ESTIMATION OF MEANINGFUL CHANGE SCORES FOR THE EQ-5D-5L VISUAL ANALOG SCALE (EQ-VAS) IN PATIENTS WITH TARDIVE DYSKINESIA
Author(s)
A Simon Pickard, PhD1, Morgan Bron, PharmD, MS2, Susan Mathias, MPH3, Dawn Vanderhoef, PhD, DNP, PMHNP-BC, FAANP2, Michelle Turner, MS3.
1Retzky College of Pharmacy, University of Illinois Chicago, Chicago, IL, USA, 2Neurocrine Biosciences, Inc., San Diego, CA, USA, 3Health Outcomes Solutions, Palm Beach Gardens, FL, USA.
1Retzky College of Pharmacy, University of Illinois Chicago, Chicago, IL, USA, 2Neurocrine Biosciences, Inc., San Diego, CA, USA, 3Health Outcomes Solutions, Palm Beach Gardens, FL, USA.
OBJECTIVES: Tardive dyskinesia (TD) is a potentially disabling movement disorder that can impact health-related quality of life. EQ-VAS, a component of EQ-5D-5L, is a patient-reported outcome measuring overall health today. To support interpretation of EQ-VAS scores in patients with TD, meaningful within patient change (MWPC) was estimated.
METHODS: Anchor- and distribution-based approaches were used to estimate MWPC for EQ-VAS (range 0-100, with higher scores indicating better health) using data from two studies (KINECT-PRO, TD4002). For the anchor-based (primary) approach, analyses utilized KINECT-PRO data (N=59 participants with underlying psychiatric diagnosis and mild-to-severe TD). Participants were categorized based on scores of 3 (“minimally improved”) at Week 8 on the Patient Global Impression of Change (PGI-C) and Clinical Global Impression of Change (CGI-C) (range: 0 [“very much worse”] to 7 [“very much improved”]). For the distribution-based (supportive) approach, analyses included data from KINECT-PRO and TD4002 (N=135 participants with underlying psychiatric diagnosis and moderate-to-severe TD). Distribution-based benchmarks included ~0.33 standard deviation (SD) and ~0.50 SD of the baseline score, representing small-to-moderate and moderate effects, respectively. MWPC was considered the minimal meaningful change from baseline in EQ-VAS at Week 8.
RESULTS: Baseline EQ-VAS scores in both studies were concentrated in the 50-90 range, with distribution skewed towards higher values. Floor and ceiling effects were not observed. Participants with minimal improvement per patient report (PGI-C=3) and clinician assessment (CGI-C=3) had average EQ-VAS score improvements of 5 points at Week 8. For KINECT-PRO, the baseline SD (16.2) corresponded to distribution-based MWPC benchmarks of ~5.3 (0.33 SD) and ~8.1 (0.50 SD) points. Similar results were observed for TD4002, with the baseline SD (18.4) corresponding to benchmarks of ~6 (0.33 SD) and ~9.2 (0.50 SD) points.
CONCLUSIONS: These analyses support an EQ-VAS MWPC of 6 points. Clinicians can use this 6-point change as a minimal threshold of treatment benefit in patients with TD.
METHODS: Anchor- and distribution-based approaches were used to estimate MWPC for EQ-VAS (range 0-100, with higher scores indicating better health) using data from two studies (KINECT-PRO, TD4002). For the anchor-based (primary) approach, analyses utilized KINECT-PRO data (N=59 participants with underlying psychiatric diagnosis and mild-to-severe TD). Participants were categorized based on scores of 3 (“minimally improved”) at Week 8 on the Patient Global Impression of Change (PGI-C) and Clinical Global Impression of Change (CGI-C) (range: 0 [“very much worse”] to 7 [“very much improved”]). For the distribution-based (supportive) approach, analyses included data from KINECT-PRO and TD4002 (N=135 participants with underlying psychiatric diagnosis and moderate-to-severe TD). Distribution-based benchmarks included ~0.33 standard deviation (SD) and ~0.50 SD of the baseline score, representing small-to-moderate and moderate effects, respectively. MWPC was considered the minimal meaningful change from baseline in EQ-VAS at Week 8.
RESULTS: Baseline EQ-VAS scores in both studies were concentrated in the 50-90 range, with distribution skewed towards higher values. Floor and ceiling effects were not observed. Participants with minimal improvement per patient report (PGI-C=3) and clinician assessment (CGI-C=3) had average EQ-VAS score improvements of 5 points at Week 8. For KINECT-PRO, the baseline SD (16.2) corresponded to distribution-based MWPC benchmarks of ~5.3 (0.33 SD) and ~8.1 (0.50 SD) points. Similar results were observed for TD4002, with the baseline SD (18.4) corresponding to benchmarks of ~6 (0.33 SD) and ~9.2 (0.50 SD) points.
CONCLUSIONS: These analyses support an EQ-VAS MWPC of 6 points. Clinicians can use this 6-point change as a minimal threshold of treatment benefit in patients with TD.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PCR125
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Neurological Disorders, No Additional Disease & Conditions/Specialized Treatment Areas