Author Contributions: Dr Tricoci 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: Tricoci, Allen, Kramer, Califf, Smith.
Acquisition of data: Tricoci, Allen.
Analysis and interpretation of data: Tricoci, Allen, Kramer, Califf, Smith.
Drafting of the manuscript: Tricoci, Allen, Kramer.
Critical revision of the manuscript for important intellectual content: Tricoci, Allen, Kramer, Califf, Smith.
Statistical analysis: Tricoci, Allen.
Obtained funding: Allen, Kramer.
Administrative, technical, or material support: Califf.
Study supervision: Tricoci, Califf, Smith.
Financial Disclosures: Dr Tricoci reports that as a faculty member of the Duke Clinical Research Institute, an academic clinical research organization, his salary is partially supported by research grants from Schering-Plough. Dr Kramer reports that as a faculty member of the Duke Clinical Research Institute, an academic clinical research organization, and as executive director of the Clinical Trials Transformation Initiative (CTTI), her salary is supported in part by CTTI membership fees paid by the following companies: Amgen Inc, Bayer, bioMerieux, Biotronik, Bristol-Myers Squibb, CR Bard Inc, Eli Lilly, Gemin X, Genentech, GlaxoSmithKline, Hoffman-La Roche Inc, Human Genome Sciences Inc, J&J Medical Devices & Diagnostics, J&J Pharmaceutical Research and Development, Novartis, Pfizer, St Jude Medical, The Medicines Company, and Wright Medical. Dr Califf reports that he receives research funding from Novartis Pharmaceutical and Schering-Plough; is a member of the speakers bureaus for Heart.org, Kowa Research Institute, and Novartis Pharmaceutical; and consults for ABC, Amylin, Bayer, Boehringer Ingelheim, Boston Scientific, GSK, Heart.org, Kowa Research Institute, Medtronic, Nitrox LLC, Novartis Pharmaceutical, Roche, Sanofi-Aventis, Schering-Plough, SCIUS, Targacept, University of Florida, and Vivus; and owns equity in Nitrox LLC. No other financial disclosures were reported.
Funding/Support: This project was supported by grant U18HS010548 from the Agency for Healthcare Research and Quality. Dr Smith's efforts in this work were supported by a Distinguished Scholarship from the Rose Azus Cardiac Research Education Fund, Sharp Hospital Foundation, San Diego, California.
Role of the Sponsors: No sponsor of this research participated in the design and conduct of the study, in the collection, analysis, and interpretation of the data, or in the preparation, review, or approval of the manuscript.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality.