TY - JOUR
T1 - Lung Ultrasound Protocol and Quality Control of Image Interpretation Using an Adjudication Panel in the Household Air Pollution Intervention Network (HAPIN) Trial
AU - HAPIN investigators
AU - Simkovich, Suzanne M.
AU - Hossen, Shakir
AU - McCollum, Eric D.
AU - Toenjes, Ashley K.
AU - McCracken, John P.
AU - Thompson, Lisa M.
AU - Castañaza, Adly
AU - Diaz, Anaite
AU - Rosa, Ghislaine
AU - Kirby, Miles A.
AU - Mukeshimana, Alexie
AU - Myers, Rachel
AU - Lenzen, Patricia M.
AU - Craik, Rachel
AU - Jabbarzadeh, Shirin
AU - Elon, Lisa
AU - Garg, Sarada S.
AU - Balakrishnan, Kalpana
AU - Thangavel, Gurusamy
AU - Peel, Jennifer L.
AU - Clasen, Thomas F.
AU - Dávila-Román, Victor G.
AU - Papageorghiou, Aris T.
AU - de las Fuentes, Lisa
AU - Checkley, William
N1 - Funding Information:
We thank our pneumonia experts who participated in our workshops: Professor Heather Zar of the University of Cape Town (Cape Town, South Africa), Professor Harry Campbell of the University of Edinburgh (Edinburgh, UK), Professor Claudio Lanata of the Instituto De Investigación Nutricional (Lima, Peru), Dr. Carina King (Karolinska Institute, Sweden) and Dr. Laura Hammitt (Johns Hopkins University, Baltimore, MD, USA). We also thank Katerina Lescouflair, MSPH, and Delaney Connolly, both of Johns Hopkins University, for assistance with preparation of the protocols and development of materials. A multidisciplinary, independent Data and Safety Monitoring Board (DSMB) appointed by the National Heart, Lung, and Blood Institute (NHLBI) monitors the quality of the data and protects the safety of patients enrolled in the HAPIN trial. NHLBI DSMB: Nancy R. Cook, Sc.D.; Stephen Hecht, Ph.D.; Catherine Karr, M.D. Ph.D.; Katie H. Kavounis, M.P.H.; Dong-Yun Kim, Ph.D.; Joseph Millum, Ph.D.; Lora A. Reineck, M.D. M.S.; Nalini Sathiakumar, M.D. Dr. P.H.; Paul K. Whelton, M.D.; Gail G. Weinmann, M.D. Program Coordination: Gail Rodgers, M.D. Bill & Melinda Gates Foundation; Claudia L. Thompson, Ph.D. National Institute of Environmental Health Science (NIEHS); Mark J. Parascandola, Ph.D. M.P.H. National Cancer Institute (NCI); Danuta M. Krotoski, Ph.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Joshua P. Rosenthal, Ph.D. Fogarty International Center (FIC); Conception R. Nierras, Ph.D. NIH Office of Strategic Coordination Common Fund; Antonello Punturieri, M.D. Ph.D. and Barry S. Schmetter, B.S. NHLBI. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the U.S. National Institutes of Health or Department of Health and Human Services. HAPIN Investigators: Vigneswari Aravindalochanan, Kalpana Balakrishnan, Dana Boyd Barr, Vanessa Burrowes, Devan Campbell, Julia McPeek Campbell, Eduardo Canuz, Adly Castañaza, Howard Chang, William Checkley, Yunyun Chen, Marilú Chiang, Maggie L. Clark, Thomas Clasen, Rachel Craik, Mary Crocker, Victor G. Dávila-Román, Lisa de las Fuentes, Oscar De Léon, Anaité Diaz-Artiga, Ephrem Dusabimana, Lisa Elon, Juan Gabriel Espinoza, Irma Sayury Pineda Fuentes, Sarada Garg, Dina Goodman, Savannah Gupton, Meghan Hardison, Stella Hartinger, Steven A. Harvey, Mayari