The written informed consent form (WICF): factors that interfere with acceptance.

BACKGROUND: The written informed consent form (WICF) provides information that must be written in simple, easily understood language, highlighting voluntary participation safeguards, risks, possible benefits, and procedures. Currently, the possibility that research subjects do not fully understand the text of the WICF or their rights as participants, despite having signed the WICF and agreed to participate in the study, has been a point of discussion. AIM: To evaluate the readability of the WICFs, as well as to correlate research subject acceptance of the WICF with demographic status, social factors, risk-benefit relationship, and education level. METHODS: The study involved 793 patients treated in public or private hospitals and asked to give informed consent for their inclusion. Were reviewed patient medical charts in order to obtain demographic and social data, and was used the Flesch Reading Ease and the Flesch-Kincaid Readability Indices to evaluate the reading level of the WICF texts. RESULTS: Acceptance was higher (99.7%) among patients treated in public health care facilities and among patients (99.73%) who participated in protocols involving lower risk. Although acceptance was not influenced by education level, 462 patients (58.26%) had eight or less years of schooling. The obtained readability index ranged from 9.9 to 12 on the Flesch-Kincaid test, and from 33.1 to 51.3 on the Flesch Reading Ease test. CONCLUSION: The WICFs had high degree of reading difficulty. Although patient acceptance was not found to be related to demographic or social factors, it was found to be influenced by the risk-benefit relationship.

Termo de consentimento livre e esclarecido (TCLE): fatores que interferem na adesão / The written informed consent form (WICF): factors that interfere with acceptance

RACIONAL: O Termo de Consentimento Livre e Esclarecido (TCLE) aborda informações que precisam estar descritas de forma clara e de fácil compreensão, destacando riscos, possíveis benefícios e procedimentos. Atualmente discute-se a possibilidade de sujeitos de pesquisa não entenderem totalmente o texto do TCLE nem seus direitos como participantes, mesmo tendo assinado o TCLE e aderido à pesquisa. OBJETIVOS: Avaliar a legibilidade dos TCLE, bem como correlacionar a aceitação do sujeito da pesquisa com estado demográfico, fatores sociais, relação risco-benefício e nível de instrução. MÉTODOS: Análise dos dados de 793 pacientes, que foram convidados a participar de diferentes protocolos de pesquisa clínica em hospitais privados e públicos. Foram revistos os dados dos prontuários médicos para obtenção dos dados demográficos e sociais. Foram usados os Índices de Legibilidade Flesch Reading Ease e Flesch-Kincaid para avaliar o nível de legibilidade dos textos dos TCLE. RESULTADOS: A adesão dos sujeitos de pesquisa aos protocolos propostos não teve influência dos fatores demográficos e sociais, no entanto, verificou-se maior adesão entre os pacientes de instituição de tratamento público (99,7%) em comparação com instituição de tratamento privada (93,7%). A adesão foi maior entre os pacientes que participaram de protocolos com menor risco (99,73%) em comparação com os que participaram de protocolos com maior risco (81,3%). Apesar da adesão não ter tido influência do nível de escolaridade, ele foi menor ou igual a oito anos de estudo para 462 pacientes (58,26%), entre os quais 444 (96,1%) eram de instituição de tratamento público. Os índices de legibilidade obtidos variaram de 9.9 a12 para o teste de Flesch-Kincaid e 33,1 a 51,3 para o teste de Flesch Reading Ease. CONCLUSÕES: Os TCLE apresentaram altos graus de dificuldade para leitura. Apesar da aceitação pelo paciente não estar relacionada com fatores sociais ou demográficos, foi influenciado pela relação risco-benefício.

BACKGROUND: The written informed consent form (WICF) provides information that must be written in simple, easily understood language, highlighting voluntary participation safeguards, risks, possible benefits, and procedures. Currently, the possibility that research subjects do not fully understand the text of the WICF or their rights as participants, despite having signed the WICF and agreed to participate in the study, has been a point of discussion. AIM: To evaluate the readability of the WICFs, as well as to correlate research subject acceptance of the WICF with demographic status, social factors, risk-benefit relationship, and education level. METHODS: The study involved 793 patients treated in public or private hospitals and asked to give informed consent for their inclusion. Were reviewed patient medical charts in order to obtain demographic and social data, and was used the Flesch Reading Ease and the Flesch-Kincaid Readability Indices to evaluate the reading level of the WICF texts. RESULTS: Acceptance was higher (99.7%) among patients treated in public health care facilities and among patients (99.73%) who participated in protocols involving lower risk. Although acceptance was not influenced by education level, 462 patients (58.26%) had eight or less years of schooling. The obtained readability index ranged from 9.9 to 12 on the Flesch-Kincaid test, and from 33.1 to 51.3 on the Flesch Reading Ease test. CONCLUSION: The WICFs had high degree of reading difficulty. Although patient acceptance was not found to be related to demographic or social factors, it was found to be influenced by the risk-benefit relationship.

