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Observational Study
. 2022 Jan;62(1):89-105.
doi: 10.1111/head.14229. Epub 2021 Dec 28.

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

Richard B Lipton  1 , Pranav Gandhi  2 , Jonathan Stokes  2 , Mary Lynn Cala  3 , Christopher J Evans  3 , Naomi Knoble  4 , Heather L Gelhorn  4 , Dennis Revicki  4   5 , Hema N Viswanathan  6 , David W Dodick  7
Affiliations
Observational Study

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

Richard B Lipton et al. Headache. 2022 Jan.

Abstract

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, activity impairment was identified as the target in the preliminary conceptual framework, which had two domains: performance of daily activities (PDAs) and physical impairment (PI). Revision of the draft AIM-D through multiple rounds of cognitive interviews and expert panel meetings resulted in a content valid 11-item version. Exploratory factor analysis supported both one- and two-domain structures for the AIM-D, which were further supported by confirmatory factor analysis (factor loadings all >0.90). The AIM-D domains (PDA and PI) and total score showed high internal consistency reliability (Cronbach's alpha 0.95-0.97), acceptable test-retest reliability for weekly average scores (intraclass correlation coefficient >0.60 for participants with no change in PGI-S between baseline and week 2), and good convergent and known-groups validity. There was evidence of responsiveness based on changes in PGI-S score and monthly migraine days.

Conclusion: The AIM-D is a content valid and psychometrically sound measure designed to evaluate activity impairment and is suitable for use in clinical trials of preventive treatments for EM or CM.

Keywords: Activity Impairment in Migraine Diary; activity impairment; content validity; migraine; patient-reported outcome; psychometric analysis.

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Conflict of interest statement

RBL receives research support from the NIH and the National Headache Foundation; holds stock options in Biohaven Holdings and Ctrl M Health; serves as a consultant, advisory board member, or has received honoraria from: Abbvie (Allergan), Amgen, Axsome, Biohaven, Biovision, Dr. Reddy's (Promius), Electrocore, Eli Lilly, Equinox, GlaxoSmithKline, Grifols, Lundbeck (Alder), Merck, Pernix, Pfizer, Satsuma, and Teva; and receives royalties from Wolff's Headache 7th and 8th Editions (Oxford Press University, Wiley, and Informa). PG and JS are employees of AbbVie and may own AbbVie stock. MLC was, during this work, an employee of Endpoint Outcomes, which received funds from Allergan to carry out the research. CJE has received support for research and consulting services from Allergan (at the time the research was conducted) and AbbVie (currently). NK was an employee of Evidera at the time of this research and received funding from Allergan for time spent conducting this research. HLG is an employee of Evidera, a company that received funding from Allergan for time spent conducting this research. DR has received support for research and consulting services from Allergan, AbbVie, and Amgen. HNV was an employee and shareholder of Allergan (now AbbVie) at the time the study was conducted. DWD reports the following conflicts of interest within the past 12 months: consulting: AEON, Amgen, Clexio, Cerecin, Cooltech, Ctrl M, Allergan, Alder, Biohaven, GSK, Linpharma, Lundbeck, Promius, Eli Lilly, eNeura, Novartis, Impel, Satsuma, Theranica, WL Gore, Nocira, XoC, Zosano, Upjohn (Division of Pfizer), Pieris, Praxis, Revance, Equinox. Honoraria: CME Outfitters, Curry Rockefeller Group, DeepBench, Global Access Meetings, KLJ Associates, Academy for Continued Healthcare Learning, Majallin LLC, Medlogix Communications, MJH Lifesciences, Miller Medical Communications, Southern Headache Society (MAHEC), WebMD Health/Medscape, Wolters Kluwer, Oxford University Press, Cambridge University Press. Research Support: Department of Defense, National Institutes of Health, Henry Jackson Foundation, Sperling Foundation, American Migraine Foundation, Patient Centered Outcomes Research Institute (PCORI); stock options/shares/board of directors: Ctrl M (options), Aural analytics (options), ExSano (options), Palion (options), Healint (options), Theranica (options), Second Opinion/Mobile Health (options), Epien (options/board), Nocira (options), Matterhorn (shares/board), Ontologics (shares/board), King‐Devick Technologies (options/board), Precon Health (options/Board); and patent: 17189376.1‐1466:vTitle: Botulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis.

Figures

FIGURE 1
FIGURE 1
Qualitative development of the AIM‐D
FIGURE 2
FIGURE 2
Participant disposition. †Participants from two clinical sites were excluded because of data collection problems. ‡Reasons for exclusion were not mutually exclusive. §Change of current treatment, including change of dosing (preventive or acute for episodic migraine; preventive for chronic migraine) within the previous 2 weeks. FAS, full analysis set
FIGURE 3
FIGURE 3
Final conceptual framework for the AIM‐D
See this image and copyright information in PMC

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