Key points are not available for this paper at this time.
Objective: To evaluate the psychometric properties and establish meaningful within-patient change (MWPC) thresholds of the Activity Impairment in Migraine-Diary (AIM-D) Performance of Daily Activities (PDA) and Physical Impairment (PI) domain scores, using data collected in a chronic migraine (CM) trial. Background: The AIM-D is a novel, 11-item patient-reported outcome (PRO) daily diary measure comprising 2 domains: PDA (7 items) and PI (4 items) based on a 24-hour recall. Design/Methods: In a phase 3, 12-week, double-blind controlled trial (NCT03855137), participants with chronic migraine (CM) were randomized to receive atogepant 30 mg BID, 60 mg QD, or placebo. Based on pooled data, psychometric properties were evaluated using confirmatory factor analysis (CFA), assessments of reliability, validity (convergent and known-groups), responsiveness, and estimation of MWPC thresholds. Results: Of the 778 participants enrolled, the analysis included 682. CFA confirmed the 11-item, 2-domain factor structure (PDA and PI). Both domains demonstrated good internal consistency (Cronbach’s alpha: ≥ 0. 90), and excellent test-retest reliability (intraclass correlation coefficients: >0. 90). Convergent/divergent validity was supported by moderate/strong correlations between domain scores and migraine/headache days (0. 30–0. 48) and activity level/limitation (0. 53–0. 94). PDA and PI scores significantly differentiated based on Patient Global Impression of Severity (PGI-S) (P Conclusions: The AIM-D psychometric properties were confirmed and MWPC estimates were established using phase 3 CM trial data. The AIM-D is a robust and valid measure to assess treatment benefit related to improvement in performance of daily activities and reduction in physical impairment in clinical trials. Disclosure: Pranav Gandhi has received personal compensation for serving as an employee of AbbVie. Pranav Gandhi has stock in AbbVie Inc. Dr. Lipton has received personal compensation in the range of 10, 000-49, 999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of 10, 000-49, 999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of 10, 000-49, 999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of 50, 000-99, 999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of 10, 000-49, 999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of 5, 000-9, 999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of 10, 000-49, 999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of 10, 000-49, 999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of 50, 000-99, 999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of 10, 000-49, 999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of 5, 000-9, 999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of 10, 000-49, 999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of 10, 000-49, 999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton has received personal compensation in the range of 10, 000-49, 999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has stock in Biohaven. Dr. Lipton has stock in Manistee. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH. The institution of Dr. Lipton has received research support from NIH. The institution of Dr. Lipton has received research support from NINDS. The institution of Dr. Lipton has received research support from NIH. The institution of Dr. Lipton has received research support from NIA. The institution of Dr. Lipton has received research support from NIH. The institution of Dr. Lipton has received research support from NIA. The institution of Dr. Lipton has received research support from NIH. The institution of Dr. Lipton has received research support from Veterans Administration. The institution of Dr. Lipton has received research support from NIH. Dr. Lipton has received publishing royalties from a publication relating to health care. Dr. Dodick has received personal compensation for serving as an employee of Mayo Clinic. Dr. Dodick has received personal compensation for serving as an employee of Atria Health. Dr. Dodick has received personal compensation for serving as an employee of Thomas Jefferson University. Dr. Dodick has received personal compensation for serving as an employee of Norwegian University of Science and Technology. Dr. Dodick has received personal compensation in the range of 10, 000-49, 999 for serving as a Consultant for Amgen. Dr. Dodick has received personal compensation in the range of 5, 000-9, 999 for serving as a Consultant for Allergan. Dr. Dodick has received personal compensation in the range of 10, 000-49, 999 for serving as a Consultant for Abbvie. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Biohaven. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Biopharm Communications. Dr. Dodick has received personal compensation in the range of 10, 000-49, 999 for serving as a Consultant for Lundbeck. Dr. Dodick has received personal compensation in the range of 10, 000-49, 999 for serving as a Consultant for Eli Lilly. