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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Version: author
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Serval ID
serval:BIB_EE7E186FEA50
Type
Article: article from journal or magazin.
Publication sub-type
Minutes: analyse of a published work.
Collection
Publications
Institution
Title
Forum report: issues in the evaluation of diagnostic tests, use of historical controls, and merits of the current multicenter collaborative groups
Journal
Clinical Infectious Diseases : An Official Publication of the Infectious Diseases Society of America
Author(s)
Bennett J.E., Kauffman C., Walsh T., de Pauw B., Dismukes W., Galgiani J., Glauser M., Herbrecht R., Lee J., Pappas P., Powers J., Rex J., Verweij P., Viscoli C.
ISSN
1537-6591 (Electronic)
ISSN-L
1058-4838
Publication state
Published
Issued date
2003
Volume
36
Number
Suppl 3
Pages
S123-S127
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
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.
Keywords
Antifungal Agents/therapeutic use, Mycoses/diagnosis, Mycoses/drug therapy
Pubmed
Web of science
Open Access
Yes
Create date
13/07/2018 10:00
Last modification date
25/09/2019 7:11
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