Journal Article

Forum Report: Issues in the Evaluation of Diagnostic Tests, Use of Historical Controls, and Merits of the Current Multicenter Collaborative Groups

John E. Bennett, Carol Kauffman, Thomas Walsh, Ben de Pauw, William Dismukes, John Galgiani, Michel Glauser, Raoul Herbrecht, Jeannette Lee, Peter Pappas, John Powers, John Rex, Paul Verweij and Claudio Viscoli

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 36, issue Supplement_3, pages S123-S127
Published in print April 2003 | ISSN: 1058-4838
Published online April 2003 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/367840
Forum Report: Issues in the Evaluation of Diagnostic Tests, Use of Historical Controls, and Merits of the Current Multicenter Collaborative Groups

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This forum report contains conclusions about 3 different issues relevant to conducting clinical trials in deep mycoses. (1) Trials of diagnostic tests for deep mycoses must define the population appropriate for testing and the clinical question being asked. The unanswered question for the serum Aspergillus galactomannan assay is whether knowledge of results can change use of empirical therapy to treat febrile patients at high risk of invasive aspergillosis. (2) Use of historical controls is suboptimal but offers a pragmatic solution for studying rare mycoses; use of contemporaneous controls, matched for critical variables and evaluated by a blinded data review committee using detailed criteria, appears optimal. (3) Established groups of independent investigators, such as the European Organization for Research on Treatment of Cancer's Invasive Fungal Infections Group and National Institute of Allergy and Infectious Diseases's Bacteriology and Mycology Study Group, provide a pool of experienced investigators, defined operating rules, impartiality, and specialized expertise. Considering the enormous investment required for adequately powered efficacy trials of antifungal agents and the importance of these trials to guide clinical practice, use of collaborative groups outweighs the extra administrative time that is sometimes required.

Journal Article.  3075 words. 

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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