Published Online: March 25, 2013. doi:10.1001/jamainternmed.2013.3004
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, Baker, Brown, Kornegay, and Platt. Acquisition of data: Toh, Baker, Brown, and Platt. Analysis and interpretation of data: Toh, Baker, Brown, Kornegay, and Baker. Drafting of the manuscript: Toh, Baker, and Platt. Critical revision of the manuscript for important intellectual content: Toh, Baker, Brown, Kornegay, and Platt. Statistical analysis: Toh and Baker. Obtained funding: Kornegay and Platt. Administrative, technical, and material support: Toh, Baker, Brown, and Platt. Study supervision: Toh, Brown, Kornegay, and Platt.
Mini-Sentinel Investigators: Site principal investigators (designated as PIs in this list) and lead analysts (all others) (for data partners) at the Mini-Sentinel collaborating institutions: Aetna, Blue Bell, Pennsylvania: Claire M. Spettell (PI) and Yihai Liu; America's Health Insurance Plans, Washington, DC: Barbara Lardy (PI); Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts: Sebastian Schneeweiss (PI); Division of General Internal Medicine, Brigham and Women's Hospital: David W. Bates (PI); Center for Health Care Quality, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio: Carole Lannon (PI); Department of Statistics, Columbia University, New York, New York: David Madigan (PI); Critical Path Institute, Tucson, Arizona: Klaus Romero (PI); Duke Clinical Research Institute, Duke University, Durham, North Carolina: Lesley H. Curtis (PI); HealthCore, Inc, Wilmington, Delaware: Gregory Daniel (past PI), Nandini Selvam (current PI), and Tom Puenpatom; Group Health Research Institute, Seattle, Washington: Denise Boudreau (PI) and Tyler Ross; Harvard Pilgrim Health Care Institute, Boston: Richard Platt (PI) and Yury Vilk; HealthPartners Research Foundation, Minneapolis, Minnesota: Pamala A. Pawloski (PI) and Lucas Ovans; Henry Ford Health System, Detroit, Michigan: Sharon H. Alford (PI) and Steve Anteau; Lovelace Clinic Foundation, Albuquerque, New Mexico: Margaret J. Gunter (PI) and Michael Schum; Marshfield Clinic Research Foundation, Marshfield, Wisconsin: Robert T. Greenlee (PI), Valerie McManus, and Kerry Sparks; Meyers Primary Care Institute, Worcester, Massachusetts: Jerry H. Gurwitz (PI) and Daniel Peterson; Humana, Miami, Florida: Vinit Nair (PI) and Qianli Ma; Kaiser Permanente Colorado, Denver: Marsha A. Raebel (PI) and Carsie Nyirenda; Kaiser Permanente Georgia, Atlanta: Melissa G. Butler (PI) and Lee Cromwell; Kaiser Permanente Hawaii, Honolulu: Cynthia Nakasato (PI), John V. Parker, and Mark M. Schmidt; Kaiser Permanente MidAtlantic, Rockville, Maryland: Christine Bredfeldt (PI) and Veronica Song; Kaiser Permanente Northern California, Oakland: Lisa J. Herrinton (PI) and Jack Hamilton; Kaiser Permanente Northwest, Portland, Oregon: David H. Smith (PI) and Donald Bachman; Kaiser Permanente Southern California, Pasadena (currently not contributing data): Aniket A. Kawatkar (PI) and Julie W. Liu; OptumInsight, Waltham, Massachusetts (joined the Mini-Sentinel program after the smoking cessation drug rapid assessment was completed): K. Arnold Chan (PI) and Eva Ng; Outcome Sciences, Inc, Cambridge, Massachusetts: Daniel Campion (PI); Chronic Disease Management and Outcomes, Center for Health Services Research on Pharmacotherapy, Rutgers University, New Brunswick, New Jersey: Stephen Crystal (PI); Deep South Musculoskeletal Center for Education and Research on Therapeutics, University of Alabama at Birmingham: Kenneth G. Saag (PI); College of Pharmacy, University of Illinois at Chicago: Bruce L. Lambert (PI); Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City: Elizabeth A. Chrischilles (PI); Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia: Sean Hennessy (PI); Departments of Pediatrics and Preventive Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee: William O. Cooper (PI) and Tony Morrow; and Weill Cornell Medical College, New York: Alvin I. Mushlin (PI).
Conflict of Interest Disclosures: None reported.
Funding/Support: The Mini-Sentinel program is funded by the FDA through the Department of Health and Human Services contract HHSF223200910006.
Role of the Sponsor: The FDA initiated the smoking cessation drug rapid assessment and participated in the choice of exposure, outcome, and cohort definitions; the interpretation of the data; and the preparation and review of the manuscript. The FDA was not involved in the collection and management of the data. Other aspects of the analysis highlighted in this article were proposed and performed by the Mini-Sentinel Investigators in collaboration with the FDA.
Additional Contributions: Nicolas Beaulieu, MA, Melissa Robb, RN, Susan E. Andrade, ScD, Denise M. Boudreau, PhD, RPh, Melissa G. Butler, PharmD, PhD, Ryan Carnahan, PharmD, MS, Elizabeth A. Chrischilles, MS, PhD, William O. Cooper, MD, MPH, Lesley H. Curtis, PhD, Richard Elmore, MA, Sean Hennessy, PharmD, PhD, Lisa J. Herrinton, PhD, Aniket A. Kawatkar, PhD, Cheryl N. McMahill-Walraven, PhD, Vinit P. Nair, MS, RPh, Jennifer C. Nelson, PhD, Marsha A. Raebel, PharmD, Klaus Romero, MD, MS, Sebastian Schneeweiss, MD, ScD, Jasvinder A. Singh, MD, MPH, David H. Smith, RPh, PhD, Brian L. Strom, MD, MPH, Marcus D. Wilson, PharmD, and Raymond L. Woosley, MD, PhD, provided comments to an earlier draft of this manuscript. Lisa Trebino, MS, Ashley Wong, MS, and Tiffany S. Woodworth, MPH, from the Harvard Pilgrim Health Care Institute provided programming support; Roberta Constantine, RN, MBA, PhD, and Kimberly Lane, MPH, contributed managerial support; and Elizabeth Cavagnaro, BA, provided administrative support. Our FDA colleagues who helped develop this rapid response capability and this specific rapid assessment included Judy Racoosin, MD, MPH, Rachel Sherman, MD, MPH, Janet Woodcock, MD, Gerald Dal Pan, MD, MHS, Marsha Reichman, PhD, Judy Staffa, PhD, RPh, Celia Winchell, MD, Azadeh Shoaibi, MS, MHS, Carlos Bell, MPH, and Mitra Rocca, MS.