Pharmacoepidemiol Drug Saf. 2026 Feb;35(2):e70328. doi: 10.1002/pds.70328.
ABSTRACT
PURPOSE: Claims data are a valuable source to study neonatal outcomes across a wide range of clinical questions. Infants’ delayed enrollment in infant insurance poses challenges in capture of neonatal outcomes, which may be charged to the maternal health plan, posing misclassification risks. We evaluated outcome ascertainment across three infant enrollment scenarios.
METHODS: We used Merative MarketScan databases (2012-2018) in the United States to construct a mother-infant linked cohort and assess the outcome ascertaiment precision with varying infant enrollment requirement.
RESULT: We found that allowing delayed infant enrollment in their own insurance within the first 4 weeks of life retained sample size, nearly doubled case numbers and yielded outcome prevalences similar to those of cohorts with full enrollment since birth. Use of maternal claims in addition to infant claims in this cohort made minor contributions to case capture for neonatal-specific outcomes, while significantly decreasing specificity of more general outcomes. Longer delays in enrollment yielded lower outcome prevalences with higher contributions of maternal claims even for neonatal-specific outcomes. For small for gestational age (SGA), both maternal and infant claims contributed similar proportions of cases.
CONCLUSION: These findings inform strategies for outcome ascertainment in claims-based perinatal research and emphasize outcome-specific case ascertainment strategies to balance sensitivity and specificity.
PMID:41548053 | DOI:10.1002/pds.70328
