title: Development of a patient-reported outcome instrument to assess complex activities of daily living and interpersonal functioning in persons with mild cognitive impairment: The qualitative research phase.
abstract: BACKGROUND
  As drug development research efforts move toward studying patients earlier in the course of Alzheimer's disease (AD), it is important to incorporate the patient's perspective into measurement of outcomes.
  
  
  METHODS
  This article summarizes the qualitative work of the Patient-Reported Outcome Consortium's Cognition Working Group in the development of a new self-reported outcome measure in persons with mild cognitive impairment (MCI) due to suspected AD, herein referred to as MCI.
  
  
  RESULTS
  The draft measure captures the patient's voice for two functional domains, complex activities of daily living and interpersonal functioning.
  
  
  CONCLUSIONS
  This work represents a series of initial steps in the development of this rating scale. The next steps are to conduct psychometric analysis and evaluate the role of insight.
authors.affiliation: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA. Electronic address: mark.gordon@boehringer-ingelheim.com.
authors.forename: Mark Forrest
authors.initials: MF
authors.lastname: Gordon
authors.affiliation: Evidera, formerly United BioSource Corporation (UBC), Lexington, MA, USA.
authors.forename: William R
authors.initials: WR
authors.lastname: Lenderking
authors.affiliation: Xcenda, Palm Harbor, FL, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Duhig
authors.affiliation: Merck, Kenilworth, NJ, USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Chandler
authors.affiliation: Outcometrix, Tucson, AZ, USA.
authors.forename: J Jason
authors.initials: JJ
authors.lastname: Lundy
authors.affiliation: Bracket, Wayne, PA, USA.
authors.forename: David S
authors.initials: DS
authors.lastname: Miller
authors.affiliation: Genentech, South San Francisco, CA, USA.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Piault-Louis
authors.affiliation: Alzheimer's Disease and Memory Disorders Center, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Rachelle S
authors.initials: RS
authors.lastname: Doody
authors.affiliation: University of California, San Diego, School of Medicine, San Diego, CA, USA.
authors.forename: Douglas
authors.initials: D
authors.lastname: Galasko
authors.affiliation: McGill Centre for Studies in Aging, Montreal, Canada.
authors.forename: Serge
authors.initials: S
authors.lastname: Gauthier
authors.affiliation: Patient-Centered Outcomes Research Institute (PCORI), Washington, D.C, USA.
authors.forename: Lori
authors.initials: L
authors.lastname: Frank
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000523:psychology; D060825:Cognitive Dysfunction / Q000523:psychology*; D005260:Female; D006801:Humans; D007398:Interpersonal Relations; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests / Q000592:standards; D063868:Patient Outcome Assessment; D036301:Qualitative Research; D057566:Self Report
keywords: Activities of daily living; Alzheimer's disease; Cognition; Critical Path Institute; Interpersonal functioning; Mild cognitive impairment; Patient-reported outcome; Qualitative