Abstract
BackgroundPoint-of-care ultrasound (POC-US) is a diagnostic test conducted at the site of patient care with direct interpretation by the clinician, providing immediate results. POC-US for gynecologic application is not well characterized by current literature yet has the potential to increase access in limited resource settings. We compared the diagnostics of three POC-US devices for gynecologic (GYN) pathology and then performed evaluation of sensitivity and specificity of a single best POC-US device for intended use in a low resource setting.MethodsThis is prospective, pilot descriptive study of 60 subjects. In part 1, comparison of three POC-US devices was performed. Twenty subjects underwent POC-US with three test units [GE Vscan (Vscan), Sonosite Iviz (Iviz), Philips Lumify (Lumify)] followed by diagnostic ultrasound (Dx-US) for reference imaging. Image quality and correlation for devices was scored by blinded reviewers and quantitative measurements of GYN pathology were compared. In part 2, forty subjects underwent POC-US validation with the highest scoring device (Lumify) and Dx-US for reference imaging. Concordance of POC-US operator-interpreted diagnosis with reference imaging interpretation were assessed by Cohen’s unweighted kappa coefficient. Accuracy and agreement of POC-US were assessed by linear regression and Bland–Altman plot analysis. Sensitivity and specificity of POC-US for gynecologic pathologies were calculated.ResultsIn aggregate qualitative measurements, Lumify and Iviz units performed superiorly to Vscan. There was no statistically significant difference in quantitative measurements between devices, but a trend towards lower mean error was seen for Lumify and Iviz as compared to Vscan. Lumify device had highest overall scoring and was selected for further testing. In validation comparison of Lumify to Dx-US, no statistically significant differences were found for measurements of endometrium, uterus, ovaries, adnexal pathology, or leiomyomata, (P < 0.02) with excellent agreement in operator-interpreted diagnosis (Kappa > 0.7). Sensitivity and specificity of detecting pathology was 80–100% with PPV and NPV 76–100%.ConclusionAmong three POC-US devices, Lumify and Iviz devices show highest potential for successful application to clinical gynecologic ultrasound. Clinician-performed POC-US has high diagnostic accuracy, sensitivity, and specificity for basic GYN anatomy and pathology. POC-US is an acceptable and feasible diagnostic tool with potential for future application in a low resource setting to increase access to ultrasound.
Highlights
Point-of-care ultrasound (POC-US) is a diagnostic test conducted at the site of patient care with direct interpretation by the clinician, providing immediate results
POC-US devices have an array of available software and probes and sources report good agreement in image quality between these devices and higher-end machines [2,3,4,5,6], though some reports demonstrate lower resolution and total image quality which could lead to missed diagnoses [5]
A total of three ultrasound devices were chosen for evaluation based on ability for the study team to obtain the device, prior Food and Drug Administration (FDA) approval for gynecologic imaging, weight less than 2 lb, and cost less than $10,000, making it a reasonable option for POC-US in a low resource setting
Summary
Point-of-care ultrasound (POC-US) is a diagnostic test conducted at the site of patient care with direct interpretation by the clinician, providing immediate results. We compared the diagnostics of three POC-US devices for gynecologic (GYN) pathology and performed evaluation of sensitivity and specificity of a single best POC-US device for intended use in a low resource setting. Point of care ultrasound testing (POC-US) is an ultrasound performed at the bedside by the clinician and interpreted directly by the clinician for immediate diagnosis and treatment planning [1]. Ultrasound is costeffective, safe, and has the benefit of real-time imaging for immediate diagnosis. It is highly operator and equipment dependent which carries implications about its use in guiding moment-to-moment therapeutic decisions when used in a point-of-care context. Handheld POC-US devices allow physicians greater ease of use in a variety of settings, including low resource international and rural settings. POC-US devices have an array of available software and probes and sources report good agreement in image quality between these devices and higher-end machines [2,3,4,5,6], though some reports demonstrate lower resolution and total image quality which could lead to missed diagnoses [5]
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