Análise dos lipídios biliares no cálculo e na bile em portadores brasileiros de litíase biliar / Analysis of gallstones and biliar lipids in gallbladder disease of Brazilians patients

INTRODUÇÃO: A litíase biliar é uma doença do trato digestivo que apresenta prevalência variada em diferentes grupos étnicos e que gera altos gastos aos sistemas de saúde. A possibilidade de aplicação de tratamento não invasivo medicamentoso está direcionada a presença de cálculo de colesterol o que leva a necessidade de identificar corretamente os pacientes que podem beneficiar-se com o tratamento. No Brasil estima-se uma prevalência da doença em 9,3% da população em geral. Porém, ainda não há estudos que demonstrem a composição de cálculo de colesterol e pigmentos nos pacientes, bem como não há estudos de análise dos lipídios biliares e sua relação com os mecanismos fisiopatológicos da doença. Nossos objetivos foram analisar a composição do cálculo e da bile e compará-la com fatores pré-dispositivos da doença como tempo de nucleação e hiper saturação de colesterol em pacientes brasileiros. MÉTODOS: Foram analisadas 72 amostras de bile vesicular e cálculo biliar de pacientes com litíase biliar submetidos a procedimento cirúrgico laparoscópico em diferentes hospitais da grande São Paulo. Quatorze amostras de bile vesicular de pacientes que foram submetidos à laparoscopia por problemas gastrointestinais, mas que não apresentavam litíase biliar foram usadas como controle. Foram realizadas análises bioquímicas para avaliar a composição dos cálculos e da bile. Os cálculos foram analisados de acordo com a porcentagem de colesterol e bilirrubina em relação ao peso total do cálculo. A concentração dos ácidos biliares foi determinada pela técnica HPLC. O índice de saturação do colesterol foi calculado de acordo com a metodologia descrita por Carey. O tempo de nucleação foi avaliado através de microscopia de luz polarizada durante 21 dias. RESULTADOS: No grupo de pacientes com litíase biliar, 48 eram do sexo feminino (66,7%) e a média de idade foi 54,1 anos ± 13,1 (mínima de 18 anos e máxima de 75 anos). Do total de cálculos analisados (n=72) 75% foram classificados...

Introduction: Gallstone disease represents a prevalent and costly health problem. The changing epidemiology and the emerging non-surgical interventions for gallstone disease necessitate the definition of target populations for future therapies. The prevalence of biliary lithiasis in Brazil is around 9,3% of the general population with more than 20 years old, however it is necessary investigative studies to determine the composition of the gallstones and the correlation between bile lipids and disease physiopathology factors. Objectives: This study aimed to define patterns of gallstone composition and evaluate the biliary predictors factors of gallstone disease as nucleation time and cholesterol saturation index in Brazilian patients. Methods: Seventy two post- cholecystectomy gallstone specimens and gallbladder bile were obtained from different hospitals of the city of Sao Paulo. Fourteen gallbladder bile samples were obtained as control samples, from patients who underwent laparoscopic surgery due to gastrointestinal symptoms without gallbladder disease. Biochemistry analyses were performed to determine the composition of the gallstones and bile. Gallstones were classified according to their cholesterol and bilirrubin content linked with their dry weight. The concentration of bile salts was evaluated by HPLC technique. The cholesterol saturation index (CSI) was calculated in accordance with Carey methods. The nucleation time was evaluated by polarized light microscopy during 21 days. Results: There were 48 women and 22 men in the Gallbladder disease patients group. The mean age of the patients were 54,1 ± 13,1 years old (range 18 75 years old). Cholesterol stones were found in 75% of the stones. The bile of the cholesterol gallstone patients presented lower concentration of phospholipids (p<0,05), higher CSI (p<0,001), lower nucleation time (p<0,05) and higher concentration of deoxicholic acid (p<0,05) when compared with control group...