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

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.