title: Optimization of a Digital Medicine System in Psychiatry.
abstract: Nonadherence to medication compromises the effectiveness of psychiatric treatments in patients with serious mental illness (SMI). A newly developed digital medicine system (DMS) offers an opportunity to objectively assess and report patient medication adherence. DMS includes a wearable sensor that receives a data signal from a medication tablet with an embedded ingestible sensor after ingestion of the medication and transmits that data to the patient's mobile device to display health care information for the patient and treatment team.
  
  
  
  Development of a DMS requires a program that investigates safety, tolerability, and usability of the system in patients with SMI. It necessitates rapid design adaptation of the individual components and the integrated system and human factors studies with the intended users. This article describes the program's methodology and shows results from 3 early studies, conducted in 2013 and 2014, to illustrate diversity of the programs' methodology. First, a standard 28-day study showed minimal skin irritation and demonstrated acceptable wearability of the wearable sensor. Second, a 16-week study provided usability feedback from patients with SMI and caregivers to improve the mobile application. Third, end-to-end bench-level integrated system testing led to multiple substudies of a master protocol (ClinicalTrials.gov identifier: NCT02091882) to investigate various aspects of the system (eg, ingestible sensor detection and latency).
  
  
  
  To develop a DMS in psychiatry, the system's multiple components must be considered simultaneously using various methodologies. A focus on usability, along with agile evaluation and feedback across studies, provides an optimal strategy for ensuring patient acceptance and successful regulatory review.
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc, 508 Carnegie Center Blvd, Princeton, NJ 08540. shashank.rohatagi@otsuka-us.com.|Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, New Jersey, USA.
authors.forename: Shashank
authors.initials: S
authors.lastname: Rohatagi
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, New Jersey, USA.
authors.forename: Deborah
authors.initials: D
authors.lastname: Profit
authors.affiliation: ODH, Inc, Princeton, New Jersey, USA.
authors.forename: Ainslie
authors.initials: A
authors.lastname: Hatch
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, New Jersey, USA.
authors.forename: Cathy
authors.initials: C
authors.lastname: Zhao
authors.affiliation: ODH, Inc, Princeton, New Jersey, USA.
authors.forename: John P
authors.initials: JP
authors.lastname: Docherty
authors.affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, New Jersey, USA.
authors.forename: Timothy S
authors.initials: TS
authors.lastname: Peters-Strickland
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015374:Biosensing Techniques / Q000379:methods* / Q000592:standards; D001714:Bipolar Disorder / Q000188:drug therapy*; D004867:Equipment Design / Q000379:methods* / Q000592:standards; D005260:Female; D006801:Humans; D008297:Male; D008491:Medical Informatics Applications; D055118:Medication Adherence; D008875:Middle Aged; D063731:Mobile Applications / Q000592:standards; D010043:Outcome and Process Assessment, Health Care; D011570:Psychiatry / Q000379:methods; D013607:Tablets / Q000592:standards; D055815:Young Adult
chemical_list: D013607:Tablets