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

Guideline
Publicly Available, No Cost
Yes (CDEs for COVID-19 Studies Including Pregnant Participants)
12/15/2020
04/04/2022
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 pregnant and lactating women and their neonates. Experts across eight large pregnancy cohort studies developed these recommendations for use by any planned or upcoming COVID-19 study that includes women of reproductive age or pregnant women. We encourage researchers to include some or all of these measures, which cover key medical and psychosocial domains relevant to pregnancy and childbirth, 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 the disease and its effects on pregnant women and their neonates, which will continue to evolve as treatments and vaccines become available. Here we highlight CDEs and measures across seven domains, which include: Baseline Maternal / Pregnancy Characteristics; Maternal COVID-19 Treatment; Maternal Outcomes; Obstetric / Pregnancy Outcomes; Neonatal Characteristics; Neonatal COVID-19 Testing; and Early Neonatal Outcomes. Recommendations assume that information from all patient visits (e.g., prenatal visits, 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 pregnant women and their neonates. Here we highlight CDEs and measures across six domains, including: Socioeconomic Status, Housing, and Emergent Financial Strain; Medical Care; Impact on Parenting; Stressful Life Events; Maternal Mental Health; and Health Related Behaviors.
2020 COVID-19 Household Pulse Survey; All of Us Research Program: COVID-19 Participant Experience Survey (COPE); Brief Resilient Coping Scale (from MACS-WIHS Baseline COVID-19 Abbreviated Questionnaire); Columbia COVID-19 Questionnaire; Coronavirus Health Impact Survey (CRISIS); Coronavirus Perinatal Experiences-Impact Survey (COPE-IS); Environmental Influences on Child Health Outcomes (ECHO) COVID-19 Questionnaire; Everyday Discrimination Scale (Short version); GAD 7; Impact of Event Scale-6; Infant Feeding Practices Study II; Intimate Partner Violence ACOG Practice Bulletin; JHU Community Response; MACS-WIHS Baseline COVID-19 Abbreviated Questionnaire; National Health and Nutrition Examination Survey (NHANES), Demographics Module, 2019-2020; PhenX: Health Reform Monitoring Survey 2015; PhenX: 6 item standard measure from USDA Economic Research Service; PhenX: Edinburgh Postnatal Depression Scale (EPDS); PhenX: Panel Study of Income Dynamics (PSID), 2007; PhenX: Pregnancy Risk Assessment Monitoring System (PRAMS); Pittsburgh Hill / Homewood Research on Neighborhood Change and Health (PHRESH); Postpartum Bonding Questionnaire; RAND American Life Panel Impact of COVID-19 Survey; Stanford COVID-19 Community Outcomes (COCO) Survey; Study of Pregnancy and Neonatal Health (SPAN)

Additional Descriptors

  • Medical Professional, Researcher or Professional Interviewer, Self, Trained Non-Expert, Untrained Non-Expert
  • In-Person Interview, Online or Mobile App, Paper, Phone Interview
    • 16-30
      • RedCap
        • English
          • 100+
          • Guideline
            • Age, Occupation or Worker, Sex or Gender
              • Age: Adult, Child
                • Children: Infant
              • Occupation or Worker: First Responder or Emergency Medical Services (EMS) or Police or Firefighter, Military Personnel, Other
                • Other (write in): Adult Workers
              • Sex or Gender: Female or Women
                • Female or Women: Pregnant or Lactating Women
            • Infectious Disease Outbreak
              • Biological or Infectious Agent
                • Biological or Infectious Agent: Virus
                  • Virus: SARS-CoV-2, SARS-CoV-1, MERS
                • Developmental, Mental Health or Well-Being, Reproductive
                  • Community Impacts, Demographics, Diagnosis or Status or Treatment or Recovery, Government Support, Lifestyle or Quality of Life, Risk Reduction Behaviors, Symptoms

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