Published Online: June 18, 2012. doi:10.1001/jama.2012.6147
Author Contributions: Dr King 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: King, Mitchell.
Acquisition of data: Mitchell, Courcoulas, Pories.
Analysis and interpretation of data: King, Chen, Mitchell, Kalarchian, Steffen, Engel, Courcoulas, Pories, Yanovski.
Drafting of the manuscript: King.
Critical revision of the manuscript for important intellectual content: King, Chen, Mitchell, Kalarchian, Steffen, Engel, Courcoulas, Pories, Yanovski.
Statistical analysis: King, Chen.
Obtained funding: Mitchell, Courcoulas, Pories.
Study supervision: Mitchell, Courcoulas, Pories, Yanovski.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Courcoulas reported receiving research grants from Allergan, Pfizer, Covidien, and EndoGastric Solutions; and is both a consultant for and serves on the scientific advisory board of Johnson & Johnson's Ethicon Healthcare System. Dr Pories reported serving as a consultant to Johnson & Johnson's Ethicon Endo-Surgery Inc; and receiving research grants from Johnson & Johnson's Ethicon Endo-Surgery Inc and GlaxoSmithKline.
Funding/Support: The Longitudinal Assessment of Bariatric Surgery-2 was funded by a cooperative agreement by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grants U01 DK066557 (data coordinating center); U01-DK66667 and UL1-RR024996 (Columbia-Presbyterian in collaboration with Cornell University Medical Center Clinical and Translational Research Center [CTRC]); U01-DK66568 and M01RR-00037 (University of Washington in collaboration with Cornell University Medical Center CTRC); U01-DK66471 (Neuropsychiatric Research Institute); U01-DK66526 (East Carolina University); U01-DK66585 and UL1-RR024153 (University of Pittsburgh Medical Center in collaboration with Cornell University Medical Center CTRC); and U01-DK66555 (Oregon Health & Science University).
Role of the Sponsor: The NIDDK scientists contributed to the design and conduct of the study, which included collection, and management of data. The project scientist from the NIDDK served as a member of the steering committee, along with the principal investigator from each clinical site and the data coordinating center. The data coordinating center housed all data during the study and performed data analyses according to a prespecified plan developed by the data coordinating center biostatistician and approved by the steering committee and independent data and safety monitoring board. The decision to publish was made by the Longitudinal Assessment of Bariatric Surgery-2 steering committee, with no restrictions imposed by the sponsor. As a coauthor, an NIDDK scientist contributed to the interpretation of the data and preparation, review, or approval of the manuscript.
Online-Only Material: The Author Video Interview is available here.