Author Contributions: Dr Patkar, who is independent of any commercial funder, 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: Winthrop, Chen, Liu, Grijalva, Delzell, Beukelman, Patkar, Herrinton, Solomon, Lewis, Curtis.
Acquisition of data: Grijalva, Saag, Herrinton, Curtis.
Analysis and interpretation of data: Winthrop, Baddley, Chen, Grijalva, Delzell, Beukelman, Patkar, Xie, Saag, Herrinton, Curtis.
Drafting of the manuscript: Winthrop, Delzell, Herrinton, Curtis.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Winthrop, Baddley, Chen, Liu, Delzell, Beukelman, Xie, Curtis.
Obtained funding: Patkar, Saag, Herrinton, Solomon, Lewis, Curtis.
Administrative, technical, or material support: Winthrop, Baddley, Patkar, Herrinton, Curtis.
Study supervision: Winthrop, Patkar, Saag, Herrinton, Solomon.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Winthrop reported that he has consulted for Genentech, Abbott, Pfizer, UCB Pharma, and Amgen and received research grant support from Pfizer. Dr Baddley reported that he has consulted for Pfizer and Merck. Dr Delzell reported that she has received research and other support from Amgen. Dr Grijalva reported that he has received research grant support from National Institutes of Health. Dr Beukelman reported that he has received research support from Pfizer and National Institutes of Health and consultant fees from Novartis and Genentech. Dr Saag reported that he has received research support from Amgen, Genentech, Horizon, Merck, National Institutes of Health, and Apollo Health Resources Ltd, consulted for Amgen, Abbott, Ardea, Lilly, Merck, Regeneron, Savient, and URL Pharma, and has served on the board for National Osteoporosis Foundation. Dr Herrinton reported that she has received research support from Centocor, Genentech, and Procter and Gamble and has served as an expert witness for Hoffman La Roche. Dr Solomon reported that he has received research support from Amgen, Lilly, and the Consortium of Rheumatology Researchers of North America Inc. He serves in unpaid roles on trials funded by Pfizer and Novartis. Dr Lewis reported that he has received research support from Centocor, Takeda, and Shire and consultant honoraria from Abbott, Amgen, Millennium Pharmaceuticals, Prometheus, and Pfizer. Dr Curtis reported that he has received consultant fees from Roche/Genentech, UCB Pharma, Centocor, Consortium of Rheumatology Researchers of North America Inc, Amgen, Pfizer, Bristol-Myers Squibb, Crescendo, and Abbott. No other disclosures were reported.
Funding/Support: This work was supported by the US Food and Drug Administration (FDA), US Department of Health and Human Services (DHHS), and by grant U18 HS17919 from the Agency for Healthcare Research and Quality (AHRQ), administered through the AHRQ Centers for Education and Research on Therapeutics Program. Dr Winthrop's work on this article was funded by grant 1K08HS017552-01 from AHRQ. Dr Curtis was supported by grant AR053351 from the National Institutes of Health (NIH) and by grant R01HS018517 from AHRQ. Dr Beukelman was supported by grant 5KL2 RR025776-03 from NIH via the University of Alabama at Birmingham Center for Clinical and Translational Science. Dr Grijalva was supported by grant 5P60AR56116 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
Role of the Sponsor: Dr Ouellet Hellstrom (FDA) and Dr Parivash Nourjah (AHRQ) participated as coinvestigators in the design and conduct of the study, interpretation of the data, review, and approval of the manuscript.
Disclaimer: The authors of this report are responsible for its content. Statements in the report should not be construed as endorsements by AHRQ, FDA, or DHHS.
Additional Contributions: We thank Rita Ouellet-Hellstrom, PhD, MPH, of the FDA, and Parivash Nourjah, PhD, of AHRQ, for their assistance with study design and Jennifer Ku, MPH, Oregon Health and Science University, with assistance in formatting the manuscript. These acknowledged individuals were not directly compensated for their effort. We also thank the Tennessee Bureau of TennCare of the Department of Finance and Administration for providing the Tennessee Medicaid data.
Online-Only Material: The Author Video Interview is available .
This article was corrected for errors on March 29, 2013.