OBJECTIVE: To 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). METHODS: This 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. RESULTS: The 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. CONCLUSIONS:LDF 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.
RCT Entities:
OBJECTIVE: To 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). METHODS: This 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. RESULTS: The 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. CONCLUSIONS: LDF 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.