Journal
JOURNAL OF MEDICAL INTERNET RESEARCH
Volume 17, Issue 7, Pages -Publisher
JMIR PUBLICATIONS, INC
DOI: 10.2196/jmir.4391
Keywords
mHealth; eHealth; clinical trials; methodology
Funding
- United States National Institutes of Health [P20 MH090318, R01 MH095753, R01 MH100482, R34 MH095907, P30DA027828, R01MH040859, R01 NS072127, K08 MH102336, F31 MH106321]
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In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology.
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