A Value Framework to Assess Patient-Facing Digital Health Technologies That Aim to Improve Chronic Disease Management: A Delphi Approach.

Digital health technologies (DHTs) can optimise healthcare costs and improve quality and efficiency of care. However, the fast-paced rate of innovation and varying evidence standards can make it difficult for decision-makers to assess these technologies in an efficient and evidence-based manner. We sought to develop a comprehensive framework to assess the value of novel patient-facing DHTs used to manage chronic diseases by eliciting stakeholder value preferences. Literature review and primary data collection from a three-round web-Delphi exercise was utilized. 79 participants from 5 stakeholder groups (patients, physicians, industry, decision makers, and influencers) and 3 countries (United States of America, United Kingdom, and Germany) took part. Likert scale data were statistically analyzed to determine intergroup differences in both country and stakeholder groups, stability of results, and overall consensus. The resulting co-created framework comprised 33 stable indicators with consensus from quantitative value judgments across domains: health inequalities, data rights and governance, technical and security, economic characteristics, clinical characteristics, and user preferences. Lack of stakeholder consensus was observed on the importance of value-based care models, optimizing resources for sustainable systems, and stakeholder involvement in DHT design, development, and implementation; however, this was because of high rates of neutrality and not negative judgments. Supply-side actors and academic experts were the most unstable stakeholder groups. Stakeholder value judgments revealed a need for a coordinated regulatory and health technology assessment policy response that updates laws to meet technological innovations, offers a pragmatic approach to evidence standards to assess DHTs, and involves stakeholders to understand and meet their needs. • Digital health technologies (DHTs) differ from traditional medical technologies because they involve widespread, and sometimes continuous, collection, analysis, and transmission of patient data after market entry. There is currently no technology-agnostic wide-reaching value framework for evaluating DHTs, capturing multiple stakeholder value preferences in different health system archetypes. Through a Delphi exercise, we incorporated diverse stakeholder viewpoints from the United Kingdom, United States, and Germany to propose an evidence-based value framework for assessing patient-facing DHTs focused on chronic disease management. • Statistically significant stakeholder consensus relates to clinical and economic characteristics, which align with current regulations and health technology assessment methodologies and around value indicators that are not reflected in current regulations and health technology assessment policies, particularly regarding personal data rights. Lack of stakeholder consensus centers around the importance of value-based care models, optimizing resources for sustainable systems, and stakeholder involvement in DHT design, development, and implementation and results from high rates of neutrality rather than negative judgments. • We have created a value framework comprising 33 stable indicators with consensus across 6 value domains, notably health inequalities, data rights and governance, technical and security, economic characteristics, clinical characteristics and user preferences. Included indicators are split between ratings of "very important" and "important" resulting from consensus between key stakeholder groups consisting of patients, physicians, supply-side actors, decision makers, and influencers. Decision makers can utilize this framework when assessing potential technologies to include in their health system packages. [ABSTRACT FROM AUTHOR]