Evidence map›Paper›PMID 24260484›Full record

ArticlePloS one2013

Could the decision of trial participation precede the informed consent process? Evidence from Burkina Faso.

Lea Paré Toe, Raffaella M Ravinetto, Susan Dierickx, Charlotte Gryseels, Halidou Tinto, Noèl Rouamba, Ibrahim Diallo, Yacouba Cissao, Korotimi Bayala, Susanna Hausmann and 3 more

Abstract read
In one paragraph

Article in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 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

25 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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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

13 authors.

Lea Paré ToeInstitut de Recherche en Sciences de la Santé (IRSS)/Centre Muraz, Bobo-Dioulasso, Burkina Faso.
Raffaella M Ravinetto
Susan Dierickx
Charlotte Gryseels
Halidou Tinto
Noèl Rouamba
Ibrahim Diallo
Yacouba Cissao
Korotimi Bayala
Susanna Hausmann
Joan Muela
Umberto D'Alessandro
Koen Peeters Grietens

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOver the last years, the number of clinical trials carried out in low-income countries with poor medical infrastructure and limited access to health care has increased. In these settings, the decision of participating in a clinical study may be influenced by factors related to participants' vulnerability that limit the efficacy of the informed consent.

methodsA mixed methods social science study, based on the triangulation of qualitative and quantitative data, was carried out in a socio-economically disadvantaged and semi-urban area of Bobo Dioulasso, Burkina Faso. The study aimed at assessing the relevance of the informed consent procedure on the decision-making process of the parents and/or guardians of potential participants in a pediatric malaria trial.

resultsFor most parents (70.4%), the decision of participating had already been taken before undergoing the informed consent process and was based on the information conveyed through the community. Access to free and good quality health care often inspired this decision. In addition, the parents' willingness to have their child included in the trial made them develop active strategies to achieve this purpose. DISCUSSION: In a context of socio-economic vulnerability and poor access to free health care, the process of informed consent does not always accomplish its goal of informing people and enabling them to make a free and informed decision. This information role is somehow anticipated by the community and trial participation becomes a strategic action to secure otherwise unavailable health resources leading community members to decide on participation even prior to the informed consent process.

Indexed as

AdolescentBurkina FasoChildChild, PreschoolClinical Trials as TopicDecision MakingFemaleHealth Knowledge, Attitudes, PracticeHumansInfantInformed ConsentMalariaMalePerceptionPovertyQualitative Research

Identifiers

PMID24260484
PMCPMC3829938

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.