Mark Forrest Gordon1, William R Lenderking2, Amy Duhig3, Julie Chandler4, J Jason Lundy5, David S Miller6, Elisabeth Piault-Louis7, Rachelle S Doody8, Douglas Galasko9, Serge Gauthier10, Lori Frank11. 1. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA. Electronic address: mark.gordon@boehringer-ingelheim.com. 2. Evidera, formerly United BioSource Corporation (UBC), Lexington, MA, USA. 3. Xcenda, Palm Harbor, FL, USA. 4. Merck, Kenilworth, NJ, USA. 5. Outcometrix, Tucson, AZ, USA. 6. Bracket, Wayne, PA, USA. 7. Genentech, South San Francisco, CA, USA. 8. Alzheimer's Disease and Memory Disorders Center, Baylor College of Medicine, Houston, TX, USA. 9. University of California, San Diego, School of Medicine, San Diego, CA, USA. 10. McGill Centre for Studies in Aging, Montreal, Canada. 11. Patient-Centered Outcomes Research Institute (PCORI), Washington, D.C, USA.
Abstract
INTRODUCTION: 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. DISCUSSION: 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.
INTRODUCTION: 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. DISCUSSION: 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: Arenda Mank; Ingrid S van Maurik; Els D Bakker; Esther M M van de Glind; Linus Jönsson; Milica G Kramberger; Petr Novak; Ana Diaz; Dianne Gove; Philip Scheltens; Wiesje M van der Flier; Leonie N C Visser Journal: Alzheimers Dement (N Y) Date: 2021-08-20