Human Epidemiology and Response to SARS-CoV-2 (HEROS): objectives, design, and enrollment results of a 12-city remote observational surveillance study of households with children, using direct-to-participant methods.

Autor: Fulkerson PC; National Institute of Allergy and Infectious Diseases, Rockville, MD 20892, United States., Lussier SJ; Rho, Inc., Chapel Hill, NC 27713, United States., Bendixsen CG; Marshfield Clinic Research Institute, Marshfield Clinic Health System, Marshfield, WI 54449, United States., Castina SM; Rho, Inc., Chapel Hill, NC 27713, United States., Gebretsadik T; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN 37232, United States., Marlin JS; Vanderbilt Coordinating Center, Vanderbilt University Medical Center, Nashville, TN 37232, United States., Russell PB; Department of Medicine, Center for Asthma Research, Vanderbilt University Medical Center, Nashville, TN 37232, United States., Seibold MA; Center for Genes, Environment, and Health, National Jewish Health, Denver, CO 80206, United States.; Department of Pediatrics, National Jewish Health, Denver, CO 80206, United States.; Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine, Aurora, CO 80045, United States., Everman JL; Center for Genes, Environment, and Health, National Jewish Health, Denver, CO 80206, United States., Moore CM; Center for Genes, Environment, and Health, National Jewish Health, Denver, CO 80206, United States.; Department of Biomedical Research, National Jewish Health, Denver, CO 80206, United States.; Department of Biostatistics and Informatics, University of Colorado, Denver, CO 80204, United States., Snyder BM; Department of Medicine, Center for Asthma Research, Vanderbilt University Medical Center, Nashville, TN 37232, United States., Thompson K; National Institute of Allergy and Infectious Diseases, Rockville, MD 20892, United States., Tregoning GS; Vanderbilt Coordinating Center, Vanderbilt University Medical Center, Nashville, TN 37232, United States., Wellford S; Rho, Inc., Chapel Hill, NC 27713, United States., Arbes SJ; Rho, Inc., Chapel Hill, NC 27713, United States., Bacharier LB; Department of Medicine, Center for Asthma Research, Vanderbilt University Medical Center, Nashville, TN 37232, United States., Calatroni A; Rho, Inc., Chapel Hill, NC 27713, United States., Camargo CA Jr; Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA 02114, United States., Dupont WD; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN 37232, United States., Furuta GT; Digestive Health Institute, Children's Hospital Colorado and Section of Pediatric Gastroenterology, Hepatology and Nutrition, Gastrointestinal Eosinophilic Diseases Program, University of Colorado School of Medicine, Aurora, CO 80045, United States., Gruchalla RS; University of Texas Southwestern Medical Center, Dallas, TX 75390, United States., Gupta RS; Ann & Robert H. Lurie Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States., Hershey GK; Division of Asthma Research, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, United States., Jackson DJ; University of Wisconsin School of Medicine and Public Health, Madison, WI 53705, United States., Johnson CC; Henry Ford Health System, Detroit, MI 48202, United States., Kattan M; Columbia University Medical Center, New York, NY 10032, United States., Liu AH; Breathing Institute, Children's Hospital Colorado, and Section of Pediatric Pulmonary and Sleep Medicine, University of Colorado School of Medicine, Aurora CO 80045, United States., Murrison L; Division of Asthma Research, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, United States., O'Connor GT; Pulmonary Center, Boston University School of Medicine, Boston, MA 02118, United States., Phipatanakul W; Boston Children's Hospital, Harvard Medical School, Boston, MA 02115, United States., Rivera-Spoljaric K; Washington University School of Medicine, St. Louis, MO 63110, United States., Rothenberg ME; Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH 45229, United States., Seroogy CM; University of Wisconsin School of Medicine and Public Health, Madison, WI 53705, United States., Teach SJ; Children's National Hospital, Washington, DC 20010, United States., Zoratti EM; Henry Ford Health System, Detroit, MI 48202, United States., Togias A; National Institute of Allergy and Infectious Diseases, Rockville, MD 20892, United States., Hartert TV; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN 37232, United States.; Center for Asthma Research, Vanderbilt University Medical Center, Nashville, TN 37232, United States., Heros Study Team OBOT
Jazyk: angličtina
Zdroj: American journal of epidemiology [Am J Epidemiol] 2024 Oct 07; Vol. 193 (10), pp. 1329-1338.
DOI: 10.1093/aje/kwae077
Abstrakt: The Human Epidemiology and Response to SARS-CoV-2 (HEROS) Study is a prospective, multicity, 6-month incidence study conducted from May 2020 to February 2021. The objectives were to identify risk factors for SARS-CoV-2 infection and household transmission among children and people with asthma and allergic diseases, and to use the host nasal transcriptome sampled longitudinally to understand infection risk and sequelae at the molecular level. To overcome challenges of clinical study implementation due to the coronavirus pandemic, this surveillance study used direct-to-participant methods to remotely enroll and prospectively follow eligible children who are participants in other National Institutes of Health-funded pediatric research studies and their household members. Households participated in weekly surveys and biweekly nasal sampling regardless of symptoms. The aim of this report is to widely share the methods and study instruments and to describe the rationale, design, execution, logistics, and characteristics of a large, observational, household-based, remote cohort study of SARS-CoV-2 infection and transmission in households with children. The study enrolled a total of 5598 individuals, including 1913 principal participants (children), 1913 primary caregivers, 729 secondary caregivers, and 1043 other household children. This study was successfully implemented without necessitating any in-person research visits and provides an approach for rapid execution of clinical research. Trial registration: ClinicalTrials.gov. Identifier: NCT04375761.
(Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health 2024.)
Databáze: MEDLINE