Previous presentation: Partial findings of this study were presented at the 18th Annual HMO Research Network conference in Seattle, Washington, May 2012, and the 28th International Conference on Pharmacoepidemiology and Therapeutic Risk Management in Barcelona, Spain, August 2012.
Validation of an algorithm to estimate gestational age in electronic health plan databases†
Article first published online: 21 JAN 2013
Copyright © 2013 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 22, Issue 5, pages 524–532, May 2013
How to Cite
Li, Q., Andrade, S. E., Cooper, W. O., Davis, R. L., Dublin, S., Hammad, T. A., Pawloski, P. A., Pinheiro, S. P., Raebel, M. A., Scott, P. E., Smith, D. H., Dashevsky, I., Haffenreffer, K., Johnson, K. E. and Toh, S. (2013), Validation of an algorithm to estimate gestational age in electronic health plan databases. Pharmacoepidem. Drug Safe., 22: 524–532. doi: 10.1002/pds.3407
- Issue published online: 3 MAY 2013
- Article first published online: 21 JAN 2013
- Manuscript Accepted: 12 DEC 2012
- Manuscript Revised: 4 DEC 2012
- Manuscript Received: 7 AUG 2012
- U.S. Food and Drug Administration. Grant Numbers: HHSF223200510012C, HHSF223200510009C, HHSF223200510008C
- gestational age;
- maternal exposure;
- validation studies
To validate an algorithm that uses delivery date and diagnosis codes to define gestational age at birth in electronic health plan databases.
Using data from 225 384 live born deliveries to women aged 15–45 years in 2001–2007 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.
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 273.5 days) but not among multiple-gestation deliveries (253.9 vs 252.6 days). 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.
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 © 2013 John Wiley & Sons, Ltd.