Evidence map›Paper›PMID 25762713›Full record

ReviewNeurology2015

Ethics of genetic and biomarker test disclosures in neurodegenerative disease prevention trials.

Scott Y H Kim, Jason Karlawish, Benjamin E Berkman

Open access · bronzeAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Neurology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 2 pooled it
10.1field-weighted citation impact, top 2% 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

43 citing papers in PubMed, 2 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. The roles of biomarkers in Alzheimer's disease clinical trials.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  4. Review
  5. Review
  6. Observational
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Designing the First Trials for Parkinson's Prevention.Journal of Parkinson's disease · 2024
    Review
  15. Review
  16. Biomarker disclosure protocols in prodromal Alzheimer's disease clinical trials.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2023
    Review
  17. Article
  18. Article
  19. Testing the amyloid cascade hypothesis: Prevention trials in autosomal dominant Alzheimer disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2022
    Article
  20. 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

3 authors at 1 institution in 1 country.

Scott Y H KimFrom the Department of Bioethics, Clinical Center (S.Y.H.K., B.E.B.), National Institutes of Health, Bethesda, MD; and the Departments of Medicine and Medical Ethics and Health Policy (J.K.), University of Pennsylvania, Perelman School of Medicine, Philadelphia. scott.kim@nih.gov.
Jason KarlawishFrom the Department of Bioethics, Clinical Center (S.Y.H.K., B.E.B.), National Institutes of Health, Bethesda, MD; and the Departments of Medicine and Medical Ethics and Health Policy (J.K.), University of Pennsylvania, Perelman School of Medicine, Philadelphia.
Benjamin E BerkmanFrom the Department of Bioethics, Clinical Center (S.Y.H.K., B.E.B.), National Institutes of Health, Bethesda, MD; and the Departments of Medicine and Medical Ethics and Health Policy (J.K.), University of Pennsylvania, Perelman School of Medicine, Philadelphia.
National Institutes of Health Clinical Center · US

Funding

UPenn ADCC Biomarker CoreP30AG010124 · NIA · UNIVERSITY OF PENNSYLVANIA · PI XIE, SHARON XIANGWEN · 1991 to 2020
$35.1M
NIA NIH HHS P30 AG010124NIA NIH HHS P30-AG10124
6 · The paper itself

Abstract

objectivePrevention trials for neurodegenerative diseases use genetic or other risk marker tests to select participants but there is concern that this could involve coercive disclosure of unwanted information. This has led some trials to use blinded enrollment (participants are tested but not told of their risk marker status). We examined the ethics of blinded vs transparent enrollment using well-established criteria for assessing the ethics of clinical research.

methodsNormative analysis applying 4 key ethical criteria-favorable risk-benefit ratio, informed consent, fair subject selection, and scientific validity-to blinded vs transparent enrollment, using current evidence and state of Alzheimer disease (AD) and other prevention trials.

resultsCurrent evidence on the psychosocial impact of risk marker disclosure and considerations of scientific benefit do not support an obligation to use blinded enrollment in prevention trials. Nor does transparent enrollment coerce or involve undue influence of potential participants. Transparent enrollment does not unfairly exploit vulnerable participants or limit generalizability of scientific findings of prevention trials. However, if the preferences of a community of potential participants would affect the rigor or feasibility of a prevention trial using transparent enrollment, then investigators are required by considerations of scientific validity to use blinded enrollment.

conclusionsConsiderations of risks and benefits, informed consent, and fair subject selection do not require the use of blinded enrollment for AD prevention trials. Blinded enrollment in AD prevention trials may sometimes be necessary because of the need for scientific validity, not because it prevents coercion or undue influence.

Indexed as

BiomarkersAlzheimer DiseaseClinical Trials as TopicHumansInformed ConsentPatient SelectionTruth DisclosureBiomarkers

Identifiers

PMID25762713
PMCPMC4395889
OpenAlexW2088503700

What OpenQuestion holds

Textmetadata
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.