University of Michigan Scleroderma Program, Division of Rheumatology Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Statistics Core, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Clin Exp Rheumatol. 2019 Jul-Aug;37 Suppl 119(4):49-56. Epub 2019 Sep 4.
PROMIS-29 is a generic health-related quality of life instrument. Our objective was to assess the reliability, construct validity, and responsiveness to change of PROMIS-29 in systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Seventy-three participants with SSc-ILD were administered patient reported outcomes (PROs) at baseline and follow-up visits which included PROMIS-29 and other measures of generic health, dyspnea, and cough instruments. We assessed internal consistency reliability using Cronbach's α, an alpha of ≥ 0.70 was considered satisfactory. We assessed the responsiveness to change using linear regression models.
Mean age of the participants was 51.9 years and the mean disease duration was 7.9 years after first non-Raynaud's symptom. Of the 73 participants, 56.2% were classified as diffuse SSc and 26% limited SSc. The baseline (mean ± SD) FVC % predicted was 73.9±15.5 with a DLCO % predicted of 57.7±21.1; 95.9% had fibrotic NSIP pattern on HRCT. PROMIS-29 scores were 0.2 to 0.9 SD below the US population. Cronbach's α reliability was acceptable for all domains (ranged from 0.77 to 0.98). All scales showed statistically significant correlations with hypothesised PROMIS-29 domains (p≤0.05 for all comparisons). PROMIS-29 showed none-to-small discriminatory ability in comparison with physiologic measures (FVC and DLCO). There was no significant relationship between the change in FVC versus the change in PROMIS-29 measures over time.
PROMIS-29 has adequate reliability and construct validity for evaluation in SSc-ILD. It has moderate-to-large correlations with other PROs. The PROMIS-29 domains were not found to change over time in this cohort, likely due to stable nature of the observational cohort.
PROMIS-29 是一种通用的健康相关生活质量工具。我们的目的是评估 PROMIS-29 在系统性硬化症相关间质性肺病（SSc-ILD）中的可靠性、结构有效性和对变化的反应能力。
73 名 SSc-ILD 患者在基线和随访时接受了患者报告的结果（PROs），包括 PROMIS-29 和其他一般健康、呼吸困难和咳嗽仪器的测量。我们使用 Cronbach's α 评估内部一致性可靠性，≥0.70 的 α 值被认为是令人满意的。我们使用线性回归模型评估对变化的反应能力。
参与者的平均年龄为 51.9 岁，首次出现非雷诺现象后平均疾病持续时间为 7.9 年。73 名参与者中，56.2%被分类为弥漫性 SSc，26%为局限性 SSc。基线（平均值±标准差）FVC%预测值为 73.9±15.5，DLCO%预测值为 57.7±21.1；95.9%的人在 HRCT 上有纤维化 NSIP 模式。PROMIS-29 评分比美国人群低 0.2 至 0.9 个标准差。所有领域的 Cronbach's α 可靠性都可以接受（范围为 0.77 至 0.98）。所有量表与假设的 PROMIS-29 领域均显示出统计学上显著的相关性（所有比较的 p 值均≤0.05）。与生理测量（FVC 和 DLCO）相比，PROMIS-29 显示出无到小的区分能力。在时间上，FVC 的变化与 PROMIS-29 测量值的变化之间没有显著关系。
PROMIS-29 在 SSc-ILD 评估中具有足够的可靠性和结构有效性。它与其他 PROs 有中度到高度的相关性。在这个队列中，没有发现 PROMIS-29 各领域随时间发生变化，这可能是由于观察队列的稳定性所致。
