Evidence map›Paper›PMID 26777978›Full record

ArticleAtencion primaria2016

[Informed consent process in clinical trials: Insights of researchers, patients and general practitioners].

Nuria Giménez, David Pedrazas, Susana Redondo, Salvador Quintana

Open access · goldAbstract read
In one paragraph

Article in Atencion primaria, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.5field-weighted citation impact, top 15% 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

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Review
  3. [Ortographic standarization. Answer].Atencion primaria · 2018
    Article
  4. [Ortographic standarization].Atencion primaria · 2017
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 1 country.

Nuria GiménezUnidad de Investigación, Fundación para la Investigación Mútua Terrassa, Universitat de Barcelona, Barcelona, España; Comité Ético de Investigación Clínica, Hospital Universitari Mútua Terrassa, Universitat de Barcelona, Barcelona, España; Laboratorio de Toxicología, Universitat Autònoma de Barcelona, España. Electronic address: nuria.gimenez@uab.cat.
David PedrazasUnidad de Investigación, Fundación para la Investigación Mútua Terrassa, Universitat de Barcelona, Barcelona, España; ABS Abrera, Direcció d'Atenció Primària Costa de Ponent, Institut Català de la Salut, Barcelona, España; Departamento de Medicina, Universitat Autònoma de Barcelona, Barcelona, España.
Susana RedondoComité Ético de Investigación Clínica, Hospital Universitari Mútua Terrassa, Universitat de Barcelona, Barcelona, España; Servicio de Farmacia, Hospital Universitari Mútua Terrassa, Fundación para la Investigación Mútua Terrassa, Universitat de Barcelona, Barcelona, España.
Salvador QuintanaComité Ético de Investigación Clínica, Hospital Universitari Mútua Terrassa, Universitat de Barcelona, Barcelona, España.
Mútua Terrassa · ESInstitut Català de la Salut · ESUniversitat de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAdequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP.

designA cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports.

settingGPs, researchers and patients involved in clinical trials.

participantsIncluded, 504 GPs, 108 researchers, and 71 patients.

resultsConsulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection.

conclusionsGPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation.

Indexed as

Clinical Trials as TopicGeneral PractitionersInformed ConsentComprehensionCross-Sectional StudiesHumansResearch PersonnelAtención PrimariaBioethicsBioéticaClinical trialsConsentimiento informadoEnsayos clínicosInformed consentPercepcionesPerceptionsPersonal autonomyPrimary health carePrincipio de autonomía

Identifiers

PMID26777978
PMCPMC6877861
OpenAlexW2233047883

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.