Stochastic modeling of the human middle ear dynamics under pathological conditions.

BACKGROUND: Although the dynamics of the middle ear (ME) have been modeled since the mid-twentieth century, only recently stochastic approaches started to be applied. In this study, a stochastic model of the ME was utilized to predict the ME dynamics under both healthy and pathological conditions. METHODS: The deterministic ME model is based on a lumped-parameter representation, while the stochastic model was developed using a probabilistic non-parametric approach that randomizes the deterministic model. Subsequently, the ME model was modified to represent the ME under pathological conditions. Furthermore, the simulated data was used to develop a classifier model of the ME condition based on a machine learning algorithm. RESULTS: The ME model under healthy conditions exhibited good agreement with statistical experimental results. The ranges of probabilities from models under pathological conditions were qualitatively compared to individual experimental data, revealing similarities. Moreover, the classifier model presented promising results. DISCUSSION: The results aimed to elucidate how the ME dynamics, under different conditions, can overlap across various frequency ranges. Despite the promising results, improvements in the stochastic and classifier models are necessary. Nevertheless, this study serves as a starting point that can yield valuable tools for researchers and clinicians.

Public engagement for the conduct of a controlled human infection study testing vaccines against Necator americanus (hookworm) in areas of active hookworm transmission in Brazil.

Controlled Human Infection Models (CHIS) involve administering human pathogens to healthy participants in controlled medical settings, which can elicit complex bioethical issues. Understanding how the community perceives such studies can significantly increase the participant's sense of cooperation and increases the researcher's and the participant's transparency. The current study describes the development of an educational intervention to achieve these ends as it aims to (1) analyze perceptions of the Controlled Human Infection Studies (CHIS), and (2) evaluate the participants' comprehension of the CHIS. METHODS: This is a qualitative action research that includes the development of an educational intervention with residents of a rural area in Minas Gerais, Brazil, where there is continuous natural transmission of the human pathogen Necator americanus ("hookworm"). In this area, it is intended to carry out a proposed phase 3 vaccine clinical trial in the future to test the efficacy of hookworm vaccines using controlled human infection. Two data collection strategies were used: an educational intervention and a focus group. RESULTS: The participants' perceptions showed distinct perspectives on CHIS. On one side, they recognized that the investigation is essential for the community, but on the other side, they thought that there would be resistance to its conduct by fear of infection. The idea that the study would generate a benefit for the greater good, contributing to the prevention of hookworm infection, was clearly stated. The participants perceived that the study offered concrete risks that could be reduced by constant monitoring by the researchers. They also mentioned the importance of access to information and the positive influence those who express interest in participating in the study can exert in the community. In relation to comprehension the participants memorized the information, mobilized it to explain everyday situations and created strategies to disseminate the study and engage the community in its development. By repeating and making sense of the information, the participant not only assimilates the knowledge transmitted, but also creates new knowledge. CONCLUSION: We concluded that an educational process of discussion and dialogue around participants' perceptions about the CHIS, promotes understanding and allows ways to disseminate information about the research to be collectively created.

Stochastic model of the human middle ear using a nonparametric probabilistic approach.

Several mathematical models of the human middle ear dynamics have been studied since the mid-twentieth century. Despite different methods applied, all of these models are based on deterministic approaches. Experimental data have shown that the middle ear behaves as an uncertain system due to the variability among individuals. In this context, stochastic models are useful because they can represent a population of middle ears with its intrinsic uncertainties. In this work, a nonparametric probabilistic approach is used to model the human middle ear dynamics. The lumped-element method is adopted to develop deterministic baseline models, and three different optimization processes are proposed and applied to the adjustment of the stochastic models. Results show that the stochastic models proposed can reproduce the experimental data in terms of mean and coefficient of variation. In addition, this study shows the importance of properly defining the acceptable range of each input parameter in order to obtain a reliable stochastic model.

Statistical analysis of the human middle ear mechanical properties.

