Validation of algorithms to estimate gestational age at birth in the Medicaid Analytic extract—Quantifying the misclassification of maternal drug exposure during pregnancy

摘要

Purpose: Accurate ascertainment of gestational age (GA) has been a challenge in perinatal epidemiologic research. To date, no study has validated GA algorithms in Medicaid Analytic extract (MAX). Methods: We linked livebirths of mothers enrolled in Medicaid >30 days after delivery in 1999-2010 MAX to state birth certificates. We used clinical/obstetric estimate of gestation on the birth certificates as gold standard to validate claims-based GA algorithms. We calculated the proportions of deliveries with algorithm-estimated GA within 1-/2-weeks of the gold standard, the sensitivity, specificity, and positive/negative predictive value (PPV/NPV) of exposure to select medications during specific gestation windows, and quantified the impact of exposure misclassification on hypothetical relative risk (RR) estimates. Results: We linked 1 336 495 eligible deliveries. Within 1-week agreement was 77-80 overall and 47-56 for preterm deliveries. The trimester-specific drug exposure status had high sensitivities and PPVs (88.5-98.5), and specificities and NPVs (>99.0). Assuming a hypothetical RR of 2.0, bias associated with exposure misclassification during first trimester ranged from 10 to 40 under non-differential/differential misclassification assumptions. Conclusions: Claims-based GA algorithms had good agreement with the gold standard overall, but lower agreement among preterm deliveries, potentially resulting in biased risk estimated for pregnancy exposure evaluations.