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Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study

BACKGROUND: Assessing the real-world effectiveness of COVID-19 vaccines and understanding the incidence and severity of SARS-CoV-2 illness in children are essential to inform policy and guide health care professionals in advising parents and caregivers of children who test positive for SARS-CoV-2. O...

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Autores principales: Burns, Joy, Rivers, Patrick, LeClair, Lindsay B, Jovel, Krystal S, Rai, Ramona P, Lowe, Ashley A, Edwards, Laura J, Khan, Sana M, Mathenge, Clare, Ferraris, Maria, Kuntz, Jennifer L, Lamberte, Julie Mayo, Hegmann, Kurt T, Odean, Marilyn J, McLeland-Wieser, Hilary, Beitel, Shawn, Odame-Bamfo, Leah, Schaefer Solle, Natasha, Mak, Josephine, Phillips, Andrew L, Sokol, Brian E, Hollister, James, Ochoa, Jezahel S, Grant, Lauren, Thiese, Matthew S, Jacoby, Keya B, Lutrick, Karen, Pubillones, Felipe A, Yoo, Young M, Rentz Hunt, Danielle, Ellingson, Katherine, Berry, Mark C, Gerald, Joe K, Lopez, Joanna, Gerald, Lynn B, Wesley, Meredith G, Krupp, Karl, Herring, Meghan K, Madhivanan, Purnima, Caban-Martinez, Alberto J, Tyner, Harmony L, Meece, Jennifer K, Yoon, Sarang K, Fowlkes, Ashley L, Naleway, Allison L, Gwynn, Lisa, Burgess, Jefferey L, Thompson, Mark G, Olsho, Lauren EW, Gaglani, Manjusha
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9377426/
https://www.ncbi.nlm.nih.gov/pubmed/35635842
http://dx.doi.org/10.2196/37929
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author Burns, Joy
Rivers, Patrick
LeClair, Lindsay B
Jovel, Krystal S
Rai, Ramona P
Lowe, Ashley A
Edwards, Laura J
Khan, Sana M
Mathenge, Clare
Ferraris, Maria
Kuntz, Jennifer L
Lamberte, Julie Mayo
Hegmann, Kurt T
Odean, Marilyn J
McLeland-Wieser, Hilary
Beitel, Shawn
Odame-Bamfo, Leah
Schaefer Solle, Natasha
Mak, Josephine
Phillips, Andrew L
Sokol, Brian E
Hollister, James
Ochoa, Jezahel S
Grant, Lauren
Thiese, Matthew S
Jacoby, Keya B
Lutrick, Karen
Pubillones, Felipe A
Yoo, Young M
Rentz Hunt, Danielle
Ellingson, Katherine
Berry, Mark C
Gerald, Joe K
Lopez, Joanna
Gerald, Lynn B
Wesley, Meredith G
Krupp, Karl
Herring, Meghan K
Madhivanan, Purnima
Caban-Martinez, Alberto J
Tyner, Harmony L
Meece, Jennifer K
Yoon, Sarang K
Fowlkes, Ashley L
Naleway, Allison L
Gwynn, Lisa
Burgess, Jefferey L
Thompson, Mark G
Olsho, Lauren EW
Gaglani, Manjusha
author_facet Burns, Joy
Rivers, Patrick
LeClair, Lindsay B
Jovel, Krystal S
Rai, Ramona P
Lowe, Ashley A
Edwards, Laura J
Khan, Sana M
Mathenge, Clare
Ferraris, Maria
Kuntz, Jennifer L
Lamberte, Julie Mayo
Hegmann, Kurt T
Odean, Marilyn J
McLeland-Wieser, Hilary
Beitel, Shawn
Odame-Bamfo, Leah
Schaefer Solle, Natasha
Mak, Josephine
Phillips, Andrew L
Sokol, Brian E
Hollister, James
Ochoa, Jezahel S
Grant, Lauren
Thiese, Matthew S
Jacoby, Keya B
Lutrick, Karen
Pubillones, Felipe A
Yoo, Young M
Rentz Hunt, Danielle
Ellingson, Katherine
Berry, Mark C
Gerald, Joe K
Lopez, Joanna
Gerald, Lynn B
Wesley, Meredith G
Krupp, Karl
Herring, Meghan K
Madhivanan, Purnima
Caban-Martinez, Alberto J
Tyner, Harmony L
Meece, Jennifer K
Yoon, Sarang K
Fowlkes, Ashley L
Naleway, Allison L
Gwynn, Lisa
Burgess, Jefferey L
Thompson, Mark G
Olsho, Lauren EW
Gaglani, Manjusha
author_sort Burns, Joy
collection PubMed
description BACKGROUND: Assessing the real-world effectiveness of COVID-19 vaccines and understanding the incidence and severity of SARS-CoV-2 illness in children are essential to inform policy and guide health care professionals in advising parents and caregivers of children who test positive for SARS-CoV-2. OBJECTIVE: This report describes the objectives and methods for conducting the Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT) study. PROTECT is a longitudinal prospective pediatric cohort study designed to estimate SARS-CoV-2 incidence and COVID-19 vaccine effectiveness (VE) against infection among children aged 6 months to 17 years, as well as differences in SARS-CoV-2 infection and vaccine response between children and adolescents. METHODS: The PROTECT multisite network was initiated in July 2021, which aims to enroll approximately 2305 children across four US locations and collect data over a 2-year surveillance period. The enrollment target was based on prospective power calculations