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SACI Protocol: Preliminary Guidelines for the Development of Digital Health Technologies for Clinical Trials in Brazil

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E-Health Telecommunication Systems and Networks 2022年第3期11卷 85-100页

作者： Lídia Maria Lourençön Rodrigues Agia Jorge Luiz Dias Agia Rui Pedro Charters Lopes Rijo valdes roberto bollela Domingos Alves Department of Social Medicine Ribeir&#227 o Preto Medical School University of S&#227 o Paulo Ribeir&#227 o Preto Brazil Postgraduate Program in Production Engineering UNIP S&#227 o Paulo Brazil Polytechnic Institute of Leiria Leiria Portugal Department of Internal Medicine Ribeir&#227 o Preto Medical School University of S&#227 o Paulo Ribeir&#227 o Preto Brazil

In the last decade, evidence-based medical practice has been supported on a large scale by computerized decision support tools, aiming to reduce diagnostic and therapeutic uncertainty, complementing the actions of the health professional. With technological developments, it is now possible to consider these systems as part of clinical intervention, both for the diagnosis and treatment of diseases. The literature has described the implementation of e-health tools, that is, technological innovations in the health area such as software, applications, serious games, among others, as a strategy to improve the process and adherence to treatment. However, there is still no standardized instrument in Brazil that can be used to guide the development, from the research phase, and the implementation of these tools as a health intervention, also impacting patient outcomes. With the objective of investigating a new therapeutic and preventive form, based on intervention with a computerized system, this work proposes the creation of guidelines for the registration and implementation of e-health tools as a clinical intervention. The proposal aims to be able to assist in the reporting standardization from the development stage to the application of the e-health tool helping in the treatment of diseases, registering all the experience lived in the research and applying it in different contexts of health.

关键词： Reporting Guidelines Clinical Trials Digital Health E-Health

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SACI Protocol: Preliminary Guidelines for the Development of Digital Health Technologies for Clinical Trials in Brazil

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E-Health Telecommunication Systems and Networks（远程医疗系统和网络） 2022年第3期

作者： lídia maria lourençön rodrigues agia jorge luiz dias agia rui pedro charters lopes rijo valdes roberto bollela domingos alves

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