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Development and Validation of Algorithms to Estimate Live Birth Gestational Age in Medicaid Analytic eXtract Data.
Zhu, Yanmin; Thai, Thuy N; Hernandez-Diaz, Sonia; Bateman, Brian T; Winterstein, Almut G; Straub, Loreen; Franklin, Jessica M; Gray, Kathryn J; Wyss, Richard; Mogun, Helen; Vine, Seanna; Taylor, Lockwood G; Ouellet-Hellstrom, Rita; Ma, Yong; Qiang, Yandong; Hua, Wei; Huybrechts, Krista F.
Afiliación
  • Zhu Y; From the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
  • Thai TN; Department of Pharmaceutical Outcomes and Policy and Center for Drug Evaluation and Safety, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
  • Hernandez-Diaz S; Faculty of Pharmacy, Ho Chi Minh City University of Technology, Ho Chi Minh City, Vietnam.
  • Bateman BT; Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.
  • Winterstein AG; From the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
  • Straub L; Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
  • Franklin JM; Department of Pharmaceutical Outcomes and Policy and Center for Drug Evaluation and Safety, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
  • Gray KJ; Department of Epidemiology, College of Public Health & Health Professionals and College of Medicine, University of Florida, Gainesville, Florida, USA.
  • Wyss R; Center for Drug Evaluation and Safety, University of Florida.
  • Mogun H; From the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
  • Vine S; From the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
  • Taylor LG; Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
  • Ouellet-Hellstrom R; From the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
  • Ma Y; From the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
  • Qiang Y; From the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
  • Hua W; Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA.
  • Huybrechts KF; Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA.
Epidemiology ; 34(1): 69-79, 2023 01 01.
Article en En | MEDLINE | ID: mdl-36455247
ABSTRACT

BACKGROUND:

While healthcare utilization data are useful for postmarketing surveillance of drug safety in pregnancy, the start of pregnancy and gestational age at birth are often incompletely recorded or missing. Our objective was to develop and validate a claims-based live birth gestational age algorithm.

METHODS:

Using the Medicaid Analytic eXtract (MAX) linked to birth certificates in three states, we developed four candidate algorithms based on preterm codes; preterm or postterm codes; timing of prenatal care; and prediction models - using conventional regression and machine-learning approaches with a broad range of prespecified and empirically selected predictors. We assessed algorithm performance based on mean squared error (MSE) and proportion of pregnancies with estimated gestational age within 1 and 2 weeks of the gold standard, defined as the clinical or obstetric estimate of gestation on the birth certificate. We validated the best-performing algorithms against medical records in a nationwide sample. We quantified misclassification of select drug exposure scenarios due to estimated gestational age as positive predictive value (PPV), sensitivity, and specificity.

RESULTS:

Among 114,117 eligible pregnancies, the random forest model with all predictors emerged as the best performing algorithm MSE 1.5; 84.8% within 1 week and 96.3% within 2 weeks, with similar performance in the nationwide validation cohort. For all exposure scenarios, PPVs were >93.8%, sensitivities >94.3%, and specificities >99.4%.

CONCLUSIONS:

We developed a highly accurate algorithm for estimating gestational age among live births in the nationwide MAX data, further supporting the value of these data for drug safety surveillance in pregnancy. See video abstract at, http//links.lww.com/EDE/B989 .
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Medicaid / Nacimiento Vivo Límite: Female / Humans / Newborn / Pregnancy País/Región como asunto: America do norte Idioma: En Revista: Epidemiology Asunto de la revista: EPIDEMIOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Medicaid / Nacimiento Vivo Límite: Female / Humans / Newborn / Pregnancy País/Región como asunto: America do norte Idioma: En Revista: Epidemiology Asunto de la revista: EPIDEMIOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos
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