Accepted for Publication: September 19, 2013.
Published Online: November 4, 2013. doi:10.1001/jamapediatrics.2013.4296.
Study concept and design: Inge, Zeller, Helmrath, Brandt, Michalsky, Harmon, Horlick, Xanthakos, Dolan, Barnett, Buncher.
Acquisition of data: Inge, Jenkins, Helmrath, Brandt, Michalsky, Harmon, Courcoulas, Dolan, Barnett.
Analysis and interpretation of data: Inge, Zeller, Jenkins, Helmrath, Brandt, Michalsky, Harmon, Courcoulas, Xanthakos, Dolan, Mitsnefes, Barnett, Buncher.
Drafting of the manuscript: Inge, Zeller, Jenkins, Helmrath, Brandt, Michalsky, Harmon, Dolan, Barnett.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Jenkins, Harmon, Buncher.
Obtained funding: Inge, Zeller, Helmrath, Michalsky, Harmon, Courcoulas, Buncher.
Administrative, technical, or material support: Inge, Helmrath, Michalsky, Harmon, Courcoulas, Horlick, Xanthakos, Mitsnefes, Buncher.
Study supervision: Inge, Zeller, Brandt, Michalsky, Harmon, Xanthakos, Dolan, Barnett.
Conflict of Interest Disclosures: Dr Inge has received research grant funding from Ethicon Endosurgery. Dr Michalsky has received research grant funding from Allergan Medical Corp and serves as a proctor and speaker for Covidien. Dr Harmon has served on an advisory panel for Stryker Corp. Dr Courcoulas has received research grants from Allergan, Pfizer, Covidien, EndoGastric Solutions, and Nutrisystem and is on the scientific advisory board of Ethicon J & J Healthcare System. Dr Barnett has served as a consultant for Kaleidoscope, Surgical Innovations Ltd, and Nucleus Medical. No other disclosures were reported.
Funding/Support: The Teen-LABS Consortium was funded by cooperative agreements with the National Institute of Diabetes and Digestive and Kidney Diseases through grants U01DK072493 (Cincinnati Children’s Hospital Medical Center), UM1DK072493 (Cincinnati Children’s Hospital Medical Center), and UM1DK095710 (University of Cincinnati). The study was also supported by National Institutes of Health grants UL1 TR000077-04 (Cincinnati Children’s Hospital Medical Center), UL1RR025755 (Nationwide Children’s Hospital), M01-RR00188 (Texas Children’s Hospital/Baylor College of Medicine), UL1 RR024153 and UL1TR000005 (University of Pittsburgh), and UL1 TR000165 (University of Alabama, Birmingham).
Role of the Sponsor: The funding agencies had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Group Information: The Teen-LABS Consortium investigators are Avani Modi, PhD, Victor Garcia, MD, Jennie Noll, PhD, Rosie Miller, RN, CCRC, Rachel Akers, MPH, April Carr, BS, Lindsey Shaw, MS, Cynthia Spikes, CRC, Shelley Kirk, PhD, RD, Linda Kollar, RN, Christine Wright, RN, Stephen Daniels, MD, PhD, Jennifer Andringa, BS, Laurie Bishop, MA, MS, Carolyn Powers, RD, Michelle Starkey Christian, Yanhong Liu, MS, Tawny W. Boyce, MS, MPH, Tara Schafer-Kalkhoff, MA, CCRP, Suzanne Summer, MS, RD (Cincinnati Children’s Hospital Medical Center); Mark Simmons, MEng (University of Cincinnati); Vadim Sherman, MD, Margaret Callie Lee, MPH, David Allen, BS, Trisha Walters-Salas, BSN, Susanne Trout, RD, Gia Washington, PhD, Karin Price, PhD (Texas Children’s Hospital, Baylor Medical Center); Ronald Clements, MD, Richard Stahl, MD, Molly Bray, PhD, Beverly Haynes, BSN, Heather Austin, PhD, Constance Cushing, DPT (Children’s Hospital of Alabama University of Alabama); Ramesh Ramanathan, MD, Carol A. McCloskey, MD, George M. Eid, MD, Jessie Eagleton, MPH, William Gourash, MSN, CRNP, Lindsay Lee, MS, RD, Sheila Pierson, BS, Catherine Gibbs, MS, Dana Farrell, BS, Christopher Coburn, PhD, Dana Rofey, PhD, Rebecca Search, MPH, Mark Shaw, MS (University of Pittsburgh Medical Center); Steven Teich, MD, Allen Browne, MD, Karen Carter, CCRC, Melinda Helton, RN, Bonny Bowen, RN, Cynthia Yensel, RN, MS, Patsy Guittar, MSN, Deanna Lear, RN, MS, Robert David Murray, MD, Ihouma Eneli, MD, Andrea Hedge, Kevin Smith, PhD, Amy Baughcum, PhD, Grace Wentzel, CCRP, and Paula Davies, CCRC (Nationwide Children’s Hospital Medical Center).
Additional Contributions: We acknowledge the generous contribution of methodologic details from the LABS Consortium. We are also grateful for the important work done by the adjudication committee.