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Recommendations for Common Data Elements for COVID-19 Studies Including Pediatric Participants

Promoting Data Harmonization to Accelerate COVID-19 Pediatric Research

Guideline
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Publicly Available, No Cost
Yes (RADx CDEs, CONNECTS NHLBI Common Data Elements, Pregnancy CDEs, Clinical Data Coordination Group (Project 5) CDEs, NIH CDE Repository CDC COVID-19 Community survey question bank, RADxUP)
07/08/2021
11/29/2021
We present a battery of recommended biomedical and psychosocial common data elements (CDEs) and measures that, when combined across datasets, can improve our collective understanding of COVID-19 in children. Representatives from multiple NIH Institutes and partner federal agencies in conjunction with intramural and extramural investigators developed these recommendations for use by any planned or upcoming COVID-19 study that includes children. We encourage researchers to include some or all of these measures—which cover key medical and psychosocial domains relevant to children—into their studies to maximize the potential for data harmonization while continuing to advance their own study goals. Common biomedical data elements and measures aim to accelerate our understanding of the clinical course of COVID-19 and its effects on children, which will continue to evolve as treatments and vaccines become available. Here we highlight CDEs and measures across eight domains, which include: Baseline Child Heath, Manifestations-Clinical, Manifestations- Laboratory, Manifestations—Cardiopulmonary Diagnostic Assessments, Manifestations – Imaging, Diagnosis, Treatment, and Outcomes. Recommendations assume that information from all patient visits (e.g., pediatric check-ups, COVID-19 testing, and delivery) can be collected via medical chart or downloaded data from electronic health records. Common psychosocial data elements and measures aim to advance our understanding of the psychological, behavioral, and social effects of the virus and the pandemic on children. Here we highlight CDEs and measures across ten domains, including: Social Determinants of Health (SDOH), Educational Factors, Community, Family, and Peer Factors, Social Media/Screen Time, Well-being factors, COVID-19 Stress and Worry, COVID-19 Attitudes, Behaviors, and Experiences, Health Related Behaviors, Mental/Behavioral Health, and Health Care.
WHO Post COVID CRF https://cdn.who.int/media/docs/default-source/3rd-edl-submissions/who_crf_postcovid_feb9_2021.pdf?sfvrsn=76afd14_1&download=true, Feudtner et al.: Pediatric complex chronic conditions classification system version 2: updated for ICD-10 and complex medical technology dependence and transplantation. BMC Pediatrics 2014 14:199, St. Jude’s Pediatric COVID-19 U.S. Registry, JHU COVID-19 Community Response Survey https://www.phenxtoolkit.org/toolkit_content/PDF/JHU_C4WARD_Health.pdf, Diagnosis of MIS-C in Febrile Children CRF, Acute BRAVE Kids CRF, POP02 CRF, PRISM CRF, NIH COVID-19 Severity https://www.covid19treatmentguidelines.nih.gov/overview/clinical-spectrum/, National Survey of Children’s Health, 2020 Questionnaire https://mchb.hrsa.gov/data/national-surveys/questionnaires-datasets-supporting-documents, P270201 California Health Interview Survey https://www.phenxtoolkit.org/protocols/view/270201?origin=search| http://healthpolicy.ucla.edu/chis/design/Documents/2021%20Questionnaires%20and%20Topics%20List/English/CHIS%202021%20CAWI%20%20v1.27%2015APRIL2021%20Adult%20Questionnaire.pdf, Rutgers LINK Impact of Social Determinants of Health on Contracting COVID, P270301 PhenX: 6 item standard measure from USDA Economic Research Service https://www.phenxtoolkit.org/protocols/view/270301#tabsource, ABCD COVID-19 Impact Parent Report https://www.nlm.nih.gov/dr2/ABCD_COVID-19_Impact_Measure-Parent.pdf, ABCD COVID-19 Impact Parent Report https://www.nlm.nih.gov/dr2/ABCD_COVID-19_Impact_Measure-Parent.pdf, ABES https://www.cdc.gov/healthyyouth/data/abes.htm, Tao, X. (2021). Social Media Use, Online Racial Discrimination, and Mental Health Risks Among Adolescents of Color. Fordham University https://www.phenxtoolkit.org/protocols/view/970201?origin=search, National Household Education Survey, 2019 https://nces.ed.gov/nhes/pdf/pfi/2019_pfi.pdf, CTC 2010 Youth Survey General School Environment https://www.phenxtoolkit.org/toolkit_content/PDF/PX540501.pdf, GCS Neuro COVID CRF, P211001 https://www.phenxtoolkit.org/protocols/view/211001?origin=domain, Healthy Pathways https://link.springer.com/article/10.1007/s11136-010-9687-4, 2020 COVID-19 CENSUS HOUSEHOLD PULSE https://www.phenxtoolkit.org/toolkit_content/PDF/Census_HPS.pdf, ECHO COVID-19 Adult Questionnaire https://www.nlm.nih.gov/dr2/C19-aPV_COVID-19_Questionnaire-Adult_Primary_Version_20200409_v01.30.pdf, ECHO Child Self-Report https://www.nlm.nih.gov/dr2/C19-cPV_COVID-19_Questionnaire-Child_Self-Report_Primary_Version_20200608_v01.31.pdf, ECHO Child Parent-Report https://www.phenxtoolkit.org/toolkit_content/PDF/ECHO_Child_Parent_Report_Impacts.pdf, NIH Toolbox Emotion https://www.healthmeasures.net/explore-measurement-systems/nih-toolbox/intro-to-nih-toolbox/emotion/184-nih-toolbox-emotion, PROMIS https://www.healthmeasures.net/search-view-measures?task=Search.search, COVID-19 Experiences (COVEX) https://www.phenxtoolkit.org/toolkit_content/PDF/Fisher_COVEX_Living_Situation.pdf, PX210801 https://www.phenxtoolkit.org/toolkit_content/PDF/PX210801.pdf, Novel Coronavirus (COVID) Illness – Patient Report (NCI-PR) https://disasterinfo.nlm.nih.gov/content/files/COVID_Illness_Patient_Report_NCI-PR.pdf, P960301 https://www.phenxtoolkit.org/protocols/view/960301, DSM-5 https://www.psychiatry.org/psychiatrists/practice/dsm/educational-resources/assessment-measures, RCADS https://www.childfirst.ucla.edu/resources/, Census https://www.phenxtoolkit.org/protocols/view/11901, ACS-6 https://www.cdc.gov/ncbddd/disabilityandhealth/datasets.html, Functional Disability Inventory https://pubmed.ncbi.nlm.nih.gov/16480823/, MAP-DB Externalizing Symptoms: https://www.niehs.nih.gov/research/programs/disaster/database/map_db_crosswalk_neonatal_esa_for_documentation_2021_04_05_508.xlsx

