Establishing minimal clinically important difference for PROMIS physical function improvement after revascularization for peripheral artery disease

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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.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.