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; Clement Fraboulet; Laurent Boyer; Tanguy Le Carrour; Scott Horban; Daniel R. Morales; Jordi Martínez Roldán; Juan Manuel Ramírez-Anguita; Miguel A. Mayer; Marcel de Wilde; Luis H. John; Talita Duarte-Salles; Elena Roel; Andrea Pistillo; Raivo Kolde; Filip Maljković; Spiros Denaxas; Vaclav Papez; Michael G. Kahn; Karthik Natarajan; Christian Reich; Alex Secora; Evan P. Minty; Nigam H. Shah; Jose D. Posada; Maria Teresa Garcia Morales; Diego Bosca; Honorio Cadenas Juanino; Antonio Diaz Holgado; Miguel Pedrera Jiménez; Pablo Serrano Balazote; Noelia García Barrio; Selçuk Şen; Ali Yağız Üresin; Baris Erdogan; Luc Belmans; Geert Byttebier; Manu L.N.G. Malbrain; Daniel J. Dedman; Zara Cuccu; Rohit Vashisht

doi:10.1016/j.eclinm.2023.101932

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 (Lead / Corresponding author), Azza Shoaibi, Lana Yin Hui Lai, Clair Blacketer, Thamir Alshammari, Rupa Makadia, Kevin Haynes, Anthony G. Sena, Gowtham Rao, Sebastiaan van Sandijk, Clement Fraboulet, Laurent Boyer, Tanguy Le Carrour, Scott Horban, Daniel R. Morales, Jordi Martínez Roldán, Juan Manuel Ramírez-Anguita, Miguel A. Mayer, Marcel de WildeLuis H. John, Talita Duarte-Salles, Elena Roel, Andrea Pistillo, Raivo Kolde, Filip Maljković, Spiros Denaxas, Vaclav Papez, Michael G. Kahn, Karthik Natarajan, Christian Reich, Alex Secora, Evan P. Minty, Nigam H. Shah, Jose D. Posada, Maria Teresa Garcia Morales, Diego Bosca, Honorio Cadenas Juanino, Antonio Diaz Holgado, Miguel Pedrera Jiménez, Pablo Serrano Balazote, Noelia García Barrio, Selçuk Şen, Ali Yağız Üresin, Baris Erdogan, Luc Belmans, Geert Byttebier, Manu L.N.G. Malbrain, Daniel J. Dedman, Zara Cuccu, Rohit Vashisht

Population Health and Genomics

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

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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.

Original language	English
Article number	101932
Number of pages	12
Journal	eClinicalMedicine
Volume	58
Early online date	4 Apr 2023
DOIs	https://doi.org/10.1016/j.eclinm.2023.101932
Publication status	Published - Apr 2023

Keywords

Adverse events of special interest
COVID-19
Observational research
OMOP CDM

ASJC Scopus subject areas

General Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.eclinm.2023.101932Licence: CC BY

Final Published VersionFinal published version, 577 KBLicence: CC BY

Cite this

, Voss, E. A., Shoaibi, A., Yin Hui Lai, L., Blacketer, C., Alshammari, T., Makadia, R., Haynes, K., Sena, A. G., Rao, G., van Sandijk, S., Fraboulet, C., Boyer, L., Le Carrour, T., Horban, S., Morales, D. R., Martínez Roldán, J., Ramírez-Anguita, J. M., Mayer, M. A., ... Vashisht, R. (2023). 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. eClinicalMedicine, 58, Article 101932. https://doi.org/10.1016/j.eclinm.2023.101932

@article{4d978a22777b444f80a660fd716d2a08,

title = "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- Barr{\'e} 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.",

keywords = "Adverse events of special interest, COVID-19, Observational research, OMOP CDM",

author = "Voss, {Erica A.} and Azza Shoaibi and {Yin Hui Lai}, Lana and Clair Blacketer and Thamir Alshammari and Rupa Makadia and Kevin Haynes and Sena, {Anthony G.} and Gowtham Rao and {van Sandijk}, Sebastiaan and Clement Fraboulet and Laurent Boyer and {Le Carrour}, Tanguy and Scott Horban and Morales, {Daniel R.} and {Mart{\'i}nez Rold{\'a}n}, Jordi and Ram{\'i}rez-Anguita, {Juan Manuel} and Mayer, {Miguel A.} and {de Wilde}, Marcel and John, {Luis H.} and Talita Duarte-Salles and Elena Roel and Andrea Pistillo and Raivo Kolde and Filip Maljkovi{\'c} and Spiros Denaxas and Vaclav Papez and Kahn, {Michael G.} and Karthik Natarajan and Christian Reich and Alex Secora and Minty, {Evan P.} and Shah, {Nigam H.} and Posada, {Jose D.} and {Garcia Morales}, {Maria Teresa} and Diego Bosca and {Cadenas Juanino}, Honorio and {Diaz Holgado}, Antonio and {Pedrera Jim{\'e}nez}, Miguel and {Serrano Balazote}, Pablo and {Garc{\'i}a Barrio}, Noelia and Sel{\c c}uk {\c S}en and {\"U}resin, {Ali Yağız} and Baris Erdogan and Luc Belmans and Geert Byttebier and Malbrain, {Manu L.N.G.} and Dedman, {Daniel J.} and Zara Cuccu and Rohit Vashisht",

