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Abstract Details

Establishing Responder Definitions for Short-form Headache Impact Test (HIT-6) Total and Item Scores in Chronic Migraine
Headache
P14 - Poster Session 14 (8:00 AM-9:00 AM)
7-001
To identify responder definitions for HIT-6 total and item scores in patients with chronic migraine (CM).
Responder definitions represent the minimum amount of within-individual change needed to be interpreted as treatment benefit. HIT-6 total score responder thresholds have been defined in several headache populations; item-level thresholds have not been examined.
A literature search identified quantitative research of HIT-6 responder definitions. Data from PROMISE-2 (NCT02974153; n=1024) were used to conduct new responder definition analyses for HIT-6 total and item scores in CM. Distribution-based and anchor-based (patient global impression of change; ≥75% reduction in migraine frequency; EQ-5D-5L visual analog scale) methods were used to identify possible responder definition values. Candidate values from the literature (total score) and PROMISE-2 (total and item scores) were plotted against cumulative distribution functions of change values (baseline to Week 12) and used to triangulate to empirically supported responder definitions.

For the HIT-6 total score, responder definitions in the literature ranged from −2.5 to −8 points. Distribution- and anchor-based candidate values from PROMISE-2 ranged from −2.2 to −10.8 points. Triangulation resulted in a final HIT-6 total score responder definition value of ≥6 point decrease.

Only anchor-based analyses were used to identify item-level candidate responder definition values, using the same anchors previously defined above. Final responder definitions for individual HIT-6 items were an improvement of ≥1 category on items 1 (pain severity), 2 (limits daily activities), and 3 (wish to lie down) and an improvement of ≥2 categories on items 4 (too tired to work), 5 (felt fed up/irritated), and 6 (limits concentration).
In patients with CM, HIT-6 total score reduction of ≥6 points likely represents clinically meaningful change in headache impact. Item-level response is evidenced by an improvement of ≥1 category on items 1–3 or ≥2 categories on items 4–6.
Authors/Disclosures
Carrie R. Houts
PRESENTER 		Carrie R. Houts has received personal compensation for serving as an employee of Vector Psychometric Group, LLC.
RJ Wirth, PhD (Vector Psychometric Group, LLC) RJ Wirth has received personal compensation for serving as an employee of Vector Psychometric Group, LLC.
James McGinley James McGinley has received personal compensation for serving as an employee of Vector Psychometric Group, LLC. An immediate family member of James McGinley has received personal compensation for serving as an employee of UPMC Children's Community Pediatrics. James McGinley has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for McGinley Statistical Consulting, LLC. James McGinley has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for SAGE Cephalalgia (journal). James McGinley has stock in various companies. The institution of James McGinley has received research support from National Headache Foundation.
Richard B. Lipton, MD, FÂ鶹´«Ã½Ó³»­ (Albert Einstein College of Medicine) 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 $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. 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 or had stock in Biohaven.Dr. Lipton has or had stock in Manistee.Dr. Lipton has or had stock in Axon.Dr. Lipton has or had stock in CoolTech. 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 Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.
No disclosure on file
Roger Cady, MD (RK Consulting, LLC) Dr. Cady has received personal compensation for serving as an employee of Lundbeck. Dr. Cady has stock in Alder Biopharmaceutical.