Many experimental data on the human middle ear (ME) mechanics and dynamics can be found in the literature. Nevertheless, discussions about the uncertainties of these data are scarce. The present study compiles experimental data on the mechanical properties of the human ME. The summary statistics of mean and standard deviation of the data were collected and the coefficients of variation were computed and pooled. Moreover, the linear correlation and distribution were assessed for the ossicles' mass. Results show that, generally, the uncertainties of the stiffness properties of the tympanic membrane, ligaments, and tendons are larger than the uncertainties of the ossicles' mass. In addition, the uncertainties of the ME response vary across frequency. The vibration measures, such as the stapes' velocity normalized by the sound pressure at the tympanic membrane, are more uncertain than ME input impedance and reflectance. It is expected that the results presented in this study will provide the basis for the development of probabilistic models of the human ME.

Analysis of the Human Middle Ear Dynamics Through Multibody Modeling.

The dynamics of the human middle ear (ME) has been studied in the past using several computational and experimental approaches in order to observe the effect on hearing of different conditions, such as conductive disease, corrective surgery, or implantation of a middle ear prosthesis. Multibody (MB) models combine the analysis of flexible structures with rigid body dynamics, involving fewer degrees-of-freedom (DOF) than finite element (FE) models, but a more detailed description than traditional 1D lumped parameter (LP) models. This study describes the reduction of a reference FE model of the human middle ear to a MB model and compares the results obtained considering different levels of model simplification. All models are compared by means of the frequency response of the stapes velocity versus sound pressure at the tympanic membrane (TM), as well as the system natural frequencies and mode shapes. It can be seen that the flexibility of the ossicles has a limited impact on the system frequency response function (FRF) and modes, and the stiffness of the tendons and ligaments only plays a role when above certain levels. On the other hand, the restriction of the stapes footplate movement to a piston-like behavior can considerably affect the vibrational modes, while constraints to the incudomalleolar joint (IMJ) and incudostapedial joint (ISJ) can have a strong impact on the system FRF.

How Stapes Ankylosis and Fracture Affect Middle Ear Dynamics: A Numerical Study.

Numerical models of the human middle ear have been developed throughout the last 30 years, for different purposes. While several types of pathologies have been studied, stapedial disorders were seldomly explored. This papers aims to clarify how stapes fracture and some forms of stapes ankylosis, such as stapedial tendon (ST) ossification, augmented pyramidal eminence (PE) and bony bar presence, affect the sound transmission through the middle ear. In addition, the stapes dynamics is also analyzed by means of total displacement and first principal strain. For the purpose of the study, first, a three-dimensional finite element model of the human middle ear is detailed and validated under normal (healthy) conditions. The model is then modified to represent the stapedial disorders of interest. A measure is established for evaluating how the disorders reduce sound transmission through the middle ear. Results of the reduction of sound transmission showed that the different forms of stapes ankylosis affect primarily low frequencies, while the stapes fracture mostly affects high frequency sound transmission. According to the results, an augmented PE does not restrict stapes movement unless followed by some ossification of the ST. In addition, the question whether the fracture is in the anterior or posterior crus and the distance of the fractured part from the stapes footplate have a relevant role in the reduction of the sound transmission. Finally, the analysis of total displacement and first principal strain of the stapes helped to highlight some differences among the stapedial disorders.

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.

Conhecimento de crianças sobre o termo de assentimento livre e esclarecido / Children's knowledge of the terms of informed assent / Conocimientos de los niños sobre el documento de consentimiento libre e informado

Este estudo tem como objetivo descrever o conhecimento de crianças e adolescentes sobre as informações divulgadas pelo termo de assentimento em pesquisa clínica pediátrica, além de relatar as atitudes dos participantes. Trata-se de estudo experimental com abordagem quantitativa, realizado em municípios do Nordeste de Minas Gerais com 142 participantes de 7 a 15 anos, escolhidos para estudo clínico sobre esquistossomose. Essas crianças e adolescentes participaram do processo de assentimento, com a utilização do termo correspondente. Avaliaram-se os participantes com questionário semiestruturado. O conhecimento médio dos participantes sobre as informações da pesquisa foi 41,22%, com apenas 1,4% apresentando alto grau de conhecimento. Concluiu-se que a maioria das crianças desconhece as informações sobre a investigação e seus direitos enquanto participantes de pesquisa.

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.

