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Responder definition of the Multiple Sclerosis Impact Scale physical impact subscale for patients with physical
Glenn A Phillips1, Kathleen W Wyrwich2, Shien Guo3
1Health Economics and Outcomes Research, Global Market Access, Biogen Idec, 133 Boston Post Road, Weston, MA 02493, USA glenn.phillips@biogenidec.com.
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.
Insights
A responder definition (RD) for the Multiple Sclerosis Impact Scale (MSIS-29) physical impact subscale (PHYS) was established. A worsening of ≥7.50 points on the MSIS-29 PHYS indicates a clinically significant physical impact change in multiple sclerosis (MS) patients.
Area of Science:
- Neurology
- Clinical Research
- Patient-Reported Outcomes
Background:
- The Multiple Sclerosis Impact Scale (MSIS-29) assesses physical and psychological functioning in multiple sclerosis (MS) patients.
- Establishing a clear responder definition (RD) is crucial for interpreting changes in patient-reported outcomes.
Purpose of the Study:
- To determine the responder definition (RD) for the MSIS-29 physical impact subscale (PHYS).
- To identify a clinically significant threshold for physical worsening in relapsing-remitting MS (RRMS) patients.
Main Methods:
- Utilized data from the SELECT clinical trial involving RRMS patients.
- Employed both anchor-based and distribution-based methods to define the RD for MSIS-29 PHYS.
- Correlated MSIS-29 PHYS scores with the Expanded Disability Status Scale (EDSS) as a primary anchor.
Main Results:
- Anchor-based methods suggested RD values between 6.91 and 7.50 for MSIS-29 PHYS.
- Distribution-based methods yielded RD estimates ranging from 6.24 to 10.40.
- A threshold of 7.50 was selected as the most appropriate RD for physical worsening, aligning with EDSS changes.
Conclusions:
- A ≥7.50 point increase on the MSIS-29 PHYS subscale is a practical threshold.
- This threshold effectively identifies clinically significant physical impact changes in RRMS patients.
- The established RD enhances the interpretability of MSIS-29 PHYS in clinical trials and practice.
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