Evidence map›Paper›PMID 31517032›Full record

ArticleAlzheimer's & dementia (New York, N. Y.)2019

Two-period linear mixed effects models to analyze clinical trials with run-in data when the primary outcome is continuous: Applications to Alzheimer's disease.

Guoqiao Wang, Andrew J Aschenbrenner, Yan Li, Eric McDade, Lei Liu, Tammie L S Benzinger, Randall J Bateman, John C Morris, Jason J Hassenstab, Chengjie Xiong

Abstract read
In one paragraph

Article in Alzheimer's & dementia (New York, N. Y.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
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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.

Guoqiao WangDivision of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.
Andrew J AschenbrennerDepartment of Neurology, Washington University School of Medicine, St. Louis, MO, USA.
Yan LiDepartment of Neurology, Washington University School of Medicine, St. Louis, MO, USA.
Eric McDadeDepartment of Neurology, Washington University School of Medicine, St. Louis, MO, USA.
Lei LiuDivision of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.
Tammie L S BenzingerDepartment of Radiology, Washington University School of Medicine, St. Louis, MO, USA.
Randall J BatemanDepartment of Neurology, Washington University School of Medicine, St. Louis, MO, USA.
John C MorrisDepartment of Neurology, Washington University School of Medicine, St. Louis, MO, USA.
Jason J HassenstabDepartment of Neurology, Washington University School of Medicine, St. Louis, MO, USA.
Chengjie XiongDivision of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.

Funding

DIAN-TU Next Generation Prevention Trial - Data Request Management SupplementR01AG053267 · NIA · WASHINGTON UNIVERSITY · PI BATEMAN, RANDALL J · 2017 to 2023
$34.9M
DOMINANTLY INHERITED ALZHEIMER NETWORK TRIAL: AN OPPORTUNITY TO PREVENT DEMENTIAU01AG042791 · NIA · WASHINGTON UNIVERSITY · PI BATEMAN, RANDALL J · 2013 to 2018
$8.9M
DIAN-TU: Next Generation Prevention TrialR56AG053267 · NIA · WASHINGTON UNIVERSITY · PI BATEMAN, RANDALL J · 2016 to 2016
$3.2M
NIA NIH HHS R01 AG053267NIA NIH HHS R56 AG053267NIA NIH HHS U01 AG042791
6 · The paper itself

Abstract

introductionStudy outcomes can be measured repeatedly based on the clinical trial protocol before randomization during what is known as the "run-in" period. However, it has not been established how best to incorporate run-in data into the primary analysis of the trial.

methodsWe proposed two-period (run-in period and randomization period) linear mixed effects models to simultaneously model the run-in data and the postrandomization data.

resultsCompared with the traditional models, the two-period linear mixed effects models can increase the power up to 15% and yield similar power for both unequal randomization and equal randomization. DISCUSSION: Given that analysis of run-in data using the two-period linear mixed effects models allows more participants (unequal randomization) to be on the active treatment with similar power to that of the equal-randomization trials, it may reduce the dropout by assigning more participants to the active treatment and thus improve the efficiency of AD clinical trials.

Indexed as

Alzheimer's diseaseLinear mixed effects modelRun-in clinical trialsTwo-period modelsUnequal randomization

Identifiers

PMID31517032
PMCPMC6732759

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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.