Development Of A Patient-Reported Outcome (Pro) Instrument To Assess Complex Activities Of Daily Living And Interpersonal Functioning In Patients With Mild Cognitive Impairment Due To Suspected Alzheimer'S Disease: The Qualitative Research Phase

OBJECTIVE: The Cognition Working Group (WG) of the Critical Path Institute9s Patient-Reported Outcome (PRO) Consortium is developing a PRO instrument for qualification by FDA as a “fit for purpose” endpoint in clinical trials of patients with MCI due to AD. BACKGROUND: Most existing outcome measures for patients on the Alzheimer9s spectrum were developed to assess impairment in Alzheimer9s disease (AD) and have not been validated for use in those with mild cognitive impairment (MCI) due to suspected AD. In addition, clinical assessments may lack sensitivity to detect subtle cognitive decline. The WG identified complex activities of daily living (CADL) and interpersonal functioning (IF) as areas where existing measures are not adequate. DESIGN/METHODS: The WG conducted qualitative research involving semi-structured interview focus groups in patients with MCI due to suspected AD (n=25) or AD (n=40), controls (n=14), and informants (n=65). Concepts important to patients were elicited regarding their functioning. The WG and an expert panel evaluated the incorporation of these patient-generated concepts into two scales: Complex Activities of Daily Living (CADLs) and Interpersonal Functioning (IF). To document the insight of patients into their symptoms, 22 1:1 interviews with dyads (n=11 dyads) were conducted to simultaneously compare informant and patient (MCI or AD) reports about specific scenarios reflecting CADLs and IF. RESULTS: During the interviews, MCI patients and informants showed concordance in describing specific concerns relevant to CADLs and IF, suggesting the reliability and validity of patient reports for these domains. This work supports the conceptual framework9s core domains, CADLs and IF. The dyad interviews demonstrated that MCI patients retain insight regarding their deficits, as indicated by parallel descriptions of impairments from informants. CONCLUSIONS: The Cognition WG9s draft PRO instrument incorporates the patient9s perspective. Following demonstration of its content validity, the instrument will undergo quantitative testing to evaluate its psychometric properties. Disclosure: Dr. Gordon has received personal compensation for activities with Boehringer-Ingelheim Pharmaceuticals, Inc., as an employee. Dr. Duhig has received personal compensation for activities with Abbott Laboratories as an employee. Dr. Duhig holds stock and/or stock options in Abbott Laboratories. Dr. Chandler has received personal compensation for activities with Merck and Co as an employee. Dr. Lenderking hs received personal compensation for activities with United Biosource Corporation as an employee. Dr. Lenderking holds stock in Pfizer Inc.