BACKGROUND
In the burgeoning area of clinical digital phenotyping research, there is a dearth of literature that details methodology, including the key challenges and dilemmas in developing and implementing a successful architecture for technological infrastructure, patient engagement, longitudinal study participation, and successful reporting and analysis of diverse passive and active digital data streams.
OBJECTIVE
This article provides a narrative rationale for our study design in the context of current evidence base and best practices with an emphasis on our initial lessons learned from the implementation challenges and successes of this study.
METHODS
We describe the specific study methodology we implemented for this study with an attention to synthesizing key literature and the reasoning for pragmatic adaptations in implemenating in a multi-site study encompassing distinct geographic and population settings.
RESULTS
We describe the feasibility of a multi-site digital phenotyping pilot study for patients with mood disorders, focused on the informatics framework for our study, practical learnings about study subject use of our hardware and software tools, and perceived strengths, weaknesses, opportunities, and barriers to success in implementing digital phenotyping research for mood disorders and other psychiatric conditions.
CONCLUSIONS
We leverage our experience with developing a pilot feasibility study to help academic and industry researchers and developers efficiently and effectively conceptualize and operationalize further digital phenotyping investigations in this promising area of mental health research. We believe the methodology described will be readily reproducible and generalizable to other study settings and patient populations.