Evidence map›Paper›PMID 34591264›Full record

ArticleDrug safety2021

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 1 more

Open access · hybridAbstract read
In one paragraph

Article in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed
14.7field-weighted citation impact, top 1% 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

56 citing papers in PubMed, 65 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
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

11 authors at 4 institutions in 1 country.

Keran MollIBM Watson Health, Cambridge, MA, USA. kmoll@us.ibm.com.ORCID 0000-0002-6502-5212
Hui Lee WongCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Kathryn FingarIBM Watson Health, Cambridge, MA, USA.
Shayan HobbiIBM Global Business Services, Bethesda, MD, USA.
Minya ShengIBM Watson Health, Cambridge, MA, USA.
Timothy A BurrellIBM Watson Health, Cambridge, MA, USA.
Linda O EckertUniversity of Washington School of Medicine, Seattle, WA, USA.
Flor M MunozBaylor College of Medicine, Houston, TX, USA.
Bethany BaerCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Azadeh ShoaibiCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Steven AndersonCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Center for Biologics Evaluation and Research · USIBM (United States) · USBaylor College of Medicine · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPregnancy 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.

methodsWe developed algorithms to classify pregnancy outcomes and estimate GA using ICD-10-CM/PCS and service codes on claims in the 2016-2018 IBM

resultsThe 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.

conclusionsThe pregnancy outcome algorithms had high agreement with physician adjudication of EMRs and may inform post-market maternal safety surveillance.

Indexed as

Abortion, SpontaneousPregnancy OutcomeAlgorithmsElectronic Health RecordsFemaleGestational AgeHumansInfant, NewbornPregnancyStillbirth

Identifiers

PMID34591264
PMCPMC8481319
OpenAlexW3202701094

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.