Additional Descriptors

  • Medical Professional, Parent/Teacher, Researcher/Professional Interviewer, Self, Trained Non-Expert
  • In-Person Interview, Online/Mobile App, Paper/Written, Phone Interview
    • 60+
      • Moderate
      • RedCap
        • English
          • 75-99
          • Guideline
            • Age
              • Age: Child
                • Children: Infant, Adolescent/Teen
            • Infectious Disease Outbreak
              • Biological/Infectious Agent
                • Biological/Infectious Agent: Virus
                  • Virus: SARS-CoV-2, SARS-CoV-1, MERS
                • Circulatory/Cardiovascular, Developmental, Diabetes/Obesity, Digestive/Excretory, Endocrine, Hepatic, Immune/Lymphatic, Malnutrition/Food Insecurity, Mental Health/Well-Being, Morbidity/Mortality, Neurological/Nervous System, Renal/Urinary, Respiratory, Skeletal
                  • Developmental: Birth Outcomes, Cognitive/Neurological/Psychological Disorder
                • Community Impacts, Comorbidities, Demographics, Diagnosis/Status/Treatment/Recovery, Domestic Violence/Family Impacts, Illicit Drug Use/Substance Abuse, Lifestyle/Quality of Life, Perceptions, Preparedness, Risk Reduction Behaviors, Social Determinants of Health, Social Support/Resilience, Symptoms
                  • Risk Reduction Behaviors: Vaccine-related
                • National Institues of Health

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