Abstract
In this chapter we call upon our experiences as principal statistician (E.D.M.) and principal investigator (G.M.M.) in a controlled study of plasmapheresis in the treatment of the acute Guillain-Barré Syndrome (GBS) [1–3]. We will present a description of the disease and a brief history of attempts at therapy of this disorder. The conceptual development and design used in our study are emphasized. Comprehensive results are given and compared with similar studies carried out by Swedish [4] and French [5] investigators. In addition, the statistical methodology that was used and the rationale for its choice are presented. In our discussion, we identify several points learned from our experiences. In particular, we stress the importance of standardization of clinical data, definition of the endpoints involved, the strategy for choosing the sample size, and the choice of statistical methods, as dictated by the analytic definition of the problem.
Keywords
- Clinical Grade
- Conventional Therapy Group
- Actuarial Approach
- Continuous Machine
- Prior Illness
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
This is a preview of subscription content, access via your institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsPreview
Unable to display preview. Download preview PDF.
References
Guillain-Barré Syndrome Study Group (1985). Plasmapheresis and acute Guillain-Barré syndrome. Neurology 35:1096–1104.
McKhann GM, Griffin JW, Cornblath DR, et al. (1988). Plasmapheresis and Guillain-Barré syndrome: Analysis of prognostic factors and the effect of plasmapheresis. Ann Neurol 23:347–353.
McKhann GM, Griffin JW, Cornblath DR, et al. (1988). Role of therapeutic plasmapheresis in the acute Guillain-Barré syndrome. J Neuroimmunol 20:297–300.
Osterman PO, Lundemo G, Pirskanen R, et al. (1984). Beneficial effects of plasma exchange in acute inflammatory polyradiculoneuropathy. Lancet 2:1296–1299.
French Cooperative Group on Plasma Exchange and Guillain-Barré Syndrome (1987). Efficiency of plasma exchange in Guillain-Barré syndrome: role of replacement fluids. Ann Neurol 22:753–761.
Hughes RAC, Newsom-Davis JM, Perkins GD, et al. (1978). Controlled trial of prednisolone in acute polyneuropathy. Lancet 2:750–753.
Koski CL, Humphrey R, Shin ML (1985). Anti-peripheral myelin antibodies in patients with demyelinating neuropathy: quantitative and kinetic determination of serum antibodies by complement component 1 fixation. Proc Natl Acad Sci USA 82:905–909.
Greenwood RJ, Hughes RAC, Bowden AN, et al. (1984). Controlled trial of plasma exchange in acute inflammatory polyradiculoneuropathy. Lancet 1:877–879.
Kaplan EL, Meier P (1958). Nonparametric estimation from incomplete observations. J Am Statist Assoc 53:457–481.
Breslow N (1970). A generalized Kruskal-Wallis Test for comparing k samples subject to unequal patterns of censorship. Biometrika 57:579–594.
Jennrick RI, Moore RH (1975). Maximum likelihood estimation by means of nonlinear least squares. In Proceedings of the Statistical Computing Section. J Am Statist Assoc 57–65.
Morrison DF (1967). Multivariate Statistical Methods. New York: McGraw-Hill.
Kalbfleisch JD, Prentice RL (1980). The Statistical Analysis of Failure Time Data. New York: John Wiley.
Peto R, Pike MC, Armitage P, et al. (1976). Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 34:585–612.
Loffel NB, Rossi LN, Mumenthaler M, et al. (1977). The Landry-Guillain-Barré syndrome: complications, prognosis and natural history in 123 cases. J Neurol Sci 33:71–79.
Vermeulen M, van der Meche FGA, Speelman JD, et al. (1985). Plasma and gamma-globulin infusion in chronic inflammatory polyneuropathy. J Neurol Sci 70: 317–326.
McKhann GM (1989). The trials of clinical trials. Arch Neurol 46:611–614.
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1990 Kluwer Academic Publishers
About this chapter
Cite this chapter
Mellits, E.D., McKhann, G.M. (1990). Guillain-Barré: Plasmapheresis. In: Porter, R.J., Schoenberg, B.S. (eds) Controlled Clinical Trials in Neurological Disease. Foundations of Neurology, vol 1. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-1495-0_17
Download citation
DOI: https://doi.org/10.1007/978-1-4613-1495-0_17
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4612-8804-6
Online ISBN: 978-1-4613-1495-0
eBook Packages: Springer Book Archive