Evidence map›Paper›PMID 27195806›Full record

ArticlePloS one2016

How Health Professionals Conceptualize and Represent Placebo Treatment in Clinical Trials and How Their Patients Understand It: Impact on Validity of Informed Consent.

Pascal-Henri Keller, Olivier Grondin, François Tison, Francois Gonon

Abstract read
In one paragraph

Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Perceptions and Attitudes of Cancer Patients and Caregivers Towards Enrollment in Clinical Trials in Lebanon.Journal of cancer education : the official journal of the American Association for Cancer Education · 2019
    Article
  8. Putting placebos to the test.PLoS biology · 2017
    Review
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

4 authors.

Pascal-Henri KellerDepartment of Psychology, University of Poitiers, 86000, Poitiers, France.
Olivier GrondinDepartment of Psychology, University of Bordeaux, 33076 Bordeaux, France.
François TisonInstitute of Neurodegenerative Diseases, University of Bordeaux, 33076 Bordeaux, France.
Francois GononInstitute of Neurodegenerative Diseases, University of Bordeaux, 33076 Bordeaux, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextPrevious studies suggested that many patients, who have given their informed consent to participate in randomized controlled trials (RCT), have somewhat limited understanding of what a placebo treatment is. We hypothesized that the relationship between patients and their health professionals plays a central role in this understanding.

methodsWe interviewed 12 patients included in RCTs (nine suffering from Parkinson's disease and three from Huntington's disease) and 18 health professionals involved with RCTs (eight principal investigators, four associated physicians and six clinical research associates). Semi-structured interviews were conducted after the RCTs had ended but before the treatment allocation was revealed.

resultsOnly two patients clearly understood the aim of placebo-controlled RCTs. Only one principal investigator said she asks all her patients whether they agree to participate in RCTs. The seven others said they only ask patients who seem more likely to be compliant. Their selection criteria included docility and personality traits associated in other studies with enhanced placebo responses. According to 13 of the 18 health professionals, their relationship with patients may influence the amplitude of the placebo response. All but one clinical research associates added that the placebo response could result from a "maternal" type of care. All principal investigators said they have a strong influence on their patient's decision to participate. Finally, when interviewees were asked to narrate a memory of a medically unexplained healing, in eight of 11 physicians' narratives the beneficiary was a child while in 10 of 12 patients' narratives it was an adult.

conclusionOur observations suggest that the interrelationship between health professionals and patients involved in RCTs could be compared to that between parents and children. Therefore, adherence to formal rules regarding informed consent does not ensure a balanced relationship between patients and health professionals.

Indexed as

Physician-Patient RelationsPlacebosHealth Knowledge, Attitudes, PracticeHealth PersonnelHumansHuntington DiseaseInformed ConsentParkinson DiseasePatientsRandomized Controlled Trials as TopicPlacebos

Identifiers

PMID27195806
PMCPMC4873029

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.