Dwivedi Nishant, Goldfarb Charles A, Calfee Ryan P
Department of Orthopedics, Washington University, St. Louis, MO.
Department of Orthopedics, Washington University, St. Louis, MO.
J Hand Surg Am. 2023 Feb;48(2):134-140. doi: 10.1016/j.jhsa.2021.11.029. Epub 2022 Jun 24.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) and PROMIS Physical Function (PF) are increasingly referenced patient-reported outcomes. To interpret treatment effects with these patient-reported outcomes, investigators must understand magnitudes of change that represent clinically relevant improvement. This study assessed the responsiveness of PROMIS UE and PF in patients with cubital tunnel syndrome.
A retrospective analysis of PROMIS UE and PROMIS PF computer adaptive test scores was performed for patients treated nonoperatively for cubital tunnel syndrome over 3 years at a tertiary institution. The Patient-Reported Outcomes Measurement Information System UE and PROMIS PF outcome scores were collected at initial and return clinic visits. At follow-up appointments, patients completed clinical anchor questions evaluating their degree of interval clinical improvement. Anchor questions allowed categorization of patients into groups that had experienced "no change," "minimal change," and "much change." Minimal clinically important difference (MCID) values were calculated for the PROMIS assessments with anchor-based and distribution-based methods.
A total of 304 patients with PROMIS PF scores and 111 with PROMIS UE scores were analyzed. The MCID for the PROMIS UE was 3.1 (95% confidence interval, 1.4-4.8) using the anchor-based method and 3.7 (95% confidence interval, 2.9-4.4) using the distribution-based method. These point estimates exceeded the minimal detectable change of 2.3. The MCID for the PROMIS PF was unable to be determined in this patient sample because patients reporting mild change did not have score changes exceeding measurement error.
The PROMIS UE v2.0 computer adaptive test detected minimal change in patients managed nonoperatively for cubital tunnel syndrome with an estimated MCID range of 3.1-3.7. While PROMIS PF has demonstrated acceptable performance in patients with a variety of upper extremity conditions, for cubital tunnel syndrome, it was less able to detect subtle change. PROMIS UE appears more responsive to subtle changes in cubital tunnel syndrome symptoms.
Patient-reported outcomes may have varied responsiveness depending on the condition studied.
患者报告结局测量信息系统(PROMIS)上肢(UE)和PROMIS身体功能(PF)越来越多地被用作患者报告结局的参考指标。为了解释这些患者报告结局的治疗效果,研究人员必须了解代表临床相关改善的变化幅度。本研究评估了PROMIS UE和PF在肘管综合征患者中的反应性。
对一家三级医疗机构3年内接受非手术治疗的肘管综合征患者的PROMIS UE和PROMIS PF计算机自适应测试分数进行回顾性分析。在初次就诊和复诊时收集患者报告结局测量信息系统UE和PROMIS PF结局分数。在随访预约时,患者完成临床锚定问题,评估其间隔期临床改善程度。锚定问题可将患者分为经历“无变化”“微小变化”和“显著变化”的组。采用基于锚定和基于分布的方法计算PROMIS评估的最小临床重要差异(MCID)值。
共分析了304例有PROMIS PF分数的患者和111例有PROMIS UE分数的患者。采用基于锚定的方法,PROMIS UE的MCID为3.1(95%置信区间,1.4 - 4.8);采用基于分布的方法,MCID为3.7(95%置信区间,2.9 - 4.4)。这些点估计值超过了最小可检测变化值2.3。在该患者样本中无法确定PROMIS PF的MCID,因为报告轻微变化的患者的分数变化未超过测量误差。
PROMIS UE v2.0计算机自适应测试在非手术治疗的肘管综合征患者中检测到微小变化,估计MCID范围为3.1 - 3.7。虽然PROMIS PF在各种上肢疾病患者中表现出可接受的性能,但对于肘管综合征,它检测细微变化的能力较弱。PROMIS UE似乎对肘管综合征症状的细微变化更敏感。
根据所研究的疾病情况,患者报告结局可能具有不同的反应性。