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Comparing the ability of various compositive outcomes to discriminate treatment effects in MS clinical trials

The UCSF/MT Zion Multiple Sclerosis Center, University of California at San Francisco, San Francisco, USA

R L Priore

Department of Social and Preventive Medicine, State University of New York at Buffalo, Buffalo, N.Y., USA

K E Wende

MSCRG Data Management and Statistical Center, Department of Neurology, The Buffalo General Hospital and the Department of Social and Preventive Medicine, State University of New York at Buffalo, Buffalo, N.Y., USA

M Campion

Biogen Inc., Cambridge MA., USA

D N Bourdette

Department of Neurology, Oregon Health Sciences University and Neurology Service, Department of Veterans Affairs Medical Center Portland, OR., USA

R M Herndon

Department of Neurology, G.V. (Sonny) Montgomery VAMC, Jackson, MS., and University of Mississipi Medical Center, USA

J S Fischer

Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Foundation, Cleveland, OH., USA

L D Jacobs

William C. Baird Multiple Sclerosis Research Center, Millard Fillmore Health System, Buffalo, and the Department of Neurology, The Buffalo General Hospital, Buffalo, N.Y., USA

D L Cookfair

MSCRG Data Management and Statistical Center, Department of Neurology, The Buffalo General Hospital and the Department of Social and Preventive Medicine, State University of New York at Buffalo, Buffalo, N.Y., USA

R A Rudick

Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Foundation, Cleveland, OH., USA

J R Richert

Department of Neurology, Georgetown University Medical Center, Washington, DC., USA

A M Salazar

Department of Neurology, Walter Reed Army Medical Center, Washington, DC., USA

C V Granger

Department of Rehabilitation Medicine, School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, N.Y., USA

J H Simon

Department of Radiology-MRI, University of Colorado Health Sciences Center, Denver, Co., USA

J J Alam

Biogen Inc., Cambridge MA., USA

D M Bartoszak

Slocum-Dickson Medical Group, New Hartford, N.Y., USA

J Braiman

Department of Neurology, University of Colorado Health Sciences Center, Denver, Co., USA

C M Brownscheidle

William C. Baird Multiple Sclerosis Research Center, Millard Fillmore Health System, Buffalo, and the Department of Neurology, The Buffalo General Hospital, Buffalo, N.Y., USA

M E Coats

Department of Neurology, Walter Reed Army Medical Center, Washington, DC., USA

S L Cohan

Department of Neurology, Georgetown University Medical Center, Washington, DC., USA

D S Dougherty

Department of Neurology, Walter Reed Army Medical Center, Washington, DC., USA

R P Kinke

Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Foundation, Cleveland, OH., USA

M K Mass

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

F E Munschauer, III

William C. Baird Multiple Sclerosis Research Center, Millard Fillmore Health System, Buffalo, and the Department of Neurology, The Buffalo General Hospital, Buffalo, N.Y., USA

P M Pullicino

William C. Baird Multiple Sclerosis Research Center, Millard Fillmore Health System, Buffalo, and the Department of Neurology, The Buffalo General Hospital, Buffalo, N.Y., USA

B J Scherokman

Department of Neurology, Kaiser Permanente Medical Center, Springfield, VA., USA

B Weinstock-Guttman

Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Foundation, Cleveland, OH., USA

R H Whitham

Department of Neurology, Oregon Health Sciences University and Neurology Service, Department of Veterans Affairs Medical Center Portland, OR., USA

The Multiple Sclerosis Collaborative Research Group (MSCRG)

We compared the ability of the Kurtzke Expanded Disability Status Scale (EDSS) and a composite outcome of non-physician-based measures of time to ambulate 25 feet (TA) and manual dexterity (the Box and Block Test [BBT], and 9-Hole Peg Test [9HPT]) to discriminate treatment effects in the Phase III study of interferon beta-1a. A log-rank comparison of Kaplan-Meier curves by treatment group showed the non-physicianbased composite of BBT, 9HPT, and TA was of comparable sensitivity (P=0.013) in discriminating sustained treatment failure as the EDSS alone (P=0.029). The composite of BBT, 9HPT, TA, and EDSS was more sensitive (P=0.009) in discriminating sustained treatment failure than the EDSS alone. Compositive outcomes of the EDSS and non-physician-based measures of manual dexterity and timed ambulation provide an appealing strategy to reduce the number of patients required to discriminate treatment effects in MS clinical trials.

Key Words: multiple sclerosis • clinical trials • outcome measures

Multiple Sclerosis, Vol. 4, No. 6, 480-486 (1998)
DOI: 10.1177/135245859800400604


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