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From the Center for Research Methodology and Biometrics (Dr. Baier), Cooper Institute, Golden, CO, Department of Biostatistics (Dr. Cutter), University of Alabama, Birmingham, Department of Neurology (Mellen Center) (Drs. Rudick, Miller, and Cohen), Cleveland Clinic Foundation, OH, Department of Neurology (Dr. Weinstock-Guttman), Buffalo General Hospital, NY, Department of Neurology (Dr. Mass), Oregon Health Sciences University, Portland, and Departments of Neurology and Ophthalmology (Dr. Balcer), University of Pennsylvania School of Medicine, Philadelphia.
Address correspondence and reprint requests to Dr. M. Baier, Center for Research Methodology and Biometrics, Cooper Institute, 14023 Denver West Parkway, 100, Golden, CO, 80401; e-mail: mbaier{at}denver.cooperinst.org
Objective: To evaluate concurrent and predictive validity for low-contrast letter acuity (L-CLA) testing as a candidate visual component for the Multiple Sclerosis Functional Composite (MSFC).
Methods: L-CLA testing was conducted in two MS patient cohorts. In the MSFC Validation Study, 137 participants from a Phase III trial of inteferon beta-1a (Avonex) for relapsing–remitting MS were followed. A second cohort included 65 patients with secondary progressive MS who participated in a substudy of the International MS Secondary Progressive Avonex Controlled Trial (IMPACT). The total number of letters read correctly at four contrast levels (100, 5, 1.25, and 0.6%) was correlated with Expanded Disability Status Scale (EDSS), MSFC, Sickness Impact Profile, Multiple Sclerosis Quality of Life Inventory, and brain parenchymal fraction (BPF), as determined by MRI.
Results: Low- and high-contrast letter acuity scores correlated with BPF at follow-up in the MSFC Validation Study (5%: r = 0.40, p < 0.0001; 100%: r = 0.31, p = 0.0002). L-CLA also correlated with EDSS (5%: r = –0.35, p < 0.0001; 1.25%: r = –0.26, p = 0.0003) and MSFC (5%: r = 0.47, p < 0.0001; 1.25%: r = 0.45, p < 0.0001). In the IMPACT Substudy, change in L-CLA scores from baseline to year 1 predicted subsequent change in the EDSS from year 1 to 2 at the 5% (p = 0.0142) and the 1.25% (p = 0.0038) contrast levels, after adjusting for change in MSFC scores from baseline to year 1.
Conclusions: Low-contrast letter acuity (L-CLA) scores demonstrate concurrent and predictive validity in patients with relapsing–remitting and secondary progressive multiple sclerosis (MS). L-CLA testing provides additional information relevant to the MS disease process that is not entirely captured by the Multiple Sclerosis Functional Composite.
Supported by Biogen, Inc. (IMPACT and MSFC Validation Study).
Dr. Cutter has received consulting/speaker fees and honoraria from Biogen. Drs. Rudick and Miller have received honoraria from Biogen. Dr. Weinstock-Guttman has received grants in excess of $10,000 from Biogen.
Received September 16, 2004. Accepted in final form November 19, 2004.
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