Evidence map›Paper›PMID 25377601›Full record

ArticleBMC public health2014

Impact of gender on the decision to participate in a clinical trial: a cross-sectional study.

Lucas Lobato, Jeffrey Michael Bethony, Fernanda Bicalho Pereira, Shannon Lee Grahek, David Diemert, Maria Flávia Gazzinelli

Abstract readComparative Study
In one paragraph

Article in BMC public health, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing 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

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

  1. Pooled it
  2. A public and patient consultation process as an aid to design a person-centred randomized clinical trial.Health expectations : an international journal of public participation in health care and health policy · 2021
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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

6 authors.

Lucas LobatoSchool of Nursing, Federal University of Minas Gerais, 190 Av, Alfredo Balena, Room 508, Belo Horizonte, MG 30130-100, Brazil. dalukxz@gmail.com.
Jeffrey Michael Bethony
Fernanda Bicalho Pereira
Shannon Lee Grahek
David Diemert
Maria Flávia Gazzinelli

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn order for Informed Consent to be ethical and valid each clinical trial participant must be able to make a voluntary decision to participate, free from pressure or coercion. Nonetheless, many factors may influence the decision reached, and such influences may be different for male and female volunteers. Being aware of these differences may help researches develop better processes for obtaining consent that safeguard the right of autonomy for all participants. The goal of this study was to evaluate potential gender-based differences in the factors influencing clinical trial participation.

methodsThis cross-sectional study was conducted in the Northeast region of Minas Gerais, Brazil, in October 2011. A structured questionnaire was administered to 143 volunteers (48 male, 95 female) screened for participation in a clinical study of an investigational functional food with potential anthelminthic properties. Answers regarding their decision to participate in the study were compared, by gender, using chi-square and Mann Whitney tests. Odds ratios (OR) was used to measure association.

resultsA majority of subjects (58% of males, 59% of females) listed the desire to collaborate with the development of a product against parasitic worms as their main reason for participation. Females were significantly more likely to report a decision influenced by friends, family, or researchers (OR 3.14, 3.45, and 3.46 respectively, p < 0.005). Females were also significantly more likely to report a decision influenced by general altruistic considerations (OR 8.45, p < 0.005). There was no difference, by gender, in the report of decisions influenced by informational meetings, understanding of the disease, or the availability of medical treatments or exams. There was also no difference in knowledge of the rights of research participants.

conclusionStudy results indicate that there is a strong difference between male and female participants regarding social influences on the decision to participate in clinical research. Further research into the impact this may have on autonomy is warranted.

Indexed as

Clinical Trials as TopicDecision MakingInformed ConsentAdultBrazilCross-Sectional StudiesFemaleHealthy VolunteersHumansMaleMiddle AgedPatient ParticipationSex FactorsSocioeconomic FactorsSurveys and Questionnaires

Identifiers

PMID25377601
PMCPMC4232621

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.