TY - JOUR
T1 - Development and validation of a novel patient-reported outcome measure in people with episodic migraine and chronic migraine
T2 - The Activity Impairment in Migraine Diary
AU - Lipton, Richard B.
AU - Gandhi, Pranav
AU - Stokes, Jonathan
AU - Cala, Mary Lynn
AU - Evans, Christopher J.
AU - Knoble, Naomi
AU - Gelhorn, Heather L.
AU - Revicki, Dennis
AU - Viswanathan, Hema N.
AU - Dodick, David W.
N1 - Funding Information:
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.
Funding Information:
The study was funded by AbbVie Author Dennis Revicki passed away during finalization of this manuscript. The authors thank Nancy Kline-Leidy of Evidera for her contributions as a measurement expert throughout the development and evaluation of the measure, and Mark Kosinski of QualityMetric for his contributions as an expert during the item development phase. The authors also thank Nicole Lyn and Christina Graham of Endpoint Outcomes for conducting qualitative interviews; Yulia Savva of Evidera for conducting the data analyses; Jennifer Copeland of Evidera for providing project oversight and for contributing to the data analyses and study reporting; Krystal Anson of AbbVie for providing project oversight; and Caroline Burk of HEOR Consulting for contributing to the data analyses and study reporting. Lastly, the authors thank Stephen Gilliver, PhD, of Evidera for providing medical writing support, which was funded by AbbVie in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).
Publisher Copyright:
© 2021 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.
PY - 2022/1
Y1 - 2022/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85122098362&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85122098362&partnerID=8YFLogxK
U2 - 10.1111/head.14229
DO - 10.1111/head.14229
M3 - Article
C2 - 34962305
AN - SCOPUS:85122098362
SN - 0017-8748
VL - 62
SP - 89
EP - 105
JO - Headache
JF - Headache
IS - 1
ER -