Previously submitted to: JMIR Formative Research (no longer under consideration since Mar 31, 2023)
Date Submitted: Oct 15, 2022
Open Peer Review Period: Oct 14, 2022 - Oct 21, 2022
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Development of a Value Assessment and Integration Guide for Digital Therapeutics
ABSTRACT
Digital therapeutics have potential to transform healthcare, but they have low adoption. One of the impediments to broader adoption of DTx is lack of standardization of coding, coverage, and reimbursement. There is also a need to standardize the way we discuss and assess outcomes from the use of DTx. The Digital Therapeutics Alliance (DTA) developed the Value Assessment and Integration Guide (Guide) to provide Healthcare Decision Makers (HCDMs) with a framework to evaluate the value of and enable the implementation of DTx in clinical practice. In this mixed-methods study, authors aimed to determine the Guide's usefulness and to transparently characterize the development process of the Guide. DTA initially developed a first draft of the Guide based on internal staff and DTA member organization subject matter expertise. Authors subsequently sought HCDMs’ input on the Guide through surveys, workshops, and interviews. Authors used a purposive sampling method to capture HCDM perspectives from a wide range of disciplines. Across the survey, workshops, and interviews, there were 420 discrete pieces of feedback or responses collected. Pieces of feedback included responses to survey questions and discrete comments captured during workshops or interviews. This mixed-methods study found that the Guide was generally well-designed with high quality content and iteratively improved from feedback from a robust albeit not fully representative group of HCDMs. The process for the Guide development was made transparent with the characterization of the five phases of Guide development including a summary of findings from each phase. More research is needed to address some of the limitations of this study as well as to understand adoption and utility of the Guide after it is publicly launched.
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