4.2 Article

Validation of an algorithm to estimate gestational age in electronic health plan databases

Journal

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
Volume 22, Issue 5, Pages 524-532

Publisher

WILEY-BLACKWELL
DOI: 10.1002/pds.3407

Keywords

algorithm; database; gestational age; maternal exposure; pharmacoepidemiology; pregnancy; validation studies

Funding

  1. U.S. Food and Drug Administration (Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Silver Spring, MD, USA) [HHSF223200510012C, HHSF223200510009C, HHSF223200510008C]
  2. National Institute on Aging [K23AG028954]
  3. Group Health Research Institute internal funds
  4. NATIONAL INSTITUTE ON AGING [K23AG028954] Funding Source: NIH RePORTER

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Purpose To validate an algorithm that uses delivery date and diagnosis codes to define gestational age at birth in electronic health plan databases. Methods Using data from 225384 live born deliveries to women aged 1545years in 20012007 within eight of the 11 health plans participating in the Medication Exposure in Pregnancy Risk Evaluation Program, we compared (1) the algorithm-derived gestational age versus the gold-standard gestational age obtained from the infant birth certificate file and (2) the prenatal exposure status of two antidepressants (fluoxetine and sertraline) and two antibiotics (amoxicillin and azithromycin) as determined by the algorithm-derived versus the gold-standard gestational age. Results The mean algorithm-derived gestational age at birth was lower than the mean obtained from the birth certificate file among singleton deliveries (267.9 vs 273.5days) but not among multiple-gestation deliveries (253.9 vs 252.6days). The algorithm-derived prenatal exposure to the antidepressants had a sensitivity and a positive predictive value of 95%, and a specificity and a negative predictive value of almost 100%. Sensitivity and positive predictive value were both 90%, and specificity and negative predictive value were both >99% for the antibiotics. Conclusions A gestational age algorithm based upon electronic health plan data correctly classified medication exposure status in most live born deliveries, but trimester-specific misclassification may be higher for drugs typically used for short durations. Copyright (c) 2013 John Wiley & Sons, Ltd.

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