Validating Claims-Based Algorithms Determining Pregnancy Outcomes and Gestational Age Using a Linked Claims-Electronic Medical Record Database

Keran Moll (), Hui Lee Wong, Kathryn Fingar, Shayan Hobbi, Minya Sheng, Timothy A. Burrell, Linda O. Eckert, Flor M. Munoz, Bethany Baer, Azadeh Shoaibi and Steven Anderson
Additional contact information
Keran Moll: IBM Watson Health
Hui Lee Wong: US Food and Drug Administration
Kathryn Fingar: IBM Watson Health
Shayan Hobbi: IBM Global Business Services
Minya Sheng: IBM Watson Health
Timothy A. Burrell: IBM Watson Health
Linda O. Eckert: University of Washington School of Medicine
Flor M. Munoz: Baylor College of Medicine
Bethany Baer: US Food and Drug Administration
Azadeh Shoaibi: US Food and Drug Administration
Steven Anderson: US Food and Drug Administration

Drug Safety, 2021, vol. 44, issue 11, No 3, 1164 pages

Abstract: Abstract Introduction Pregnancy outcome identification and precise estimates of gestational age (GA) are critical in drug safety studies of pregnant women. Validated pregnancy outcome algorithms based on the International Classification of Diseases, Tenth Revision, Clinical Modification/Procedure Coding System (ICD-10-CM/PCS) have not previously been published. Methods We developed algorithms to classify pregnancy outcomes and estimate GA using ICD-10-CM/PCS and service codes on claims in the 2016–2018 IBM® MarketScan® Explorys® Claims-EMR Data Set and compared the results with ob-gyn adjudication of electronic medical records (EMRs). Obstetric services were grouped into episodes using hierarchical and spacing requirements. GA was based on evidence with the highest clinical accuracy. Among pregnancies with obstetric EMRs, 100 full-term live births (FTBs), 100 preterm live births (PTBs), 100 spontaneous abortions (SAs), and 24 stillbirths were selected for review. Physicians adjudicated cases using Global Alignment of Immunization safety Assessment in pregnancy (GAIA) definitions applied to structured EMRs. Results The claims-based algorithms identified 34,204 pregnancies, of which 9.9% had obstetric EMRs. Of sampled pregnancies, 92 FTBs, 93 PTBs, 75 SAs, and 24 stillbirths were adjudicated. Among these pregnancies, the percent agreement was 97.8%, 62.4%, 100.0%, and 70.8% for FTBs, PTBs, SAs, and stillbirths, respectively. The percent agreement on GA within 7 and 28 days, respectively, was 85.9% and 100.0% for FTBs, 81.7% and 98.9% for PTBs, 61.3% and 94.7% for SAs, and 66.7% and 79.2% for stillbirths. Conclusions The pregnancy outcome algorithms had high agreement with physician adjudication of EMRs and may inform post-market maternal safety surveillance.

Date: 2021
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DOI: 10.1007/s40264-021-01113-8

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