Study concept and design: Puzziferri, Livingston.
Acquisition, analysis, or interpretation of data: Puzziferri, Roshek, Mayo, Gallagher, Belle.
Drafting of the manuscript: Puzziferri, Mayo, Gallagher, Livingston.
Critical revision of the manuscript for important intellectual content: Puzziferri, Roshek, Mayo, Belle, Livingston.
Statistical analysis: Puzziferri, Gallagher.
Obtained funding: Puzziferri.
Administrative, technical, or material support: Puzziferri, Roshek, Mayo, Gallagher, Livingston.
Study supervision: Puzziferri, Livingston.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: The Department of Surgery of the University of Texas Southwestern Medical Center, Dallas, provided funding for all aspects of the preparation of this manuscript. A grant from the National Institutes of Health National Center for Advancing Translational Sciences (NIH/NCATS) (KL2TR001103) supported part of the primary author’s salary, allowing time to conceive and prepare the manuscript.
Role of Funders/Sponsors: The Department of Surgery, University of Texas Southwestern Medical Center, Dallas, provided administrative assistance and protected time to conduct all aspects of this project. NIH/NCATS provided salary support for protected time to conduct all aspects of this project in its initial year. NIH/NCATS also provided funding for training in all aspects of conducting clinical research culminating in attainment of a Master’s of Clinical Science degree. The training enabled competency required for the conception, data collection, analyses, interpretation of results, and writing of this manuscript.
Disclaimer: Dr Livingston, a JAMA Deputy Editor, did not participate in the review of or decision to publish this article.
Additional Contributions: We thank John Rush, MD, and Milton Packer, MD, Department of Clinical Science, Internal Medicine, University of Texas Southwestern Medical Center, Dallas, for consulting on bias within clinical study designs and analyses of outcome measures. He received no compensation for his contribution.