Evidence map›Paper›PMID 28054412›Full record

Observational studyPharmacoepidemiology and drug safety2017

Identifying birth defects in automated data sources in the Vaccine Safety Datalink.

Elyse Olshen Kharbanda, Gabriela Vazquez-Benitez, Paul A Romitti, Allison L Naleway, T Craig Cheetham, Heather S Lipkind, Shanthi Sivanandam, Nicola P Klein, Grace M Lee, Michael L Jackson and 5 more

Open access · greenAbstract readObservational Study
In one paragraph

Observational study in Pharmacoepidemiology and drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 1 country.

Elyse Olshen KharbandaHealthPartners Institute, Minneapolis, MN, USA.
Gabriela Vazquez-BenitezHealthPartners Institute, Minneapolis, MN, USA.
Paul A RomittiUniversity of Iowa, Iowa City, IA, USA.
Allison L NalewayCenter for Health Research Kaiser Permanente Northwest, Portland, OR, USA.
T Craig CheethamKaiser Permanente Southern California, Los Angeles, CA, USA.
Heather S LipkindYale University School of Medicine, New Haven, CT, USA.
Shanthi SivanandamUniversity of Minnesota, Minneapolis, MN, USA.
Nicola P KleinKaiser Permanente Northern California, San Francisco, CA, USA.
Grace M LeeHarvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA.
Michael L JacksonGroup Health Research Institute, Seattle, WA, USA.
Simon J HambidgeInstitute for Health Research, Kaiser Permanente Colorado and Ambulatory Care Services, Denver Health, Denver, CO, USA.
Avalow OlsenHealthPartners Institute, Minneapolis, MN, USA.
Natalie McCarthyCenters for Disease Control and Prevention, Atlanta, GA, USA.
Frank DeStefanoCenters for Disease Control and Prevention, Atlanta, GA, USA.
James D NordinHealthPartners Institute, Minneapolis, MN, USA.
HealthPartners · USCenters for Disease Control and Prevention · USHarvard Pilgrim Health Care · USKaiser Permanente · USKaiser Permanente Center for Health Research · USKaiser Permanente San Francisco Medical Center · USKaiser Permanente Washington Health Research Institute · USUniversity of Colorado Denver · USUniversity of Iowa · USUniversity of Minnesota · USYale University · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

purposeThe Vaccine Safety Datalink (VSD), a collaboration between the Centers for Disease Control and Prevention and several large healthcare organizations, aims to monitor safety of vaccines administered in the USA. We present definitions and prevalence estimates for major structural birth defects to be used in studies of maternal vaccine safety.

methodsIn this observational study, we created and refined algorithms for identifying major structural birth defects from electronic healthcare data, conducted formal chart reviews for severe cardiac defects, and conducted limited chart validation for other defects. We estimated prevalence for selected defects by VSD site and birth year and compared these estimates to those in a US and European surveillance system.

resultsWe developed algorithms to enumerate >50 major structural birth defects from standardized administrative and healthcare data based on utilization patterns and expert opinion, applying criteria for number, timing, and setting of diagnoses. Our birth cohort included 497 894 infants across seven sites. The period prevalence for all selected major birth defects in the VSD from 2004 to 2013 was 1.7 per 100 live births. Cardiac defects were most common (65.4 per 10 000 live births), with one-fourth classified as severe, requiring emergent intervention. For most major structural birth defects, prevalence estimates were stable over time and across sites and similar to those reported in other population-based surveillance systems.

conclusionsOur algorithms can efficiently identify many major structural birth defects in large healthcare datasets and can be used in studies evaluating the safety of vaccines administered to pregnant women. Copyright © 2017 John Wiley & Sons, Ltd.

Indexed as

Adverse Drug Reaction Reporting SystemsPopulation SurveillanceAdolescentAdultAlgorithmsCongenital AbnormalitiesFemaleHumansInfantMaleMiddle AgedPregnancyPrevalenceUnited StatesVaccinesYoung AdultVaccinescongenital anomalieselectronic health datapharmacoepidemiologyprevalencevalidity

Identifiers

PMID28054412
PMCPMC6506837
OpenAlexW2571425891

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.