title: Change in quality of life in patients with relapsing-remitting multiple sclerosis over 2 years in relation to other clinical parameters: results from a trial of intramuscular interferon {beta}-1a.
abstract: BACKGROUND
  A randomized, placebo-controlled, multicenter study of weekly intramuscular injections of interferon beta-1a (IFNβ-1a) in relapsing-remitting multiple sclerosis included the Sickness Impact Profile (SIP), a validated measure of patient-reported quality of life (QoL).
  
  
  OBJECTIVE
  To demonstrate the impact of moderate to severe SIP disability at baseline and change in QoL as measured by SIP over 2 years in relation to other study parameters.
  
  
  METHODS
  In 158 patients, SIP scores were determined at baseline and 2 years. Scores were correlated with disease progression and treatment.
  
  
  RESULTS
  Patients who experienced disability progression, as defined by Expanded Disability Status Scale (EDSS) and annualized relapse rate, during the study demonstrated significant worsening in Physical SIP scores compared with patients who did not progress (p=0.031). In patients with low SIP scores, indicating moderate or severe disability at baseline, treatment with IFNβ-1a significantly improved Physical SIP subscores.
  
  
  CONCLUSIONS
  Patients with disability progression defined using EDSS, the physician-derived primary outcome measure, had Physical SIP scores indicating worsening disability, validating the physician-derived primary outcome measure using patient self-report. Treatment with IFNβ-1a had beneficial effects on QoL in patients with worse SIP scores at baseline.
authors.affiliation: Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Foundation, U-10 9500 Euclid Avenue, Cleveland, OH 44118, USA. millerd@ccf.org
authors.forename: D M
authors.initials: DM
authors.lastname: Miller
authors.forename: B
authors.initials: B
authors.lastname: Weinstock-Guttman
authors.forename: D
authors.initials: D
authors.lastname: Bourdette
authors.forename: X
authors.initials: X
authors.lastname: You
authors.forename: P
authors.initials: P
authors.lastname: Foulds
authors.forename: R A
authors.initials: RA
authors.lastname: Rudick
mesh_terms: D000328:Adult; D004185:Disability Evaluation; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage*; D007273:Injections, Intramuscular; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D012720:Severity of Illness Index; D018434:Sickness Impact Profile; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D007155:Immunologic Factors; D016899:Interferon-beta; D000068556:Interferon beta-1a