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Factors that predict Health-Related Q uality of Life in patients with relapsing -remitting multiple sclerosis

Mellen Center for Multiple Sclerosis Treatment and Research, Department of Neurology, Cleveland Clinic Foundation, Cleveland, OH, USA, millerd{at}ccf.org

Richard A Rudick

Mellen Center for Multiple Sclerosis Treatment and Research, Department of Neurology, Cleveland Clinic Foundation, Cleveland, OH, USA

Monika Baier

Center for Research Methodology and Biometrics, AMC Cancer Research Center, Lakewood, CO, USA

Gary Cutter

Center for Research Methodology and Biometrics, AMC Cancer Research Center, Lakewood, CO, USA

David S Doughtery

Department of Neurology, Thomas Jefferson University, Philadelphia, PA, USA

Bianca Weinstock-Guttman

Department of Neurology, Buffalo General Hospital, Buffalo, NY, USA

Michele K Mass

Department of Neurology, Oregon Health Sciences Center, Portland, OR, USA

Elizabeth Fisher

Department of Biomedical Engineering, Cleveland Clinic Foundation, Cleveland, OH, USA

Nancy Simonian

Biogen, Inc., Cambridge, MA, USA

Health-Related Q uality of Life (HRQ oL) research is gaining acceptance in the field of multiple sclerosis (MS). Little is known about what precipitates quality of life change. It was hypothesized that physical aspects of quality of life decline with worsening objective disease measures and psychosocial aspects remain relatively stable regardless of change in objective measures. These assumptions are tested using data from a Phase 3 study of relapsing -remitting MS patients treated with interferon b-1a and reassessed approximately eight years after study initiation. The Sickness Impact Profile (SIP) questionnaire is the generic quality of life measure used in this study. Three summary scores of the SIP (Physical, Psychosocial, and Total scores), Expanded Disability Status Scores, Multiple Sclerosis Functio nal C omposite, and Brain Parenchymal Fraction were determined at baseline, year 2, and after an average of 8.1 years from study entry. SIP data collected during a clinic visit were available from 137 of the original 172 participants. A ll objective indicators worsened by follow-up. SIP Physical and Total scores significantly worsened from baseline to follow-up. SIP Psychosocial showed nonsignificant worsening. Regression analysis indicated that final measures of SIP Physical and Total scores were most strongly associated with change in objective measures and follow-up SIP Psychosocial was most strongly related to earlier scores on the same measure.

Key Words: clinical trials • multiple sclerosis • outcomes assessment • quality o f life • Sickness Impact Profile

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