Evidence map›Paper›PMID 36798386›Full record

ArticlemedRxiv : the preprint server for health sciences2023

Incorporating data from multiple endpoints in the analysis of clinical trials: example from RSV vaccines.

Ottavia Prunas, Joukje E Willemsen, Louis Bont, Virginia E Pitzer, Joshua L Warren, Daniel M Weinberger

Abstract readPreprint
In one paragraph

Article in medRxiv : the preprint server for health sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Ottavia PrunasDepartment of Epidemiology of Microbial Diseases and Public Health Modeling Unit, Yale School of Public Health, Yale University; New Haven, CT USA.
Joukje E WillemsenCentre for Translational Immunology, University Medical Center Utrecht; Utrecht, The Netherlands.
Louis BontDivision of Infectious Diseases, Department of Pediatrics, University Medical Center Utrecht, Utrecht, The Netherlands.
Virginia E PitzerDepartment of Epidemiology of Microbial Diseases and Public Health Modeling Unit, Yale School of Public Health, Yale University; New Haven, CT USA.
Joshua L WarrenDepartment of Epidemiology of Microbial Diseases and Public Health Modeling Unit, Yale School of Public Health, Yale University; New Haven, CT USA.
Daniel M WeinbergerDepartment of Epidemiology of Microbial Diseases and Public Health Modeling Unit, Yale School of Public Health, Yale University; New Haven, CT USA.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Predicting and monitoring variations in the effects of vaccines against RSVR01AI137093 · NIAID · YALE UNIVERSITY · PI Virginia E Pitzer, Daniel Martin Weinberger · 2018 to 2026
$3.4M
NCATS NIH HHS UL1 TR001863NIAID NIH HHS R01 AI137093
6 · The paper itself

Abstract

Background: To achieve licensure, interventions typically must demonstrate efficacy against a primary outcome in a randomized clinical trial. However, selecting a single primary outcome Method: We simulated data from three different populations in which the efficacy of the intervention and the correlation among outcomes varied. We developed a novel permutation-based approach that represents a weighted average of individual outcome test statistics ( Results: When the vaccine efficacy against different outcomes was similar, Conclusions: Analyzing multiple endpoints using a weighted permutation method can increase power while controlling the type I error rate in settings where outcomes share similar characteristics, like RSV outcomes. We developed an R package,

Identifiers

PMID36798386
PMCPMC9934779

What OpenQuestion holds

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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.