Author Contributions: Dr Kollef had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Kollef, Anzueto, Schinner.
Acquisition of data: Afessa, Anzueto, Veremakis, Kerr, Margolis, Craven, Arroliga, Hubmayr, Restrepo, Auger.
Analysis and interpretation of data: Afessa, Anzueto, Veremakis, Craven, Roberts, Arroliga, Hubmayr, Schinner.
Drafting of the manuscript: Kollef, Afessa, Anzueto, Craven, Arroliga, Schinner.
Critical revision of the manuscript for important intellectual content: Kollef, Afessa, Anzueto, Veremakis, Kerr, Margolis, Craven, Roberts, Arroliga, Hubmayr, Restrepo, Auger, Schinner.
Statistical analysis: Schinner.
Obtained funding: Kollef, Afessa, Anzueto, Roberts, Arroliga, Restrepo.
Administrative, technical, or material support: Veremakis, Margolis, Hubmayr.
Study supervision: Kollef, Afessa, Anzueto, Kerr, Margolis, Craven, Roberts, Hubmayr, Restrepo, Auger.
Financial Disclosures: All authors received grant support from Bard. In addition, Dr Kollef reported receiving a consulting fee from Kimberly Clark and lecture fees and grant support from Elan, Merck, and Pfizer. Dr Anzueto reported receiving grant support from Bayer and GlaxoSmithKline and consulting and lecture fees from Bayer, Boehringer Ingelheim, GlaxoSmithKline, KCI (lecturing only), and sanofi-aventis (consulting only). Dr Margolis reported owning stock in Johnson & Johnson, receiving lecture fees from GlaxoSmithKline, and receiving grant support from Easi, Hospira, and Pfizer. Dr Craven reported receiving grant support from Nomir Medical Technologies; lecture fees from Arpida, Cubist, Elan, Merck, Ortho-McNeil, Pfizer, Sanofi Pasteur, and Wyeth; and consulting fees from Arpida, Bayer-Nektar, Cubist, Johnson & Johnson, Ortho-McNeil, and Wyeth. Dr Roberts reported receiving lecture fees from Nestle Clinical Nutrition; grant support from Lilly; and consulting fees from Bard, Corbett Accel Healthcare, and sanofi-aventis. Dr Hubmayr reported receiving grant support from the National Institutes of Health, serving on a data and safety monitoring board for Novartis, and receiving lecture fees from Maquet. Dr Restrepo reported receiving lecture fees from Elan, Ortho-McNeil (and consulting fees), Pfizer (and consulting fees), and Wyeth. No other disclosures were reported.
Funding/Support: This study, including design, data collection, statistical analysis, and manuscript preparation, was supported by a research grant from C. R. Bard Inc.
Role of the Sponsor: C. R. Bard Inc contributed to the study design but did not participate in the conduct of the study; the collection, analysis, and interpretation of the data; or the review or approval of the manuscript.
Independent Data and Safety Monitoring Board: Robert P. Baughman, MD, University of Cincinnati Medical Center, Cincinnati, Ohio; Richard P. Chiacchierini, PhD, R. P. Chiacchierini & Associates, Rockville, Maryland; Mark J. Rumbak, MD, FCCP, University of South Florida College of Medicine, Tampa; Andrew F. Shorr, MD, MPH, Washington Hospital Center, Washington, DC.
Independent Statistical Analysis: The accuracy of the data analysis was independently verified by William Shannon, PhD, Department of Biostatistics in Medicine, Washington University School of Medicine. Dr Shannon received the entire raw database and the statistical analysis plan, replicated all analyses, and discovered no discrepancies. All results reported in this article are those performed by Dr Shannon. Dr Shannon received compensation from the sponsor.
