Author Contributions: Drs Shui and Baggs 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: Shui, Baggs, Parashar, Belongia, Glanz, Weintraub.
Acquisition of data: Shui, Baggs, Rett, Hambidge, Glanz, Klein, Weintraub.
Analysis and interpretation of data: Shui, Baggs, Patel, Parashar, Glanz, Klein, Weintraub.
Drafting of the manuscript: Shui, Baggs, Parashar, Glanz.
Critical revision of the manuscript for important intellectual content: Shui, Baggs, Patel, Parashar, Rett, Belongia, Hambidge, Klein, Weintraub.
Statistical analysis: Shui, Baggs, Glanz, Weintraub.
Obtained funding: Klein.
Administrative, technical, or material support: Rett, Hambidge, Weintraub.
Study supervision: Shui, Patel, Parashar, Hambidge, Weintraub.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Shui reports receiving institutional support from America's Health Insurance Plan (AHIP) for writing or reviewing a manuscript and for travel support. Dr Rett reports receiving institutional support for writing or reviewing a manuscript and travel support from AHIP. Dr Belongia reports receiving institutional grant support from the Centers for Disease Control and Prevention (CDC) and AHIP and pending research support from MedImmune. Dr Hambidge reports receiving institutional grant and travel support from Kaiser Colorado Institute for Health Research—funding for Vaccine Safety Datalink work from the CDC through a cooperative agreement with AHIP and pending institutional support from the CDC for several vaccine safety investigations under the umbrella of the Vaccine Safety Datalink. Dr Glanz reports receiving institutional grant support from the CDC. Dr Klein reports receiving institutional grant support from the CDC and research support for other projects from Merck, GlaxoSmithKline, Pfizer, Sanofi Pasteur, and Novartis. No other financial conflicts were reported.
Participating Organizations: Group Health Cooperative of Puget Sound, Seattle, Washington; Kaiser Permanente Northwest, Portland, Oregon; Kaiser Permanente of Northern California, Oakland; Kaiser Permanente of Southern California, Los Angeles; Kaiser Permanente of Colorado, Denver; Marshfield Clinic Research Foundation, Marshfield, Wisconsin; Health Partners Research Foundation, Minneapolis, Minnesota; and Harvard Vanguard Medical Associates and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
Funding/Support: This study was supported in part by the Vaccine Safety Datalink contract (200-2002-00732) with AHIP, funded by the CDC.
Disclaimer: Although the CDC played a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript, the findings and conclusions in this manuscript are those of the authors and do not necessarily represent the official position of the CDC.
Online-Only Material: Author Video Interview is available here.
Additional Contributions: We thank Allison L. Naleway, PhD, Jill Mesa, BA, and Lois Drew, BA, Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon; Lisa A. Jackson, MD, MPH, Group Health Research Institute, Seattle, Washington; Stephanie Irving, MHS, and Nicholas Berger, BA, Marshfield Clinic Research Foundation, Marshfield, Wisconsin for their participation and role in data coordination, none of whom received compensation beyond his or her regular salary.