Assigning Pregnancy Outcomes and Gestational Age at Outcome for Robust Pregnancy Safety Analyses: Application in US Claims

Speaker(s)

Hamid A1, Nowacki G2, Tagliabue S1, Raad H3, Furegato M1, Subiron-Naidoo N4
1Oracle Life Sciences, Paris, Paris, France, 2Oracle Life Sciences, Paris, France, 3Oracle Life Sciences, Paris, 75, France, 4Oracle Life Sciences, Le Perreux-sur-Marne, 94, France

Presentation Documents

OBJECTIVES: Drug safety data in pregnancy prior to marketing approval and authorization is limited. Real-world data sources can support robust risk-benefit evaluation, as contraindicated drugs may be prescribed to unaware pregnant women or when no alternative exist for treating maternal conditions. Robust claims-based pregnancy safety analyses rely on valid code algorithms. We aimed to apply published algorithms in a large representative closed-claims database in the US.

METHODS: We applied an outcomes-based algorithm using diagnosis and procedure codes to identify pregnancy outcomes: live, full term, preterm and still birth (LB, FTB, PTB and SB), spontaneous and elective abortion (SA or AB), and ectopic pregnancy (ETC), between January 2022-January 2023, among women aged 15-49. Estimated date of conception and gestational age (GA) at outcome was assigned using a hierarchical code algorithm.

RESULTS: The outcomes algorithm assigned a pregnancy outcome to 842,583 (100%) pregnancy episodes: LB (62%) [of which 34% FTB, 4% PTB, 24% unassigned LB], SB (1%), SA (17%), AB (12%), ECT (3%) and unknown (5%).

The hierarchical algorithm assigned a GA at outcome to 649,995 (77.1%) episodes.

There were some inconsistencies between assigned outcomes and assigned GA at outcome: 11.3% of FTB outcomes were assigned GA at outcome of ≤36 weeks while 21.6% of PTB outcomes were assigned GA >36 weeks. All assigned SB and SA outcomes were accurately assigned GA of ≥20 and <20 weeks respectively. The hierarchical algorithm allowed for assignment of GA at outcome for 92.3% of the unassigned LB where15.3% GA ≤ 36 weeks, and 77% GA >36 weeks.

CONCLUSIONS: Estimating date of conception and gestational age at outcome with code algorithms are crucial for defining pregnancy episode trimesters as exposure windows in claims data for inferential safety analyses. Linkage with electronic health record (EHR) data to validate a proportion of assigned outcomes and GA at outcome is needed.

Code

EPH186

Topic

Epidemiology & Public Health, Study Approaches

Topic Subcategory

Disease Classification & Coding

Disease

No Additional Disease & Conditions/Specialized Treatment Areas