Lucas Lobato

Health Education through Analogies: Preparation of a Community for Clinical Trials of a Vaccine against Hookworm in an Endemic Area of Brazil

Background Obtaining informed consent for clinical trials is especially challenging when working in rural, resource-limited areas, where there are often high levels of illiteracy and lack of experience with clinical research. Such an area, a remote field site in the northeastern part of the state of Minas Gerais, Brazil, is currently being prepared for clinical trials of experimental hookworm vaccines. This study was conducted to assess whether special educational tools can be developed to increase the knowledge and comprehension of potential clinical trial participants and thereby enable them to make truly informed decisions to participate in such research. Methodology/Principal Findings An informational video was produced to explain the work of the research team and the first planned hookworm vaccine trial, using a pedagogical method based on analogies. Seventy-two adults living in a rural community of Minas Gerais were administered a structured questionnaire that assessed their knowledge of hookworm, of research and of the planned hookworm vaccine trial, as well as their attitudes and perceptions about the researchers and participation in future vaccine trials. The questionnaire was administered before being shown the educational video and two months after and the results compared. After viewing the video, significant improvements in knowledge related to hookworm infection and its health impact were observed: using a composite score combining related questions for which correct answers were assigned a value of 1 and incorrect answers a value of 0, participants had a mean score of 0.76 post-video compared to 0.68 pre-video (p = 0.0001). Similar improvements were seen in understanding the purpose of vaccination and the possible adverse effects of an experimental vaccine. Although 100% of participants expressed a positive opinion of the researchers even before viewing the film and over 90% said that they would participate in a hookworm vaccine trial, an increase in the number who expressed fear of being vaccinated with a novel vaccine was seen after viewing the video (51.4% post-video versus 29.2% pre-video). Increases were also seen in the proportion who thought that participation in a vaccine trial would be inconvenient or disrupt their daily activities. Conclusions/Significance Even in rural, resource-limited populations, educational tools can be specially designed that significantly improve understanding and therefore the likelihood of obtaining truly informed consent for participation in clinical research. The observed changes in the knowledge and perceptions of the research participants about hookworm infection and the experimental hookworm vaccine demonstrate that the video intervention was successful in increasing understanding and that the subjects acquired knowledge pertinent to the planned research.

Development of cognitive abilities of children infected with helminths through health education

INTRODUCTION The aim of this study was to evaluate the effect of health education in learning and cognitive development of children infected, previously treated in an endemic area for helminthiasis. METHODS It is a longitudinal, experimental, with random allocation of participants. The study included 87 children of both sexes enrolled in the school hall of Maranhão, State of Minas Gerais, Brazil, and divided into two groups: intervention and control. Initially the children were submitted to the parasitological fecal examination for infection diagnosis and, when positive, they were treated. For the data collection, a structured questionnaire and the psychological tests Raven, Wisc-III and DAP III were applied, before and after the educational intervention. For the group comparison, the Mann Whitney test was used, and established significance level of 5%. RESULTS It was found that previously infected children who received the educational intervention, children showed higher performance than the control group in strutured questionnaire (p<0.05). CONCLUSIONS It is acceptable to suppose the positive influence and the importance in the use of educational interventions in the cognitive recovery and learning of children previously treated with anthelmintics.

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

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.

Legibilidade dos termos de consentimento livre e esclarecido em ensaios clínico

The aim of this study is to analyze the readability of two Informed Consent Forms (ICF) used for the participation in a clinical trial and the correlation of the degree of difficulty with the education level of the participants. The two ICF were analyzed using the Flesch Reading Ease (FRE) and the Flesch-Kincaid (FLK) readability tests. Through analysis by the Flesch score the ICF for selection of volunteers and participation in a clinical trial had, respectively, a value of 61 and 56, while the FLK values were 6.59 and 8.4 respectively. The ICF for selection and participation in the clinical trial was inadequate for 49% and 72% of these participants. Those two ICF used for participation in clinical trials were not suitable for the education of the majority of its participants.El objetivo de este estudio es analizar la legibilidad de dos terminos de consentimiento libre y aclarado (TCLA) utilizados para participar en un ensayo clinico y correlacionar el grado de dificultad de los documentos con el nivel educativo de los participantes. Siendo un TCLA para la elegibilidad en el estudio y otro para la participacion.Los TCLA fueron analizados mediante utilizacion del indice de facilidad de lectura de Flesch Reading Ease (IFLF) Index y el Flesch-Kincaid (ILFK). A traves del analisis por el IFRE, los TCLA para la seleccion de los voluntarios y participacion en el ensayo clinico obtuvieron respectivamente, el valor de 61 y 56, mientras por el IFLK los valores fueron 6,59 y 8,4, respectivamente. El TCLA para la seleccion de voluntarios y para la participacion en el ensayo clinico fue insuficiente para el 49% y el 72% de esos participantes. Los dos TCLA utilizados para la participacion en los ensayos clinicos no eran adecuados para la escolaridad de la mayoria de sus participantes.

