Evidence map›Paper›PMID 37034358›Full record

ArticleEClinicalMedicine2023

Contextualising adverse events of special interest to characterise the baseline incidence rates in 24 million patients with COVID-19 across 26 databases: a multinational retrospective cohort study.

Erica A Voss, Azza Shoaibi, Lana Yin Hui Lai, Clair Blacketer, Thamir Alshammari, Rupa Makadia, Kevin Haynes, Anthony G Sena, Gowtham Rao, Sebastiaan van Sandijk and 54 more

Open access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
4.9field-weighted citation impact, top 4% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
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  6. Review
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  11. Observational
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  13. Observational
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

64 authors at 20 institutions in 13 countries.

Erica A VossOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Azza ShoaibiOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Lana Yin Hui LaiOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Clair BlacketerOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Thamir AlshammariOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Rupa MakadiaOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Kevin HaynesJanssen Pharmaceutical Research and Development LLC, Titusville, NJ, USA.
Anthony G SenaOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Gowtham RaoOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Sebastiaan van SandijkOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Clement FrabouletDepartment of Medical Information, Assistance Publique - Hopitaux de Marseille, Marseille, France.
Laurent BoyerDepartment of Medical Information, Assistance Publique - Hopitaux de Marseille, Marseille, France.
Tanguy Le CarrourEaster Eggs, Paris, France.
Scott HorbanHealth Informatics Centre, University of Dundee, Dundee, UK.
Daniel R MoralesDivision of Population Health and Genomics, University of Dundee, Dundee, UK.
Jordi Martínez RoldánHospital del Mar, Department of Innovation and Digital Transformation, Barcelona, Spain.
Juan Manuel Ramírez-AnguitaHospital del Mar Medical Research Institute (IMIM), Barcelona, Spain.
Miguel A MayerHospital del Mar Medical Research Institute (IMIM), Barcelona, Spain.
Marcel de WildeOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Luis H JohnOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Talita Duarte-SallesOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Elena RoelFundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol I Gurina (IDIAPJGol), Barcelona, Spain.
Andrea PistilloFundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol I Gurina (IDIAPJGol), Barcelona, Spain.
Raivo KoldeUniversity of Tartu, Tartu, Estonia.
Filip MaljkovićHeliant, Belgrade, Serbia.
Spiros DenaxasUniversity College London, Institute of Health Informatics, London, UK.
Vaclav PapezUniversity College London, Institute of Health Informatics, London, UK.
Michael G KahnOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Karthik NatarajanOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Christian ReichOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Alex SecoraIQVIA, Falls Church, VA, USA.
Evan P MintyOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Nigam H ShahOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Jose D PosadaOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Maria Teresa Garcia MoralesInstituto de Investigación, Hospital 12 de Octubre, Madrid, Spain.
Diego BoscaVeraTech for Health, Valencia, Spain.
Honorio Cadenas JuaninoFundación para la Investigación e Innovación Biosanitaria en Atención Primaria (FIIBAP), Madrid, Spain.
Antonio Diaz HolgadoFundación para la Investigación e Innovación Biosanitaria en Atención Primaria (FIIBAP), Madrid, Spain.
Miguel Pedrera JiménezHospital Universitario 12 de Octubre, Madrid, Spain.
Pablo Serrano BalazoteHospital Universitario 12 de Octubre, Madrid, Spain.
Noelia García BarrioHospital Universitario 12 de Octubre, Madrid, Spain.
Selçuk ŞenDivision of Clinical Pharmacology, Department of Medical Pharmacology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Türkiye.
Ali Yağız ÜresinDivision of Clinical Pharmacology, Department of Medical Pharmacology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Türkiye.
Baris ErdoganClinerion, Basel, Switzerland.
Luc BelmansMedaman BV, Geel, Flanders, Belgium.
Geert ByttebierMedaman BV, Geel, Flanders, Belgium.
Manu L N G MalbrainMedaman BV, Geel, Flanders, Belgium.
Daniel J DedmanClinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK.
Zara CuccuClinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK.
Rohit VashishtOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Atul J ButteOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Ayan PatelOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Lisa DahmOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Cora HanOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Fan BuDepartment of Biostatistics, University of California, Los Angeles, Los Angeles, CA, USA.
Faaizah ArshadOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Anna OstropoletsOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Fredrik NybergSchool of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
George HripcsakOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Marc A SuchardOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Dani Prieto-AlhambraOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Peter R RijnbeekOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Martijn J SchuemieOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Patrick B RyanOHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Office for National Statistics · GBUnited States Department of Veterans Affairs · USErasmus MC · NLClinical Practice Research Datalink · GBUniversity of California, San Francisco · USHospital Universitario 12 De Octubre · ESInstitut Universitari d'Investigació en Atenció Primària Jordi Gol · ESResearch Institute Hospital 12 de Octubre · ESUniversity of California, Los Angeles · USUniversity of Gothenburg · SEBioef - Fundación Vasca de Innovación e Investigación Sanitarias · ESBritish Heart Foundation · GBClinical Insights · USColumbia University Irving Medical Center · USIstanbul University · TRJanssen (United States) · USMedical University of Lublin · PLNewYork–Presbyterian Hospital · USUniversidad del Norte · COUniversitat Pompeu Fabra · ES

Funding

Medical Research Council MC_PC_20030Medical Research Council MC_PC_20051Medical Research Council MC_PC_20059
6 · The paper itself

Abstract

Background: Adverse events of special interest (AESIs) were pre-specified to be monitored for the COVID-19 vaccines. Some AESIs are not only associated with the vaccines, but with COVID-19. Our aim was to characterise the incidence rates of AESIs following SARS-CoV-2 infection in patients and compare these to historical rates in the general population. Methods: A multi-national cohort study with data from primary care, electronic health records, and insurance claims mapped to a common data model. This study's evidence was collected between Jan 1, 2017 and the conclusion of each database (which ranged from Jul 2020 to May 2022). The 16 pre-specified prevalent AESIs were: acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, deep vein thrombosis, disseminated intravascular coagulation, encephalomyelitis, Guillain- Barré syndrome, haemorrhagic stroke, non-haemorrhagic stroke, immune thrombocytopenia, myocarditis/pericarditis, narcolepsy, pulmonary embolism, transverse myelitis, and thrombosis with thrombocytopenia. Age-sex standardised incidence rate ratios (SIR) were estimated to compare post-COVID-19 to pre-pandemic rates in each of the databases. Findings: Substantial heterogeneity by age was seen for AESI rates, with some clearly increasing with age but others following the opposite trend. Similarly, differences were also observed across databases for same health outcome and age-sex strata. All studied AESIs appeared consistently more common in the post-COVID-19 compared to the historical cohorts, with related meta-analytic SIRs ranging from 1.32 (1.05 to 1.66) for narcolepsy to 11.70 (10.10 to 13.70) for pulmonary embolism. Interpretation: Our findings suggest all AESIs are more common after COVID-19 than in the general population. Thromboembolic events were particularly common, and over 10-fold more so. More research is needed to contextualise post-COVID-19 complications in the longer term. Funding: None.

Indexed as

Adverse events of special interestCOVID-19Observational researchOMOP CDM

Identifiers

PMID37034358
PMCPMC10072853
OpenAlexW4362633643

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Registered trials

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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.