Evidence map›Paper›PMID 35635842›Full record

ArticleJMIR research protocols2022

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

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 and 40 more

Open access · goldAbstract read
In one paragraph

Article in JMIR research protocols, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 11 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

50 authors at 9 institutions in 1 country.

Joy Burns *Abt Associates, Atlanta, GA, United States.ORCID https://orcid.org/0000-0002-1574-2571
Patrick Rivers *Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.ORCID https://orcid.org/0000-0001-5195-518X
Lindsay B LeClair *Abt Associates, Atlanta, GA, United States.ORCID https://orcid.org/0000-0002-5580-9750
Krystal S Jovel *Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.ORCID https://orcid.org/0000-0001-6568-4229
Ramona P Rai *Abt Associates, Atlanta, GA, United States.ORCID https://orcid.org/0000-0003-3225-6919
Ashley A Lowe *Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.ORCID https://orcid.org/0000-0001-6252-0368
Laura J Edwards *Abt Associates, Atlanta, GA, United States.ORCID https://orcid.org/0000-0003-1579-2074
Sana M Khan *Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.ORCID https://orcid.org/0000-0003-0699-2103
Clare Mathenge *College of Medicine, Texas A&M University, Temple, TX, United States.ORCID https://orcid.org/0000-0001-7022-4593
Maria Ferraris *Leonard M Miller School of Medicine, University of Miami, Miami, FL, United States.ORCID https://orcid.org/0000-0001-5874-430X
Jennifer L Kuntz *Kaiser Permanente Northwest Center for Health Research, Portland, OR, United States.ORCID https://orcid.org/0000-0002-0017-6853
Julie Mayo Lamberte *COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, United States.ORCID https://orcid.org/0000-0002-8134-9081
Kurt T Hegmann *Rocky Mountain Center for Occupational and Environmental Health, Department of Family and Preventive Medicine, University of Utah Health, Salt Lake City, UT, United States.ORCID https://orcid.org/0000-0002-0743-1888
Marilyn J Odean *St. Luke's Regional Health Care System, Duluth, MN, United States.ORCID https://orcid.org/0000-0001-6892-9543
Hilary McLeland-Wieser *Abt Associates, Atlanta, GA, United States.ORCID https://orcid.org/0000-0001-9082-5716
Shawn Beitel *Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.ORCID https://orcid.org/0000-0003-1709-0906
Leah Odame-Bamfo *College of Medicine, Texas A&M University, Temple, TX, United States.ORCID https://orcid.org/0000-0002-5781-6735
Natasha Schaefer Solle *Leonard M Miller School of Medicine, University of Miami, Miami, FL, United States.ORCID https://orcid.org/0000-0001-8166-2732
Josephine Mak *COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, United States.ORCID https://orcid.org/0000-0001-9557-2690
Andrew L Phillips *Rocky Mountain Center for Occupational and Environmental Health, Department of Family and Preventive Medicine, University of Utah Health, Salt Lake City, UT, United States.ORCID https://orcid.org/0000-0003-2320-3567
Brian E Sokol *Abt Associates, Atlanta, GA, United States.ORCID https://orcid.org/0000-0002-6058-3792
James Hollister *Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.ORCID https://orcid.org/0000-0002-4328-1071
Jezahel S Ochoa *Leonard M Miller School of Medicine, University of Miami, Miami, FL, United States.ORCID https://orcid.org/0000-0003-4690-9757
Lauren Grant *COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, United States.ORCID https://orcid.org/0000-0002-8656-3538
Matthew S Thiese *Rocky Mountain Center for Occupational and Environmental Health, Department of Family and Preventive Medicine, University of Utah Health, Salt Lake City, UT, United States.ORCID https://orcid.org/0000-0003-4505-2907
Keya B Jacoby *Abt Associates, Atlanta, GA, United States.ORCID https://orcid.org/0000-0002-1450-4934
Karen Lutrick *Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.ORCID https://orcid.org/0000-0003-3480-849X