Conhecimento e voluntariedade para participação em pesquisas: um estudo descritivo com participantes de um ensaio clínico

O objetivo deste estudo e avaliar o conhecimento sobre as informacoes do Termo de Consentimento Livre e Esclarecido (TCLE) e a voluntariedade de participantes de um ensaio clinico. Trata-se de um estudo quantitativo, descritivo, transversal, realizado em novembro de 2011 com participantes de um ensaio clinico realizado em Americaninhas, no Nordeste de Minas Gerais, Brasil. Amostra por conveniencia, com 143 adultos de 18 a 45 anos, de ambos os sexos. Utilizou-se um questionario estruturado, aplicado uma semana apos a assinatura do TCLE. A maioria dos participantes do ensaio clinico assinou o TCLE sem o conhecimento suficiente das informacoes da pesquisa, e sofreu influencia em sua decisao de participar do ensaio clinico. Concluimos que a assinatura do TCLE nao garante a expressao da autonomia de todos os participantes de pesquisa clinica.

A Comparison of the Quality of Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and Developing Countries.

Informed consent is one of the principal ethical requirements of conducting clinical research, regardless of the study setting. Breaches in the quality of the informed consent process are frequently described in reference to clinical trials conducted in developing countries, due to low levels of formal education, a lack of familiarity with biomedical research, and limited access to health services in these countries. However, few studies have directly compared the quality of the informed consent process in developed and developing countries using the same tool and in similar clinical trials. This study was conducted to compare the quality of the informed consent process of a series of clinical trials of an investigational hookworm vaccine that were performed in Brazil and the United States. A standardized questionnaire was used to assess the ethical quality of the informed consent process in a series of Phase 1 clinical trials of the Na-GST-1/Alhydrogel hookworm vaccine that were conducted in healthy adults in Brazil and the United States. In Brazil, the trial was conducted at two sites, one in the hookworm non-endemic urban area of Belo Horizonte, Minas, and one in the rural, resource-limited town of Americaninhas, both in the state of Minas Gerais; the American trial was conducted in Washington, DC. A 32-question survey was administered after the informed consent document was signed at each of the three trial sites; it assessed participants’ understanding of information about the study presented in the document as well as the voluntariness of their decision to participate. 105 participants completed the questionnaire: 63 in Americaninhas, 18 in Belo Horizonte, and 24 in Washington, DC. Overall knowledge about the trial was suboptimal: the mean number of correct answers to questions about study objectives, methods, duration, rights, and potential risks and benefits, was 45.6% in Americaninhas, 65.2% in Belo Horizonte, and 59.1% in Washington, DC. Although there was no difference in the rate of correct answers between participants in Belo Horizonte and Washington, DC, there was a significant gap between participants at these two locations compared to Americaninhas (p = 0.0002 and p = 0.0001, respectively), which had a lower percentage of correct answers. Attitudes towards participating in the clinical trial also differed by site: while approximately 40% had doubts about participating in Washington, DC and Belo Horizonte, only 1.5% had concerns in Americaninhas. Finally, in Belo Horizonte and Washington, high percentages cited a desire to help others as motivation for participating, whereas in Americaninhas, the most common reason for participating was personal interest (p = 0.001). Understanding of information about a Phase 1 clinical trial of an experimental hookworm vaccine following informed consent was suboptimal, regardless of study site. Although overall there were no differences in knowledge between Brazil and the US, a lower level of understanding about the trial was seen in participants at the rural, resource-limited Brazilian site. These findings demonstrate the need for educational interventions directed at potential clinical trial participants, both in developing and developed countries, in order to improve understanding of the informed consent document.

Autonomous decision and behavior required in clinical trials: study with a socioeconomically vulnerable population

Quasi-experimental study conducted to assess the effects of an educational intervention based on the Health Action Process Approach Model, in which autonomous decision-making and behaviors required for the participation in a clinical study were favored. This is an intervention study involving participants in a clinical trial conducted in the State of Minas Gerais, Brazil. The intervention was based on the social and cognitive variables of the Health Action Process Approach model and assessed by applying questionnaires before and after intervention. The results were compared using the McNemar test. The educational intervention favored knowledge on both the expectations about the results of the clinical trial and risk of infection by intestinal helminths, development of the ability to plan the behaviors required by the clinical trial and the necessary confidence to lead, keep, and retrieve them. Analysis of the results showed that the educational intervention favored both autonomous decision-making and the behavior required by clinical trials.Quasi-experimental study conducted to assess the effects of an educational intervention based on the Health Action Process Approach Model, in which autonomous decision-making and behaviors required for the participation in a clinical study were favored. This is an intervention study involving participants in a clinical trial conducted in the State of Minas Gerais, Brazil. The intervention was based on the social and cognitive variables of the Health Action Process Approach model and assessed by applying questionnaires before and after intervention. The results were compared using the McNemar test. The educational intervention favored knowledge on both the expectations about the results of the clinical trial and risk of infection by intestinal helminths, development of the ability to plan the behaviors required by the clinical trial and the necessary confidence to lead, keep, and retrieve them. Analysis of the results showed that the educational intervention favored both autonomous decision-making and the behavior required by clinical trials. DESCRIPTORS: Personal autonomy. Trial. Social vulnerability. Cognitive sciences

