Análisis de legibilidad de formatos de consentimiento informado para pruebas genéticas en México / Readability analysis of informed consent forms for genetic tests in Mexico

Resumen Introducción: Es importante conocer si el documento que ampara el consentimiento informado (CI) del paciente a quien se le realizan pruebas genéticas de laboratorio (PGL) es legible y comprensible. Objetivo: Analizar la legibilidad de documentos de CI para pruebas genéticas de laboratorio (PGL) en México. Métodos: Se analizó la legibilidad de 10 formatos de CI libres en internet utilizados para PGL mediante el programa Legible.es; se evaluó índice de Flesh, versión de Fernández Huerta, y la escala INFLESZ. Se contabilizó el número de sílabas, palabras, frases, párrafos y palabras raras, tiempo para leer el documento y años de escolaridad mínima para entenderlo. Resultados: Se identificó que 60 % de los formatos de CI analizados son poco legibles. En promedio, se contabilizaron 3290 sílabas, 1459 palabras, 124 frases, 58 párrafos y 52 palabras raras. El tiempo requerido para la lectura fue de siete minutos y la escolaridad mínima de seis años. Conclusiones: Los formatos de CI analizados tuvieron bajos índices de legibilidad y exceden el número recomendado de palabras. Proponemos un modelo de CI para PGL en México, que cumple con los índices de legibilidad para la correcta comprensión del documento.

Abstract Introduction: Knowing if the document that supports the informed consent (IC) granted by the patient who undergoes genetic laboratory tests is legible and understandable is important. Objective: To analyze the readability of IC documents for laboratory genetic tests (LGT) in Mexico. Methods: Readability of 10 free IC forms on the internet used for LGT was analyzed using the Legible.es program; the Flesh index, Fernández-Huerta version, and the INFLESZ scale were evaluated. The number of syllables, words, phrases, paragraphs and strange words, time to read the document and minimum years of education required to understand it were counted. Results: 60 % of the analyzed IC documents were found to have poor readability. On average, 3,290 syllables, 1,459 words, 124 sentences, 58 paragraphs and 52 strange words were counted. The time required for reading it was seven minutes and minimum level of education to understand it was six years. Conclusions: The analyzed IC forms for LGT have low readability rates and exceed the recommended number of words. We propose an IC model for LGT in Mexico that complies with appropriate readability indexes for a correct understanding of the document.

Como tornar os termos de consentimento mais fáceis de ler? / How to make consent forms easier to read?

OBJETIVO: Reconhecer o nível de alfabetismo funcional de usuários do ambulatório do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCMFUSP) com a finalidade de identificar recomendações para adequar a redação do TCLE ao nível de alfabetismo dos usuários, pois estes podem vir a ser sujeitos de pesquisa. MÉTODOS: Estudo transversal quantitativo com 399 sujeitos. A amostra foi intencional, selecionada entre usuários dos ambulatórios do HCFMUSP. A coleta de dados utilizou instrumento que continha um texto em prosa compatível para a avaliação das habilidades de leitura necessárias para a compreensão de um TCLE. RESULTADOS: Mais de 46,6 por cento dos entrevistados foram classificados como analfabetos funcionais. Desses, 12,7 por cento sequer foram capazes de entender a tarefa proposta no texto lido. Apesar disto, quase 50 por cento dos entrevistados declararam ter ao menos iniciado o ensino médio. CONCLUSÃO: Os resultados e as orientações para a redação de texto centrada no leitor permitiu que elaborássemos recomendações para tornar os termos de consentimento mais fáceis de ler. Recomendamos que o pesquisador elabore o TCLE como um texto em estrutura narrativa, dirigido ao leitor, usando palavras e termos familiares, ou seja, termos comuns à linguagem dos sujeitos e à linguagem médica. Além de contribuir para melhorar a relação entre o sujeito e o pesquisador, acredita-se que estas recomendações possam contribuir para a diminuição do tempo de tramitação de projetos de pesquisa. Já que os problemas na redação do TCLE motivam boa parte das pendências que retardam este andamento.

OBJECTIVE: Define the literacy level of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCMFUSP) outpatients, for the purpose of identifying recommendations to adapt writing of the informed consent form to the outpatients literacy level, since these can become the subject of research. METHODS: Quantitative cross sectional study with 399 subjects. The sample was intentional, selected from different outpatient care units of HCFMUSP. Data collection used an instrument that contained a text with prose compatible for assessment of reading skills needed for comprehension of the consent form. Results. More than 46.6 percent of the interviewees were classified as functionally illiterate, of these, 12.7 percent were even unable to understand the proposed task in the text they read . Nevertheless , nearly 50 percent of the interviewees reported having at least started high school . CONCLUSION: The results and the orientations for the text writing centered on the reader allowed us to make recommendations to render the consent form easier to read . We recommend that the researcher modifies the text to a structural narrative, addressed to the reader, using terms that are familiar., In other words, with terms common to the subjects' and to the medical language. In addition to improving the relationship between the subject and researcher, it is believed that these recommendations may reduce the time taken for the proceeding of research projects, since problems in the wording of consent forms contribute significantly to project delays.

