Evidence map›Paper›PMID 35653017›Full record

Observational studyDrug safety2022

Phenotype Algorithms for the Identification and Characterization of Vaccine-Induced Thrombotic Thrombocytopenia in Real World Data: A Multinational Network Cohort Study.

Azza Shoaibi, Gowtham A Rao, Erica A Voss, Anna Ostropolets, Miguel Angel Mayer, Juan Manuel Ramírez-Anguita, Filip Maljković, Biljana Carević, Scott Horban, Daniel R Morales and 16 more

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Drug safety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 13% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Transforming and evaluating the UK Biobank to the OMOP Common Data Model for COVID-19 research and beyond.Journal of the American Medical Informatics Association : JAMIA · 2022
    Observational
  7. 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

26 authors at 14 institutions in 7 countries.

Azza ShoaibiJanssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USA. ashoaibi@its.jnj.com.ORCID 0000-0002-6976-2594
Gowtham A RaoJanssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USA.
Erica A VossJanssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USA.
Anna OstropoletsObservational Health Data Sciences and Informatics (OHDSI), OHDSI Collaborators, New York, NY, USA.
Miguel Angel MayerHospital del Mar Medical Research Institute (IMIM), Barcelona, Spain.
Juan Manuel Ramírez-AnguitaHospital del Mar Medical Research Institute (IMIM), Barcelona, Spain.
Filip MaljkovićHeliant Ltd, Belgrade, Serbia.
Biljana CarevićDepartment of Hospital Epidemiology, University Clinical Center of Serbia, Belgrade, Serbia.
Scott HorbanHealth Informatics Centre (HIC), University of Dundee, Dundee, Scotland.
Daniel R MoralesHealth Informatics Centre (HIC), University of Dundee, Dundee, Scotland.
Talita Duarte-SallesFundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
Clement FrabouletAssistance Publique - Hôpitaux de Marseille, Marseille, Provence-Alpes-Cote d'Azur, France.
Tanguy Le CarrourEaster-eggs, Paris, France.
Spiros DenaxasUniversity College London, Institute of Health Informatics, London, UK.
Vaclav PapezUniversity College London, Institute of Health Informatics, London, UK.
Luis H JohnDepartment of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands.
Peter R RijneekDepartment of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands.
Evan MintyDepartmnet of Biomedical Data Sciences, Stanford University, California, USA.
Thamir M AlshammariObservational Health Data Sciences and Informatics (OHDSI), OHDSI Collaborators, New York, NY, USA.
Rupa MakadiaJanssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USA.
Clair BlacketerJanssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USA.
Frank DeFalcoJanssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USA.
Anthony G SenaJanssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USA.
Marc A SuchardObservational Health Data Sciences and Informatics (OHDSI), OHDSI Collaborators, New York, NY, USA.
Daniel Prieto-AlhambraCentre for Statistics in Medicine (CSM), Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDROMS), University of Oxford, Oxford, UK.
Patrick B RyanJanssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USA.
Janssen (United States) · USErasmus MC · NLHospital del Mar Research Institute · ESUniversity College London · GBUniversity of Dundee · GBAssistance Publique Hôpitaux de Marseille · FRColumbia University Irving Medical Center · USInstitut Universitari d'Investigació en Atenció Primària Jordi Gol · ESNuffield Orthopaedic Centre · GBReliant Technologies (United States) · USRiyadh Elm University · SAStanford University · USUniversity Children's Hospital, Belgrade · RSUniversity of California, Los Angeles · US

Funding

DISCOVERING AND APPLYING KNOWLEDGE IN CLINICAL DATABASESR01LM006910 · NLM · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI HRIPCSAK, GEORGE M · 2000 to 2023
$10.6M
Medical Research Council MC_PC_20051Medical Research Council MC_PC_20059Medical Research Council MR/K006584/1NLM NIH HHS R01 LM006910
6 · The paper itself

Abstract

introductionVaccine-induced thrombotic thrombocytopenia (VITT) has been identified as a rare but serious adverse event associated with coronavirus disease 2019 (COVID-19) vaccines.

objectivesIn this study, we explored the pre-pandemic co-occurrence of thrombosis with thrombocytopenia (TWT) using 17 observational health data sources across the world. We applied multiple TWT definitions, estimated the background rate of TWT, characterized TWT patients, and explored the makeup of thrombosis types among TWT patients.

methodsWe conducted an international network retrospective cohort study using electronic health records and insurance claims data, estimating background rates of TWT amongst persons observed from 2017 to 2019. Following the principles of existing VITT clinical definitions, TWT was defined as patients with a diagnosis of embolic or thrombotic arterial or venous events and a diagnosis or measurement of thrombocytopenia within 7 days. Six TWT phenotypes were considered, which varied in the approach taken in defining thrombosis and thrombocytopenia in real world data.

resultsOverall TWT incidence rates ranged from 1.62 to 150.65 per 100,000 person-years. Substantial heterogeneity exists across data sources and by age, sex, and alternative TWT phenotypes. TWT patients were likely to be men of older age with various comorbidities. Among the thrombosis types, arterial thrombotic events were the most common.

conclusionOur findings suggest that identifying VITT in observational data presents a substantial challenge, as implementing VITT case definitions based on the co-occurrence of TWT results in large and heterogeneous incidence rate and in a cohort of patints with baseline characteristics that are inconsistent with the VITT cases reported to date.

Indexed as

COVID-19COVID-19 VaccinesThrombocytopeniaThrombosisAlgorithmsCohort StudiesHumansPhenotypeRetrospective StudiesCOVID-19 Vaccines

Identifiers

PMID35653017
PMCPMC9160850
OpenAlexW4282936489

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.