Study concept and design: Kuppermann, Bishop, Gregorich, Vargas, Caughey, Norton.
Acquisition, analysis, or interpretation of data: Kuppermann, Pena, Bishop, Nakagawa, Gregorich, Sit, Vargas, Caughey, Sykes, Pierce, Norton.
Drafting of the manuscript: Kuppermann, Bishop, Nakagawa, Gregorich, Norton.
Critical revision of the manuscript for important intellectual content: Kuppermann, Pena, Bishop, Gregorich, Sit, Vargas, Caughey, Sykes, Pierce, Norton.
Statistical analysis: Nakagawa, Gregorich.
Obtained funding: Kuppermann, Gregorich, Norton.
Administrative, technical, or material support: Kuppermann, Pena, Bishop, Sit, Vargas, Sykes, Norton.
Study supervision: Kuppermann, Pena, Gregorich, Norton.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Kuppermann reports that she was the UCSF site primary investigator of a clinical study of cell-free DNA testing funded by Ariosa Diagnostics and receipt of unrestricted research funding from Verinata Health and Natera. Dr Caughey reports serving as a medical advisor to Ariosa and Cellscape and receipt of stock options in both companies. Dr Norton reports that she was a site primary investigator and lead coprimary investigator of a clinical study of cell-free DNA testing funded by Ariosa Diagnostics, and was site primary investigator of a clinical study of noninvasive prenatal testing funded by Cellscape; receipt of unrestricted research funding from Natera; and being an unpaid clinical advisor to Natera. No other disclosures are reported.
Funding/Support: This study was funded by grants from the National Institutes of Health (R01HD049686) and the March of Dimes Foundation (Social and Behavioral Sciences Research Grant 12-FY09-213).
Role of the Sponsors: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Previous Presentation: Preliminary findings from this study were presented at the annual meeting of the Society for Medical Decision Making in Baltimore, Maryland, on October 21, 2013 (abstract TRA2-2).