Published Online: February 2, 2009 (doi:10.1001/jama.2009.56).
Author Contributions: Drs Riker and Shehabi had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Riker, Shehabi, Bokesch, Ely.
Acquisition of data: Riker, Ceraso, Koura, Whitten, Margolis, Rocha.
Analysis and interpretation of data: Riker, Bokesch, Wisemandle, Byrne, Ely, Rocha.
Drafting of the manuscript: Riker, Shehabi, Bokesch, Wisemandle, Byrne, Ely, Rocha.
Critical revision of the manuscript for important intellectual content: Riker, Shehabi, Bokesch, Ceraso, Wisemandle, Koura, Whitten, Margolis, Byrne, Ely, Rocha.
Statistical analysis: Riker, Wisemandle, Byrne, Ely.
Administrative, technical, or material support: Bokesch, Koura, Whitten, Margolis, Ely.
Study supervision: Shehabi, Bokesch, Ceraso.
Financial Disclosures: Dr Riker reports that he has received honoraria and/or grant support from Aspect Medical Systems Inc, AstraZeneca, Eli Lilly, Hospira, Takeda, and the Academy for Continued Healthcare Learning. Dr Shehabi reports that he has received honoraria and/or grant support from Hospira, Edward Lifesciences, Theravance, and the Intensive Care Foundation. Dr Ceraso reports that he has received honoraria and/or grant support from Hospira. Dr Koura reports that he has received honoraria and/or grant support from Altana, Artisan Pharma, Boehringer-Ingelheim, CSL, Hospira, Ortho-McNeil, Sepracor, Schering-Plough, and United BioScience Corp. Dr Whitten reports that he has received honoraria and/or grant support from Hospira. Dr Margolis reports that he has received honoraria and/or grant support from Hospira. Mr Byrne reports that he was paid a consulting fee for serving as the independent statistical reviewer by the sponsor. Dr Ely reports that he has received honoraria and/or grant support from Hospira, Pfizer, Eli Lilly, GlaxoSmithKline, and Aspect Medical, and is an advisor to Healthways. Dr Rocha reports that he has received honoraria and/or grant support from Hospira, Theravance, Altana, Novartis and the Canadian Institute of Health Research. Dr Bokesch and Mr Wisemandle reported no disclosures.
Funding/Support: This study was funded by Hospira Inc, Lake Forest, Illinois, which manufactures dexmedetomidine.
Role of the Sponsor: Hospira employees worked collaboratively with the investigators in designing the study and interpreting the data and were involved in the conduct of the study, including the collection, management, and initial analysis of the data. Hospira employees reviewed the manuscript, but approval of the Hospira was not required prior to manuscript submission.
SEDCOM Study Group: Argentina:Buenos Aires: M. Torres Boden (Hospital Argerich); D. Ceraso (Hospital General de Agudos Juan A. Fernández); A. Raimondi (Sanatorio Mater Dei); Mar del Plata: M. Gonzalez (Hospital Privado de Comunidad). Australia:Randwick, NSW: Y. Shehabi (Prince of Wales Hospital); Hobart, TAS: A. Turner (Royal Hobart Hospital); Box Hill, VIC: D. Ernest (Box Hill Hospital); Perth, WA: G. Dobb (Royal Perth Hospital). Brazil:Porto Alegre: F. Dias (Hospital São Lucas da PUCRS), M. Rocha (Irmandade da Santa Casa de Misericórdia de Porto Alegre); Santo André: A. Baruzzi (Hospital Estadual Mário Covas–Santo André); São Paulo: I. da Silva (Real e Benemérita Sociedade Portuguesa de Beneficência–Hospital São Joaquim); São Paulo: E. Rezende (Hospital do Servidor Público Estadual–IAMSPE). United States: Arizona:Chandler: G. Margolin (Progressive Medical Intensivists); Phoenix: J. Feldman (Arizona Pulmonary Specialists); Scottsdale: J. Tillinghast (Arizona Pulmonary