Evidence map›Paper›PMID 33419457›Full record

ArticleAlzheimer's research & therapy2021

Recruitment and retention of participant and study partner dyads in two multinational Alzheimer's disease registration trials.

Olivia M Bernstein, Joshua D Grill, Daniel L Gillen

Open access · goldAbstract read
In one paragraph

Article in Alzheimer's research & therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 8% of its field
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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

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  9. The Role ofJournal of transcultural nursing : official journal of the Transcultural Nursing Society · 2023
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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

3 authors at 1 institution in 1 country.

Olivia M BernsteinDepartment of Statistics, University of California, Irvine, Bren Hall 2019, Irvine, CA, 92697-1250, USA. obernste@uci.edu.ORCID 0000-0003-3345-4263
Joshua D GrillInstitute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, CA, USA.
Daniel L GillenDepartment of Statistics, University of California, Irvine, Bren Hall 2019, Irvine, CA, 92697-1250, USA.
University of California, Irvine · US

Funding

TRIAL OF VALPROATE TO ATTENUATE THE PROGRESSION OF ADU01AG010483 · NIA · UNIVERSITY OF ROCHESTER · PI AISEN, PAUL S. · 1991 to 2012
$116.2M
RECRUITMENT COREU19AG010483 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FELDMAN, HOWARD · 2013 to 2020
$80.6M
University of California Health Participation in the National COVID Cohort Collaborative (N3C)UL1TR001414 · NCATS · UNIVERSITY OF CALIFORNIA-IRVINE · PI COOPER, DAN M, VILAIN, ERIC J. · 2015 to 2023
$35.1M
The Alzheimer's Disease Research Center at the University of California, IrvineP30AG066519 · NIA · UNIVERSITY OF CALIFORNIA-IRVINE · PI Elizabeth Head · 2020 to 2026
$27.9M
Neuroimaging biomarkers for cognitive decline in elderly with amyloid pathologyR01AG053555 · NIA · UNIVERSITY OF CALIFORNIA-IRVINE · PI Michael A Yassa · 2017 to 2026
$17.0M
Effects of Alzheimers Disease Clinical Trial Study Partners-Diversity SupplementRF1AG059407 · NIA · UNIVERSITY OF CALIFORNIA-IRVINE · PI GILLEN, DANIEL L, GRILL, JOSHUA · 2018 to 2019
$1.6M
NCATS NIH HHS UL1 TR001414NIA NIH HHS 1RF1AG059407NIA NIH HHS AG066519NIA NIH HHS P30 AG066519NIA NIH HHS R01 AG053555NIA NIH HHS RF1 AG059407NIA NIH HHS U01 AG010483NIA NIH HHS U19 AG010483
6 · The paper itself

Abstract

backgroundEarly study exit is detrimental to statistical power and increases the risk for bias in Alzheimer's disease clinical trials. Previous analyses in early phase academic trials demonstrated associations between rates of trial incompletion and participants' study partner type, with participants enrolling with non-spouse study partners being at greater risk.

methodsWe conducted secondary analyses of two multinational phase III trials of semagacestat, an oral gamma secretase inhibitor, for mild-to-moderate AD dementia. Cox's proportional hazards regression model was used to estimate the relationship between study partner type and the risk of early exit from the trial after adjustment for a priori identified potential confounding factors. Additionally, we used a random forest model to identify top predictors of dropout.

resultsAmong participants with spousal, adult child, and other study partners, respectively, 35%, 38%, and 36% dropped out or died prior to protocol-defined study completion, respectively. In unadjusted models, the risk of trial incompletion differed by study partner type (unadjusted p value = 0.027 for test of differences by partner type), but in models adjusting for potential confounding factors, the differences were not statistically significant (p value = 0.928). In exploratory modeling, participant age was identified as the primary characteristic to explain the relationship between study partner type and the risk of failing to complete the trial. Participant age was also the strongest predictor of trial incompletion in the random forest model.

conclusionsAfter adjustment for age, no differences in the risk of incompletion were observed when comparing participants with different study partner types in these trials. Differences between our findings and the findings of previous studies may be explained by differences in trial phase, size, geographic regions, or the composition of academic and non-academic sites.

Indexed as

Alzheimer DiseaseAdultAdult ChildrenHumansResearch DesignAlzheimer’s diseaseClinical trialsRecruitmentRetentionStudy partner

Identifiers

PMID33419457
PMCPMC7791680
OpenAlexW3112823611

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.