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Ann Thorac Surg 2000;70:327-334
© 2000 The Society of Thoracic Surgeons

Special report

Myasthenia gravis: recommendations for clinical research standards1

Alfred Jaretzki, III, MDa, Richard J. Barohn, MDb, Raina M. Ernstoff, MDc, Henry J. Kaminski, MDd, John C. Keesey, MDe, Audrey S. Penn, MDf, Donald B. Sanders, MDg, Task Force of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America

a Department of Surgery, Columbia Presbyterian Medical Center, New York, New York, USA
b Department of Neurology, University of Texas Southwestern Medical Center, Dallas, Texas, USA
c Neurology Service, William Beaumont Hospital, Royal Oak, Michigan, USA
d Departments of Neurology and Neurosciences, Case Western Reserve University, Department of Veterans Affairs Medical Center, University Hospitals of Cleveland, Cleveland, Ohio, USA
e Department of Neurology, University of California at Los Angeles, Los Angeles, California, USA
f National Institute for Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, USA
g Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA

Address reprint requests to The Myasthenia Gravis Foundation of America, Inc, 123 West Madison, Suite 800, Chicago, IL 60602
e-mail: myastheniagravis@msn.com

The need for universally accepted classifications, grading systems, and methods of analysis for patients undergoing therapy for MG is widely recognized and is particularly needed for therapeutic research trials. The Medical Scientific Advisory Board (MSAB) of the Myasthenia Gravis Foundation of America (MGFA) formed a Task Force in May 1997 to address these issues. Initially, the Task Force planned to develop classifications and outcome measures pertaining only to standardizing thymectomy trials. However, it quickly became apparent that their efforts should apply to all therapeutic trials for MG, and thus the scope of the mission was expanded.

During the development of these recommendations, the Task Force faced numerous dilemmas for which no universally satisfactory solution was available. Dilemmas were defined as "situations that require one to choose between two equally balanced alternatives or predicaments that seemingly defy satisfactory solutions." The Task Force members agreed at the outset, however, that their primary goal was to develop a uniform set of classifications to be used in the comparative analysis of the various therapeutic interventions for MG. With this as the primary goal, a consensus was gradually developed. In developing a consensus, at least two meetings were held each year during a 3-year period. Between meetings there was exchange of all proposals by electronic and surface mail, consultation with national and international experts in the field, critical analysis of all proposals, and many revisions. All conflicts (both minor and major) were resolved by vote. Virtually all issues were eventually approved unanimously; a few received a plurality of six.

This report presents the work of the Task Force and proposes classification systems and definitions of response to therapy designed to achieve more uniformity in recording and reporting clinical trials and outcomes research. Although designed primarily for research purposes, we think physicians may find some of . . . [Full Text of this Article]


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