Evidence map›Paper›PMID 36203759›Full record

ArticleFrontiers in medicine2022

Patients' knowledge about their involvement in clinical trials. A non-randomized controlled trial.

Pablo Juan-Salvadores, Marcela Sánchez Michel Gómez, Víctor Alfonso Jiménez Díaz, Cristina Martínez Reglero, Andrés Iñiguez Romo

Abstract read
In one paragraph

Article in Frontiers in medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. 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

5 authors.

Pablo Juan-SalvadoresCardiovascular Research Unit, Cardiology Department, Hospital Álvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.
Marcela Sánchez Michel GómezCardiovascular Research Unit, Cardiology Department, Hospital Álvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.
Víctor Alfonso Jiménez DíazCardiovascular Research Unit, Cardiology Department, Hospital Álvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.
Cristina Martínez RegleroMethodology and Statistics Unit, Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain.
Andrés Iñiguez RomoCardiovascular Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Nowadays, good clinical practice should be established in human research. Patient's rights and autonomy must be respected above the interest of the researcher, making mandatory to raise patient's awareness on the implications of participating in a clinical study. Contrary to popular belief, this is not always the case. This means that, after signing the informed consent form, some patients have difficulties understanding their responsibilities as participants. Materials and methods: This study is a prospective, multicenter, non-randomized controlled trial comparative survey conducted on patients enrolled in a clinical trial to evaluate and improve their understanding after an educational intervention was applied to the research staff. Results: Females were underrepresented in the clinical trials performed in this study, 21.5%. Most of the participants had a low educational level (74.4%). Around 5 and 10% of the research participants were not aware they were part of a clinical study, and more 24% just trusted in the medical decision to be enrolled. After the interventional education, the following items: "given time and resolution of the patient doubts" ( Conclusion: The research participants understanding of their involvement in clinical trials is limited. An educational intervention on the research team can improve the process of empowerment and transit of information.

Indexed as

bioethicsclinical trialscommunication in researcheducational researchevaluation researchinformed consenttrial participants

Identifiers

PMID36203759
PMCPMC9531127

What OpenQuestion holds

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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.