OP06 Development Of A Tool To Support The Collection Of Policy-Relevant, Stakeholder-Informed Clinical Evidence For Innovative Digital Health Technologies

Abstract

IntroductionThe number of studies on digital health technologies (DHTs) for remote treatment and patient self-management is increasing. Existing health technology assessment (HTA) frameworks for DHTs, which guide researchers in generating evidence suitable for HTA, do not cover all domains of the commonly used EUnetHTA Core Model, and DHT-specific considerations have not been informed by a large stakeholder preference study. Our aim was to develop a stakeholder prioritized, literature-informed checklist of DHT-specific considerations that aligns with the EUnetHTA model.MethodsWe conducted two systematic reviews to identify: (i) DHT evaluation frameworks published to March 2020 for content; and (ii) primary research on DHTs published from 1 January 2015 to 20 March 2020.Stakeholder prioritization of issues was performed using a best-worst scaling preference study among a broad cross-section of patients, carers, health professionals, and the general population in Australia, Canada, New Zealand, and the UK. Systematic review issues were prioritized and adapted for use as a practical checklist.ResultsDHT evaluation content was recommended by the 44 identified frameworks for 28 of the 145 issues in the EUnetHTA model and for 22 new DHT-specific issues. A coverage assessment of 112 clinical studies of remote treatment and self-management DHTs for patients with cardiovascular disease or diabetes revealed that less than half covered DHT-specific content in all but one domain, or traditional HTA content in clinical effectiveness and ethical analysis. The preference survey of 1,251 stakeholders identified broad agreement on the 12 most important DHT attributes, six of which were related to safety. The most important attribute was “helps health professionals respond quickly when changes in patient care are needed”, which is not a focus of existing DHT HTA frameworks.ConclusionsThe review identified mismatches in the content generated by DHT clinical studies and that required for DHT-specific HTAs. These findings informed the development of an extended checklist comprising 22 stakeholder-prioritized DHT-specific considerations, which are aligned with the EUnetHTA model and will help ensure the planning of DHT-specific research generates evidence suitable for HTA.