title: Tracking medication changes to assess outcomes in comparative effectiveness research: A bipolar CHOICE study.
abstract: Comparative effectiveness research uses multiple tools, but lacks outcome measures to assess large electronic medical records and claims data. Aggregate changes in medications in response to clinical need may serve as a surrogate outcome measure. We developed the Medication Recommendation Tracking Form (MRTF) to record the frequency, types, and reasons for medication adjustments in order to calculate Necessary Clinical Adjustments (NCAs), medication adjustments to reduce symptoms, maximize treatment response, or address problematic side effects.
  
  
  
  The MRTF was completed at every visit for 482 adult patients in Bipolar CHOICE, a 6-month randomized comparative effectiveness trial.
  
  
  
  Responders had significantly fewer NCAs compared to non-responders. NCAs predicted subsequent response status such that every additional NCA during the previous visit decreased a patient's odds of response by approximately 30%. Patients with more severe symptoms had a greater number of NCAs at the subsequent visit. Patients with a comorbid anxiety disorder demonstrated a significantly higher rate of NCAs per month than those without a comorbid anxiety disorder. Patients with greater frequency, intensity, and interference of side effects had higher rates of NCAs. Participants with fewer NCAs reported a higher quality of life and decreased functional impairment.
  
  
  
  The MRTF has not been examined in community clinic settings and did not predict response more efficiently than the Clinical Global Impression-Bipolar Version (CGI-BP).
  
  
  
  The MRTF is a feasible proxy of clinical outcome, with implications for clinical training and decision-making. Analyses of big data could use changes in medications as a surrogate outcome measure.
authors.affiliation: Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States. Electronic address: nharrington11@mgh.harvard.edu.
authors.forename: Noreen A
authors.initials: NA
authors.lastname: Reilly-Harrington
authors.affiliation: Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
authors.forename: Louisa G
authors.initials: LG
authors.lastname: Sylvia
authors.affiliation: Biostatistics Center, Massachusetts General Hospital, Boston, MA, United States.
authors.forename: Dustin J
authors.initials: DJ
authors.lastname: Rabideau
authors.affiliation: Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States.
authors.forename: Alexandra K
authors.initials: AK
authors.lastname: Gold
authors.affiliation: Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
authors.forename: Thilo
authors.initials: T
authors.lastname: Deckersbach
authors.affiliation: Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, United States.
authors.forename: Charles L
authors.initials: CL
authors.lastname: Bowden
authors.affiliation: Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, United States.
authors.forename: William V
authors.initials: WV
authors.lastname: Bobo
authors.affiliation: Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, United States.
authors.forename: Vivek
authors.initials: V
authors.lastname: Singh
authors.affiliation: Bipolar Disorders Research Center, University Hospital's Case Medical Center, Case Western Reserve University, Cleveland, OH, United States.
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Calabrese
authors.affiliation: Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, United States.
authors.forename: Richard C
authors.initials: RC
authors.lastname: Shelton
authors.affiliation: Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.
authors.forename: Edward S
authors.initials: ES
authors.lastname: Friedman
authors.affiliation: Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA, United States.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Thase
authors.affiliation: Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.
authors.forename: Masoud
authors.initials: M
authors.lastname: Kamali
authors.affiliation: Department of Psychiatry, University of New Mexico, Health Sciences Center, Albuquerque, NM, United States.
authors.forename: Mauricio
authors.initials: M
authors.lastname: Tohen
authors.affiliation: Department of Psychiatry, University of Michigan, Ann Arbor, MI, United States.
authors.forename: Melvin G
authors.initials: MG
authors.lastname: McInnis
authors.affiliation: Lindner Center of HOPE, Mason, OH, United States; Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, OH, United States.
authors.forename: Susan L
authors.initials: SL
authors.lastname: McElroy
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, United States.
authors.forename: Terence A
authors.initials: TA
authors.lastname: Ketter
authors.affiliation: Department of Psychiatry, Weill Cornell Medical College of Cornell University, New York, NY, United States.
authors.forename: James H
authors.initials: JH
authors.lastname: Kocsis
authors.affiliation: Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
authors.forename: Gustavo
authors.initials: G
authors.lastname: Kinrys
authors.affiliation: Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
authors.forename: Andrew A
authors.initials: AA
authors.lastname: Nierenberg
mesh_terms: D000328:Adult; D000368:Aged; D018692:Antimanic Agents / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000175:diagnosis / Q000178:diet therapy*; D002755:Choice Behavior; D057186:Comparative Effectiveness Research; D003657:Decision Making; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011788:Quality of Life; D055815:Young Adult
chemical_list: D018692:Antimanic Agents; D014150:Antipsychotic Agents
keywords: Big data; Bipolar disorder; Comparative effectiveness; Electronic medical record; Medication