Responder definition of the Multiple Sclerosis Impact Scale physical impact subscale for patients with physical worsening

Abstract

Background:The 29-item Multiple Sclerosis Impact Scale (MSIS-29) was developed to examine the impact of multiple sclerosis (MS) on physical and psychological functioning from a patient’s perspective.Objective:To determine the responder definition (RD) of the MSIS-29 physical impact subscale (PHYS) in a group of patients with relapsing–remitting MS (RRMS) participating in a clinical trial.Methods:Data from the SELECT trial comparing daclizumab high-yield process with placebo in patients with RRMS were used. Physical function was evaluated in SELECT using three patient-reported outcomes measures and the Expanded Disability Status Scale (EDSS). Anchor- and distribution-based methods were used to identify an RD for the MSIS-29.Results:Results across the anchor-based approach suggested MSIS-29 PHYS RD values of 6.91 (mean), 7.14 (median) and 7.50 (mode). Distribution-based RD estimates ranged from 6.24 to 10.40. An RD of 7.50 was selected as the most appropriate threshold for physical worsening based on corresponding changes in the EDSS (primary anchor of interest).Conclusion:These findings indicate that a ≥7.50 point worsening on the MSIS-29 PHYS is a reasonable and practical threshold for identifying patients with RRMS who have experienced a clinically significant change in the physical impact of MS.

Health-Related Quality of Life in Patients with Multiple Sclerosis: Impact of Disease-Modifying Drugs

“…The differences between the groups were statistically significant (physical impact score, p   <  0.001) or tended towards significance (psychological impact score, p   =  0.068). Further analysis of the trial data suggested that an increase of ≥7.5 on the MSIS-29 physical scale could be considered indicative of clinically relevant increase (deterioration) [60]. Using this MCID, the proportion of patients with MSIS-29 physical deterioration at 52 weeks was lower in the daclizumab group than in the placebo group (20 vs. 28%; p   <  0.01).…”

Patient‐reported outcomes in multiple sclerosis: a systematic comparison of available measures

“…Only 14 out of 82 PROs evaluated had an overall mean score above the threshold of 50 (Table S1). Here results are presented for the eight MS-specific PROs that were most commonly used instruments in MS clinical trials, namely Multiple Sclerosis Impact Scale-29 (MSIS-29) [12][13][14][15][16][17][18][19][20][21], Leeds Multiple Sclerosis Quality of Life (LMSQoL) [22][23][24], Multiple Sclerosis Walking Scale-12 (MSWS-12) [25][26][27][28][29][30], Functional Assessment of Multiple Sclerosis [15,18,[31][32][33], Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS) [34][35][36], Multiple Sclerosis International Quality of Life (MUSIQoL) questionnaire [37,38], Patient-Reported Indices for MS Activity Limitations Scale (PRIMUS) [39][40][41] and Multiple Sclerosis Quality of Life-54 (MSQoL-54) [18,[42][43][44][45][46]. The characteristics of these eight PROs are summarized in Table 2.…”

“…The FDA-published guidance for industry includes information on how it evaluates existing, modified or new PROs used to support labeling claims. Although the The rationale for and description of the concept and the populations that a measure is intended to assess and the relationship between them Reliability (items [8][9][10][11][12][13][14][15] The degree to which an instrument is free from random error Validity (items [16][17][18][19][20][21] The degree to which the instrument measures what it purports to measure Responsiveness (items 22-24)…”

Prolonged-release fampridine treatment improved subject-reported impact of multiple sclerosis: Item-level analysis of the MSIS-29

“…Thresholds for clinically meaningful worsening in the MSIS-29 PHYS subscale score have been established in both the clinical trial and the community setting [17,18]. Clinically meaningful worsening in the MSIS-29 PHYS subscale score was reported as ≥7.5 points in a clinical trial population [17] and ≥ 7.0 points in a community setting [18], for subjects with MS and an EDSS score of 0 to 5 [17]. For subjects based in a community setting with an EDSS score of 5.5 to 8, the clinically meaningful threshold for MSIS-29 PHYS subscale worsening was reported as ≥ 8 points [18].…”

“…Thresholds for a clinically meaningful change in the MSIS-29 PHYS have been proposed to be between 7 and 8 points [17,18]. Therefore, analyses were also conducted to evaluate the percentages of subjects who achieved a ≥7-point improvement in the MSIS-29 PHYS subscale score, by MSIS-12 improver status.…”