Evidence map›Paper›PMID 29182458›Full record

Trial reportClinical gerontologist

Multimedia Aided Consent for Alzheimer's Disease Research.

Barton W Palmer, Alexandrea L Harmell, Laura B Dunn, Scott Y Kim, Luz L Pinto, Shahrokh Golshan, Dilip V Jeste

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase III
In one paragraph

Trial report in Clinical gerontologist. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00453544 (Enhancing Consent for Alzheimer's Research), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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.

NCT00453544 nacompletednot on this map

Enhancing Consent for Alzheimer's Research

TypeinterventionalSponsorUniversity of California, San DiegoRan2006 to 2012Enrolled252ConditionsAlzheimer DiseaseArmsEnhanced Consent Procedure, Routine Consent Procedure
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
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

7 authors.

Barton W Palmera Veterans Affairs San Diego Healthcare System , San Diego , California , USA.
Alexandrea L Harmellc Department of Psychiatry , University of California, San Diego , La Jolla , California , USA.
Laura B Dunng Department of Psychiatry and Behavioral Sciences , Stanford University , Stanford , California , USA.
Scott Y Kimh Department of Bioethics , National Institute of Health , Bethesda , Maryland , USA.
Luz L Pintob Veterans Medical Research Foundation , San Diego , California , USA.
Shahrokh Golshanb Veterans Medical Research Foundation , San Diego , California , USA.
Dilip V Jestec Department of Psychiatry , University of California, San Diego , La Jolla , California , USA.

Funding

FELLOWSHIP IN GERIATRIC MENTAL HEALTHT32MH019934 · NIMH · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Elizabeth W Twamley · 1994 to 2026
$9.5M
Enhancing Consent for Alzheimer ResearchR01AG028827 · NIA · VETERANS MEDICAL RESEARCH FDN/SAN DIEGO · PI PALMER, BARTON W. · 2006 to 2010
$1.4M
Decision-making capacity in clinical and research settingsZIACL010542 · CLC · CLINICAL CENTER · PI KIM, SCOTT · 2017 to 2025
$0k
Intramural NIH HHS Z99 CL999999NIA NIH HHS R01 AG028827NIMH NIH HHS T32 MH019934
6 · The paper itself

Abstract

objectivesOptimizing the research consent process simultaneously fosters respect for autonomy and protection of those with diminished capacity for autonomy. This study evaluated the effectiveness of an enhanced research consent procedure, employing multimedia disclosure and corrective feedback, in improving decisional capacity among 114 people with mild-to-moderate Alzheimer's disease (AD) and 134 non-psychiatric comparison (NC) subjects.

methodsParticipants were randomized to consent type (routine versus enhanced) and protocol type (lower versus higher risk). Outcomes included a 5-item questionnaire assessing immediate comprehension, MacArthur Competence Assessment Tool for Clinical Research assessing four components of decision-making capacity, and categorical decisional capacity (based on a cut-score established in reference to expert judgments for a subset of participants).

resultsThere was no significant effect of the enhanced consent procedure, relative to routine consent, on immediate comprehension or decisional capacity.

conclusionsMultimedia tools do not appear to be the solution to better consent for AD research. CLINICAL IMPLICATIONS: Given the ethical primacy of informed consent and issues of justice for impaired populations who might be harmed by an absence of research-based treatment advances, continued search for ways to more meaningfully engage people with AD in the consent or assent process is warranted.

Indexed as

AgedAged, 80 and overAlzheimer DiseaseAmyloidAntibodiesCase-Control StudiesCholinergic AgentsDrugs, InvestigationalFemaleHumansImmunotherapyInformed ConsentMaleMental CompetencyMultimediaRandom AllocationAmyloidAntibodiesCholinergic AgentsDrugs, InvestigationalAutonomycompetencedementiaethicsinformed consent

Identifiers

PMID29182458
PMCPMC6085078

What OpenQuestion holds

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Registered trials

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.