Estimating a minimal clinically important difference for the EuroQol 5-dimension health status index in persons with multiple sclerosis

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.

Positive impact of cladribine on quality of life in people with relapsing multiple sclerosis

“…Changes in EQ-5D were examined using the index of ‘minimal clinically important difference’ (MCID), 23 defined as the smallest QoL change that pwRMS considered important. This is because changes greater than the MCID are more likely to translate to real-world patient benefit.…”

“… 24 Previously, based on data from the North American Research Committee on Multiple Sclerosis (NARCOMS) registry, the EQ-5D-3L MCID was between 0.050 and 0.084. 23 The likelihood that a patient experienced a QoL change greater than the MCID, set at 0.08, was assessed using a logistic regression model. The covariates were high-dose groups, low-dose groups and index scores at baseline.…”

The Minimum Clinically Important Difference in the Repeatable Battery for the Assessment of Neuropsychological Status

“…Secondly, there was only cross-sectional data available for the analysis, so MCID estimates were based on between patient differences; estimates based on within patient differences were not possible. Therefore, these estimates would be more suited to discriminate between patient groups rather than assessing response to treatment (Kohn et al, 2014). For example, in a clinical trial setting where one is trying to determine if a statistically significant difference between treatment groups, is large enough to be considered clinically significant.…”

“…The MCID has already been established for a number of instruments based on summary scores across multiple dimensions similar to the RBANS. For example, Kohn, Sidovar, Kaur, Zhu & Coleman (2014) established a range of MCIDs using distribution based methods for the EuroQol 5-dimension (EQ-5D) health status index in persons with multiple sclerosis; and Y.T. Cheung et al, (2014) used both anchor and distribution based techniques to establish the MCID for the functional assessment of cancer therapy: cognitive function (FACT-Cog) in breast cancer patients.…”

Combined walking outcome measures identify clinically meaningful response to prolonged-release fampridine

“…EQ index value ranged from 0 (death) to 1 (full health) and we considered a MCID a difference of 0.05. 25 EQ-VAS ranges from 0 (worst quality of life) to 100 (best quality of life). Descriptive analyses (means, ranges, and standard deviations) and the significance of group differences ( p values, 95% confidence intervals) from baseline to on-treatment visit were evaluated using a Student’s paired t test and nonparametric Wilcoxon signed rank, otherwise.…”