Este estudio tiene como objetivo describir los conocimientos de los niños y adolescentes sobre la información divulgada por el documento de consentimiento en la investigación clínica pediátrica, además de describir las actitudes de los participantes. Se trata de un estudio experimental con un enfoque cuantitativo, llevado a cabo en ciudades del noreste de Minas Gerais, Brasil, con 142 participantes, de 7 a 15 años de edad, seleccionados para un estudio clínico sobre esquistosomiasis. Estos niños y adolescentes participaron en el proceso de consentimiento mediante el documento de consentimiento correspondiente. Se evaluó a los participantes con un cuestionario semiestructurado. El conocimiento promedio de los participantes sobre la información de la encuesta fue del 41,22%, siendo que solo un 1,4% presentó un alto grado de conocimiento. Se concluye que la mayoría de los niños desconoce las informaciones sobre la investigación y sobre sus derechos en tanto participantes de la misma.

Improving the understanding of schistosomiasis among adolescents in endemic areas in Brazil: A comparison of educational methods.

OBJECTIVE: To evaluate the effectiveness of two teaching strategies, both guided by the concept of dialogicity, on adolescents' knowledge about schistosomiasis and adherence to diagnostic fecal testing. METHODS: Two teaching strategies related to schistosomiasis were developed, an educational video and group conversation, which were tested in two groups of students aged 10-15 years old. Before and after the intervention, a questionnaire was applied to assess participants' knowledge about schistosomiasis and, after the intervention, two fecal samples were requested from each participant. Comparisons were performed by paired t- and McNemar tests. RESULTS: Both strategies resulted in statistically significant improvements in knowledge between the pre- and post-tests. Students who watched the video had a higher return rate of fecal samples and percentage of correct questionnaire answers, mainly on questions about schistosomiasis infection. CONCLUSION: Teaching strategies based on dialogue favored the construction of concepts about schistosomiasis that can influence the adoption of positives attitudes related to health. PRACTICAL IMPLICATIONS: Using teaching strategies based on the concept of dialogicity can favor the increase of knowledge of school age children about schistosomiasis and can influence behavioral change related to health.

O consentimento informado nos países em desenvolvimento é realmente autônomo?: um estudo descritivo com participantes de um ensaio clínico sobre helmintoses / ¿Es verdaderamente autónomo el consentimiento informado en los países en desarrollo?: un estudio descriptivo con los participantes en un ensayo clínico de helmintiasis / The informed consent in developing countries is truly autonomous?: a descriptive study of participants in a helmintiasis clinical trial

Este estudo demonstra que a assinatura do Termo de Consentimento Livre e Esclarecido não representa uma decisão autônoma para todos participantes de um ensaio clínico sobre Helmintoses. Os resultados desse estudo evidenciam que a maioria dos participantes de um ensaio clínico desconhecem diversas informações sobre a pesquisa e seus direitos. O desconhecimento dessas informações é influenciado pelas características individuais dessas participantes, sendo associado negativamente pela idade dos participantes de pesquisa e positivamente pela renda mensal, o acesso a meios eletrônicos de comunicação e a educação formal. Realizamos um estudo transversal, descritivo, com 70 participantes de um ensaio clínicos sobre Helmintoses realizado no Nordeste de Minas Gerais. Utilizamos a regressão linear múltipla para análise de associação. Os resultados deste estudo apontam para a necessidade de se criar estratégias capazes de melhorar o conhecimento dos participantes de ensaios clínicos, sobretudo naqueles com características individuais que atuam como barreiras para esse conhecimento.

Este estudio demuestra que la firma del consentimiento informado no es una decisión autónoma para todos los participantes en un ensayo clínico de helmintiasis. Los resultados del estudio muestran que la mayoría de los participantes en un ensayo clínico desconocen distintas informaciones acerca de la investigación y de sus derechos. El desconocimiento de esas informaciones está influenciado por las características individuales de los participantes, y se asocia negativamente con la edad de los participantes en el estudio y positivamente con el ingreso mensual, el acceso a los medios electrónicos y la educación formal. Se realizó un estudio descriptivo, con 70 participantes en un ensayo clínico sobre helmintiasis en la región noreste del Estado de Minas Gerais. Se utilizó la regresión lineal múltiple para el análisis de asociación. Los resultados de este estudio apuntan para la necesidad de crear estrategias para mejorar el conocimiento de los participantes de los ensayos clínicos, especialmente de aquellos cuyas características individuales actúan como obstáculos para este conocimiento.

