Diagnostic Tools to Establish the Presence of Peripheral Arterial Disease in People With Diabetes (DMPAD): A Multicenter Comparative Diagnostic Accuracy Study.

Abstract

Accurate diagnosis of peripheral arterial disease (PAD) in people with diabetes is critical, but the accuracy of common bedside tests remains uncertain. This study evaluated the diagnostic accuracy of five bedside tests-ankle brachial pressure index (ABPI), exercise ABPI, toe brachial pressure index (TBPI), visual Doppler, and audible Doppler. Results were compared against the reference standard of computed tomography angiography (CTA) or magnetic resonance angiography (MRA). A prospective multicenter diagnostic accuracy study was conducted across 16 sites in the U.K. Participants aged ≥18 years, with a history of diabetes (symptomatic and asymptomatic), without contraindications to CTA or MRA, PAD status known on imaging, or a known history of PAD intervention, were eligible to partake. Patients were recruited from both primary and secondary care. Radiologists, blinded to index test results, used the ANGIO scoring system, with ≥50% stenosis defining PAD. The primary outcome was test sensitivity. From April 2022 to November 2023, 604 participants were enrolled; 536 completed the study with valid reference imaging. PAD was identified in 37% of participants. Sensitivity was low across all bedside tests: audible Doppler (36%, 95% CI 27-45), visual Doppler (42%, 95% CI 33-51), TBPI (55%, 95% CI 46-64), ABPI (41%, 95% CI 32-50), and exercise ABPI (41%, 95% CI 31-51). In people with diabetes, visual Doppler, audible Doppler, ABPI, TBPI, and exercise ABPI demonstrated poor diagnostic performance for PAD and should not be considered as accurate diagnostic tools in this population.