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

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.

Keywords: Activities of daily living; Alzheimer's disease; Cognition; Critical Path Institute; Interpersonal functioning; Mild cognitive impairment; Patient-reported outcome; Qualitative.