Department of Internal Medicine, University of Missouri, Kansas City (P.A.P.-O., D.A., M.B., J.A.S.).
Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, Kansas City, MO (P.A.P.-O., J.W., J.G., D.S, Y.T., M.B., J.A.S.).
Circ Cardiovasc Qual Outcomes. 2021 May;14(5):e007232. doi: 10.1161/CIRCOUTCOMES.120.007232. Epub 2021 May 5.
Understanding minimum clinically important differences (MCID) in patient-reported outcomes is essential in interpreting the magnitude of changes in these measures. No MCID from patients' perspectives has ever been published for peripheral artery disease-specific health status assessment tools. The Peripheral Artery Questionnaire (PAQ) is a commonly used, validated peripheral artery disease-specific health status instrument for which we sought to prospectively establish its MCID from patients' perspectives.
Patients presenting to vascular clinics with new or worsened claudication in the US cohort of the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry who completed baseline and follow-up PAQ assessments along with the Global Assessment of Functioning scale were included. Mean change in PAQ summary scores from 3- to 6-month follow-up was calculated according to Global Assessment of Functioning category. MCID was defined as the mean difference in scores between those with small improvement or deterioration and those with no change. Multivariable linear regression was used to provide an MCID estimate after adjusting for patients' 3-month PAQ score. Of the 483 patients who completed the Global Assessment of Functioning score at 6 months and who had available 3- and 6-month PAQ assessments, the mean age was 69 years, 42% were female, and 71% were White. The MCIDs for PAQ summary scale improvement and worsening were 8.7 (2.9-14.5) and -11.0 (-18.6 to -3.3), respectively. After multivariable adjustment, these were 8.9 (3.0-14.8) and -11.2 (-18.2 to -4.2), respectively. There was no significant interaction between treatment (invasive versus noninvasive) and Global Assessment of Functioning response (=0.75).
In patients with new or worsened claudication, a 10-point change in PAQ summary score represents an MCID. This estimate needs external validation and may inform the interpretation of PAQ scores when used as outcomes in clinical trials or in routine clinical care. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01419080.
理解患者报告结局中的最小临床重要差异（MCID）对于解释这些指标的变化程度至关重要。目前尚未从患者角度发布过外周动脉疾病特定健康状况评估工具的 MCID。外周动脉问卷（PAQ）是一种常用的、经过验证的外周动脉疾病特定健康状况工具，我们旨在从患者角度前瞻性确定其 MCID。
纳入了在美国 PORTRAIT（患者为中心的外周动脉疾病治疗相关结局：探索轨迹）登记处新出现或恶化跛行的血管诊所就诊的患者，他们完成了基线和随访 PAQ 评估以及总体功能评估量表。根据总体功能评估类别，计算 PAQ 综合评分从 3 个月到 6 个月的随访变化。MCID 定义为在小改善或恶化与无变化之间的评分差异的平均值。多变量线性回归用于调整患者 3 个月的 PAQ 评分后提供 MCID 估计。在完成 6 个月总体功能评估量表且可获得 3 个月和 6 个月 PAQ 评估的 483 名患者中，平均年龄为 69 岁，42%为女性，71%为白人。PAQ 综合量表改善和恶化的 MCIDs 分别为 8.7（2.9-14.5）和-11.0（-18.6 至-3.3）。多变量调整后，分别为 8.9（3.0-14.8）和-11.2（-18.2 至-4.2）。治疗（有创与非侵入性）与总体功能反应之间没有显著交互作用（=0.75）。
在新出现或恶化跛行的患者中，PAQ 综合评分的 10 分变化代表 MCID。该估计值需要外部验证，当在临床试验或常规临床护理中用作结局时，可能有助于解释 PAQ 评分。注册：网址：https://www.clinicaltrials.gov；独特标识符：NCT01419080。