Hengstermann, Phabiola Herrera, Shakir Hossen, Penelope Howards, Lindsay Jaacks, Shirin Jabbarzadeh, Michael A. Johnson, Abigail Jones, Katherine Kearns, Miles Kirby, Jacob Kremer, Margaret Laws, Patricia M. Lenzen, Jiawen Liao, Amy Lovvorn, Fiona Majorin, Eric McCollum, John P. McCracken, Rachel M. Meyers, J. Jaime Miranda, Erick Mollinedo, Lawrence Moulton, Krishnendu Mukhopadhyay, Laura Nicolaou, Luke Naeher, Abidan Nambajimana, Florien Ndagijimana, Azhar Nizam, Jean de Dieu Ntivuguruzwa, Aris Papageorghiou, Jennifer Peel, Ricardo Piedrahita, Ajay Pillarisetti, Naveen Puttaswamy, Elisa Puzzolo, Ashlinn Quinn, Sarah Rajkumar, Usha Ramakrishnan, Davis Reardon, Ghislaine Rosa, Joshua Rosenthal, P. Barry Ryan, Zoe Sakas, Sankar Sambandam, Jeremy Sarnat, Suzanne Simkovich, Sheela Sinharoy, Kirk R. Smith, Kyle Steenland, Damien Swearing, Gurusamy Thangavel, Lisa M. Thompson, Ashley K. Toenjes, Lindsay Underhill, Jean Damascene Uwizeyimana, Viviane Valdes, Amit Verma, Lance Waller, Megan Warnock, Kendra Williams, Wenlu Ye, Bonnie Young. HAPIN sonographers: Libny Yadira Monroy Alarcón, Adly Castañaza Gonzalez de Durante, Claudia López Ortega, Irma Sayury Pineda, Maria Fernada Gonzalez, Lakshminarayanan Sowrirajan, Shanthi Priya Paramanandam, K Shanmugavadivu, Sudharsanan V. Suresh Seshadri, Vigneswari Aravindalochanan, Danielle Mendoza Apaza, Adhemir Edwing Yupanqui Fredes, Mario Hancco Gómez, Ronald Apaza R, Juan Felix Persivale Calle, Elizabeth Quispe, Carlos Leon Ponce, Victor Villar Gonzales, Rebeca Andrade Salas, Jhon Elmer Herrera, Luzdelia Ramos Mamani, Yessica Lopez, Giovanna Quiza, Yadel Hinojosa, Madeluz Gomez Quispe, Gery Frisancho Parada, Danielle Isabel Mendoza Apaza, Luz Roxana Quispe Flores, Alexie Mukeshimana, Niyitegeka Francois Xavier, Grace Utfimana, Elie Tuzayisenga, Valens Nkurunziza. The HAPIN trial is registered in clinicaltrials.gov (NCT02944682 Checkley, Clasen, Peel). This study is funded by the U.S. National Institutes of Health (Cooperative Agreement 1UM1HL134590) in collaboration with the Bill & Melinda Gates Foundation (OPP1131279). Participating NIH organizations include the National Heart, Lung and Blood Institute (NHLBI), National Institute of Environmental Health Sciences, National Cancer Institute, National Institute of Child Health and Human Development, Fogarty International Center and NIH Common Fund. Suzanne M. Simkovich was supported by funding under NHLBI Grants T32 HL007534-36, 1F32HL143909-01 and K12HL137942. A de-identified data set is available on request to the authors.
Funding Information:
Program Coordination: Gail Rodgers, M.D., Bill & Melinda Gates Foundation; Claudia L. Thompson, Ph.D., National Institute of Environmental Health Science (NIEHS); Mark J. Parascandola, Ph.D., M.P.H., National Cancer Institute (NCI); Danuta M. Krotoski, Ph.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Joshua P. Rosenthal, Ph.D., Fogarty International Center (FIC); Conception R. Nierras, Ph.D., NIH Office of Strategic Coordination Common Fund; Antonello Punturieri, M.D., Ph.D. and Barry S. Schmetter, B.S., NHLBI.
