Table 2.
Challenge | Key Points | Suggestions for Addressing Challenges |
---|---|---|
Commercial apps and devices lack evidence | Limited use of evidence-based behavior change techniques in the design of features; lack of rigorous testing for efficacy or effectiveness on clinical outcomes | Extended efforts to evaluate the usability and efficacy of commercial tools; partnerships between academia and industry to develop and evaluate tools, which will result in more effective, useful, and marketable products |
Current evaluation methods do not match the needs for determining the effectiveness of digital health tools | RCTs test full intervention packages at the group level, which do not test individual components of interventions or mechanisms of action, and do not allow for iterative improvements; lack of appropriate control conditions; limited opportunities to publish on studies with alternative designs (e.g., N-of-1) | Use of MOST framework and innovative trial designs such as SMART, N-of-1, etc.; increased publishing outlets for alternative research designs |
Current evaluation methods do not match the needs for determining the effectiveness of digital health tools | RCTs test full intervention packages at the group level, which do not test individual components of interventions or mechanisms of action, and do not allow for iterative improvements; lack of appropriate control conditions; limited opportunities to publish on studies with alternative designs (e.g., N-of-1) | Use of MOST framework and innovative trial designs such as SMART; greater us of N-of-1 designs in lieu of traditional pilot and feasibility trials; increased publishing outlets for N-of-1 and other non-traditional research designs. |
No science of engagement | Engagement is not well-defined or consistently measured across studies; optimal engagement (amount, type, individual or contextual differences) is unknown | Development of definitions and measures; research to identify meaningful engagement and how to nurture it; consistent reporting of engagement in published research; funding for studies with engagement as an endpoint in its own right |
An unknown landscape of privacy and data security | Protecting privacy of both participants and bystanders; commercial tools request unnecessary data and have been vulnerable to data breaches | Greater researcher understanding of privacy and security agreements; responsibility of researchers to fully inform participants of potential risks of using technologies; reaching out to or partnering with industry to create ethical guidelines for research; use of CORE research resources for study design. |
Principles vs. technologies | Technology evolves much more quickly than research to develop and evaluate it; researchers develop and evaluate individual tools that rarely reach the market | Designing APIs and designing/evaluating tool-agnostic interventions |
Note: RCT = randomized controlled trial; MOST = multiphase optimization strategy; SMART = sequential multiple assignment randomized trials; I-Corps = Innovation Corps (National Institutes of Health); CORE = Connected and Open Research Ethics initiative (https://thecore.ucsd.edu/)