Dataset Information

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.

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.

SUBMITTER: Voss EA

PROVIDER: S-EPMC10072853 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Voss Erica A EA Shoaibi Azza A Yin Hui Lai Lana L Blacketer Clair C Alshammari Thamir T Makadia Rupa R Haynes Kevin K Sena Anthony G AG Rao Gowtham G van Sandijk Sebastiaan S Fraboulet Clement C Boyer Laurent L Le Carrour Tanguy T Horban Scott S Morales Daniel R DR Martínez Roldán Jordi J Ramírez-Anguita Juan Manuel JM Mayer Miguel A MA de Wilde Marcel M John Luis H LH Duarte-Salles Talita T Roel Elena E Pistillo Andrea A Kolde Raivo R Maljković Filip F Denaxas Spiros S Papez Vaclav V Kahn Michael G MG Natarajan Karthik K Reich Christian C Secora Alex A Minty Evan P EP Shah Nigam H NH Posada Jose D JD Garcia Morales Maria Teresa MT Bosca Diego D Cadenas Juanino Honorio H Diaz Holgado Antonio A Pedrera Jiménez Miguel M Serrano Balazote Pablo P García Barrio Noelia N Şen Selçuk S Üresin Ali Yağız AY Erdogan Baris B Belmans Luc L Byttebier Geert G Malbrain Manu L N G MLNG Dedman Daniel J DJ Cuccu Zara Z Vashisht Rohit R Butte Atul J AJ Patel Ayan A Dahm Lisa L Han Cora C Bu Fan F Arshad Faaizah F Ostropolets Anna A Nyberg Fredrik F Hripcsak George G Suchard Marc A MA Prieto-Alhambra Dani D Rijnbeek Peter R PR Schuemie Martijn J MJ Ryan Patrick B PB

EClinicalMedicine 20230404

<h4>Background</h4>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.<h4>Methods</h4>A multi-national cohort study with data from primary care, electronic health records, and insurance claims mapped to a comm ...[more]

PMID: 37034358

Similar Datasets

Project description:ObjectiveTo quantify the background incidence rates of 15 prespecified adverse events of special interest (AESIs) associated with covid-19 vaccines.DesignMultinational network cohort study.SettingElectronic health records and health claims data from eight countries: Australia, France, Germany, Japan, the Netherlands, Spain, the United Kingdom, and the United States, mapped to a common data model.Participants126 661 070 people observed for at least 365 days before 1 January 2017, 2018, or 2019 from 13 databases.Main outcome measuresEvents of interests were 15 prespecified AESIs (non-haemorrhagic and haemorrhagic stroke, acute myocardial infarction, deep vein thrombosis, pulmonary embolism, anaphylaxis, Bell's palsy, myocarditis or pericarditis, narcolepsy, appendicitis, immune thrombocytopenia, disseminated intravascular coagulation, encephalomyelitis (including acute disseminated encephalomyelitis), Guillain-Barré syndrome, and transverse myelitis). Incidence rates of AESIs were stratified by age, sex, and database. Rates were pooled across databases using random effects meta-analyses and classified according to the frequency categories of the Council for International Organizations of Medical Sciences.ResultsBackground rates varied greatly between databases. Deep vein thrombosis ranged from 387 (95% confidence interval 370 to 404) per 100 000 person years in UK CPRD GOLD data to 1443 (1416 to 1470) per 100 000 person years in US IBM MarketScan Multi-State Medicaid data among women aged 65 to 74 years. Some AESIs increased with age. For example, myocardial infarction rates in men increased from 28 (27 to 29) per 100 000 person years among those aged 18-34 years to 1400 (1374 to 1427) per 100 000 person years in those older than 85 years in US Optum electronic health record data. Other AESIs were more common in young people. For example, rates of anaphylaxis among boys and men were 78 (75 to 80) per 100 000 person years in those aged 6-17 years and 8 (6 to 10) per 100 000 person years in those older than 85 years in Optum electronic health record data. Meta-analytic estimates of AESI rates were classified according to age and sex.ConclusionThis study found large variations in the observed rates of AESIs by age group and sex, showing the need for stratification or standardisation before using background rates for safety surveillance. Considerable population level heterogeneity in AESI rates was found between databases.

Project description:BackgroundIn May 2020, the ACCESS (The vACCine covid-19 monitoring readinESS) project was launched to prepare real-world monitoring of COVID-19 vaccines. Within this project, this study aimed to generate background incidence rates of 41 adverse events of special interest (AESI) to contextualize potential safety signals detected following administration of COVID-19 vaccines.MethodsA dynamic cohort study was conducted using a distributed data network of 10 healthcare databases from 7 European countries (Italy, Spain, Denmark, The Netherlands, Germany, France and United Kingdom) over the period 2017 to 2020. A common protocol (EUPAS37273), common data model, and common analytics programs were applied for syntactic, semantic and analytical harmonization. Incidence rates (IR) for each AESI and each database were calculated by age and sex by dividing the number of incident cases by the total person-time at risk. Age-standardized rates were pooled using random effect models according to the provenance of the events.FindingsA total number of 63,456,074 individuals were included in the study, contributing to 211.7 million person-years. A clear age pattern was observed for most AESIs, rates also varied by provenance of disease diagnosis (primary care, specialist care). Thrombosis with thrombocytopenia rates were extremely low ranging from 0.06 to 4.53/100,000 person-years for cerebral venous sinus thrombosis (CVST) with thrombocytopenia (TP) and mixed venous and arterial thrombosis with TP, respectively.InterpretationGiven the nature of the AESIs and the setting (general practitioners or hospital-based databases or both), background rates from databases that show the highest level of completeness (primary care and specialist care) should be preferred, others can be used for sensitivity. The study was designed to ensure representativeness to the European population and generalizability of the background incidence rates.FundingThe project has received support from the European Medicines Agency under the Framework service contract nr EMA/2018/28/PE.

Dataset Information

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.

Background

Methods

Findings

Interpretation

Funding

Publications

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets