Empirical Use of Fluconazole in Critically Ill Patients: Good Study, but What Was the Hold-up?
Authors: Mindy Schuster
Journal: Annals of Internal Medicine (2009)

Letters6 January 2009Empirical Use of Fluconazole in Critically Ill Patients: Good Study, but What Was the Hold-up?Mindy Schuster, MD, Helene Panzer, PhD, and John Edwards, MDMindy Schuster, MDFrom the University of Pennsylvania Medical Center, Philadelphia, PA 19104; Pfizer, New York, NY 10017; and Harbor University of California Los Angeles Medical Center, Torrance, CA 90502.Search for more papers by this author, Helene Panzer, PhDFrom the University of Pennsylvania Medical Center, Philadelphia, PA 19104; Pfizer, New York, NY 10017; and Harbor University of California Los Angeles Medical Center, Torrance, CA 90502.Search for more papers by this author, and John Edwards, MDFrom the University of Pennsylvania Medical Center, Philadelphia, PA 19104; Pfizer, New York, NY 10017; and Harbor University of California Los Angeles Medical Center, Torrance, CA 90502.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-150-1-200901060-00018 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:We appreciate the readers' interest in our study. Dr. Shelburne and Dr. Lee bring up the very important issue of publication delay. Some of the delays that occurred in the reporting of this trial—and in other, similarly complex, multicentered clinical trials conducted in critically ill patient populations—are invariably due to the difficulties in completing the data set after the final patient is enrolled. Performance of quality assurance, data cleaning, site answers to data queries, and review of each individual case by a busy data review committee can be cumbersome and time-intensive processes, which clearly took too long in ...References1. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al; International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors [Editorial]. N Engl J Med. 2004;351:1250-1. [PMID: 15356289] CrossrefMedlineGoogle Scholar2. Pfaller MA, Messer SA, Boyken L, Tendolkar S, Hollis RJ, Diekema DJ. Variation in susceptibility of bloodstream isolates of Candida glabrata to fluconazole according to patient age and geographic location. J Clin Microbiol. 2003;41:2176-9. [PMID: 12734273] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Mindy Schuster, MD; Helene Panzer, PhD; John Edwards, MDAffiliations: From the University of Pennsylvania Medical Center, Philadelphia, PA 19104; Pfizer, New York, NY 10017; and Harbor University of California Los Angeles Medical Center, Torrance, CA 90502.Disclosures:Employment: H. Panzer (Pfizer). Grants received: M. Schuster (Pfizer, Astellas, Merck). Consultancies: J. Edwards (Merck, Pfizer, Cerexa, Eisai, Enzon). PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoEmpirical Fluconazole versus Placebo for Intensive Care Unit Patients Mindy G. Schuster , John E. Edwards Jr. , Jack D. Sobel , Rabih O. Darouiche , Adolf W. Karchmer , Susan Hadley , Gus Slotman , Helene Panzer , Pinaki Biswas , and John H. Rex Empirical Use of Fluconazole in Critically Ill Patients: Good Study, but What Was the Hold-up? Samuel A. Shelburne Empirical Use of Fluconazole in Critically Ill Patients: Good Study, but What Was the Hold-up? Dong Heun Lee Metrics 6 January 2009Volume 150, Issue 1Page: 59-60KeywordsBloodCandidaClinical trial reportingClinical trialsConflicts of interestDeath ratesHealth care quality assessment ePublished: 6 January 2009 Issue Published: 6 January 2009 Copyright & PermissionsCopyright © 2009 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...