ULTRASOUND CORE LABORATORY FOR THE HOUSEHOLD AIR POLLUTION INTERVENTION NETWORK TRIAL: STANDARDIZED TRAINING AND IMAGE MANAGEMENT FOR FIELD STUDIES USING PORTABLE ULTRASOUND IN FETAL, LUNG, AND VASCULAR EVALUATIONS

• Type of Material: Article
• Authors: Víctor G Dávila-Román, Washington University in St. Louis; Ashley K Toenjes, Washington University in St. Louis; Rachel M Meyers, Washington University in St. Louis; Pattie M Lenzen, Washington University in St. Louis; Suzanne M Simkovich, Johns Hopkins University; Phabiola Herrera, Johns Hopkins University; Elizabeth Fung, Johns Hopkins University; Aris T Papageorghiou, University of Oxford; Rachel Craik, University of Oxford; John P McCracken, Universidad del Valle de Guatemala; Lisa Thompson, Emory University; Kalpana Balakrishnan, Sri Ramachandra Institute of Higher Education and Research; Ghislaine Rosa, London School of Hygiene & Tropical Medicine; Jennifer Peel, Colorado State University; Thomas Clasen, Emory University; Shakir Hossen, Johns Hopkins University; William Checkley, Johns Hopkins University; Lisa de las Fuentes, Washington University in St. Louis
• Language: English
• Date: 2021-04-07
• Publisher: ELSEVIER SCIENCE INC
• Publication Version: Final Published Version
• Copyright Statement: © 2021 The Authors
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.ultrasmedbio.2021.02.015
• Title of Journal or Parent Work: ULTRASOUND IN MEDICINE AND BIOLOGY
• Volume: 47
• Issue: 6
• Start Page: 1506
• End Page: 1513
• Grant/Funding Information: Participating NIH organizations include the National Heart, Lung and Blood Institute; the National Institute of Environmental Health Sciences; the National Cancer Institute; the National Institute of Child Health and Human Development; the Fogarty International Center; and the NIH Common Fund. S.M.S. was supported by funding from the National Heart, Lung and Blood Institute (MCB1110957 T32 HL007534-36 and 1 F32 HL143909-01); This study is funded by the US National Institutes of Health (cooperative agreement 1 UM1 HL134590) in collaboration with the Bill & Melinda Gates Foundation (OPP1131279).
• Keywords: Competency; Technology; Radiology, Nuclear Medicine & Medical Imaging; Sonographer; Ultrasound; Core Laboratory; BART; Science & Technology; Life Sciences & Biomedicine; Acoustics; Lung ultrasound; CIMT; Multidisciplinary; Education; Quality control; Fetal ultrasound
• Research Categories: Health Sciences, Medicine and Surgery; Health Sciences, Public Health; Health Sciences, Nursing

Abstract

Ultrasound Core Laboratories (UCL) are used in multicenter trials to assess imaging biomarkers to define robust phenotypes, to reduce imaging variability and to allow blinded independent review with the purpose of optimizing endpoint measurement precision. The Household Air Pollution Intervention Network, a multicountry randomized controlled trial (Guatemala, Peru, India and Rwanda), evaluates the effects of reducing household air pollution on health outcomes. Field studies using portable ultrasound evaluate fetal, lung and vascular imaging endpoints. The objective of this report is to describe administrative methods and training of a centralized clinical research UCL. A comprehensive administrative protocol and training curriculum included standard operating procedures, didactics, practical scanning and written/practical assessments of general ultrasound principles and specific imaging protocols. After initial online training, 18 sonographers (three or four per country and five from the UCL) participated in a 2 wk on-site training program. Written and practical testing evaluated ultrasound topic knowledge and scanning skills, and surveys evaluated the overall course. The UCL developed comprehensive standard operating procedures for image acquisition with a portable ultrasound system, digital image upload to cloud-based storage, off-line analysis and quality control. Pre- and post-training tests showed significant improvements (fetal ultrasound: 71% ± 13% vs. 93% ± 7%, p < 0.0001; vascular lung ultrasound: 60% ± 8% vs. 84% ± 10%, p < 0.0001). Qualitative and quantitative feedback showed high satisfaction with training (mean, 4.9 ± 0.1; scale: 1 = worst, 5 = best). The UCL oversees all stages: training, standardization, performance monitoring, image quality control and consistency of measurements. Sonographers who failed to meet minimum allowable performance were identified for retraining. In conclusion, a UCL was established to ensure accurate and reproducible ultrasound measurements in clinical research. Standardized operating procedures and training are aimed at reducing variability and enhancing measurement precision from study sites, representing a model for use of portable digital ultrasound for multicenter field studies.