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Evaluating sensitivity and specificity of handheld point-of-care ultrasound testing for gynecologic pathology: a pilot study for use in low resource settings

BACKGROUND: 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 for gynecologic application is not well characterized by current literature yet has the potential to increase acce...

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Autores principales: Toscano, Marika, Szlachetka, Kam, Whaley, Natalie, Thornburg, Loralei L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7590494/
https://www.ncbi.nlm.nih.gov/pubmed/33109134
http://dx.doi.org/10.1186/s12880-020-00518-8
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author Toscano, Marika
Szlachetka, Kam
Whaley, Natalie
Thornburg, Loralei L.
author_facet Toscano, Marika
Szlachetka, Kam
Whaley, Natalie
Thornburg, Loralei L.
author_sort Toscano, Marika
collection PubMed
description BACKGROUND: 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 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. METHODS: This 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. RESULTS: In 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%. CONCLUSION: Among 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.
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spelling pubmed-75904942020-10-27 Evaluating sensitivity and specificity of handheld point-of-care ultrasound testing for gynecologic pathology: a pilot study for use in low resource settings Toscano, Marika Szlachetka, Kam Whaley, Natalie Thornburg, Loralei L. BMC Med Imaging Research Article BACKGROUND: 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 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. METHODS: This 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. RESULTS: In 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%. CONCLUSION: Among 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. BioMed Central 2020-10-27 /pmc/articles/PMC7590494/ /pubmed/33109134 http://dx.doi.org/10.1186/s12880-020-00518-8 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
Toscano, Marika
Szlachetka, Kam
Whaley, Natalie
Thornburg, Loralei L.
Evaluating sensitivity and specificity of handheld point-of-care ultrasound testing for gynecologic pathology: a pilot study for use in low resource settings
title Evaluating sensitivity and specificity of handheld point-of-care ultrasound testing for gynecologic pathology: a pilot study for use in low resource settings
title_full Evaluating sensitivity and specificity of handheld point-of-care ultrasound testing for gynecologic pathology: a pilot study for use in low resource settings
title_fullStr Evaluating sensitivity and specificity of handheld point-of-care ultrasound testing for gynecologic pathology: a pilot study for use in low resource settings
title_full_unstemmed Evaluating sensitivity and specificity of handheld point-of-care ultrasound testing for gynecologic pathology: a pilot study for use in low resource settings
title_short Evaluating sensitivity and specificity of handheld point-of-care ultrasound testing for gynecologic pathology: a pilot study for use in low resource settings
title_sort evaluating sensitivity and specificity of handheld point-of-care ultrasound testing for gynecologic pathology: a pilot study for use in low resource settings
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7590494/
https://www.ncbi.nlm.nih.gov/pubmed/33109134
http://dx.doi.org/10.1186/s12880-020-00518-8
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