note = "Copyright: {\textcopyright} 2023 The Author(s). Published by Elsevier Ltd.",

year = "2023",

month = apr,

doi = "10.1016/j.eclinm.2023.101932",

language = "English",

volume = "58",

}

Voss, EA, Shoaibi, A, Yin Hui Lai, L, Blacketer, C, Alshammari, T, Makadia, R, Haynes, K, Sena, AG, Rao, G, van Sandijk, S, Fraboulet, C, Boyer, L, Le Carrour, T, Horban, S, Morales, DR, Martínez Roldán, J, Ramírez-Anguita, JM, Mayer, MA, de Wilde, M, John, LH, Duarte-Salles, T, Roel, E, Pistillo, A, Kolde, R, Maljković, F, Denaxas, S, Papez, V, Kahn, MG, Natarajan, K, Reich, C, Secora, A, Minty, EP, Shah, NH, Posada, JD, Garcia Morales, MT, Bosca, D, Cadenas Juanino, H, Diaz Holgado, A, Pedrera Jiménez, M, Serrano Balazote, P, García Barrio, N, Şen, S, Üresin, AY, Erdogan, B, Belmans, L, Byttebier, G, Malbrain, MLNG, Dedman, DJ & Cuccu, Z & Vashisht, R 2023, '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', eClinicalMedicine, vol. 58, 101932. https://doi.org/10.1016/j.eclinm.2023.101932

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. (Lead / Corresponding author); Shoaibi, Azza et al.
In: eClinicalMedicine, Vol. 58, 101932, 04.2023.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Contextualising adverse events of special interest to characterise the baseline incidence rates in 24 million patients with COVID-19 across 26 databases

T2 - a multinational retrospective cohort study

AU - Voss, Erica A.

AU - Shoaibi, Azza

AU - Yin Hui Lai, Lana

AU - Blacketer, Clair

AU - Alshammari, Thamir

AU - Makadia, Rupa

AU - Haynes, Kevin

AU - Sena, Anthony G.

AU - Rao, Gowtham

AU - van Sandijk, Sebastiaan

AU - Fraboulet, Clement

AU - Boyer, Laurent

AU - Le Carrour, Tanguy

AU - Horban, Scott

AU - Morales, Daniel R.

AU - Martínez Roldán, Jordi

AU - Ramírez-Anguita, Juan Manuel

AU - Mayer, Miguel A.

AU - de Wilde, Marcel

AU - John, Luis H.

AU - Duarte-Salles, Talita

AU - Roel, Elena

AU - Pistillo, Andrea

AU - Kolde, Raivo

AU - Maljković, Filip

AU - Denaxas, Spiros

AU - Papez, Vaclav

AU - Kahn, Michael G.

AU - Natarajan, Karthik

AU - Reich, Christian

AU - Secora, Alex

AU - Minty, Evan P.

AU - Shah, Nigam H.

AU - Posada, Jose D.

AU - Garcia Morales, Maria Teresa

AU - Bosca, Diego

AU - Cadenas Juanino, Honorio

AU - Diaz Holgado, Antonio

AU - Pedrera Jiménez, Miguel

AU - Serrano Balazote, Pablo

AU - García Barrio, Noelia

AU - Şen, Selçuk

AU - Üresin, Ali Yağız

AU - Erdogan, Baris

AU - Belmans, Luc

AU - Byttebier, Geert

AU - Malbrain, Manu L.N.G.

AU - Dedman, Daniel J.

AU - Cuccu, Zara

AU - Vashisht, Rohit

PY - 2023/4

Y1 - 2023/4

N2 - 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.

AB - 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.

KW - Adverse events of special interest

KW - COVID-19

KW - Observational research

KW - OMOP CDM

UR - http://www.scopus.com/inward/record.url?scp=85151525434&partnerID=8YFLogxK

U2 - 10.1016/j.eclinm.2023.101932

DO - 10.1016/j.eclinm.2023.101932

M3 - Article

C2 - 37034358

AN - SCOPUS:85151525434

VL - 58

JO - eClinicalMedicine

JF - eClinicalMedicine

M1 - 101932

ER -

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

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ASJC Scopus subject areas

UN SDGs

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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

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

Other files and links

Fingerprint

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Health Informatics Centre

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