Department of Medicine, University of Michigan, Ann Arbor, MI, 48105, USA.
Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, 300 North Ingalls Street, SPC 5422, Ann Arbor, MI, 48109, USA.
Arthritis Res Ther. 2019 Jan 16;21(1):23. doi: 10.1186/s13075-019-1809-y.
This study aimed to assess the minimal clinically important differences (MCIDs) for the modified Rodnan skin score (mRSS) using combined data from the Scleroderma Lung Studies (I and II).
MCID estimates for the mRSS at 12 months were calculated using three anchors: change in scores on the Health Assessment Questionnaire- Disability Index from baseline to 12 months, change in scores on the Patient Global Assessment from baseline to 12 months, and answer at 12 month for the Short Form-36 health transition question "Compared to one year ago, how would you rate your health in general now?" We determined the mRSS MCID estimates for all participants and for those with diffuse cutaneous systemic sclerosis (dcSSc). We then assessed associations between MCID estimates of mRSS improvement and patient-reported outcomes, using Student's t test to compare the mean differences in patient outcomes between those who met the MCID improvement criteria versus those who did not meet the improvement criteria.
The mean (SD) mRSS at baseline was 14.75 (10.72) for all participants and 20.93 (9.61) for those with dcSSc. The MCID estimate for mRSS improvement at 12 months ranged from 3 to 4 units for the overall group (improvement of 20-27% from baseline) and was 5 units for those with dcSSc (improvement of 24% from baseline). Those who met the mRSS MCID improvement criteria had statistically significant improvements in scores on the Short Form-36 Physical Component Summary, the Transition Dyspnea Index, and joint contractures at 12 months.
MCID estimates for the mRSS were 3-4 units for all participants and 5 units for those with dcSSc. These findings are consistent with previously reported MCID estimates for systemic sclerosis.
本研究旨在使用硬皮病肺研究（I 期和 II 期）的合并数据评估改良 Rodnan 皮肤评分（mRSS）的最小临床重要差异（MCID）。
使用三个锚定物计算 mRSS 在 12 个月时的 MCID 估计值：从基线到 12 个月健康评估问卷残疾指数评分的变化，从基线到 12 个月患者整体评估评分的变化，以及在 12 个月时对简短表格-36 健康转换问题“与一年前相比，你现在如何评价自己的健康状况？”的回答。我们确定了所有参与者和弥漫性皮肤系统性硬皮病（dcSSc）患者的 mRSS MCID 估计值。然后，我们使用学生 t 检验比较符合 MCID 改善标准与不符合改善标准的患者之间的患者报告结果之间的关联，以比较患者结局的平均差异。
所有参与者的平均（SD）mRSS 基线值为 14.75（10.72），dcSSc 患者为 20.93（9.61）。mRSS 改善的 MCID 估计值在 12 个月时范围为 3 至 4 个单位（与基线相比改善 20-27%），对于 dcSSc 患者为 5 个单位（与基线相比改善 24%）。符合 mRSS MCID 改善标准的患者在 12 个月时的简短表格-36 身体成分摘要、过渡性呼吸困难指数和关节挛缩评分均有统计学显著改善。
所有参与者的 mRSS 的 MCID 估计值为 3-4 个单位，dcSSc 患者为 5 个单位。这些发现与先前报道的系统性硬化症的 MCID 估计值一致。
