Development and validation of a novel patient‐reported outcome measure in people with episodic migraine and chronic migraine: The Activity Impairment in Migraine Diary

作者：Richard B. Lipton, Pranav Gandhi, Jonathan Stokes, Mary Lynn Cala, Christopher J. Evans, Naomi B. Knoble, Heather L. Gelhorn, Dennis A. Revicki, Hema N. Viswanathan, David W. Dodick · 发表于：Headache The Journal of Head and Face Pain · 年份：2021 · DOI：10.1111/head.14229 · 被引用次数：22 · 研究领域：Migraine and Headache Studies、Traumatic Brain Injury Research、Hemispheric Asymmetry in Neuroscience

OBJECTIVE: To evaluate the content validity and psychometric properties of the Activity Impairment in Migraine Diary (AIM-D). BACKGROUND: Measuring treatment effects on migraine impairment requires a psychometrically sound patient-reported outcome (PRO) measure developed consistent with U.S. Food and Drug Administration guidance. METHODS: The AIM-D was created from concepts that emerged during qualitative interviews with five clinicians experienced in treating migraine and concept elicitation (CE) interviews with 40 adults with episodic migraine (EM) or chronic migraine (CM). The initial version was refined based on three waves of cognitive interviews with 38 adults with EM or CM and input from a panel of clinical and measurement experts. The AIM-D was psychometrically evaluated using data from 316 adults with EM or CM who participated in a 13-week prospective observational study. Study participants completed PRO assessments including the AIM-D and a daily headache diary. Exploratory and confirmatory factor analysis were used to determine the factor structure. The reliability, validity, and responsiveness of the AIM-D were assessed. Additional PRO measures including the Patient Global Impression - Severity (PGI-S), Migraine Specific Quality of Life Questionnaire, Version 2.1 Role Function-Restrictive domain, and Headache Impact Test were used for psychometric evaluation of the AIM-D. RESULTS: Based on CE interviews with adults with migraine and input from an expert panel, act...