Our group has also pioneered the use of advanced epidemiologic analytic methods to study drug safety in pregnancy using large administrative databases to estimate causal effects of in utero drug exposure.
The five large administrative databases that we use are the Medicaid Analytic Extract, the Marketscan database, the International Pregnancy Safety Study consortium, Mass General Brigham RPDR, and Maccabi.
The five large administrative databases that we use are the Medicaid Analytic Extract, the Marketscan database, the International Pregnancy Safety Study consortium, Mass General Brigham RPDR, and Maccabi.
Medicaid Analytic eXtract/transformed analytic files (Medicaid)
The Medicaid Analytic eXtract/Transformed Analytic Files (Medicaid) is based on the records of Medicaid beneficiaries nationwide. Our group has access to nationwide data from 2000-2020. Our group created the Medicaid pregnancy mother-infant linked cohort as part of an R01-funded study of antidepressant medications in pregnancy (R01: HS018533-03), and it has subsequently formed the basis for an R01-funded study of the safety of other psychotropic medications in pregnancy (R01: MH100216) and an R01-funded study on the impact of opioid use during pregnancy (R01: DA044293-01A1).
We have used the Medicaid pregnancy cohort to study the associations between antidepressants, antipsychotics, mood stabilizers and other anticonvulsants, stimulants, and cardiovascular medications and various pregnancy safety endpoints. As it reflects the Medicaid population, the cohort includes an overrepresentation of teens and young women, African-Americans, and disabled persons; groups which are frequently underrepresented in clinical trials and voluntary cohort studies, but are those most at-risk for adverse pregnancy outcomes.
Publication on the Development of H4P Medicaid Mother-Infant Linked Live Birth Cohort:
Palmsten K, Huybrechts KF, Mogun H, Kowal MK, Williams PL, Michels KB, Setoguchi S, Hernández-Díaz S. Harnessing the Medicaid Analytic eXtract (MAX) to evaluate medications in pregnancy: design considerations. PloS one. 2013 Jun 26;8(6):e67405.
We have used the Medicaid pregnancy cohort to study the associations between antidepressants, antipsychotics, mood stabilizers and other anticonvulsants, stimulants, and cardiovascular medications and various pregnancy safety endpoints. As it reflects the Medicaid population, the cohort includes an overrepresentation of teens and young women, African-Americans, and disabled persons; groups which are frequently underrepresented in clinical trials and voluntary cohort studies, but are those most at-risk for adverse pregnancy outcomes.
Publication on the Development of H4P Medicaid Mother-Infant Linked Live Birth Cohort:
Palmsten K, Huybrechts KF, Mogun H, Kowal MK, Williams PL, Michels KB, Setoguchi S, Hernández-Díaz S. Harnessing the Medicaid Analytic eXtract (MAX) to evaluate medications in pregnancy: design considerations. PloS one. 2013 Jun 26;8(6):e67405.
MERATIVE MARKETSCAN RESEARCH DATABASES
The Merative MarketScan Research Database is a database of >100 commercial health insurers that provide comprehensive medical coverage for about 25 million members annually with active policies located throughout the US. The database includes medical and pharmacy claims for privately insured patients. The pregnancy cohort is based on data from 2003 to 2023.
International pregnancy safety study
The International Pregnancy Safety Study (InPreSS) consortium is a collaborative between investigators from the Denmark, Finland, Iceland, Norway, and Sweden and our group. All groups have access to high quality data on medication exposure during pregnancy and infant outcomes. The nationwide Scandinavian registers data and US Medicaid data are analyzed with harmonized protocols in order to provide timely and accurate information on medication safety during pregnancy. This collaboration is funded by the NIH (R21 HD087913-01A1).
Mass General brigham RPDR (Research Patient Data Registry)
Mass General Brigham (MGB) RPDR is a centralized clinical data registry that contains data from EHR in 2 tertiary medical centers (Brigham and Women’s Hospital and Massachusetts General Hospital) and 4 community hospitals (Faulkner Hospital, Newton Wellesley Hospital, North Shore Medical Center, and Wentworth-Douglass Hospital), 3 specialty hospitals (Dana-Farber Cancer Institute, McLean Hospital, and Massachusetts Eye and Ear), a Rehabilitation center (Spaulding Rehabilitation Hospital), and >35 primary care centers within the Mass General Brigham system. The EHR databases contain information on patient demographics, medical problems, medications, vital signs, smoking status, body mass index (BMI), immunizations, laboratory data, and various clinical notes, documents, and reports.
the Research and Innovation Center of Maccabi Health Services (MHS)
The Kahn-Sagol-Maccabi (KSM) Research and Innovation Center of Maccabi Healthcare Services (MHS) is a large Israeli Health Fund, which provides medical services to 2.7 million active members (27% of the Israeli population). MHS’ centralized database includes more than 30 years of anonymized demographic and clinical information, including inpatient and outpatient clinical diagnoses, medical procedures, visit notes, hospitalizations, medication prescriptions and dispensing data, laboratory test results, and medical imaging.
