ArticleVaccine2021
Methodologic approaches in studies using real-world data (RWD) to measure pediatric safety and effectiveness of vaccines administered to pregnant women: A scoping review.
Article in Vaccine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
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.
Who cites it
1 citing paper in PubMed, 5 citations in OpenAlex.
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
Abstract
objectiveThis scoping review mapped studies using real-world data (RWD) to measure pediatric safety and effectiveness of vaccines administered to pregnant women.
introductionIn the US, two vaccines are recommended for all pregnant women to prevent illness in the infant: inactivated influenza vaccine (recommended since 2004), and the combined tetanus-diphtheria-acellular pertussis (Tdap) vaccine (recommended since 2013). This scoping review maps the studies conducted to date that address questions about pediatric safety and effectiveness of vaccines administered during pregnancy and provides a knowledge base for evaluating the use of RWD to study this issue.
methodsThe scoping review was conducted following a published protocol. Methods included an electronic search of PubMed and Embase, screening of titles and abstracts by two reviewers, and double extraction of data for summary and synthesis. Studies that reported on pregnant women and the effectiveness or safety outcomes in their infants were included.
resultsForty-eight studies met the inclusion criteria of the scoping review protocol using RWD to assess safety or effectiveness of influenza or pertussis vaccinations administered to pregnant women with respect to pregnancy, infant or child outcomes. Detailed information about data sources, linkage of maternal and infant data, and operational definitions for gestational age were largely absent from the majority of studies raising concerns about reproducibility and validity of study findings.
conclusionsA body of literature is available from which to plan and design future studies of vaccination in pregnant women using RWD. This is of intense importance as new vaccines, such as those for COVID-19, become available to the general population via approval or authorization without inclusion of pregnant women in the clinical trials.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.