DECISÃO AUTÔNOMA E O COMPORTAMENTO REQUERIDO EM UM ENSAIO CLÍNICO: ESTUDO COM UMA POPULAÇÃO SOCIOECONOMICAMENTE VULNERÁVEL

Quasi-experimental study conducted to assess the effects of an educational intervention based on the Health Action Process Approach Model, in which autonomous decision-making and behaviors required for the participation in a clinical study were favored. This is an intervention study involving participants in a clinical trial conducted in the State of Minas Gerais, Brazil. The intervention was based on the social and cognitive variables of the Health Action Process Approach model and assessed by applying questionnaires before and after intervention. The results were compared using the McNemar test. The educational intervention favored knowledge on both the expectations about the results of the clinical trial and risk of infection by intestinal helminths, development of the ability to plan the behaviors required by the clinical trial and the necessary confidence to lead, keep, and retrieve them. Analysis of the results showed that the educational intervention favored both autonomous decision-making and the behavior required by clinical trials.Quasi-experimental study conducted to assess the effects of an educational intervention based on the Health Action Process Approach Model, in which autonomous decision-making and behaviors required for the participation in a clinical study were favored. This is an intervention study involving participants in a clinical trial conducted in the State of Minas Gerais, Brazil. The intervention was based on the social and cognitive variables of the Health Action Process Approach model and assessed by applying questionnaires before and after intervention. The results were compared using the McNemar test. The educational intervention favored knowledge on both the expectations about the results of the clinical trial and risk of infection by intestinal helminths, development of the ability to plan the behaviors required by the clinical trial and the necessary confidence to lead, keep, and retrieve them. Analysis of the results showed that the educational intervention favored both autonomous decision-making and the behavior required by clinical trials. DESCRIPTORS: Personal autonomy. Trial. Social vulnerability. Cognitive sciences

Knowledge and willingness to participate in research: a descriptive study of volunteers in a clinical trial

O objetivo deste estudo e avaliar o conhecimento sobre as informacoes do Termo de Consentimento Livre e Esclarecido (TCLE) e a voluntariedade de participantes de um ensaio clinico. Trata-se de um estudo quantitativo, descritivo, transversal, realizado em novembro de 2011 com participantes de um ensaio clinico realizado em Americaninhas, no Nordeste de Minas Gerais, Brasil. Amostra por conveniencia, com 143 adultos de 18 a 45 anos, de ambos os sexos. Utilizou-se um questionario estruturado, aplicado uma semana apos a assinatura do TCLE. A maioria dos participantes do ensaio clinico assinou o TCLE sem o conhecimento suficiente das informacoes da pesquisa, e sofreu influencia em sua decisao de participar do ensaio clinico. Concluimos que a assinatura do TCLE nao garante a expressao da autonomia de todos os participantes de pesquisa clinica.

Conhecimento de crianças sobre o termo de assentimento livre e esclarecido

Children’s knowledge of the terms of informed assent The objective of this study is to describe the knowledge of children and adolescents regarding the information disclosed by the terms of assent used in pediatric clinical research, and report the attitudes of the participants. It is an experimental study with a quantitative approach, conducted in cities in the Northeast of Minas Gerais, Brazil, with 142 participants from 7 to 15 years old, chosen for a clinical study of schistosomiasis. These children and adolescents participated in the assent process using the corresponding term. We evaluated the participants through a semi-structured questionnaire. The average knowledge of participants regarding the survey information was 41.22%, with only 1.4% having a high level of knowledge. Most participants demonstrated not knowing essential information of the clinical research. This study concluded that most children are unaware of the information regarding the research and were unaware of their rights as research participants.The objective of this study is to describe the knowledge of children and adolescents regarding the information disclosed by the terms of assent used in pediatric clinical research, and report the attitudes of the participants. It is an experimental study with a quantitative approach, conducted in cities in the Northeast of Minas Gerais, Brazil, with 142 participants from 7 to 15 years old, chosen for a clinical study of schistosomiasis. These children and adolescents participated in the assent process using the corresponding term. We evaluated the participants through a semi-structured questionnaire. The average knowledge of participants regarding the survey information was 41.22%, with only 1.4% having a high level of knowledge. This study concluded that most children are unaware of the information regarding the research and were unaware of their rights as research participants.The objective of this study is to describe the knowledge of children and adolescents regarding the information disclosed by the terms of assent used in pediatric clinical research, and report the attitudes of the participants. It is an experimental study with a quantitative approach, conducted in cities in the Northeast of Minas Gerais, Brazil, with 142 participants from 7 to 15 years old, chosen for a clinical study of schistosomiasis. These children and adolescents participated in the assent process using the corresponding term. We evaluated the participants through a semi-structured questionnaire. The average knowledge of participants regarding the survey information was 41.22%, with only 1.4% having a high level of knowledge. This study concluded that most children are unaware of the information regarding the research and were unaware of their rights as research participants.