and accounts for expected attrition and nonresponse. Study sites recruit parents and legal guardians of age-eligible children participating in the existing Arizona Healthcare, Emergency Response, and Other Essential Workers Surveillance (HEROES)-Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel (RECOVER) network as well as from surrounding communities. Child demographics, medical history, COVID-19 exposure, vaccination history, and parents/legal guardians’ knowledge and attitudes about COVID-19 are collected at baseline and throughout the study. Mid-turbinate nasal specimens are self-collected or collected by parents/legal guardians weekly, regardless of symptoms, for SARS-CoV-2 and influenza testing via reverse transcription-polymerase chain reaction (RT-PCR) assay, and the presence of COVID-like illness (CLI) is reported. Children who test positive for SARS-CoV-2 or influenza, or report CLI are monitored weekly by online surveys to report exposure and medical utilization until no longer ill. Children, with permission of their parents/legal guardians, may elect to contribute blood at enrollment, following SARS-CoV-2 infection, following COVID-19 vaccination, and at the end of the study period. PROTECT uses electronic medical record (EMR) linkages where available, and verifies COVID-19 and influenza vaccinations through EMR or state vaccine registries. RESULTS: Data collection began in July 2021 and is expected to continue through the spring of 2023. As of April 13, 2022, 2371 children are enrolled in PROTECT. Enrollment is ongoing at all study sites. CONCLUSIONS: As COVID-19 vaccine products are authorized for use in pediatric populations, PROTECT study data will provide real-world estimates of VE in preventing infection. In addition, this prospective cohort provides a unique opportunity to further understand SARS-CoV-2 incidence, clinical course, and key knowledge gaps that may inform public health. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/37929
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spelling pubmed-93774262022-08-16 Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study Burns, Joy Rivers, Patrick LeClair, Lindsay B Jovel, Krystal S Rai, Ramona P Lowe, Ashley A Edwards, Laura J Khan, Sana M Mathenge, Clare Ferraris, Maria Kuntz, Jennifer L Lamberte, Julie Mayo Hegmann, Kurt T Odean, Marilyn J McLeland-Wieser, Hilary Beitel, Shawn Odame-Bamfo, Leah Schaefer Solle, Natasha Mak, Josephine Phillips, Andrew L Sokol, Brian E Hollister, James Ochoa, Jezahel S Grant, Lauren Thiese, Matthew S Jacoby, Keya B Lutrick, Karen Pubillones, Felipe A Yoo, Young M Rentz Hunt, Danielle Ellingson, Katherine Berry, Mark C Gerald, Joe K Lopez, Joanna Gerald, Lynn B Wesley, Meredith G Krupp, Karl Herring, Meghan K Madhivanan, Purnima Caban-Martinez, Alberto J Tyner, Harmony L Meece, Jennifer K Yoon, Sarang K Fowlkes, Ashley L Naleway, Allison L Gwynn, Lisa Burgess, Jefferey L Thompson, Mark G Olsho, Lauren EW Gaglani, Manjusha JMIR Res Protoc Protocol BACKGROUND: Assessing the real-world effectiveness of COVID-19 vaccines and understanding the incidence and severity of SARS-CoV-2 illness in children are essential to inform policy and guide health care professionals in advising parents and caregivers of children who test positive for SARS-CoV-2. OBJECTIVE: This report describes the objectives and methods for conducting the Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT) study. PROTECT is a longitudinal prospective pediatric cohort study designed to estimate SARS-CoV-2 incidence and COVID-19 vaccine effectiveness (VE) against infection among children aged 6 months to 17 years, as well as differences in SARS-CoV-2 infection and vaccine response between children and adolescents. METHODS: The PROTECT multisite network was initiated in July 2021, which aims to enroll approximately 2305 children across four US locations and collect data over a 2-year surveillance period. The enrollment target was based on prospective power calculations and accounts for expected attrition and nonresponse. Study sites recruit parents and legal guardians of age-eligible children participating in the existing Arizona Healthcare, Emergency Response, and Other Essential Workers Surveillance (HEROES)-Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel (RECOVER) network as