Department, Assiut University Hospital, Assiut, Egypt; Department of Rheumatology, Institute for Research and Health Care (IRCCS) Policlinico San Matteo Foundation, Pavia, Italy; Department of Medicine Statistics Core, and Division of Rheumatology, Department of Medicine, University of California at Los Angeles, Los Angeles, California, USA.
Dr. Bruni has received a 6-month travel bursary grant from European League Against Rheumatism to undertake this project. Dr. Denton has been a consultant to Bayer, Roche, GSK, Actelion, Inventiva, CSL Behring, Takeda, Merck-Serono, MedImmune, and Biogen. He has received research grants from Actelion, GSK, Novartis, and CSL Behring. Dr. Furst has received grant/research support from AbbVie, Actelion, Amgen, BMS, the US National Institutes of Health, Novartis, Pfizer, and Roche/Genentech, and consultancy fees from AbbVie, Actelion, Amgen, BMS, Cytori, Novartis, Pfizer, and Roche/Genentech. Dr. Matucci-Cerinic has acted as a consultant to and/or received speaker fees from Actelion, GSK, BMS, Pfizer, and Italfarmaco, and he has received research grants from Actelion.
J Rheumatol. 2019 Jun;46(6):603-608. doi: 10.3899/jrheum.171486. Epub 2018 Nov 15.
To date, "healed/non-healed" and clinical judgment are the only available assessment tools for digital ulcers (DU) in patients with systemic sclerosis (SSc). The aim of our study is to examine a preliminary composite DU clinical assessment score (DUCAS) for SSc for face, content, and construct validity.
Patients with SSc presenting at least 1 finger DU were enrolled and assessed with the Health Assessment Questionnaire-Disability Index, Cochin scale, visual analog scale (VAS) for DU-related pain, patient global DU status, and global assessment as patient-reported outcomes (PRO), and physician VAS for DU status (phyGDU) as an SSc-DU expert physician/nurse measure. The DUCAS included 7 DU-related variables selected by a committee of SSc DU experts and weighted on a clinical basis. Face validity was examined by consensus and partial construct validity was tested through convergent correlation with other measures of hand function, using Spearman's correlations. A range of patients with SSc was examined. A linear regression model with backward stepwise analysis was used to determine the relationship of individual variables with the primary clinical parameter, phyGDU.
Forty-four patients with SSc (9 males, mean age 55 ± 15 yrs, mean disease duration 9.9 ± 5.8 yrs) were enrolled in the study. Overall DUCAS showed significant positive correlations with all abovementioned PRO (r > 0.4, p < 0.01). When all scores and scales were modeled, only DUCAS significantly predicted phyGDU (r = 0.59, R = 0.354, Akaike information criterion = 385.4).
Preliminarily, we suggest that the DUCAS may be a new clinical score for SSc-related DU, having face and content validity and convergent/divergent correlations (construct validity). These early data suggest that this score deserves further evaluation.
迄今为止，“愈合/未愈合”和临床判断是评估系统性硬化症（SSc）患者手指溃疡（DU）的唯一可用评估工具。我们研究的目的是检查 SSc 手指溃疡的初步综合临床评估评分（DUCAS）的面部、内容和结构有效性。
招募至少有 1 个手指 DU 的 SSc 患者，并使用健康评估问卷残疾指数、Cochin 量表、与 DU 相关的疼痛视觉模拟量表（VAS）、患者手指 DU 总体状况和全球评估作为患者报告的结果（PRO）、以及医生的 DU 状况 VAS（phyGDU）作为 SSc-DU 专家医生/护士的评估方法进行评估。DUCAS 包括由 SSc-DU 专家委员会选择的 7 个与 DU 相关的变量，并根据临床情况进行加权。通过专家共识检查表面有效性，并通过与手部功能其他测量方法的收敛相关性来测试部分结构有效性，使用 Spearman 相关系数。检查了一系列 SSc 患者。使用向后逐步分析的线性回归模型来确定个体变量与主要临床参数 phyGDU 的关系。
研究纳入了 44 名 SSc 患者（9 名男性，平均年龄 55 ± 15 岁，平均病程 9.9 ± 5.8 年）。总体 DUCAS 与上述所有 PRO 呈显著正相关（r > 0.4，p < 0.01）。当所有评分和量表建模时，只有 DUCAS 显著预测 phyGDU（r = 0.59，R = 0.354，Akaike 信息准则 = 385.4）。
初步表明，DUCAS 可能是一种新的 SSc 相关 DU 临床评分，具有面部和内容有效性以及收敛/发散相关性（结构有效性）。这些初步数据表明，该评分值得进一步评估。