Felipe A Pubillones *Leonard M Miller School of Medicine, University of Miami, Miami, FL, United States.ORCID https://orcid.org/0000-0003-1468-4776
Young M Yoo *COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, United States.ORCID https://orcid.org/0000-0002-0845-2293
Danielle Rentz Hunt *Abt Associates, Atlanta, GA, United States.ORCID https://orcid.org/0000-0001-7363-3165
Katherine Ellingson *Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.ORCID https://orcid.org/0000-0001-7624-312X
Mark C Berry *Abt Associates, Atlanta, GA, United States.ORCID https://orcid.org/0000-0002-8534-2012
Joe K Gerald *Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.ORCID https://orcid.org/0000-0001-8295-7049
Joanna Lopez *Abt Associates, Atlanta, GA, United States.ORCID https://orcid.org/0000-0002-0216-029X
Lynn B Gerald *Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.ORCID https://orcid.org/0000-0002-7279-0051
Meredith G Wesley *Abt Associates, Atlanta, GA, United States.ORCID https://orcid.org/0000-0003-3408-0523
Karl Krupp *Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.ORCID https://orcid.org/0000-0001-7001-9194
Meghan K Herring *Abt Associates, Atlanta, GA, United States.ORCID https://orcid.org/0000-0002-4267-4033
Purnima Madhivanan *Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.ORCID https://orcid.org/0000-0001-7818-3394
Alberto J Caban-Martinez *Leonard M Miller School of Medicine, University of Miami, Miami, FL, United States.ORCID https://orcid.org/0000-0002-5960-1308
Harmony L Tyner *St. Luke's Regional Health Care System, Duluth, MN, United States.ORCID https://orcid.org/0000-0002-4130-0793
Jennifer K Meece *Marshfield Clinic Research Institute, Marshfield, WI, United States.ORCID https://orcid.org/0000-0002-6486-3505
Sarang K Yoon *Rocky Mountain Center for Occupational and Environmental Health, Department of Family and Preventive Medicine, University of Utah Health, Salt Lake City, UT, United States.ORCID https://orcid.org/0000-0002-8500-2886
Ashley L Fowlkes *COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, United States.ORCID https://orcid.org/0000-0002-0620-6451
Allison L Naleway *Kaiser Permanente Northwest Center for Health Research, Portland, OR, United States.ORCID https://orcid.org/0000-0001-5747-4643
Lisa Gwynn *Leonard M Miller School of Medicine, University of Miami, Miami, FL, United States.ORCID https://orcid.org/0000-0003-2857-376X
Jefferey L Burgess *Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.ORCID https://orcid.org/0000-0003-2362-9509
Mark G Thompson *COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, GA, United States.ORCID https://orcid.org/0000-0003-0046-3147
Lauren Ew Olsho *Abt Associates, Atlanta, GA, United States.ORCID https://orcid.org/0000-0003-4503-9745
Manjusha Gaglani *College of Medicine, Texas A&M University, Temple, TX, United States.ORCID https://orcid.org/0000-0002-3952-9230
Schulman, Ronca & Bucuvalas · USUniversity of Arizona · USCenters for Disease Control and Prevention · USUniversity of Miami · USUniversity of Utah · USTemple College · USKaiser Permanente Center for Health Research · USSaint Luke's Health System · USMarshfield Clinic · US

Funding

Utah Center for Clinical and Translational ScienceUL1TR002538 · NCATS · UNIVERSITY OF UTAH · PI HESS, RACHEL, MAJERSIK, JENNIFER JUHL · 2018 to 2022
$26.0M
NCATS NIH HHS UL1 TR002538
6 · The paper itself

Abstract

backgroundAssessing 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.

objectiveThis 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.

methodsThe 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.

resultsData 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.

conclusionsAs 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.

Indexed as

caregiverchildchildrencohort studyCOVID-19effectivenessefficacyhealth carehealth care professionalhealth dataincidenceinoculationonline surveypediatricpublic healthSARS-CoV-2vaccinationvaccinevaccine effectiveness

Identifiers

PMID35635842
PMCPMC9377426
OpenAlexW4281479043

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.