Reliability of mercury-in-silastic strain gauge plethysmography curve reading: Influence of clinical clues and observer variation

AIM: Mercury-in-silastic strain gauge pletysmography (SGP) is a well-established technique for blood flow and blood pressure measurements. The aim of this study was to examine (i) the possible influence of clinical clues, e.g. the presence of wounds and color changes during blood pressure measurements, and (ii) intra- and inter-observer variation of curve interpretation for segmental blood pressure measurements. METHODS: A total of 204 patients with known or suspected peripheral arterial disease (PAD) were included in a diagnostic accuracy trial. Toe and ankle pressures were measured in both limbs, and primary observers analyzed a total of 804 pressure curve sets. The SGP curves were later reanalyzed separately by two observers blinded to clinical clues. Intra- and inter-observer agreement was quantified using Cohen's kappa and reliability was quantified using intra-class correlation coefficients, coefficients of variance, and Bland-Altman analysis. RESULTS: There was an overall agreement regarding patient diagnostic classification (PAD/not PAD) in 202/204 (99.0%) for intra-observer (κ = 0.969, p < 0.001), and 201/204 (98.5%) for inter-observer readings (κ = 0.953, p < 0.001). Reliability analysis showed excellent correlation between blinded versus non-blinded and inter-observer readings for determination of absolute segmental pressures (all intraclass correlation coefficients ≥ 0.984). The coefficient of variance for determination of absolute segmental blood pressure ranged from 2.9-3.4% for blinded/non-blinded data and from 3.8-5.0% for inter-observer data. CONCLUSION: This study shows a low inter-observer variation among experienced laboratory technicians for reading strain gauge curves. The low variation between blinded/non-blinded readings indicates that SGP measurements are minimally biased by clinical clues.