Acessibilidade do termo de consentimento na pesquisa clínica no Brasil / Accessibility of the consent form in Brazilian clinical research / Accesibilidad al formulario de consentimiento en la investigación clínica en Brasil

Resumo O termo de consentimento livre e esclarecido tem a função de informar o participante de pesquisas clínicas sobre a natureza da pesquisa e seus direitos, formalizando sua decisão de participar. Estudos indicam que esse documento é redigido de modo complexo, comprometendo a autonomia do participante. Para este trabalho, foram redigidos dois termos de consentimento da mesma pesquisa hipotética, com estilos de redação diferentes. Ambos os termos foram analisados pela ferramenta Coh-Metrix Port, que avalia métricas linguísticas e acessibilidade textual. A análise indicou que os textos são complexos e exigem alta escolaridade para serem entendidos. Esses achados reforçam a percepção de que, no Brasil, os termos de consentimento podem ter sua real função comprometida e apontam a importância de modificar sua forma de elaboração.

Abstract The informed consent form informs clinical research patients about the nature of the research and their rights, formalizing their decision to participate; however, studies show that this document is written in a complex manner, compromising patient autonomy. Two consent forms from the same hypothetical research were developed with different writing styles and analyzed by the Coh-Metrix Port tool, which evaluates linguistic metrics and textual accessibility. Results showed that both texts were complex and required high schooling level to be understood. These findings reinforce the perception that consent forms may have their real function compromised and point to the importance of changing its elaboration.

Resumen El formulario de consentimiento informado tiene la finalidad de mostrar la naturaleza de la investigación y sus derechos al participante de la investigación clínica para formalizar su decisión de participar en el estudio. Los estudios indican que la redacción de este documento es compleja, lo que compromete la autonomía del participante. Para este estudio se redactaron dos formularios de consentimiento de una misma investigación hipotética, con diferentes estilos de escritura. Para el análisis de ambos formularios se utilizó la herramienta Coh-Metrix Port, que evalúa las métricas lingüísticas y la accesibilidad textual. Los resultados apuntaron a que los textos son complejos, lo que requiere un alto nivel de educación para su comprensión. Estos hallazgos coinciden que, en Brasil, los formularios de consentimiento pueden tener su finalidad comprometida y señalan la necesidad de modificar su forma de elaboración.

Digital photography in skin cancer screening by mobile units in remote areas of Brazil.

BACKGROUND: Non-melanoma skin cancer (NMSC) is one of the most common neoplasms in the world. Despite the low mortality rates, NMSC can still cause severe sequelae when diagnosed at advanced stages. Malignant melanoma, the third most common type of skin cancer, has more aggressive behavior and a worse prognosis. Teledermatology provides a new tool for monitoring skin cancer, especially in countries with a large area and unequal population distribution. This study sought to evaluate the performance of digital photography in skin cancer diagnosis in remote areas of Brazil. METHODS: A physician in a Mobile Prevention Unit (MPU) took four hundred sixteen digital images of suspicious lesions between April 2010 and July 2011. All of the photographs were electronically sent to two oncologists at Barretos Cancer Hospital who blindly evaluated the images and provided a diagnosis (benign or malignant). The absolute agreement rates between the diagnoses made by direct visual inspection (by the MPU physician) and through the use of digital imaging (by the two oncologists) were calculated. The oncologists' accuracy in predicting skin cancer using digital imaging was assessed by means of overall accuracy (correct classification rate), sensitivity, specificity and predictive value (positive and negative). A skin biopsy was considered the gold standard. RESULTS: Oncologist #1 classified 59 lesions as benign with the digital images, while oncologist #2 classified 27 lesions as benign using the same images. The absolute agreement rates with direct visual inspection were 85.8% for oncologist #1 (95% CI: 77.1-95.2) and 93.5% for oncologist #2 (95% CI: 84.5-100.0). The overall accuracy of the two oncologists did not differ significantly. CONCLUSIONS: Given the high sensitivity and PPV, Teledermatology seems to be a suitable tool for skin cancer screening by MPU in remote areas of Brazil.