Abstract
BackgroundLimited data define what constitutes a minimal clinically important difference (MCID) on the EuroQol 5-Dimension (EQ-5D) health status index in persons with multiple sclerosis (PwMS). We sought to estimate the MCID for the EQ-5D health index in North American PwMS.MethodsPwMS completing the Patient Determined Disease Steps (PDDS) scale, 12-Item Multiple Sclerosis Walking Scale (MSWS-12) and EQ-5D as part of the North American Research Committee on Multiple Sclerosis (NARCOMS) registry’s spring 2011 update and supplemental survey were included in this retrospective, cross-sectional study. Distribution-based (standard error of measurement [SEM], 0.50 standard deviation [SD] and 0.33 SD unit) approaches were used to estimate a range of MCIDs for the EQ-5D based upon disease severity groups determined by the PDDS and MSWS-12 tertiles.ResultsA total of 3,044 participants were included. Moderately strong correlations between the EQ-5D and the PDDS and MSWS-12 were observed (Spearman’s r = -0.56 and -0.59, respectively, p < 0.0001 for both). MCID estimates based on PDDS score categories ranged from 0.065-0.158 (SEMs), 0.059-0.142 (0.50 SDs) and 0.039-0.095 (0.33 SDs). MCID estimates as measured by MSWS-12 tertile categories ranged from 0.068-0.098 (SEMs), 0.061-0.088 (0.50 SDs), and 0.041-0.059 (0.33 SDs). Across both the PDDS and tertiles of MSWS-12, MCID estimates tended to be larger as disease severity worsened. Mean weighted MCID estimates ranged from 0.05-0.084 for both the PDDS and MSWS-12 tertiles.ConclusionMCID estimates for the EQ-5D in PwMS were within the range of estimates seen for other disease states and appeared to be larger in those reporting more severe disease.
Highlights
Multiple sclerosis (MS) has long been known to negatively impact health-related quality of life (HRQoL) [1,2,3]
Our analysis suggests the minimal clinically important difference (MCID) for a population with MS likely falls between the values of 0.050-0.084
Another study conducted by Pickard and colleagues using a similar methodology to our own suggested MCID estimates for US-based EuroQol 5-Dimension (EQ-5D) scores ranged from 0.07-0.09 in patients with cancer, and between 0.04 and 0.07 across various types of cancer [19]
Summary
Multiple sclerosis (MS) has long been known to negatively impact health-related quality of life (HRQoL) [1,2,3]. For this reason, clinical studies have increasingly utilized validated HRQoL measures to evaluate the effect of treatment or the impact of disease progression on HRQoL in persons with MS (PwMS) [4,5,6]. The purpose of this study was to estimate the minimal clinically important difference (MCID), or smallest difference in score PwMS from North America perceive as being both beneficial and nontrivial [9]. Limited data define what constitutes a minimal clinically important difference (MCID) on the EuroQol 5-Dimension (EQ-5D) health status index in persons with multiple sclerosis (PwMS). We sought to estimate the MCID for the EQ-5D health index in North American PwMS
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