Study concept and design: Friedewald, Rafferty, Durand, Plecha, Greenberg, Hayes, Carlson, Barke, Conant.
Acquisition, analysis, or interpretation of data: Friedewald, Rafferty, Rose, Durand, Plecha, Greenberg, Hayes, Copit, Cink, Barke, Greer, Miller, Conant.
Drafting of the manuscript: Friedewald, Rafferty, Durand, Plecha, Hayes, Barke, Conant.
Critical revision of the manuscript for important intellectual content: Friedewald, Rafferty, Rose, Durand, Plecha, Greenberg, Hayes, Copit, Carlson, Cink, Greer, Miller, Conant.
Statistical analysis: Rafferty, Miller.
Obtained funding: Plecha.
Administrative, technical, or material support: Friedewald, Durand, Plecha, Greenberg, Hayes, Carlson, Cink, Barke.
Study supervision: Friedewald, Rose, Plecha, Greenberg, Hayes, Copit.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Friedewald, Plecha, Hayes, and Greer report consultancy for and membership on the Hologic Scientific Advisory Board. Drs Copit, Carlson, and Conant report membership on the Hologic Scientific Advisory Board. Dr Rose reports receipt of research grants from and consultancy for Hologic. Dr Cink reports board membership for Wellmark Blue Cross/Blue Shield for Iowa and South Dakota. Mr Miller reports consultancy for Hologic. No other disclosures were reported.
Funding/Support: Drs Friedewald, Rafferty, Rose, Durand, Plecha, Greenberg, Hayes, Copit, Carlson, Cink, Barke, and Greer received a research grant from Hologic. Dr Conant received research grant 5U54CA163316-03 from the National Cancer Institute.
Role of the Sponsors: Principal investigators from the 13 participating institutions along with Hologic jointly designed the study. Hologic provided logistical and technical support for the collection of data. The study contracts/data-sharing agreements specified that Hologic had the right to review all publications prior to submission but could not mandate any revision of the manuscript or prevent submission for publication. Each institution verified the accuracy of their performance data, which was then transferred to an independent statistical group (BioStat International) for analysis. The results reported in this manuscript are the result of the independent analysis by Maureen R. Lyden, MS, BioStat International.
Additional Contributions: All analyses for scientific publication were performed by the study statistician, Maureen R. Lyden, MS, BioStat International, who was compensated for her contribution.