NASCENT Investigation Group: (Asterisk [*] indicates investigators): Mayo Clinic & Foundation (B. Afessa,* R. Hubmayr,* G. Wilson); Greenville Hospital System (T. Ansari,* T. Manchester); South Texas Veterans Health Care System, Audie L. Murphy Division, University Hospital, and University of Texas Health Science Center at San Antonio (A. Anzueto,* M. I. Restrepo,* S. Bakhta,* D. Fiedler,* S. Kucera, T. Houlihan); The Cleveland Clinic (A. C. Arroliga,* T. Isabella, J. Komara, M. Ferrari); Penn State Hershey Medical Center (D. Carney,* S. Blosser,* T. Novchich); Saint Francis Hospital and Medical Center (G. Collin,* B. Bernstein); Staten Island University Hospital (G. Coppa,* M. Temperino); Lahey Clinic Medical Center (D. E. Craven,* S. DiGregorio, C. Lamb,* J. Polcaro); Temple University Hospital (G. Criner,* C. Grabianowski); Cooper University Health System (P. Dellinger,* C. Stillwell); Atlanta Institute for Medical Research (T. DeMarini,* N. Maslanka, B. Allen); Denver Health Medical Center (I. Douglas,* D. Lathrop); Morton Plant Hospital (E. Freilich,* D. Amin,* L. M. Woods, T. Phillips); University of Tennessee Health Services Center (A. Freire,* S. Thompson, R. Umberger); Research Consortium Doctors Hospital (B. Friedman,* D. Redman, J. Wilson); University of Florida Health Science Center (J. T. Gallagher,* J. Wishin, A. J. Lavon, L. Caruso, A. Gabrielli, N. Bennett); Jackson Memorial Hospital (E. Ginzburg,* B. Derr); University of Iowa Medical Center (S. J. Hata,* C. Shelsky), Washington Hospital Center (D. Herr,* N. Bolouri), University of Michigan Medical Center (R. Hyzy,* D. Cooperson); University of Alabama Hospital (J. E. Johnson,* M. R. Waldrum,* K. Wille,* L. O’Hare); St Louis University Hospital (C. Kaplan,* P. Dettenmeire); St Vincent Mercy Medical Center (S. Katragadda,* T. Steinhauser); Strong Memorial Hospital (D. Kaufman,* T. Harvey); Montefiore Hospital (A. Keene,* K. Moltz, S. Koppisetti, M. Liz); University of California San Diego Medical Center (K. Kerr,* W. Auger,* B. Munden, L. Gabel); St Mary’s/Duluth Clinic Health System (G. Kindt,* L. M. Funke, L. Athmann); Virginia Mason Medical Center (S. Kirtland,* J. Zeller); Cabrini Medical Center (A. Klapholz,* L. Hardinge); Henry Ford Hospital (H. Klausner,* L. A. Defoe); Washington University School of Medicine (M. Kollef, lead investigator,* A. Doyle); University of Colorado Health Sciences Center (N. Lange,* S. Giambartolomei, G. Thoutt); Olathe Medical Center (D. P. Lawlor,* M. L. Schroeder); Emory Crawford Long Hospital (K. Leeper,* C. Weyers); Mount Sinai Medical Center (A. Manasia,* R. Delguidice); Banner Desert Medical Center (D. Mapel,* R. Ponder); West Suburban Hospital (B. Margolis,* C. Doornbos); London Health Sciences Center (C. Martin*); Creighton University Medical Center (L. Morrow,* M. Galkowski); Winthrop University Hospital (M. Niederman,* P. Jacobs); Memorial Sloan Kettering Cancer Center (S. Pastores,* M. Alicea, L. Schneider); Oregon Health & Science University (C. Phillips,* K. Bacon); Wake Forest University School of Medicine (P. Roberts,* J. Bennett); Florida Hospital, Orlando (M. Rodricks,* C. Mattix); San Juan VA Medical Center (W. Rodriguez,* P. J. Yapor,* G. Ayala); Atlanta Pulmonary Group (P. Scheinberg,* C. Bensen, R. Sanders); Saint Francis Hospital (E. J. Schelbar,* W. M. Boomer,* J. K. Goulet, J. Sluss); University of Kansas Medical Center (S. Simpson,* K. Conyers); Louisiana State University Health Sciences Center (W. Summer,* C. Romaine); University of South Carolina Medical Center (A. Sy,* E. McFarland); Nebraska Medical Center (A. B. Thompson,* M. Scheetz); St John's Mercy Medical Center (C. Veremakis,* J. O’Brien); Sharp Memorial Hospital (D. Willms,* S. Middlebrook); University of Pittsburgh School of Medicine (K. A. Wood,* A. Abraham, J. H. Carlins, V. Griffin-Glatz).
Previous Presentation: Kollef M, Afessa B, Anzueto A, Schinner R. Randomized study of a silver-coated endotracheal tube to reduce the incidence of ventilator-associated pneumonia: the North American Silver-Coated Endotracheal Tube (NASCENT) study. Presented at: Annual Congress of the European Society of Intensive Care Medicine; 2007; Berlin, Germany. Abstract and poster 0242.
Additional Contributions: We thank Joan Dulin (C. R. Bard Inc) for serving as clinical study manager and Cindy W. Hamilton, PharmD, ELS (Hamilton House, Virginia Beach, Virginia), for assisting with manuscript preparation. Hamilton House received compensation from C. R. Bard Inc for its contributions.