Establishing Minimal Clinically Important Difference for PROMIS Physical Function Improvement After Revascularization for Peripheral Artery Disease

确定外周动脉疾病血管重建术后 PROMIS 身体功能改善的最小临床重要差异

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Abstract

OBJECTIVE: Patients with peripheral arterial disease (PAD) undergo revascularization to improve physical function, yet meaningful improvement has not been defined. This study aims to define a threshold for improvement in patient-reported physical function (PROMIS-PF) and establish factors predictive of improvement following lower extremity revascularization. METHODS: This study is a single-center retrospective cohort analysis of adults undergoing elective revascularization for PAD 2016-2023 who had PROMIS-PF scores. Anchor- and distribution-based approaches were used to triangulate a single minimal clinically important difference (MCID) value representing an improvement in PROMIS-PF after revascularization. The anchor question was a general health question. A least absolute shrinkage selection operator (LASSO) selected for relevant variables that predict if a patient will reach the MCID that were inputted into generalized linear mixed model regression. RESULTS: Forty five percent of patients (N=60/132) had an anchor question that changed over time (improved or declined) with a corresponding PROMIS-PF anchor-based MCID value of 5.2 (±8.3). The distribution-based MCID was calculated from 62 patients with a PROMIS-PF standard deviation (SD) of 8.4, corresponding to a distribution-based MCID (1/2 × SD) of 4.2. The MCID values from both approaches converged on a conservative MCID estimate of ≥ 5. Forty percent of patients (N=25/62) met MCID following revascularization. Patients with higher baseline PROMIS-PF scores and more advanced age are less likely to meet MCID (OR 0.81, 95%CI 0.71 - 0.93, OR 0.94, 95%CI 0.88 - 1.00, respectively). However, only 41% of patients who had an improvement in ankle brachial index (ABI) value also met the MCID. CONCLUSIONS: A 5-point change in PROMIS-PF represents a meaningful improvement after revascularization for patients with PAD. Surgical technical success with a clinically meaningful improvement in ABI does not predict a corresponding improvement in function. Whether patients achieve functional improvement after revascularization depends on their baseline function score and age.

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