Published Online: November 6, 2011. doi:10.1001/jama.2011.1692
Author Contributions: Dr Chen 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: Grijalva, Chen, Delzell, Beukelman, Winthrop, Griffin, Liu, Patkar, Solomon, Lewis, Saag, Curtis.
Acquisition of data: Winthrop, Griffin, Herrinton, Liu, Solomon, Curtis.
Analysis and interpretation of data: Grijalva, Chen, Delzell, Baddley, Beukelman, Winthrop, Griffin, Herrinton, Liu, Ouellet-Hellstrom, Patkar, Solomon, Xie, Saag, Curtis.
Drafting of the manuscript: Grijalva, Curtis.
Critical revision of the manuscript for important intellectual content: Grijalva, Chen, Delzell, Baddley, Beukelman, Winthrop, Griffin, Herrinton, Liu, Ouellet-Hellstrom, Patkar, Solomon, Lewis, Xie, Saag, Curtis.
Statistical analysis: Chen, Baddley, Beukelman, Winthrop, Herrinton, Liu, Ouellet-Hellstrom, Xie, Curtis.
Obtained funding: Griffin, Herrinton, Liu, Patkar, Solomon, Lewis, Saag, Curtis.
Administrative, technical, or material support: Winthrop, Herrinton, Patkar, Solomon, Curtis.
Study supervision: Grijalva, Herrinton, Patkar, Saag, Curtis.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Delzell reported receiving research support from Amgen. Dr Baddley reported consulting for Abbott and Merck. Dr Herrinton reported receiving research support from Genentech, Centocor, and Procter & Gamble. Dr Solomon reported receiving research support from Amgen, Abbott, Eli Lilly, and Bristol-Myers Squibb. Dr Lewis reported consulting for Genentech, Abbott, CORRONA (Consortium of Rheumatology Researchers of North America Inc), Millennium Pharmaceuticals, Elan, AstraZeneca, Procter & Gamble, GlaxoSmithKline, Alios Therapeutics, Roche, and Amgen; he also reported receiving research support from Centocor, Takeda, and Shire, and consultant honoraria from Amgen and Pfizer. Dr Winthrop reported receiving consultant fees from Genentech and Abbott, research support from Pfizer, and speakers honoraria from Amgen and Pfizer. Dr Saag reported receiving research support from Amgen, Genentech, and Pfizer. Dr Curtis reported receiving consultant fees and research grants from Roche/Genentech, UCB biopharma, Centocor, CORRONA, Amgen, Pfizer, Bristol-Myers Squibb, Crescendo, and Abbott. Other authors reported no conflicts.
Funding/Support: This work was supported by the Food and Drug Administration (FDA), US Department of Health and Human Services (DHHS), and the Agency for Healthcare Research and Quality (AHRQ) grant U18 HS17919. Dr Curtis receives support from the National Institutes of Health (NIH; AR053351) and AHRQ (R01HS018517). Dr Beukelman was supported by NIH grant 5KL2 RR025776-03 via the University of Alabama at Birmingham Center for Clinical and Translational Science. Drs Grijalva and Griffin receive support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, grant 5P60AR56116.
Role of the Sponsors: Members of the funding organizations (Dr Ouellet-Hellstrom [from FDA] and Dr Parivash Nourjah [from AHRQ]) participated in the design and conduct of the study. The sponsors had the opportunity to review and comment on the final version of the report.
The SABER Collaboration:AHRQ: Parivash Nourjah; Brigham and Women's Hospital: Robert Glynn, Mary Kowal, Joyce Lii, Jeremy Rassen, Sebastian Schneeweiss, Daniel Solomon; Fallon Medical Center and University of Massachusetts: Leslie Harrold; FDA: David Graham, Carolyn McCloskey, Rita Ouellet-Hellstrom, Kristin Phucas; Kaiser Permanente Northern California: Lisa Herrinton, Liyan Liu; Kaiser Permanente Colorado: Marcia Raebel; Universityof Alabama at Birmingham: Lang Chen, Jeffrey Curtis, Elizabeth Delzell, Nivedita Patkar, Kenneth Saag, Fenglong Xie; University of Pennsylvania: Kevin Haynes, James Lewis; Vanderbilt University: Marie Griffin, Carlos Grijalva, and Ed Mitchel.
Disclaimer: The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the FDA or AHRQ.