Specialists); California:Palo Alto: E. Geller (VA Palo Alto Health Care Systems); Pasadena: N. Singla (Huntington Memorial Hospital); Redlands: J. Dexter (Beaver Medical Group); San Clemente: K. Jones (Accurate Clinical Trials); San Francisco: J. Tang (UCSF–San Francisco General Hospital); San Jose: E. Cheng (Santa Teresa Community Hospital); Colorado:Denver: I. Douglas (Denver Health Medical Center); Delaware:Newark: G. Fulda (Christiana Care Health Services); Washington, DC: D. Herr (Washington Hospital Center); Florida:Bay Pines: L. Anderson (Bay Pines VAMC); Miami: D. Kett (Jackson Memorial Hospital/University of Miami); Tampa: J. Basile (University of South Florida Anesthesiology); Georgia:Atlanta: H. Silverboard (Northside Respiratory Care); Illinois:Arlington Heights: J. Cowen (Northwest Community Hospital); Oak Park: B. Margolis (Resurrection West Suburban Hospital); Peoria: P. Whitten (Peoria Pulmonary Associates); Kansas:Kansas City: S. Simpson (University of Kansas); Olathe: J. Bradley (Consultants in Pulmonary Medicine); Kentucky:Hazard: F. Koura (Kentucky Lung Clinic); Lousiana:Shreveport: S. Conrad (LSU HSC Shreveport); Maryland:Baltimore: C. Shanholtz (University of Maryland School of Medicine); Maine:Biddeford: R. Kahn (PrimeCare Internal Medicine); Portland: R. Riker (Maine Medical Center); Montana:Missoula: W. Bekemeyer (Western Montana Clinic); North Carolina:Greensboro: D. Simonds (Peidmont Respiratory Research Foundation); Nebraska:Omaha: L. Morrow (Creighton University Medical Center); New Jersey:Camden: J. Littman (Cooper University Hospital); Englewood: A. Shander (Englewood Hospital and Medical Center); New York:Bronx: R. Cuibotaru (St Barnabas Hospital); P. Dicpinigaitis (Montefiore Medical Center); Brooklyn: L. George (New York Medical Hospital); Mineola: M. Groth (Winthrop-University Hospital); New York: C. Carpati (St Vincent Catholic Medical Center); Rochester: D. Kaufman (University of Rochester, Strong Memorial Hospital); Ohio:Akron: J. Wilson (Summa Health System); Oregon:Medford: J. Ordal, J. Schoenhals (Pulmonary Consultants Research); Pennsylvania:Danville: M. Haupt (Geisinger Medical Center); Monroeville: J. Hoyt (Forbes Regional Hospital); South Carolina:Charleston: P. Flume (Medical University of South Carolina); D. Handshoe (Low Country Lung and Critical Care). Tennessee:Memphis: M. Pugazhenthi (University of Tennessee Health Science Center); Texas:Dallas: M. Ramsay (Baylor University Medical Center); Galveston: V. Cardenas (University of Texas Medical Branch); Houston: H. Minkowitz (Memorial-Hermann Memorial City Hospital). Utah:Ogden: T. Fujii (McKay Dee Hospital). Va:Lynchburg: A. Baker (Lynchburg Pulmonary Associates). New Zealand:Christchurch: S. Henderson (Christchurch Hospital); Hastings: R. Freebairn (Hawke's Bay Regional Hospital); Palmerston North: G. McHugh (Palmerston North Hospital).
Independent Statistical Review: Daniel Byrne, MS (Department of Biostatistics, Vanderbilt University), had access to all of the data used in the study and performed an independent analysis of the primary and key secondary end points reported in this article by repeating the analyses and verifying P values and 95% confidence intervals. The results of Mr Byrne's analysis are reported in this article. He also verified the consistency between the objectives set out in the protocol, prespecified statistical analysis plan, and results of the statistical analysis produced by the sponsor. He found no discrepancy in these reports, and all results reported in this article were identical to those obtained by the sponsor.