title: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Health Economics and Outcomes Research, Global Market Access, Biogen Idec, 133 Boston Post Road, Weston, MA 02493, USA glenn.phillips@biogenidec.com.
authors.forename: Glenn A
authors.initials: GA
authors.lastname: Phillips
authors.affiliation: Evidera, Bethesda, MD, USA.
authors.forename: Kathleen W
authors.initials: KW
authors.lastname: Wyrwich
authors.affiliation: Evidera, Lexington, MA, USA.
authors.forename: Shien
authors.initials: S
authors.lastname: Guo
authors.affiliation: Biogen Idec, Cambridge, MA, USA.
authors.forename: Rossella
authors.initials: R
authors.lastname: Medori
authors.affiliation: Evidera, Lexington, MA, USA.
authors.forename: Arman
authors.initials: A
authors.lastname: Altincatal
authors.affiliation: Envision Pharma Group, Southport, CT, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Wagner
authors.affiliation: Biogen Idec, Cambridge, MA, USA.
authors.forename: Jacob
authors.initials: J
authors.lastname: Elkins
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000077561:Daclizumab; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000150:complications* / Q000188:drug therapy*; D057566:Self Report; D012720:Severity of Illness Index
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; C000598527:daclizumab HYP; D000077561:Daclizumab
keywords: MSIS-29; Responder definition; SELECT; anchor-based method; distribution-based method; multiple sclerosis; patient-reported outcomes; physical worsening
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