RESUMO
The effectiveness of digital care applications in people with need of home care: A systematic review Abstract: Background: The growing need for long-term care poses challenges for healthcare systems. In June 2021, digital care applications (DiPA) were introduced as a new service in the statutory long-term care insurance in Germany. Their aim is to counteract the increased care need and/or support independence in the home. Aim: This project systematically identified and reported on national and international evidence on DiPA effectiveness, as described by the Federal Institute for Drugs and Medical Devices (BfArM). Methods: The systematic review was conducted in accordance with the PRISMA statement by means of systematic searches in the databases Medline and Cinahl, and supplemented by an extensive manual search (08/2022). Study quality was assessed using the Risk of Bias Tool (RoB2). The results were synthesized narratively. Results: Eight randomized controlled studies were included; improvements in cognition, activities of daily living, and mobility in home care patients, were reported. Study quality was low to moderate, due to mostly unblinded study designs and low case numbers. Conclusions: The currently available evidence fails to provide a reliable basis for assessing the benefits of DiPA, to neither DiPA manufacturers, nor to responsible parties in the healthcare system. Further research on DiPA effectiveness, particularly with high-quality studies, are necessary to assess its potential in the German care sector.
RESUMO
BACKGROUND: With its digital health application (DiGA)-system, Germany is considered one of Europe's pioneers in the field of evidence-based digital health. Incorporating DiGA into standard medical care must be based on evidence-based success factors; however, a comprehensive overview of the evidence required of scientific studies for their approval is lacking. OBJECTIVE: The study aims to, (1) identify specific requirements defined by the Federal Institute for Drugs and Medical Devices (German: Bundesinstitut für Arzneimittel- und Medizinprodukte; BfArM) to design adequate studies, proving a positive healthcare effect, and (2) to assess the evidence given for applications permanently listed in the DiGA directory. METHODS: A multi-step approach was used: (1) identification of the evidence requirements for applications permanently listed in the DiGA directory, (2) identification of the evidence available supporting them. RESULTS: All DiGA permanently listed in the DiGA directory (13 applications) are included in the formal analysis. Most DiGA addressed mental health (n = 7), and can be prescribed for one or two indications (n = 10). All permanently listed DiGA have demonstrated their positive healthcare effect through a medical benefit, and most of them provide evidence for one defined primary endpoint. All DiGA manufacturers conducted a randomized controlled trial. DISCUSSION: It is striking that- although patient-relevant structural and procedural improvements show high potential for improving care, especially in terms of processes - all DiGA have provided a positive care effect via a medical benefit. Although BfArM accepts study designs with a lower level of evidence for the proof of a positive healthcare effect, all manufacturers conducted a study with a high level of evidence. CONCLUSION: The results of this analysis indicate that permanently listed DiGA meet higher standards than required by the guideline.