This study demonstrates that the signing of the consent form is not an autonomous decision to all participants in a clinical trial of helminths. The results of this study show that the majority of participants in a clinical trial unaware various information about the research and their rights. The lack of such information is influenced by the individual characteristics of these participants, being negatively associated with age of the research participants and positively by monthly income, access to electronic media and formal education. We conducted a descriptive study, with 70 participants in a clinical trial conducted on helminths in the Northeast of Minas Gerais. We used multiple linear regression analysis of the association. The results of this study point to the need to create strategies to improve knowledge of clinical trial participants, particularly those with individual characteristics that act as barriers to this knowledge.

Autonomous decision and behavior required in clinical trials: study with a socioeconomically vulnerable population / Decisión autónoma y comportamiento requerido en un ensayo clínico: estudio con una población socioeconómicamente vulnerable / 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.

Estudio cuasi-experimental realizado para evaluar los efectos de una intervención educativa basada en el Modelo Health Action Process Approach, con el fin de proporcionar una decisión autónoma y adoptar comportamientos necesarios a la participación en un ensayo clínico. Se trata de una investigación de intervención realizada con participantes de un ensayo clínico desarrollado en Minas Gerais, Brasil. Hemos llevado a cabo la intervención basada en las variables socio cognitivas de Health Action Process Approach evaluadas por un cuestionario administrado antes y después de la misma. La comparación entre los resultados ha sido realizada con la Prueba de McNemar. La intervención educativa ha favorecido el conocimiento de las expectativas de los resultados del ensayo clínico, los riesgos de infección por helmintos intestinales, el desarrollo de la capacidad de planear los comportamientos requeridos por el ensayo y la confianza en hacerlos, mantenerlos y recuperarlos. La intervención educativa ha favorecido la decisión autónoma y la adopción de los comportamientos necesarios a la participación en el ensayo clínico.

Estudo quasi-experimental cujo objetivo foi avaliar os efeitos de uma intervenção educativa, baseada no Modelo Health Action Process Approach, para favorecer uma decisão autônoma e a adoção de comportamentos requeridos para participação em um ensaio clínico. Trata-se de um estudo de intervenção, realizado com participantes de um ensaio clínico desenvolvido em Minas Gerais, Brasil. Realizou-se uma intervenção baseada nas variáveis sociocognitivas do Health Action Process Approach, avaliada por um questionário aplicado antes e após a intervenção. A comparação entre os resultados foi realizada pelo Teste de McNemar. A intervenção educativa favoreceu o conhecimento sobre as expectativas dos resultados do ensaio clínico, os riscos de infecção por helmintíases intestinais, o desenvolvimento da habilidade de planejar os comportamentos requeridos pelo ensaio clínico e a confiança em realizá-los, mantê-los e recuperá-los. A intervenção educativa favoreceu a decisão autônoma e a adoção de comportamentos requeridos para a participação no ensaio clínico.

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

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.

[Knowledge and willingness to participate in research: a descriptive study of volunteers in a clinical trial]. / Conhecimento e voluntariedade para participação em pesquisas: um estudo descritivo com participantes de um ensaio clínico.

The aim of this study was to evaluate volunteers' knowledge of the information on the free informed consent form and their willingness to participate in a clinical trial. This was a quantitative, descriptive, cross-sectional study conducted in November 2011 with subjects from a clinical trial in Americaninhas, northeast Minas Gerais State, Brazil. A convenience sample included 143 adults of both sexes, 18 to 45 years of age. A structured questionnaire was applied one week after signing the free informed consent form. Most participants signed the free informed consent without sufficient knowledge of the research information and were influenced in their decision to participate in the trial. The authors conclude that signing the free informed consent form fails to express all participants' autonomy in clinical trials.

Conhecimento e voluntariedade para participação em pesquisas: um estudo descritivo com participantes de um ensaio clínico / Knowledge and willingness to participate in research: a descriptive study of volunteers in a clinical trial / Conocimiento y la voluntariedad de participar en la investigación: un estudio descriptivo con los participantes en un ensayo clínico

O objetivo deste estudo é avaliar o conhecimento sobre as informações do Termo de Consentimento Livre e Esclarecido (TCLE) e a voluntariedade de participantes de um ensaio clínico. Trata-se de um estudo quantitativo, descritivo, transversal, realizado em novembro de 2011 com participantes de um ensaio clínico realizado em Americaninhas, no Nordeste de Minas Gerais, Brasil. Amostra por conveniência, com 143 adultos de 18 a 45 anos, de ambos os sexos. Utilizou-se um questionário estruturado, aplicado uma semana após a assinatura do TCLE. A maioria dos participantes do ensaio clínico assinou o TCLE sem o conhecimento suficiente das informações da pesquisa, e sofreu influência em sua decisão de participar do ensaio clínico. Concluímos que a assinatura do TCLE não garante a expressão da autonomia de todos os participantes de pesquisa clínica.