Como consentir sem entender? / How consent without knowing?

INTRODUÇÃO: Termo de Consentimento Livre e Esclarecido (TCLE) é o documento que informa sobre os benefícios e riscos de um estudo. Alguns autores concluíram que os TCLE são de difícil compreensão. OBJETIVO: Correlacionar grau de dificuldade dos TCLE, pelos índices de Flesch (IF) e Flesch-Kincaid (ILFK), utilizados num ambulatório de oncologia ao perfil de escolaridade dos usuários desse mesmo serviço, bem como verificar a legibilidade e a presença das informações obrigatórias segundo o item IV.1 da Resolução 196/96 do Conselho Nacional de Saúde. RESULTADOS: Foram obtidos 10 TCLE; segundo o IF e ILFK, a média foi de 38,5 e 18,16 respectivamente, mostrando ser necessário aproximadamente 18 anos de estudo para a compreensão, dado incompatível com a realidade de nossa população, em que mais de 50 por cento tem menos de oito anos de estudos. Em relação à qualidade dos termos, estes eram bem elaborados tecnicamente, contendo a maior parte dos itens necessários. Ao correlacionarmos o ILFK com a qualidade dos TCLEs, pôde-se observar que a qualidade dos termos não apresentou correlação com a legibilidade (p= 0.884, coeficiente de correlação de Pearson 0.053). CONCLUSÃO: O grau de dificuldade dos TCLE é incompatível com a escolaridade de nossa população e nossos TCLE apresentavam informações suficientes. Esperávamos relacionar a quantidade de informações ao grau de dificuldade de compreensão do texto, não sendo confirmada, mostrando a possibilidade de um TCLE ser completo ao mesmo tempo fácil de ler.

BACKGROUND: The Consent Form (CF) is an important document that informs patients about benefits and risks of a study, it assures patients the right to accept or reject participation in a procedure related to their health. Some authors believe that Consent Forms are complex and difficult to read for most people. OBJECTIVE: Correlate the difficulty of understanding CF, through the Flesch Index (FI) and Flesch-Kincaid Index (FKI), used in our oncology outpatient clinic, with the profile of our patient's education. We also wanted to verify readability and presence of the information which must be part of these CF according to item IV.1 from Resolution 196/96 of the Brazilian Health Council. RESULTS: We obtained 10 CFs, according to FI and FKI the mean was 38.5 and 18.16 respectively, indicating that, at least, 18 years of study are needed for the comprehension. This result is incompatible with the Brazilian population where more than 50 percent have less than 8 years of study. According to the quality of the CF, they were well elaborated, and had most of the necessary contents. When the authors correlated FKI and quality of CF, they concluded that the quality of CF does not correlate with readability (p= 0.884, Pearson correlation coefficients 0.053). CONCLUSION: Despite the good content quality of most of the analyzed CF, their level of reading difficulty is not compatible with the literacy skills of a major part of the Brazilian population.

Reasons for resubmission of research projects to the research ethics committee of a University Hospital in São Paulo, Brazil

INTRODUCTION: It is important to know the reasons for resubmitting research projects to the Research Ethics Committee in order to help researchers to prepare their research projects, informed consent forms and needed research documentation. OBJECTIVES: To verify the reasons for resubmitting projects that were previously rejected by the Ethics Committee. METHOD: This is a cross-sectional study that evaluated research projects involving human beings. Research projects were submitted in 2007 to the Research Ethics Committee of the Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo. RESULTS: One thousand two hundred and fifty six research projects were submitted to the ethics committee and the average time for evaluating the research projects and related documents until a final decision was reached was 49.95 days. From the total, 399 projects were reviewed in 2 or more meetings until a final decision was reached. Of these, 392 research projects were included in the study; 35 projects were subsequently excluded for involving animals. Among the research projects included, 42.5 percent concerned research with new drugs, vaccines and diagnostic tests, 48.5 percent consisted of undergraduate students' research projects, 68.9 percent of the research had no sponsorship, and 97.5 percent were eventually approved. The main reasons for returning the projects to the researchers were the use of inadequate language and/or difficulty of understanding the informed consent form (32.2 percent), lack of information about the protocol at the informed consent form (25.8 percent), as well as doubts regarding methodological and statistical issues of the protocol (77.1 percent). Other reasons for returning the research projects involved lack of, inaccuracy on or incomplete documentation, need of clarification or approval for participation of external entities on the research, lack of information on financial support. CONCLUSION: Among the ...