Accepted for Publication: June 1, 2012.
Published Online: October 15, 2012. doi:10.1001/2013.jamainternmed.34
Author Contributions: Dr Toh had full access to all 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: Toh, Reichman, Houstoun, Ross Southworth, Ding, Levenson, McCloskey, Shoaibi, Zornberg, and Hennessy. Acquisition of data: Toh. Analysis and interpretation of data: Toh, Reichman, Houstoun, Ross Southworth, Ding, Hernandez, Li, Shoaibi, Wu, Zornberg, and Hennessy. Drafting of the manuscript: Toh. Critical revision of the manuscript for important intellectual content: Toh, Reichman, Houstoun, Ross Southworth, Ding, Hernandez, Levenson, Li, McCloskey, Shoaibi, Wu, Zornberg, and Hennessy. Statistical analysis: Toh, Reichman, Ding, Levenson, Li, Shoaibi, and Zornberg. Obtained funding: Toh and Reichman. Administrative, technical, and material support: Toh, Reichman, Houstoun, Ding, Wu, and Zornberg. Study supervision: Toh, Reichman, Houstoun, and Levenson.
Conflict of Interest Disclosures: Dr Hernandez has received research support or consulting fees from Amylin, AstraZeneca, Corthera, Johnson & Johnson, and sanofi-aventis. Dr Hennessy has received research support from AstraZeneca and Bristol-Myers Squibb and has consulted for Abbott and Novartis, unrelated to the products examined in this study.
Funding/Support: The Mini-Sentinel program is funded by the Food and Drug Administration through contract HHSF223200910006I from the Department of Health and Human Services.
Role of the Sponsor: The coauthors employed by the Food and Drug Administration participated in the design and conduct of the study; interpretation of the data; and preparation, review, and approval of the manuscript. They were not involved in the collection or management of the data.
Additional Contributions: Aarthi Iyer, MPH, and Jillian Lauer, BS, provided administrative support; Nicolas Beaulieu, MA, James Marshall, MS, Lisa Trebino, MS, Erick Moyneur, MA, and Eric Gravel, MA, contributed programming assistance; and Bruce Fireman, MA, guided application of the case-centered logistic regression approach. The following data partners participated in the study: Aetna, HealthCore Inc, the HMO Research Network (Group Health Research Institute, Harvard Pilgrim Health Care Institute, HealthPartners Research Foundation, Henry Ford Health System, Lovelace Clinic Foundation, Marshfield Clinic Research Foundation, and Meyers Primary Care Institute), Humana, the Kaiser Permanente Center for Effectiveness and Safety Research (Kaiser Permanente Colorado, Kaiser Permanente Georgia, Kaiser Permanente Hawaii, Kaiser Permanente Mid-Atlantic, Kaiser Permanente Northern California, and Kaiser Permanente Northwest), and Vanderbilt University/Tennessee Medicaid.