Evidence map›Paper›PMID 24025622›Full record

ArticleBMC medical ethics2013

Taking part in a pharmacogenetic clinical trial: assessment of trial participants understanding of information disclosed during the informed consent process.

Diana Rose, Jasna Russo, Til Wykes

Abstract read
In one paragraph

Article in BMC medical ethics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

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

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

  1. Pooled it
  2. Article
  3. Review
  4. Abandoning personalization to get to precision in the pharmacotherapy of depression.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2016
    Article
  5. Review
  6. Review
  7. Article
  8. Pharmacogenetic information for patients on drug labels.Pharmacogenomics and personalized medicine · 2014
    Article
  9. 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.

Diana RoseInstitute of Psychiatry, King's College London, de Crespigny Park, London SE5 8AF, UK. diana.rose@kcl.ac.uk.
Jasna Russo
Til Wykes

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study is the first to examine the understandings that participants have of the consent process in a pharmacogenetic trial of anti-depressant medication.

methodsThis was a qualitative cross sectional study. There were 76 participants residing in London, Mannheim, Arhuus and Poznan.

resultsOnly one quarter of participants (none in Poznan) could articulate the concept of pharmacogenetics. Heritability and testing medication were also given as the purpose of the trial. Most participants had not appreciated harms that could derive from the trial. Even when shown the consent sheet, participants were confused about DNA profiling. There was evidence that participants appreciated weekly contact with researchers. Most said they would participate in a trial again but would like choice over the intervention they were assigned to.

conclusionParticipants in this study showed a poor level of informed consent. Although this is not the first time this argument has been made, it is in the case of a pharmacogenetic trial. Further work should investigate the associations between extraneous factors such as information and social support on beneficial or untoward outcomes of antidepressant treatment.

Indexed as

ComprehensionInformed ConsentPharmacogeneticsResearcher-Subject RelationsResearch SubjectsTruth DisclosureAdultAgedClinical Trials as TopicCross-Sectional StudiesDNA FingerprintingEducational StatusFemaleGermanyHumansLondon

Identifiers

PMID24025622
PMCPMC3847084

What OpenQuestion holds

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LicenceCC BY
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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.