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]

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Summary

Introduction

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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