Author Contributions: Dr Habel 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: Chan, Cheetham, Cooper, Fireman, Habel, Ray, Selby, Sox.
Acquisition of data: Andrade, Boudreau, Chan, Cheetham, Cooper, Dublin, Habel, Pawloski, Quinn, Raebel, Selby, Smith, Sox, Uratsu.
Analysis and interpretation of data: Achacoso, Arbogast, Chan, Cheetham, Cooper, Fireman, Go, Habel, Nguyen-Huynh, Quinn, Ray, Selby, Sidney, Sox, Uratsu.
Drafting of the manuscript: Habel
Critical revision of the manuscript for important intellectual content: Achacoso, Andrade, Arbogast, Boudreau, Chan, Cheetham, Cooper, Dublin, Fireman, Go, Nguyen-Huynh, Pawloski, Quinn, Raebel, Ray, Selby, Sidney, Smith, Sox, Uratsu.
Statistical analysis: Achacoso, Arbogast, Cooper, Fireman, Uratsu.
Obtained funding: Chan, Cooper, Habel, Quinn, Selby.
Administrative, technical, or material support: Achacoso, Andrade, Chan, Quinn, Selby, Uratsu.
Study supervision: Andrade, Chan, Cooper, Habel, Quinn, Smith, Sox.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest.
Dr. Chan reported receiving support for travel to meetings for the purpose of the study or other purposes from the FDA. Dr. Chan also reported that he is a part time employee of OptumInsight, a for-profit company that receives funding from medical product manufacturers to provide consultation and conduct research on medical products. As OptumInsight is a part of UnitedHealthGroup, Dr. Chan has received UHG stock options.
Dr. Andrade reported that the Meyers Primary Care Institute has received funding from GlaxoSmithKline and Novartis Pharmaceuticals, manufacturers of medications used to treat ADHD.
Dr. Habel reported receiving grants from Merck for a study of herpes zoster in cancer patients, Takeda for a study of proglitazone and cancer, and Sanofi-Aventis for a study of insulin and cancer.
Dr. Dublin has received a Merck/American Geriatrics Society New Investigator Award for unrelated work. This consisted of an honorarium paid directly to Dr. Dublin.
Funding/Support: This project was funded in part under Contract Numbers HHSA290-2005-0042 (Vanderbilt) and HHSA290-2005-0033 (Harvard Pilgrim Health Care Institute) from the Agency for Healthcare Research and Quality, US Department of Health and Human Services as part of the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) program. The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the US Department of Health and Human Services.
The project was also funded by the Food and Drug Administration under the following contracts 223-2005-10012 (Kaiser Permanente Northern California), 223-2005-10100C (Vanderbilt), 223-2005-20006C (Ingenix), and 223-2005-10012C (Harvard Pilgrim Health Care Institute).
The project was also funded by National Institute of Aging under the following contract K23AG028954 (Group Health Research Institute).
Role of the Sponsors: Individuals from the FDA and AHRQ were on the study Steering Committee and provided input into the study design and conduct of the study, and interpretation of the data. The sponsors had no role in the preparation, review or approval of the manuscript.
Additional Contributions: We would like to also acknowledge and thank the following individuals for their contributions to this project: Andrew Mosholder, MD (FDA), member of Scientific Steering Committee; James Daugherty, MS (Vanderbilt University School of Medicine), programming; Judith Dudley, BS (Vanderbilt University School of Medicine), programming; Chantal Avila, MA (Kaiser Permanente Southern California), project management; Yan Luo, PhD (Kaiser Permanente Southern California), programming; Wansu Chen, MS (Kaiser Permanente Southern California), programming; Mary Kershner, BSN (Kaiser Permanente Colorado), chart reviews and abstraction; April Duddy, MS (Harvard Pilgrim Health Care Institute), project management; Luana Acton, BS (Kaiser Permanente Northern California), project management; Jean Lee, BA (Kaiser Permanente Northern California), medical record retrieval and abstraction; Julie Munneke, BA (Kaiser Permanente Northern California), project management; Monica Highbaugh, BA (Kaiser Permanente Northern California), medical record retrieval and abstraction; Heidi Krause, BA (Kaiser Permanente Northern California), project management. All those in the acknowledgement were compensated for their time.