Impact of digital therapeutics for the management of chronic diseases: systematic review

Context Nowadays, the increasing number of patients affected by metabolic, cardiovascular, and pulmonary chronic diseases represents one of the major challenges for National Health Systems. Chronic illnesses are the leading cause of hospitalisation, particularly among the elderly, posing sustainability issues due to the massive quantity of resources required. The development of digital health provides a new model for managing this type of health condition, which has improved the management of these patients and reduced the related healthcare direct and indirect costs. The development of digital health has provided a new management tool for chronic conditions. Digital therapeutics (DTx) are a subset of Digital Health. They are evidence-based therapeutic interventions driven by high-quality software programs designed to prevent, manage, or treat medical disorders or diseases. DTx can be used through web-based portals or smartphone applications, which allows patients to self-care and lifestyle interventions to actively engage in the management of their clinical condition. Methods This systematic review aims to synthesise recent literature on Digital Therapeutics to investigate their impact in terms of clinical effectiveness and/or cost-effectiveness in the treatment of chronic diseases. We systematically searched 4 databases (PubMed, Web of Science, Elsevier, and Scopus) to identify articles on DTx published in the last five years (2017 to 2022), in accordance with the PRISMA guidelines. We have selected only randomised controlled trials (RCTs) studies about DTx designed for chronic disease management by identifying their effectiveness in terms of efficacy and cost outcomes. We have included only studies in English. For the appraisal of the risk of bias, we have used the Risk of Bias 2 Tool for RCT studies. The included studies were narratively summarised by categorising the DTx according to the chronic diseases they were applied to. Results We retrieved 195 articles, out of which fourteen studies met the inclusion criteria and were included in the review. In all the included studies, the intervention group used DTx for the treatment of chronic diseases, while the control group received standard treatments without DTx. There are limited evidence on the cost-effectiveness of DTx, with only two articles meeting the inclusion criteria. In all the included studies, the DTx group showed significant evidence of improved patient parameters, reduced rehospitalisations, and decreased utilisation of healthcare providers, resulting in a reduction of costs in the management of chronic disease patients. The methodological quality assessment revealed moderate to high risks of bias, especially because blinding of patients was not possible due to the nature of the intervention. This may have introduced some bias in the studies included in the review. 189 Discussion This systematic review provides evidence for the impact of Digital Therapeutics in the management of chronic diseases. The introduction of DTx has been shown to result in a significant reduction in costs and an increase in the effectiveness and adherence of care, leading to an overall improvement in the quality of life of patients compared to standard care. DTx is an emerging area, especially in the postpandemic scenario, due to its potential role in patient self-management by providing evidence-based and personalised external support to chronic disease patients. Based on the results, an appropriate health technology assessment framework would be a valuable tool to evaluate these products.