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

Moll, Keran; Wong, Hui Lee; Fingar, Kathryn; Hobbi, Shayan; Sheng, Minya; Burrell, Timothy A; Eckert, Linda O; Munoz, Flor M; Baer, Bethany; Shoaibi, Azadeh; Anderson, Steven

Moll, Keran; Wong, Hui Lee; Fingar, Kathryn; Hobbi, Shayan; Sheng, Minya; Burrell, Timothy A; Eckert, Linda O; Munoz, Flor M; Baer, Bethany; Shoaibi, Azadeh; Anderson, Steven.

Afiliación

Moll K; IBM Watson Health, Cambridge, MA, USA. kmoll@us.ibm.com.
Wong HL; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Fingar K; IBM Watson Health, Cambridge, MA, USA.
Hobbi S; IBM Global Business Services, Bethesda, MD, USA.
Sheng M; IBM Watson Health, Cambridge, MA, USA.
Burrell TA; IBM Watson Health, Cambridge, MA, USA.
Eckert LO; University of Washington School of Medicine, Seattle, WA, USA.
Munoz FM; Baylor College of Medicine, Houston, TX, USA.
Baer B; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Shoaibi A; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Anderson S; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Drug Saf ; 44(11): 1151-1164, 2021 11.

Article en En | MEDLINE | ID: mdl-34591264

RESUMEN

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.

Asunto(s)

Aborto Espontáneo; Resultado del Embarazo; Algoritmos; Registros Electrónicos de Salud; Femenino; Edad Gestacional; Humanos; Recién Nacido; Embarazo; Resultado del Embarazo/epidemiología; Mortinato/epidemiología

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Resultado del Embarazo / Aborto Espontáneo Tipo de estudio: Prognostic_studies Límite: Female / Humans / Newborn / Pregnancy Idioma: En Revista: Drug Saf Asunto de la revista: TERAPIA POR MEDICAMENTOS / TOXICOLOGIA Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Nueva Zelanda

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