Funding Information:
This study is funded by the U.S. National Institutes of Health (Cooperative Agreement 1UM1HL134590) in collaboration with the Bill & Melinda Gates Foundation (OPP1131279). Participating NIH organizations include the National Heart, Lung and Blood Institute (NHLBI), National Institute of Environmental Health Sciences, National Cancer Institute, National Institute of Child Health and Human Development, Fogarty International Center and NIH Common Fund. Suzanne M. Simkovich was supported by funding under NHLBI Grants T32 HL007534-36, 1F32HL143909-01 and K12HL137942.
Publisher Copyright:
© 2023 World Federation for Ultrasound in Medicine & Biology
PY - 2023/5
Y1 - 2023/5
N2 - Objective: Lung ultrasound (LUS) is an alternative to chest radiography to confirm a diagnosis of pneumonia. For research and disease surveillance, methods to use LUS to diagnose pneumonia are needed. Methods: In the Household Air Pollution Intervention Network (HAPIN) trial, LUS was used to confirm a clinical diagnosis of severe pneumonia in infants. We developed a standardized definition of pneumonia, protocols for recruitment and training of sonographers, along with LUS image acquisition and interpretation. We use a blinded panel approach to interpretation with LUS cine-loops randomized to non-scanning sonographers with expert review. Discussion: We obtained 357 lung ultrasound scans: 159, 8 and 190 scans were collected in Guatemala, Peru and Rwanda, respectively. The diagnosis of primary endpoint pneumonia (PEP) required an expert tie breaker in 181 scans (39%). PEP was diagnosed in 141 scans (40%), not diagnosed in 213 (60%), with 3 scans (<1%) deemed uninterpretable. Agreement among the two blinded sonographers and the expert reader in Guatemala, Peru and Rwanda was 65%, 62% and 67%, with a prevalence-and-bias-corrected kappa of 0.30, 0.24 and 0.33, respectively. Conclusion: Use of standardized imaging protocols, training and an adjudication panel resulted in high confidence for the diagnosis of pneumonia using LUS.
AB - Objective: Lung ultrasound (LUS) is an alternative to chest radiography to confirm a diagnosis of pneumonia. For research and disease surveillance, methods to use LUS to diagnose pneumonia are needed. Methods: In the Household Air Pollution Intervention Network (HAPIN) trial, LUS was used to confirm a clinical diagnosis of severe pneumonia in infants. We developed a standardized definition of pneumonia, protocols for recruitment and training of sonographers, along with LUS image acquisition and interpretation. We use a blinded panel approach to interpretation with LUS cine-loops randomized to non-scanning sonographers with expert review. Discussion: We obtained 357 lung ultrasound scans: 159, 8 and 190 scans were collected in Guatemala, Peru and Rwanda, respectively. The diagnosis of primary endpoint pneumonia (PEP) required an expert tie breaker in 181 scans (39%). PEP was diagnosed in 141 scans (40%), not diagnosed in 213 (60%), with 3 scans (<1%) deemed uninterpretable. Agreement among the two blinded sonographers and the expert reader in Guatemala, Peru and Rwanda was 65%, 62% and 67%, with a prevalence-and-bias-corrected kappa of 0.30, 0.24 and 0.33, respectively. Conclusion: Use of standardized imaging protocols, training and an adjudication panel resulted in high confidence for the diagnosis of pneumonia using LUS.
KW - Developing countries
KW - Imaging
KW - Infant
KW - Pneumonia
KW - Research protocol
KW - Respiratory tract infections
KW - Ultrasound
UR - http://www.scopus.com/inward/record.url?scp=85148376910&partnerID=8YFLogxK
U2 - 10.1016/j.ultrasmedbio.2023.01.005
DO - 10.1016/j.ultrasmedbio.2023.01.005
M3 - Article
C2 - 36801180
AN - SCOPUS:85148376910
SN - 0301-5629
VL - 49
SP - 1194
EP - 1201
JO - Ultrasound in Medicine and Biology
JF - Ultrasound in Medicine and Biology
IS - 5
ER -