Evidence map›Paper›PMID 40377247›Full record

ArticleStatistics in medicine2025

Accounting for Inconsistent Use of Covariate Adjustment in Group Sequential Trials.

Marlena S Bannick, Sonya L Heltshe, Noah Simon

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Statistics in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

3 authors.

Marlena S BannickDepartment of Biostatistics, University of Washington, Seattle, Washington, USA.ORCID https://orcid.org/0000-0001-6279-5978
Sonya L HeltsheDepartment of Pediatrics, University of Washington, Seattle, Washington, USA.
Noah SimonDepartment of Biostatistics, University of Washington, Seattle, Washington, USA.ORCID https://orcid.org/0000-0002-8985-2474

Funding

Translational Research Center to Expedite Novel Therapies in Cystic FibrosisP30DK089507 · NIDDK · SEATTLE CHILDREN'S HOSPITAL · PI Christopher Hooper Goss · 2010 to 2026
$21.4M
Cystic Fibrosis Foundation HELTSHE18Y3Cystic Fibrosis Foundation RAMSEY03Y0NIDDK NIH HHS P30 DK089507
6 · The paper itself

Abstract

Group sequential designs in clinical trials allow for interim efficacy and futility monitoring. Adjustment for baseline covariates can increase power and precision of estimated effects. However, inconsistently applying covariate adjustment throughout the stages of a group sequential trial can result in inflation of type I error, biased point estimates, and anticonservative confidence intervals. We propose methods for performing correct interim monitoring, estimation, and inference in this setting that avoid these issues. We focus on two-arm trials with simple, balanced randomization and continuous outcomes. We study the performance of our boundary, estimation, and inference adjustments in simulation studies. We end with recommendations about the application of covariate adjustment in group sequential designs.

Indexed as

Clinical Trials as TopicRandomized Controlled Trials as TopicComputer SimulationConfidence IntervalsData Interpretation, StatisticalHumansModels, StatisticalResearch Designclinical trialscovariate adjustmentgroup sequential trials

Identifiers

PMID40377247
PMCPMC13090020

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.