Diagnostic accuracy of laser Doppler flowmetry versus strain gauge plethysmography for segmental pressure measurement

ObjectiveTo assess the diagnostic accuracy of laser Doppler flowmetry (LDF) with mercury-in-silastic strain gauge plethysmography (SGP) as a reference test for measuring the toe and ankle pressures in patients with known or suspected peripheral arterial disease (PAD).MethodsThis was a prospective, randomized, blinded diagnostic accuracy study. Toe and ankle pressures were measured using both methods in 200 consecutive patients, who were recruited at our vascular laboratory over a period of 30 working days. Classification of PAD and critical limb ischemia (CLI) was made in accordance with TASC-II criteria.ResultsThe LDF method demonstrated 5.8 mm Hg higher mean toe pressures than the SGP method for the right limb and 7.0 mm Hg for the left limb (both P < .001). There were no significant differences in the mean ankle pressures (both P > .129). The limits of agreement for the differences (SGP − LDF) were −31.7 to 20.2 mm Hg for right toe pressures, −28.0 to 14.0 mm Hg for left toe pressures, −25.5 to 22.8 mm Hg for right ankle pressures, and −26.9 to 24.6 mm Hg for left ankle pressures. A correlation analysis of the absolute pressures using the two methods showed an intraclass correlation coefficient of 0.902 (95% confidence interval [CI], 0.835-0.938) for right toe pressures, 0.919 (95% CI, 0.782-0.960) for the left toe pressures, 0.953 (95% CI, 0.937-0.965) for right ankle pressures, and 0.952 (95% CI, 0.936-0.964) for left ankle pressures. Cohen's Kappa showed an agreement in the diagnostic classification of κ = 0.775 (95% CI, 0.631-0.919) for PAD and κ = 0.780 (95% CI, 0.624-0.936) for CLI.ConclusionsLDF showed a good correlation with SGP over a wide range of toe and ankle pressures, as well as substantial agreement for the diagnostic classification of PAD including CLI

Reliability of laser Doppler flowmetry curve reading for measurement of toe and ankle pressures:intra- and inter-observer variation

ObjectivesTo assess the intra- and inter-observer variation in laser Doppler flowmetry curve reading for measurement of toe and ankle pressures.MethodsA prospective single blinded diagnostic accuracy study was conducted on 200 patients with known or suspected peripheral arterial disease (PAD), with a total of 760 curve sets produced. The first curve reading for this study was performed by laboratory technologists blinded to clinical clues and previous readings at least 3 months after the primary data sampling. The pressure curves were later reassessed following another period of at least 3 months. Observer agreement in diagnostic classification according to TASC-II criteria was quantified using Cohen's kappa. Reliability was quantified using intra-class correlation coefficients, coefficients of variance, and Bland–Altman analysis.ResultsThe overall agreement in diagnostic classification (PAD/not PAD) was 173/200 (87%) for intra-observer (κ = .858) and 175/200 (88%) for inter-observer data (κ = .787). Reliability analysis confirmed excellent correlation for both intra- and inter-observer data (ICC all ≥.931). The coefficients of variance ranged from 2.27% to 6.44% for intra-observer and 2.39% to 8.42% for inter-observer data. Subgroup analysis showed lower observer-variation for reading of toe pressures in patients with diabetes and/or chronic kidney disease than patients not diagnosed with these conditions. Bland–Altman plots showed higher variation in toe pressure readings than ankle pressure readings.ConclusionsThis study shows substantial intra- and inter-observer agreement in diagnostic classification and reading of absolute pressures when using laboratory technologists as observers. The study emphasises that observer variation for curve reading is an important factor concerning the overall reproducibility of the method. Our data suggest diabetes and chronic kidney disease have an influence on toe pressure reproducibility