The aim of this study was to evaluate volunteers’ knowledge of the information on the free informed consent form and their willingness to participate in a clinical trial. This was a quantitative, descriptive, cross-sectional study conducted in November 2011 with subjects from a clinical trial in Americaninhas, northeast Minas Gerais State, Brazil. A convenience sample included 143 adults of both sexes, 18 to 45 years of age. A structured questionnaire was applied one week after signing the free informed consent form. Most participants signed the free informed consent without sufficient knowledge of the research information and were influenced in their decision to participate in the trial. The authors conclude that signing the free informed consent form fails to express all participants’ autonomy in clinical trials.

El objetivo de este estudio es evaluar el conocimiento acerca de la información del Formulario de Consentimiento Informado y la disposición de los participantes para un ensayo clínico. Se trata de un análisis cuantitativo, descriptivo, de corte transversal, realizado en noviembre de 2011 con participantes de un ensayo clínico en Americaninhas, llevado a cabo en el nordeste de Minas Gerais, Brasil. Se trata de una muestra de conveniencia: 148 adultos entre 18 y 45 años, de ambos sexos. Se utilizó un cuestionario estructurado, cumplimentado una semana después de firmar el Formulario de Consentimiento Informado. La mayoría de los participantes del ensayo firmó el formulario de consentimiento informado sin un conocimiento suficiente de la investigación y fue influenciado en su decisión de participar en el ensayo clínico. Se concluye que la firma del formulario de consentimiento informado no garantiza la expresión de la autonomía de todos los participantes en la investigación clínica.

Legibilidade dos termos de consentimento livre e esclarecido em ensaios clínico / La legibilidad del consentimiento en la investigación clínica / Readability of the terms of consent in clinical research

O estudo objetiva analisar a legibilidade de dois termos de consentimento livre e esclarecido (TCLE) utilizados para participação em ensaio clínico e correlacionar o grau de dificuldade dos documentos com o nível de escolaridade dos participantes. Sendo um TCLE para a elegibilidade no estudo e outro para a participação. Os TCLE foram analisados mediante utilização do índice de facilidade de leitura de Flesch (IFLF) e índice de legibilidade de Flesch-Kincaid (ILFK). Por meio da análise pelo IFLF, os TCLE para a seleção dos voluntários e participação no ensaio clínico obtiveram, respectivamente, o valor de 61 e 56, enquanto pelo IFLK os valores foram 6,59 e 8,4, respectivamente. O TCLE para elegibilidade de voluntários e para a participação no ensaio clínico foi inadequado para 49% e 72% desses participantes. Os dois TCLE utilizados para a participação em ensaios clínicos não foram adequados para a escolaridade da maioria de seus participantes.

El objetivo de este estudio es analizar la legibilidad de dos términos de consentimiento libre y aclarado (TCLA) utilizados para participar en un ensayo clínico 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 participación.Los TCLA fueron analizados mediante utilización del índice de facilidad de lectura de Flesch Reading Ease (IFLF) Index y el Flesch-Kincaid (ILFK). A través del análisis por el IFRE, los TCLA para la selección de los voluntarios y participación en el ensayo clínico 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 selección de voluntarios y para la participación en el ensayo clínico fue insuficiente para el 49% y el 72% de esos participantes. Los dos TCLA utilizados para la participación en los ensayos clínicos no eran adecuados para la escolaridad de la mayoría de sus participantes.

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.

