Evidence map›Paper›PMID 28671136›Full record

ArticleJournal of Huntington's disease2017

Analysis of Participant Withdrawal in Huntington Disease Clinical Trials.

Haruhiko Banno, Kelly L Andrzejewski, Michael P McDermott, Alyssa Murphy, Madhurima Majumder, Elisabeth A de Blieck, Peggy Auinger, Merit E Cudkowicz, Nazem Atassi

Erratum issuedAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of Huntington's disease, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact, top 93% 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

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 1 citations in OpenAlex.

  1. Pooled it
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Haruhiko BannoNeurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Kelly L AndrzejewskiDepartment of Neurology, University of Rochester, Rochester, NY, USA.
Michael P McDermottDepartment of Biostatistics and Computational Biology, University of Rochester, Rochester, NY, USA.
Alyssa MurphyNeurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Madhurima MajumderDepartment of Biostatistics and Computational Biology, University of Rochester, Rochester, NY, USA.
Elisabeth A de BlieckDepartment of Neurology, Center for Human Experimental Therapeutics, University of Rochester, Rochester, NY, USA.
Peggy AuingerDepartment of Neurology, Center for Human Experimental Therapeutics, University of Rochester, Rochester, NY, USA.
Merit E CudkowiczNeurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Nazem AtassiNeurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
University of Rochester · USClinical Research Institute · USMassachusetts General Hospital · US

Funding

Coenzyme Q10 in Huntingtons DiseaseU01NS052592 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI CUDKOWICZ, MERIT E · 2008 to 2013
$7.3M
Coenzyme Q10 in Huntington's DiseaseR01NS052592 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI CUDKOWICZ, MERIT E · 2005 to 2007
$2.7M
NINDS NIH HHS R01 NS052592NINDS NIH HHS U01 NS052592
6 · The paper itself

Abstract

backgroundExcellent retention in Huntington disease (HD) clinical trials is essential for testing new therapies. The stage of disease, cognitive status, and availability of a care partner may influence retention in HD clinical trials.

objectiveWe sought to analyze reasons for early withdrawal in three HD clinical trials, and evaluated if either baseline characteristics or follow-up assessments were associated with time to withdrawal.

methodsAnalyses of participant withdrawal were performed for three randomized, double-blind, placebo-controlled trials including the CARE-HD (coenzyme Q10 and remacemide in HD, n = 347), DOMINO (pilot study of minocycline in HD, n = 114), and 2CARE (coenzyme Q10 in HD, n = 609) trials. Reasons for withdrawal were obtained by review of textual data in the study databases. Participant demographic and clinical characteristics were analyzed as potential predictors of time to withdrawal using Cox-proportional hazards models.

resultsEstimated probabilities of withdrawal at 12 months were 2.9% for CARE-HD, 10.5% for DOMINO, and 5.9% for 2CARE. The top reasons for withdrawal (202 in total), expressed as mean percentage across the three trials, were loss to follow-up (23.2%), death (15.9%), and loss of interest/desire to participate (15.2%). Baseline and time-dependent variables associated with time to withdrawal were mainly motor, behavioral, and functional scores. Age, gender, ethnicity, and educational level were not associated with time to withdrawal in any of the three studies.

conclusionsThe estimated withdrawal probability at 12 months ranged from 2.9% to 10.5% in the three HD trials considered here. A possible strategy to improve retention of participants in future HD clinical trials is to enroll individuals with higher baseline functional and behavioral status.

Indexed as

Patient DropoutsRandomized Controlled Trials as TopicAcetamidesFemaleHumansHuntington DiseaseKaplan-Meier EstimateMaleMiddle AgedMinocyclineNeuroprotective AgentsNeuropsychological TestsProportional Hazards ModelsUbiquinoneAcetamidescoenzyme Q10MinocyclineNeuroprotective AgentsremacemideUbiquinoneclinical trialHuntington diseasepatient selectionretention

Identifiers

PMID28671136
PMCPMC5565148
OpenAlexW2729651477

What OpenQuestion holds

Textmetadata
LicenceTDM
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.