Evidence map›Paper›PMID 35092037›Full record

ArticleStatistics in medicine2022

A modified self-controlled case series method for event-dependent exposures and high event-related mortality, with application to COVID-19 vaccine safety.

Yonas Ghebremichael-Weldeselassie, Marie Joëlle Jabagi, Jérémie Botton, Marion Bertrand, Bérangère Baricault, Jérôme Drouin, Alain Weill, Mahmoud Zureik, Rosemary Dray-Spira, Paddy Farrington

Open access · hybridAbstract read
In one paragraph

Article in Statistics in medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed
9.0field-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

39 citing papers in PubMed, 58 citations in OpenAlex.

  1. Cardiac Adverse Events and Remdesivir in Hospitalized Patients With COVID-19: A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Trial
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  10. Core Concepts: Self-Controlled Designs in Pharmacoepidemiology.Pharmacoepidemiology and drug safety · 2025
    Review
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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

10 authors at 2 institutions in 2 countries.

Yonas Ghebremichael-WeldeselassieSchool of Mathematics and Statistics, The Open University, Milton Keynes, UK.
Marie Joëlle JabagiEPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM), French National Health Insurance (CNAM), Saint-Denis, France.
Jérémie BottonEPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM), French National Health Insurance (CNAM), Saint-Denis, France.
Marion BertrandEPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM), French National Health Insurance (CNAM), Saint-Denis, France.
Bérangère BaricaultEPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM), French National Health Insurance (CNAM), Saint-Denis, France.
Jérôme DrouinEPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM), French National Health Insurance (CNAM), Saint-Denis, France.
Alain WeillEPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM), French National Health Insurance (CNAM), Saint-Denis, France.
Mahmoud ZureikEPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM), French National Health Insurance (CNAM), Saint-Denis, France.
Rosemary Dray-SpiraEPI-PHARE, French National Agency for Medicines and Health Products Safety (ANSM), French National Health Insurance (CNAM), Saint-Denis, France.
Paddy FarringtonSchool of Mathematics and Statistics, The Open University, Milton Keynes, UK.ORCID 0000-0002-7148-2612
Conservatoire National des Arts et Métiers · FRThe Open University · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We propose a modified self-controlled case series (SCCS) method to handle both event-dependent exposures and high event-related mortality. This development is motivated by an epidemiological study undertaken in France to quantify potential risks of cardiovascular events associated with COVID-19 vaccines. Event-dependence of vaccinations, and high event-related mortality, are likely to arise in other SCCS studies of COVID-19 vaccine safety. Using this case study and simulations to broaden its scope, we explore these features and the biases they may generate, implement the modified SCCS model, illustrate some of the properties of this model, and develop a new test for presence of a dose effect. The model we propose has wider application, notably when the event of interest is death.

Indexed as

COVID-19COVID-19 VaccinesBiasHumansResearch DesignVaccinationCOVID-19 Vaccinescardiovascular eventsCOVID-19epidemiological methodsself-controlled case seriesvaccines

Identifiers

PMID35092037
PMCPMC9303905
OpenAlexW4210412350

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.