Published Online: June 28, 2010. doi:10.1001/jama.2010.920
Author Contributions: Dr MaCurdy 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: Graham, Ouellet-Hellstrom, Kelman.
Acquisition of data: Worrall.
Analysis and interpretation of data: Graham, Ouellet-Hellstrom, MaCurdy, Ali, Sholley, Kelman.
Drafting of the manuscript: Graham, Ouellet-Hellstrom.
Critical revision of the manuscript for important intellectual content: Graham, Ouellet-Hellstrom, MaCurdy, Ali, Sholley, Worrall, Kelman.
Statistical analysis: Graham, Ouellet-Hellstrom, MaCurdy, Ali, Sholley.
Obtained funding: Graham, Worrall, Kelman.
Administrative, technical, or material support: Ouellet-Hellstrom, Worrall, Kelman.
Study supervision: Graham, MaCurdy.
Financial Disclosures: None reported.
Funding/Support: This study was funded by the Office of the Assistant Secretary for Planning and Evaluation (ASPE), the Centers for Medicare & Medicaid Services (CMS), and the US Food and Drug Administration (FDA).
Role of Sponsors: The authors are employees or contractors of the CMS or the FDA; however, other officials at the ASPE, the CMS, and the FDA had no role in the design and conduct of the study; the collection, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript. The manuscript was subject to administrative review prior to submission, but the content was not altered by this review.
Disclaimer: The views expressed are those of the authors and not necessarily those of the US Department of Health and Human Services, the CMS, or the FDA.
Additional Contributions: We thank the Office of the Assistant Secretary for Planning and Evaluation in the Department of Health and Human Services for scientific contributions and financial support of this study and the SafeRx Project. We also extend special thanks to Mark Levenson, PhD, and Stephine Keeton, PhD (both with the FDA Office of Biostatistics), for providing statistical advice and to Pallavi Mukherji, MSc, Richard Domurat, BS, Jonathan Gibbs, BA, and Konrad Turski, MSc (all with Acumen LLC), for assistance with programming and data analysis. These individuals are salaried employees of their respective organizations and received no additional compensation related to their contributions to this study.