Author Contributions: Dr Resnic 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: Resnic, Gross, Donnelly, Normand, Matheny.
Acquisition of data: Resnic, Donnelly, Matheny.
Analysis and interpretation of data: Resnic, Gross, Marinac-Dabic, Loyo-Berrios, Donnelly, Normand, Matheny.
Drafting of the manuscript: Resnic, Normand.
Critical revision of the manuscript for important intellectual content: Resnic, Gross, Marinac-Dabic, Loyo-Berrios, Donnelly, Matheny.
Statistical analysis: Resnic, Normand, Matheny.
Obtained funding: Resnic, Gross, Marinac-Dabic.
Administrative, technical, or material support: Resnic, Gross, Donnelly, Normand.
Study supervision: Resnic, Gross, Marinac-Dabic, Donnelly.
Financial Disclosures: Dr Resnic and Dr Matheny reported filing a patent application, currently under review at the US Patent Office, for several key analytic components of the DELTA surveillance system; the intellectual property rights of Drs Resnic and Matheny (current and former employees of Brigham and Women's Hospital) related to the development of DELTA are assigned to the institution, and Partners Healthcare, the parent organization of Brigham and Women's Hospital, retains partial rights for DELTA use and licensing. Neither Dr Resnic nor Dr Matheny have previously received or anticipate any financial compensation, stock options, income, or ownership in DELTA, Coping Systems, or any other related commercial entity. Dr Resnic reported receiving modest consulting income from Boston Scientific Inc, Abbott Vascular Inc, Cordis Corp, and St Jude Medical Inc and receiving research grants from The Medicines Company. No other authors reported dislosures.
Funding/Support: This study was funded, in part, by grants from the National Library of Medicine (NIH R01-LM008142) and the US Food and Drug Administration (HHSF 223200830058C) as well as from the Veterans Administration Health Services Research and Development Service (CDP 09-387).
Role of the Sponsors: The National Institutes of Health, the Veterans Administration Health Services Research and Development Service, and the US Food and Drug Administration had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript. However, the preliminary proposed study protocol was provided to the Veterans Administration Health Services Research and Development Service and the US Food and Drug Administration as part of the original grant and contract application process.
Disclaimer: The opinions and assertions presented in this article are the private views of the authors and are not to be construed as conveying either official endorsement or criticism by the US Department of Health and Human Services, the Public Health Service, or the US Food and Drug Administration.
Additional Contributions: We acknowledge the significant system development and technical contributions of Richard Cope, BS, and Susan Robbins, BS, of Coping Systems Inc, Andover, Massachusetts. Coping Systems was a subcontractor to Brigham and Women's Hospital, and neither Mr Cope nor Ms Robbins received extra compensation for their contributions; Mr Cope is part owner of Coping Systems and is also named on the patent application filed by Dr Resnic and Dr Matheny. We also acknowledge the support of the Division of Healthcare Quality and Statistics, Massachusetts Department of Public Health.