建立非肩部手部和上肢人群中 PROMIS 上肢计算机自适应测试版本 2.0 的最小临床重要差异。
Establishing the Minimal Clinically Important Difference for the PROMIS Upper Extremity Computer Adaptive Test Version 2.0 in a Nonshoulder Hand and Upper Extremity Population.
机构信息
Department of Orthopaedics, University of Utah, Salt Lake City, UT.
Division of Public Health, University of Utah, Salt Lake City, UT.
出版信息
J Hand Surg Am. 2021 Oct;46(10):927.e1-927.e10. doi: 10.1016/j.jhsa.2021.01.023. Epub 2021 Mar 31.
PURPOSE
Our primary purpose was to calculate the minimal clinically important difference (MCID) for the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Computer Adaptive Test (CAT) version 2.0 (v2.0) for a nonshoulder hand and upper extremity population. Secondarily, we calculated the PROMIS Physical Function (PF) CAT v2.0 and the abbreviated version of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) MCID.
METHODS
Adult patients treated by 1 of 5 fellowship-trained hand surgeons between March 2015 and September 2019 at an academic tertiary institution were identified. The PROMIS UE CAT v2.0, PROMIS PF CAT v2.0, and QuickDASH were collected via tablet computer. Inclusion required response to at least 1 of the instruments at both baseline and follow-up (6 ± 4 weeks), and a response to the anchor question: "Compared to your first evaluation at the University Orthopaedic Center, how would you describe your physical function level now?" An additional anchor question assessing treatment-related improvement was also asked. The MCID was calculated using an anchor-based approach using the mean change difference between groups reporting no change and slight change for both anchor questions, and with the 1/2 SD method.
RESULTS
Of 2,106 participants, mean age was 48 ± 17 years, 53% were female, and 53% were recovering from surgery. Of these patients, 381 completed the PROMISE UE CAT v2.0, 497 completed the PROMIS PF CAT v2.0, and 2,018 completed the QuickDASH. The score change between baseline and follow-up was significantly different between anchor groups for both anchor-based MCID calculations. Anchor-based MCID values were 3.0 to 4.0 for the UE CAT, 2.1 to 3.6 for the PF CAT, and 10.3 for the QuickDASH. The MCID values per the 1/2 SD method were 4.1, 4.1, and 10.2, respectively.
CONCLUSIONS
We propose MCID ranges of 3.0 to 4.1 for the PROMIS UE CAT v2.0, and 2.1 to 4.1 for the PROMIS PF CAT v2.0. The observed QuickDASH MCID values (10.2-10.3) are within the range of previously published values.
CLINICAL RELEVANCE
These MCID estimates will aid in interpreting clinical outcomes and in powering clinical studies.
目的
我们的主要目的是计算患者报告的结局测量信息系统（PROMIS）上肢（UE）计算机自适应测试（CAT）版本 2.0（v2.0）的最小临床重要差异（MCID），用于非肩部手部和上肢人群。其次，我们计算了 PROMIS 物理功能（PF）CAT v2.0 和简化版的手臂、肩部和手部残疾（QuickDASH）MCID。
方法
在学术三级医疗机构由 5 名 fellowship 培训的手外科医生治疗的成年患者于 2015 年 3 月至 2019 年 9 月被确定。通过平板电脑收集 PROMIS UE CAT v2.0、PROMIS PF CAT v2.0 和 QuickDASH。纳入标准为在基线和随访（6±4 周）时至少对 1 项仪器有反应，并且对以下锚定问题有反应：“与您在大学骨科中心的首次评估相比，您现在如何描述您的身体功能水平？”还询问了一个评估治疗相关改善的附加锚定问题。MCID 使用基于锚定的方法计算，该方法使用报告无变化和轻微变化的两组之间的组间均值变化差异，以及 1/2 SD 方法。
结果
在 2106 名参与者中，平均年龄为 48±17 岁，53%为女性，53%正在从手术中恢复。这些患者中，381 人完成了 PROMIS UE CAT v2.0，497 人完成了 PROMIS PF CAT v2.0，2018 人完成了 QuickDASH。基线和随访之间的得分变化在两个基于锚定的 MCID 计算的锚定组之间有显著差异。基于锚定的 MCID 值为 UE CAT 的 3.0 至 4.0，PF CAT 的 2.1 至 3.6，QuickDASH 的 10.3。1/2 SD 法的 MCID 值分别为 4.1、4.1 和 10.2。
结论
我们提出 PROMIS UE CAT v2.0 的 MCID 范围为 3.0 至 4.1，PROMIS PF CAT v2.0 的 MCID 范围为 2.1 至 4.1。观察到的 QuickDASH MCID 值（10.2-10.3）在先前发表的值范围内。
临床意义
这些 MCID 估计值将有助于解释临床结果，并为临床研究提供动力。
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