TY - JOUR
T1 - Ultrasound Core Laboratory for the Household Air Pollution Intervention Network Trial
T2 - Standardized Training and Image Management for Field Studies Using Portable Ultrasound in Fetal, Lung, and Vascular Evaluations
AU - for the HAPIN Investigators
AU - Dávila-Román, Víctor G.
AU - Toenjes, Ashley K.
AU - Meyers, Rachel M.
AU - Lenzen, Pattie M.
AU - Simkovich, Suzanne M.
AU - Herrera, Phabiola
AU - Fung, Elizabeth
AU - Papageorghiou, Aris T.
AU - Craik, Rachel
AU - McCracken, John P.
AU - Thompson, Lisa M.
AU - Balakrishnan, Kalpana
AU - Rosa, Ghislaine
AU - Peel, Jennifer
AU - Clasen, Thomas F.
AU - Hossen, Shakir
AU - Checkley, William
AU - Fuentes, Lisa de las
N1 - Funding Information:
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). 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). Sponsors participated in weekly conference calls, made recommendations about the study design and participated in final decision-making of the study protocol; however, they had no role in the writing of this report or the decision to submit it for publication. The authors share final responsibility for the decision to submit for publication. We would like to thank the multidisciplinary, independent Data and Safety Monitoring Board appointed by the National Heart, Lung, and Blood Institute to monitor the quality of the data and protect the safety of participants enrolled in the HAPIN trial: Nancy R. Cook, Stephen Hecht, Catherine Karr, Katie H. Kavounis, Dong-Yun Kim, Joseph Millum, Lora A. Reineck, Nalini Sathiakumar, Paul K. Whelton and Gail G. Weinmann. Program coordination was performed by Gail Rodgers, Bill & Melinda Gates Foundation; Claudia L. Thompson, National Institute of Environmental Health Science; Mark J. Parascandola, National Cancer Institute; Danuta M. Krotoski, Eunice Kennedy Shriver National Institute of Child Health and Human Development; Joshua P. Rosenthal, Fogarty International Center; Conception R. Nierras, National Institutes of Health Office of Strategic Coordination Common Fund; and Antonello Punturieri, and Barry S. Schmetter, National Heart, Lung, and Blood Institute. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the US National Institutes of Health or Department of Health and Human Services. The authors declare no competing interests.
Publisher Copyright:
© 2021 The Authors
PY - 2021/6
Y1 - 2021/6
N2 - 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.
AB - 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.
KW - BART
KW - CIMT
KW - Competency
KW - Core Laboratory
KW - Education
KW - Fetal ultrasound
KW - Lung ultrasound
KW - Multidisciplinary
KW - Quality control
KW - Sonographer
KW - Ultrasound
UR - http://www.scopus.com/inward/record.url?scp=85103538655&partnerID=8YFLogxK
U2 - 10.1016/j.ultrasmedbio.2021.02.015
DO - 10.1016/j.ultrasmedbio.2021.02.015
M3 - Article
C2 - 33812692
AN - SCOPUS:85103538655
SN - 0301-5629
VL - 47
SP - 1506
EP - 1513
JO - Ultrasound in Medicine and Biology
JF - Ultrasound in Medicine and Biology
IS - 6
ER -