Gerenciamento de dados de pesquisa, em pacientes com diagnóstico de câncer de pulmão, coletados sob regras de mascaramento e a sua implicação na prática clínica
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Data
2021-08-19
Autores
Lopes, Ricardo Aparecido
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Universidade Estadual Paulista (Unesp)
Resumo
Nas pesquisas envolvendo pacientes com neoplasia, muitos pesquisadores optam pela realização dos ensaios clínicos randomizados para demonstrar a eficácia de tratamentos. Esses tipos de estudo incluem grupos comparativos de pacientes. Um sistema de informação hospitalar nem sempre consegue atender a todas as modalidades de estudo, como exemplo o mascaramento do profissional e do paciente durante a pesquisa. A situação sugere um sistema independente, porém, as políticas de segurança precisam estar presentes garantindo a integridade e segurança dos dados. Objetivo: Disponibilizar um sistema web seguro, com perfis de acesso diferenciados entre aluno e professor, possibilitando o registro de informações sobre a Qualidade de Vida (QV) de pacientes com diagnóstico de câncer de pulmão, bem como quantificar esses dados para avaliação estatística. Materiais e Métodos: Em 2019, pesquisadores de várias especialidades do programa de Pós-graduação em Cirurgia e Medicina Translacional da Faculdade de Medicina de Botucatu (FMB), reuniram-se para discutir a respeito do gerenciamento de dados de QV de pacientes com diagnóstico de câncer de pulmão. A discussão previa uma produção técnica que foi dividida em duas fases: 1. Design Thinking (DT), a qual gerou dados sobre QV, 2. desenvolvimento de um aplicativo baseado no DT prevendo possíveis melhorias e mobilidade na coleta dos dados. Foi utilizado Unified Modeling Language (UML) para modelar o sistema, linguagem de programação PHP (framework Laravel), Ionic e Angular. Quanto ao banco de dados e servidor utilizou-se mysql no sistema operacional Linux Debian. Para obtenção dos dados de QV utilizou-se cinco questionários validados na literatura, comumente utilizados na avaliação desses participantes. Resultado: No plano de prototipação o objetivo de estruturar a aplicação web, transferindo para a prática o levantamento realizado na fase de planejamento, foi alcançado. Com isso o orientador teve condições de cadastrar os pesquisadores que conseguiram realizar a coleta dos dados de 19 pacientes: 10 mulheres e 9 homens. A média de idade foi de 64,19 com desvio padrão de 5,79. Foram apresentados os resultados dos escores finais dos 63 questionários preenchidos comprovando a eficácia do sistema. Conclusão: A metodologia aplicada no desenvolvimento contribuiu significativamente para o êxito da produção técnica demonstrando que os dados estão preparados para avaliação estatística. O produto pode ser expandido para outras modalidades de estudo duplo cego, porém, como é indicado a qualquer software de mercado, necessita de acompanhamento de profissionais da área de tecnologia da informação na avaliação contínua de performance e segurança para garantir o resultado proposto pela ferramenta.
In research involving patients with neoplasia, many researchers choose to conduct randomized clinical trials to demonstrate the effectiveness of treatments. These types of study include comparative groups of patients. A hospital information system is not always able to meet all study modalities, such as the blinding of the professional and the patient during the research. The situation suggests an independent system, however, security policies need to be present following ensuring data integrity and security. Objective: Provide a secure web system, with differentiated access profiles between student and professor, enabling the recording of information about the quality of life (QoL) of patients diagnosed with lung cancer, as well as quantifying these data for statistical evaluation. Materials and methods: In 2019, researchers from various specialties of the Postgraduate Program in Surgery and Translational Medicine of the Faculdade de Medicina de Botucatu (FMB), met to discuss the management of QoL data of patients diagnosed with lung cancer. The discussion provided for a technical production that was divided into two phases: 1. Design Thinking (DT), which generated data on QoL; 2. development of an application based on the DT predicting possible improvements and mobility in data collection. A Unified Modeling Language (UML) was used to model the system, PHP programming language (Laravel framework), and Ionic and Angular frameworks. As for the database and server, mysql was used in the Linux Debian operating system. To obtain the QoL data, five questionnaires validated in the literature, commonly used in the evaluation of these participants, were utilized. Result: In the prototyping plan, the objective of structuring the web application, transferring to practice the survey conducted in the planning phase, was achieved. With this, the advisor was able to register the researchers who managed to collect the data from 19 patients: 10 women and 9 men. The mean age was 64.19 with a standard deviation of 5.79. The results of the final scores of the 63 completed questionnaires proving the effectiveness of the system were presented. Conclusion: The methodology applied in the development contributed significantly to the success of the technical production, demonstrating that the data are prepared for statistical evaluation. The product can be expanded to other modalities of double-blind study; however, as indicated for any software on the market, it requires monitoring by professionals in the area of Information Technology in the continuous evaluation of performance and security to ensure the result proposed by the tool.
In research involving patients with neoplasia, many researchers choose to conduct randomized clinical trials to demonstrate the effectiveness of treatments. These types of study include comparative groups of patients. A hospital information system is not always able to meet all study modalities, such as the blinding of the professional and the patient during the research. The situation suggests an independent system, however, security policies need to be present following ensuring data integrity and security. Objective: Provide a secure web system, with differentiated access profiles between student and professor, enabling the recording of information about the quality of life (QoL) of patients diagnosed with lung cancer, as well as quantifying these data for statistical evaluation. Materials and methods: In 2019, researchers from various specialties of the Postgraduate Program in Surgery and Translational Medicine of the Faculdade de Medicina de Botucatu (FMB), met to discuss the management of QoL data of patients diagnosed with lung cancer. The discussion provided for a technical production that was divided into two phases: 1. Design Thinking (DT), which generated data on QoL; 2. development of an application based on the DT predicting possible improvements and mobility in data collection. A Unified Modeling Language (UML) was used to model the system, PHP programming language (Laravel framework), and Ionic and Angular frameworks. As for the database and server, mysql was used in the Linux Debian operating system. To obtain the QoL data, five questionnaires validated in the literature, commonly used in the evaluation of these participants, were utilized. Result: In the prototyping plan, the objective of structuring the web application, transferring to practice the survey conducted in the planning phase, was achieved. With this, the advisor was able to register the researchers who managed to collect the data from 19 patients: 10 women and 9 men. The mean age was 64.19 with a standard deviation of 5.79. The results of the final scores of the 63 completed questionnaires proving the effectiveness of the system were presented. Conclusion: The methodology applied in the development contributed significantly to the success of the technical production, demonstrating that the data are prepared for statistical evaluation. The product can be expanded to other modalities of double-blind study; however, as indicated for any software on the market, it requires monitoring by professionals in the area of Information Technology in the continuous evaluation of performance and security to ensure the result proposed by the tool.
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Palavras-chave
Sistema de informação na saúde, Qualidade de vida, Saúde móvel, Health information systems, Quality of life, Mobile health