title: Use of automated medication adherence monitoring in bipolar disorder research: pitfalls, pragmatics, and possibilities.
abstract: OBJECTIVE
  Medication nonadherence occurs in 20-60% of persons with bipolar disorder (BD) and is associated with serious negative outcomes, including relapse, hospitalization, incarceration, suicide and high healthcare costs. Various strategies have been developed to measure adherence in BD. This descriptive paper summarizes challenges and workable strategies using electronic medication monitoring in a randomized clinical trial (RCT) in patients with BD.
  
  
  METHODS
  Descriptive data from 57 nonadherent individuals with BD enrolled in a prospective RCT evaluating a novel customized adherence intervention versus control were analyzed. Analyses focused on whole group data and did not assess intervention effects. Adherence was assessed with the self-reported Tablets Routine Questionnaire and the Medication Event Monitoring System (MEMS).
  
  
  RESULTS
  The majority of participants were women (74%), African American (69%), with type I BD (77%). Practical limitations of MEMS included misuse in conjunction with pill minders, polypharmacy, cost, failure to bring to research visits, losing the device, and the device impacting baseline measurement. The advantages were more precise measurement, less biased recall, and collecting data from past time periods for missed interim visits.
  
  
  CONCLUSIONS
  Automated devices such as MEMS can assist investigators in evaluating adherence in patients with BD. Knowing the anticipated pitfalls allows study teams to implement preemptive procedures for successful implementation in BD adherence studies and can help pave the way for future refinements as automated adherence assessment technologies become more sophisticated and readily available.
authors.affiliation: Department of Psychiatry, Case Western Reserve University School of Medicine, 10524 Euclid Avenue, Cleveland, OH, 44106 USA.
authors.forename: Jennifer B
authors.initials: JB
authors.lastname: Levin
authors.affiliation: Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
authors.forename: Johnny
authors.initials: J
authors.lastname: Sams
authors.affiliation: Neurological and Behavioral Outcomes Center, University Hospitals Case Medical Center, Cleveland, OH, USA.
authors.forename: Curtis
authors.initials: C
authors.lastname: Tatsuoka
authors.affiliation: Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
authors.forename: Kristin A
authors.initials: KA
authors.lastname: Cassidy
authors.affiliation: Department of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
authors.forename: Martha
authors.initials: M
authors.lastname: Sajatovic
keywords: bipolar disorder; medication adherence; randomized controlled trial