Progress in health-related behavioral intervention research: Making it, measuring it, and meaning it.

Freedland, Kenneth E.

doi:10.1037/hea0001160

Cited by 7 publications

(8 citation statements)

References 96 publications

(118 reference statements)

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“…This approach is used because of 2 known issues with small sample trials within formative work. First, small samples render the use of frequentist inferential statistics problematic [ 60 , 81 , 82 ]. Second, humans have confirmation bias, which refers to the tendency for individuals to seek out or interpret evidence in ways that align with previous beliefs, expectations, or hopes [ 83 ].…”

Section: The Dtx Rwe Frameworkmentioning

confidence: 99%

The Digital Therapeutics Real-World Evidence Framework: An Approach for Guiding Evidence-Based Digital Therapeutics Design, Development, Testing, and Monitoring

Kim,

Patrick,

Nebeker

et al. 2024

J Med Internet Res

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Digital therapeutics (DTx) are a promising way to provide safe, effective, accessible, sustainable, scalable, and equitable approaches to advance individual and population health. However, developing and deploying DTx is inherently complex in that DTx includes multiple interacting components, such as tools to support activities like medication adherence, health behavior goal-setting or self-monitoring, and algorithms that adapt the provision of these according to individual needs that may change over time. While myriad frameworks exist for different phases of DTx development, no single framework exists to guide evidence production for DTx across its full life cycle, from initial DTx development to long-term use. To fill this gap, we propose the DTx real-world evidence (RWE) framework as a pragmatic, iterative, milestone-driven approach for developing DTx. The DTx RWE framework is derived from the 4-phase development model used for behavioral interventions, but it includes key adaptations that are specific to the unique characteristics of DTx. To ensure the highest level of fidelity to the needs of users, the framework also incorporates real-world data (RWD) across the entire life cycle of DTx development and use. The DTx RWE framework is intended for any group interested in developing and deploying DTx in real-world contexts, including those in industry, health care, public health, and academia. Moreover, entities that fund research that supports the development of DTx and agencies that regulate DTx might find the DTx RWE framework useful as they endeavor to improve how DTxcan advance individual and population health.

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Section: The Dtx Rwe Frameworkmentioning

confidence: 99%

The Digital Therapeutics Real-World Evidence Framework: An Approach for Guiding Evidence-Based Digital Therapeutics Design, Development, Testing, and Monitoring

Kim,

Patrick,

Nebeker

et al. 2024

J Med Internet Res

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show abstract

“…If psychiatric treatment success rate data systems were available, they would show us that it is difficult to improve clinical ASRs by de-vising new interventions for patients who are potentially responsive to existing ones. 5 The key to improving ASRs is to develop effective interventions for patients who do not respond to existing ones, and one of the keys to that is to design adaptive interventions and stepwise treatment algorithms in which scalable, costeffective treatments occupy the first step. The subsequent steps may be more expensive and less scalable, but they target (and are reserved for) patients who either do not respond to first-step treatments or are too severely ill to delay more intensive or specialized care.…”

Section: Using Success Rate Data To Accelerate Progressmentioning

confidence: 99%

Success Rates in Psychiatry

Freedland

Zorumski

2023

JAMA Psychiatry

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“…For example, monitoring work could be used to identify likely new populations or settings or areas for improvement of the DTx, particularly if done with other clinical/community partners. For this work, ideas from agile science, particularly the notion of usable evidence production related to evidence production for DTx elements, could be of value and interest here 46,48,82,86,87 . Standards for ongoing monitoring of RWD and RWE are emerging, thus, this is a critical area for continued work and refinement on defining expectations and standards.…”

Section: Dtx Elements To Improve? Is There a Broader Target Market?mentioning

confidence: 99%

The Digital Therapeutics Real World Evidence Framework: An approach for guiding evidence-based DTx design, development, testing, and monitoring

Kim¹,

Patrick²,

Nebeker³

et al. 2022

Preprint

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Digital Therapeutics (DTx) are increasingly seen as a promising way to provide safe, effective, accessible, sustainable, scalable, and equitable approaches to advance individual and population health. Developing DTx is inherently complex in that DTx may include multiple interacting components, such as tools to support activities like medication adherence, health behavior goal-setting or self-monitoring, and algorithms that adapt the provision of these according to individual needs. As recommended in a recent worldwide review of regulatory approaches for DTx, a way to address this complexity is to base the design, development, testing, and iterative improvements of DTx on real-world evidence (RWE). Notably, that review highlights the need for improved guidance on when and how to use RWE for DTx. In this paper, we propose the DTx RWE Framework to provide a pragmatic, iterative, milestone-driven approach for producing RWE for DTx regulation. The DTx RWE Framework is based on best practices from human-centered design, optimization trials for behavioral interventions, behavioral health research, and implementation science. It maps these onto the traditional four phase development model for pharmaceuticals but includes key adaptations relevant to RWE production for DTx, such as including early and ongoing partnerships between developers of DTx and their intended users in clinical and/or community settings. Adoption of our DTx RWE Framework may help address known problems with current DTx, including questionable marketing claims, lack of evidence-based guidance for patients, providers, and health care leaders and the need to improve economic incentives that advance the adoption and use of DTx.

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Progress in health-related behavioral intervention research: Making it, measuring it, and meaning it.

Cited by 7 publications

References 96 publications

The Digital Therapeutics Real-World Evidence Framework: An Approach for Guiding Evidence-Based Digital Therapeutics Design, Development, Testing, and Monitoring

The Digital Therapeutics Real-World Evidence Framework: An Approach for Guiding Evidence-Based Digital Therapeutics Design, Development, Testing, and Monitoring

Success Rates in Psychiatry

The Digital Therapeutics Real World Evidence Framework: An approach for guiding evidence-based DTx design, development, testing, and monitoring

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