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

Lobato L, Bethony JM, Pereira FB, Grahek SL, Diemert D, Gazzinelli MF - BMC Public Health (2014)

Bottom Line: Answers regarding their decision to participate in the study were compared, by gender, using chi-square and Mann Whitney tests.Females were also significantly more likely to report a decision influenced by general altruistic considerations (OR 8.45, p < 0.005).Study results indicate that there is a strong difference between male and female participants regarding social influences on the decision to participate in clinical research.

View Article: PubMed Central - PubMed

Affiliation: School of Nursing, Federal University of Minas Gerais, 190 Av, Alfredo Balena, Room 508, Belo Horizonte, MG 30130-100, Brazil. dalukxz@gmail.com.

ABSTRACT

Background: In 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.

Methods: This 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.

Results: A 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.

Conclusion: Study 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.

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General Influences represents the sum of influences that the participants of indicated when choosing to participate in the clinical trial (Eight types of influence evaluated by the study). The figure shows a comparison of the general Influence according to the sex of trial participants.
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Fig2: General Influences represents the sum of influences that the participants of indicated when choosing to participate in the clinical trial (Eight types of influence evaluated by the study). The figure shows a comparison of the general Influence according to the sex of trial participants.

Mentions: In the General Influence Index, female participants scored an average of 6.2 (SD: 1.76) with a median of 7.0, and male participants an average of 5.0 (SD: 1.97), median of 5.0 (Z = −3.61. U =1449.5; p =0.02). Both gender groups included participants with minimum scores of 0 (no influence) and maximum scores 8 (influenced by all factors evaluated). Figure 2 shows a boxplot of the General Influence Index, by gender.Table 2


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

Lobato L, Bethony JM, Pereira FB, Grahek SL, Diemert D, Gazzinelli MF - BMC Public Health (2014)

General Influences represents the sum of influences that the participants of indicated when choosing to participate in the clinical trial (Eight types of influence evaluated by the study). The figure shows a comparison of the general Influence according to the sex of trial participants.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4232621&req=5

Fig2: General Influences represents the sum of influences that the participants of indicated when choosing to participate in the clinical trial (Eight types of influence evaluated by the study). The figure shows a comparison of the general Influence according to the sex of trial participants.
Mentions: In the General Influence Index, female participants scored an average of 6.2 (SD: 1.76) with a median of 7.0, and male participants an average of 5.0 (SD: 1.97), median of 5.0 (Z = −3.61. U =1449.5; p =0.02). Both gender groups included participants with minimum scores of 0 (no influence) and maximum scores 8 (influenced by all factors evaluated). Figure 2 shows a boxplot of the General Influence Index, by gender.Table 2

Bottom Line: Answers regarding their decision to participate in the study were compared, by gender, using chi-square and Mann Whitney tests.Females were also significantly more likely to report a decision influenced by general altruistic considerations (OR 8.45, p < 0.005).Study results indicate that there is a strong difference between male and female participants regarding social influences on the decision to participate in clinical research.

View Article: PubMed Central - PubMed

Affiliation: School of Nursing, Federal University of Minas Gerais, 190 Av, Alfredo Balena, Room 508, Belo Horizonte, MG 30130-100, Brazil. dalukxz@gmail.com.

ABSTRACT

Background: In 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.

Methods: This 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.

Results: A 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.

Conclusion: Study 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.

Show MeSH