Efeitos de intervenção educativa na qualidade ética do consentimento livre e esclarecido / Effects of educational intervention in the ethical quality of the free and informed consent / Efectos de una intervención educativa en la calidad del consentimiento libre e informado

Las intervenciones educativas se han utilizado con el fin de mejorar la comprensión del consentimiento libre e informado. Algunas de ellas han demostrado ser ineficaces, lo que indica la necesidad de asegurar la calidad del consentimiento. El objetivo de este estudio fue analizar los efectos de una intervención educativa en el perfeccionamiento de la calidad ética de consentimiento. El estudio involucró a 148 participantes que firmaron el término de consentimiento libre e informado para participar en un ensayo clínico realizado en el nordeste de Minas Gerais/Brasil. De este total, 105 participaron en una intervención educativa instrumentalizada por un juego de mesa, mientras que sólo 43 firmaron el TCLE de aquel ensayo clínico. Para evaluar los efectos de la intervención educativa fue aplicado el Cuestionario de Evaluación de la Calidad del Consentimiento Libre e Informado (CECC). Los participantes de la intervención demuestran un mayor conocimiento sobre las informaciones del ensayo clínico, sufriendo menor influencia en relación a la decisión de participar. Los resultados sugieren que la intervención educativa favorece la calidad de consentimiento libre e informado en la participación en investigaciones clínicas.

Intervenções educativas têm sido utilizadas para melhorar a compreensão do consentimento livre e esclarecido. Algumas delas têm se mostrado ineficazes, indicando a necessidade de assegurar a qualidade do consentimento. Este estudo analisa os efeitos de intervenção educativa no aprimoramento da qualidade ética do consentimento, envolvendo 148 participantes que assinaram o termo de consentimento livre e esclarecido para participar de ensaio clínico realizado no nordeste de Minas Gerais/Brasil. Desse total, 105 participaram de intervenção educativa instrumentalizada por jogo de tabuleiro, enquanto 43 apenas assinaram o TCLE daquele ensaio clínico. Para avaliar os efeitos da intervenção educativa foi aplicado o Questionário de Avaliação da Qualidade do Consentimento Livre e Esclarecido. Os participantes da intervenção demonstram maior conhecimento sobre as informações do ensaio clínico, sofrendo menor influência quanto à decisão de participar. Os resultados sugerem que a intervenção educativa favorece a qualidade do consentimento livre e esclarecido na participação em pesquisas clínicas.

Educational interventions have been used in order to improve the quality of understanding with regards to the free and informed consent. However, some of these interventions have become ineffective, indicating the need of ensuring the ethical quality of consent. The aim of this study was to analyze the effects of an educational intervention for improving the ethical quality of consent. The study involved 148 participants who signed the free and informed consent form (FICF) for participation in a clinical trial conducted in the Northeast of Minas Gerais - Brazil. From this total, 105 participated in an educational intervention through a board game, while only 43 signed the informed consent form regarding that clinical trial. In order to assess the effects of an educational intervention, the Questionnaire on Quality Assessment of The Free and Informed Consent (QAQIC) was applied. The participants of the educational intervention showed greater knowledge about the information in the clinical trial, less influenced by the decision to participate in it. The results suggest that an educational intervention favors the quality of the free and informed consent in a clinical research.Key words: Bioethics. Informed consent. Clinical trial. Helminthiasis.

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.

Development of cognitive abilities of children infected with helminths through health education / Desenvolvimento de habilidades cognitivas de crianças infectadas por helmintos através da Educação em Saúde

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.

INTRODUÇÃO: O objetivo do estudo foi avaliar o efeito da educação em saúde na aprendizagem e desenvolvimento cognitivo de crianças infectadas, previamente tratadas, em área endêmica para helmintoses. MÉTODOS: Trata-se de um estudo longitudinal, experimental e com distribuição aleatória dos participantes. Participaram do estudo 87 crianças, de ambos os sexos, matriculadas na escola municipal de Maranhão, Minas Gerais, Brasil, e distribuídas em dois grupos: intervenção e controle. Inicialmente, as crianças foram submetidas ao exame parasitológico de fezes para diagnóstico de infecção e, em caso positivo, foram tratadas. Para a coleta de dados, foi aplicado um questionário estruturado e os testes psicológicos Raven, Wisc-III e DFH III, antes e após intervenção educativa. Para a comparação entre os grupos foi utilizado o teste Mann Whitney e estabelecido nível de significância de 5%. RESULTADOS: Verificou-se que as crianças previamente infectadas, que receberam a intervenção educativa, apresentaram desempenho superior as crianças do grupo controle no questionário estruturado (p<0,05). CONCLUSÕES: É aceitável supor a influencia positiva e a importância da utilização de intervenções educativas na recuperação cognitiva e aprendizagem das crianças previamente tratadas com antihelmínticos.

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.