Saturday, April 20, 2024

The Rise of Digital Therapeutics and the Development of the Machine Learning Framework

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Digital therapeutics has emerged as a novel approach to disease management and treatment, shifting care delivery to become more patient-centered, data-driven, and reliant on real-time information. The digital transformation has brought about significant changes in the healthcare sector, with the introduction of innovative digital technologies. These technological advancements can result in improved patient outcomes and are a much-needed support for healthcare professionals, especially considering the scarcity of resources. As these digital technologies continue to evolve, there is an increased need for the healthcare sector to integrate them into their processes to reap their benefits.

A study has been undertaken to develop a framework for the development and assessment of digital therapeutics. It was conducted using a mixed methodology, analyzing 338 studies on digital therapeutics obtained via a systematic literature review. Descriptive statistics using RStudio and machine learning algorithms were applied to analyze the variables and find patterns in the data. The findings of these analyses were summarized in a framework that was then qualitatively tested and validated through expert opinion elicitation.

Digital Therapeutics

Pioneering A Framework for the Next Generation of Digital Therapeutics Development and Evaluation

The research has led to the development of M-LEAD, a Machine Learning-Enhanced Assessment and Development framework. This framework offers best practices for developing and assessing digital therapeutics. It considers inputs such as characteristics of digital therapeutic, regulatory aspects, study purpose, and assessment domains to produce recommendations for designing the digital therapeutic study characteristics.

The framework is a significant first step towards standardized guidelines for the development and assessment of digital therapeutic. The results of the research can support manufacturers and provide valuable information to decision-makers about the relevant results of the digital therapeutic assessment.

 

Original Article DOI: 10.1186/s12913-024-10702-z

Original title: Rewiring care delivery through Digital Therapeutics (DTx): a machine learning-enhanced assessment and development (M-LEAD) framework

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