Real-world data are not always big data: the case for primary data collection on medication use in pregnancy in the context of birth defects research

Ailes, Elizabeth C.; Werler, Martha M.; Howley, Meredith M.; Jenkins, Mary M.; Reefhuis, Jennita

doi:10.1093/aje/kwae060

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CDC STACKS serves as an archival repository of CDC-published products including scientific findings, journal articles, guidelines, recommendations, or other public health information authored or co-authored by CDC or funded partners. As a repository, CDC STACKS retains documents in their original published format to ensure public access to scientific information.

Real-world data are not always big data: the case for primary data collection on medication use in pregnancy in the context of birth defects research

9-03-
By Ailes, Elizabeth C. ; Werler, Martha M. ; Howley, Meredith M. ; ...
Source: Am J Epidemiol. 193(9):1211-1214

Public Access Version Available on: September 03, 2025, 12:00 AM

Please check back on the date listed above.

English

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Alternative Title:

Am J Epidemiol
Personal Author:

Ailes, Elizabeth C. ; Werler, Martha M. ; Howley, Meredith M. ; Jenkins, Mary M. ; Reefhuis, Jennita

Ailes, Elizabeth C. ; Werler, Martha M. ; Howley, Meredith M. ; Jenkins, Mary M. ; Reefhuis, Jennita Less -
Description:

Many examples of the use of real-world data in the area of pharmacoepidemiology include "big data," such as insurance claims, medical records, or hospital discharge databases. However, "big" is not always better, particularly when studying outcomes with narrow windows of etiologic relevance. Birth defects are such an outcome, for which specificity of exposure timing is critical. Studies with primary data collection can be designed to query details about the timing of medication use, as well as type, dose, frequency, duration, and indication, that can better characterize the "real world." Because birth defects are rare, etiologic studies are typically case‑control in design, like the National Birth Defects Prevention Study, Birth Defects Study to Evaluate Pregnancy Exposures, and Slone Birth Defects Study. Recall bias can be a concern, but the ability to collect detailed information about both prescription and over-the-counter medication use and other exposures such as diet, family history, and sociodemographic factors is a distinct advantage over claims and medical record data sources. Case‑control studies with primary data collection are essential to advancing the pharmacoepidemiology of birth defects. This article is part of a Special Collection on Pharmacoepidemiology.
Subjects:

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Abnormalities, Drug-Induced Big Data Case-Control Studies Congenital Abnormalities Data Collection Female Humans Pharmacoepidemiology Pregnancy
Keywords:

[+]

Administrative Data Birth Defects Case-control Studies Medications
Source:

Am J Epidemiol. 193(9):1211-1214
Pubmed ID:

38751306
Pubmed Central ID:

PMC11372710
Document Type:

Journal Article
Funding:

CC999999/ImCDC/Intramural CDC HHSUnited States/ ; CDP 13-003/HX/HSRD VAUnited States/ ; EP-D-18-001/EPA/EPAUnited States/

CC999999/ImCDC/Intramural CDC HHSUnited States/ ; CDP 13-003/HX/HSRD VAUnited States/ ; EP-D-18-001/EPA/EPAUnited States/ Less -
Volume:

193
Issue:

9
Collection(s):

CDC Public Access
Main Document Checksum:

[+]

urn:sha-512:acb0807eac9a8b11b6a5628f5d188fa110b3561b1e401aa572e7c5283f4a666b14e3aae23828011029466cb623ae9190869fbb36f9f803305ca5722b2512e7ad
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