well as from surrounding communities. Child demographics, medical history, COVID-19 exposure, vaccination history, and parents/legal guardians’ knowledge and attitudes about COVID-19 are collected at baseline and throughout the study. Mid-turbinate nasal specimens are self-collected or collected by parents/legal guardians weekly, regardless of symptoms, for SARS-CoV-2 and influenza testing via reverse transcription-polymerase chain reaction (RT-PCR) assay, and the presence of COVID-like illness (CLI) is reported. Children who test positive for SARS-CoV-2 or influenza, or report CLI are monitored weekly by online surveys to report exposure and medical utilization until no longer ill. Children, with permission of their parents/legal guardians, may elect to contribute blood at enrollment, following SARS-CoV-2 infection, following COVID-19 vaccination, and at the end of the study period. PROTECT uses electronic medical record (EMR) linkages where available, and verifies COVID-19 and influenza vaccinations through EMR or state vaccine registries. RESULTS: Data collection began in July 2021 and is expected to continue through the spring of 2023. As of April 13, 2022, 2371 children are enrolled in PROTECT. Enrollment is ongoing at all study sites. CONCLUSIONS: As COVID-19 vaccine products are authorized for use in pediatric populations, PROTECT study data will provide real-world estimates of VE in preventing infection. In addition, this prospective cohort provides a unique opportunity to further understand SARS-CoV-2 incidence, clinical course, and key knowledge gaps that may inform public health. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/37929 JMIR Publications 2022-07-28 /pmc/articles/PMC9377426/ /pubmed/35635842 http://dx.doi.org/10.2196/37929 Text en ©Joy Burns, Patrick Rivers, Lindsay B LeClair, Krystal S Jovel, Ramona P Rai, Ashley A Lowe, Laura J Edwards, Sana M Khan, Clare Mathenge, Maria Ferraris, Jennifer L Kuntz, Julie Mayo Lamberte, Kurt T Hegmann, Marilyn J Odean, Hilary McLeland-Wieser, Shawn Beitel, Leah Odame-Bamfo, Natasha Schaefer Solle, Josephine Mak, Andrew L Phillips, Brian E Sokol, James Hollister, Jezahel S Ochoa, Lauren Grant, Matthew S Thiese, Keya B Jacoby, Karen Lutrick, Felipe A Pubillones, Young M Yoo, Danielle Rentz Hunt, Katherine Ellingson, Mark C Berry, Joe K Gerald, Joanna Lopez, Lynn B Gerald, Meredith G Wesley, Karl Krupp, Meghan K Herring, Purnima Madhivanan, Alberto J Caban-Martinez, Harmony L Tyner, Jennifer K Meece, Sarang K Yoon, Ashley L Fowlkes, Allison L Naleway, Lisa Gwynn, Jefferey L Burgess, Mark G Thompson, Lauren EW Olsho, Manjusha Gaglani. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 28.07.2022. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Burns, Joy
Rivers, Patrick
LeClair, Lindsay B
Jovel, Krystal S
Rai, Ramona P
Lowe, Ashley A
Edwards, Laura J
Khan, Sana M
Mathenge, Clare
Ferraris, Maria
Kuntz, Jennifer L
Lamberte, Julie Mayo
Hegmann, Kurt T
Odean, Marilyn J
McLeland-Wieser, Hilary
Beitel, Shawn
Odame-Bamfo, Leah
Schaefer Solle, Natasha
Mak, Josephine
Phillips, Andrew L
Sokol, Brian E
Hollister, James
Ochoa, Jezahel S
Grant, Lauren
Thiese, Matthew S
Jacoby, Keya B
Lutrick, Karen
Pubillones, Felipe A
Yoo, Young M
Rentz Hunt, Danielle
Ellingson, Katherine
Berry, Mark C
Gerald, Joe K
Lopez, Joanna
Gerald, Lynn B
Wesley, Meredith G
Krupp, Karl
Herring, Meghan K
Madhivanan, Purnima
Caban-Martinez, Alberto J
Tyner, Harmony L
Meece, Jennifer K
Yoon, Sarang K
Fowlkes, Ashley L
Naleway, Allison L
Gwynn, Lisa
Burgess, Jefferey L
Thompson, Mark G
Olsho, Lauren EW
Gaglani, Manjusha
Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study
title Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study
title_full Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study
title_fullStr Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study
title_full_unstemmed Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study
title_short Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study
title_sort pediatric research observing trends and exposures in covid-19 timelines (protect): protocol for a multisite longitudinal cohort study
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9377426/
https://www.ncbi.nlm.nih.gov/pubmed/35635842
http://dx.doi.org/10.2196/37929
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