Evidence map›Paper›PMID 36366404›Full record

ArticleVaccines2022

Early Real-World Data to Assess Benefits and Risks of COVID-19 Vaccines: A Systematic Review of Methods.

Tatiane B Ribeiro, Fátima Roque, Fidelia Ida, Ana I Plácido, Mai Vu, Jose J Hernández-Muñoz, Maria Teresa Herdeiro

Abstract read
In one paragraph

Article in Vaccines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. 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

7 authors.

Tatiane B RibeiroPostgraduate Program of Epidemiology, Department of Epidemiology, School of Public Health, Universidade de São Paulo, São Paulo 01246-904, SP, Brazil.
Fátima RoqueResearch Unit for Inland Development, Polytechnic of Guarda (UDI/IPG), 6300-559 Guarda, Portugal.ORCID 0000-0003-0169-3788
Fidelia IdaQuantitative Clinical Science and Reporting, CSL Behring, 1020 1st Ave, King of Prussia, PA 19406, USA.
Ana I PlácidoResearch Unit for Inland Development, Polytechnic of Guarda (UDI/IPG), 6300-559 Guarda, Portugal.ORCID 0000-0002-2316-6770
Mai VuFaculty of Pharmacy, HUTECH University, Ho Chi Minh City 70000, Vietnam.
Jose J Hernández-MuñozDepartment of Pharmaceutical Sciences, Irma Lerma Rangel College of Pharmacy, Texas A&M University, College Station, TX 77843-0000, USA.ORCID 0000-0002-2553-3159
Maria Teresa HerdeiroDepartment of Medical Sciences, iBiMED-Institute of Biomedicine, Universidade de Aveiro, 3810-193 Aveiro, Portugal.ORCID 0000-0002-0500-4049

Funding

Operational Programme from the budget of the Central Region of Portugal, within the European Social Fund (ESF) component. CENTRO-04-3559-FSE-000162
6 · The paper itself

Abstract

Since the authorization of the first COVID-19 vaccines in December 2020, multiple studies using real-world data (RWD) have been published to assess their effectiveness/safety profile. This systematic review aimed to characterize the methods and outcomes of studies using RWD for assessment of COVID-19 vaccines, four months after vaccine approval. MEDLINE and EMBASE were searched to identify published studies until 6 May 2021. Two independent researchers selected relevant publications and extracted data from included studies. The risk of bias was assessed using New-Castle Ottawa tools. After screening 1086 studies, 15 were included. Out of the 15 studies, 12 (80%) followed a cohort design, 8 (53%) were based on USA data, 7 (47%) assessed health care professionals, and 14 articles (93%) assessed the BNT162b2 vaccine. Data sources included institutional databases, electronic health records, and patient-generated data. The primary endpoint mainly described was SARS-CoV-2-infection. Hospitalization and mortality were assessed in 2 studies. For the comparability domain, six studies (40%) had a high risk of bias. A few months after the beginning of COVID-19 vaccination, Real-world Evidence (RWE) provided timely safety surveillance and comparative effectiveness with findings that showed similar findings to Randomized control trial (RCT). Most of the initiatives assessed BNT162b2 and were conducted in the USA and used healthcare workers' data.

Indexed as

COVID-19effectivenessmethodsreal-world datasafety

Identifiers

PMID36366404
PMCPMC9697784

What OpenQuestion holds

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LicenceCC BY
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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.