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Teva. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Inside Practice Australia. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Clinical Education Alliance. Dr. Dodick has received personal compensation in the range of 5, 000-9, 999 for serving as a Consultant for Genentech. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Headache Cooperative of the Pacific. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Medica Communications. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for MJ Healthcare. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Nocira. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Praxis. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Revance. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Synapse Medical Communications. Dr. Dodick has received personal compensation in the range of 10, 000-49, 999 for serving as a Consultant for Vector Psychometrics. Dr. Dodick has received personal compensation in the range of 0-499 for serving as a Consultant for Ayya Biosciences. Dr. Dodick has received personal compensation in the range of 0-499 for serving as a Consultant for Theranica. Dr. Dodick has received personal compensation in the range of 100, 000-499, 999 for serving as a Consultant for Atria. Dr. Dodick has received personal compensation in the range of 10, 000-49, 999 for serving as a Consultant for WebMD. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Thomas Jefferson University. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Medforce. Dr. Dodick has received personal compensation in the range of 500-4, 999 for serving as a Consultant for Precision HEOR. Dr. Dodick has received personal compensation in the range of 0-499 for serving as an officer or member of the Board of Directors for KingDevick Technologies. Dr. Dodick has received personal compensation in the range of 1, 000, 000+ for serving as an officer or member of the Board of Directors for Precon Health. Dr. Dodick has received personal compensation in the range of 0-499 for serving as an officer or member of the Board of Directors for Ontologics. Dr. Dodick has received personal compensation in the range of 0-499 for serving as an officer or member of the Board of Directors for Matterhorn. Dr. Dodick has received personal compensation in the range of 0-499 for serving as an officer or member of the Board of Directors for Axon Therapeutics. Dr. Dodick has received personal compensation in the range of 0-499 for serving as an officer or member of the Board of Directors for Cephalgia Group. Dr. Dodick has stock in Healint. Dr. Dodick has stock in Theranica. Dr. Dodick has stock in Aural Analytics. Dr. Dodick has stock in Epien. Dr. Dodick has stock in Matterhorn. Dr. Dodick has stock in Ontologics. Dr. Dodick has stock in Precon Health. Dr. Dodick has stock in King Devick Technologies. Dr. Dodick has stock in Nocira. Dr. Dodick has stock in Exsano. Dr. Dodick has stock in Palion. Dr. Dodick has stock in AYYA Biosciences. Dr. Dodick has stock in Perfood. Dr. Dodick has stock in Cephalgia Group. Dr. Dodick has stock in Atria Health. Dr. Dodick has stock in Man and Science. The institution of Dr. Dodick has received research support from Department of Defense. The institution of Dr. Dodick has received research support from Patient Centered Outcomes Research Institute. The institution of Dr. Dodick has received research support from Henry Jackson Foundation. Dr. Dodick has received intellectual property interests from a discovery or technology relating to health care. Dr. Dodick has received intellectual property interests from a discovery or technology relating to health care. Dr. Dodick has received intellectual property interests from a discovery or technology relating to health care. Dr. Dodick has received publishing royalties from a publication relating to health care. Dr. Dodick has received publishing royalties from a publication relating to health care. Dr. Dodick has received publishing royalties from a publication relating to health care. Dr. Dodick has a non-compensated relationship as a Chair with American Brain Foundation that is relevant to AAN interests or activities. Dr. Dodick has a non-compensated relationship as a Committee member/Course Director with American Academy of Neurology that is relevant to AAN interests or activities. Dr. Dodick has a non-compensated relationship as a Chair/Immediate Past Chair with American Migraine Foundation that is relevant to AAN interests or activities. Dr. Dodick has a non-compensated relationship as a Chair Global Patient Advocacy Coalition with International Headache Society that is relevant to AAN interests or activities. Diane Whalley has received personal compensation for serving as an employee of RTI Health Solutions. Prof. Nelson has received personal compensation for serving as an employee of RTI Health Solutions. Stuart Yarr has nothing to disclose. Mr. Stokes has nothing to disclose.
Gandhi et al. (Tue,) studied this question.