| Institution: | aDivision of Cancer Prevention, National Cancer Institute, 6130 Executive Blvd., Bethesda, MD, 20892, USA;bCenter for Statistical Sciences and the Department of Community Health, Brown Univ Box G-S121-7, 121 S. Main Street, Providence, RI 02912, USA;cDalla Lana School of Public Health, University of Toronto, 6th Floor, 155 College Street, Toronto, Canada, ON M5T 3M7;dWestat, 1600 Research Blvd, Rockville, MD, 20850, USA;eDavid Geffen School of Medicine, University of California at Los Angeles, Dept of Radiology, 10833 Le Conte Ave. BL-428 CHS, Los Angeles, CA 90095, USA |
| Abstract: | BackgroundRandomized controlled trials (RCTs) evaluating cancer screening modalities usually employ cause-specific mortality as their primary endpoint. Because death certificate cause of death can be inaccurate, RCTs frequently use review committees to assign an underlying cause of death. We describe the National Lung Screening Trial's (NLST's) death review approach, the Endpoint Verification Process (EVP), which strives to minimize errors in assignment of cause of death due to lung cancer.MethodsDeaths selected for review include those with a notation of lung cancer on the death certificate and those occurring among participants ever diagnosed with lung cancer. Other criteria that trigger death review include, but are not limited to, death within 6 months of a screen suspicious for lung cancer and death within 60 days of certain diagnostic evaluation procedures associated with a screen suspicious for lung cancer or a lung cancer diagnosis. EVP requires concordance on whether death was due to lung cancer. Deaths are first reviewed by the EVP chair. If concordance is not achieved, the death is next reviewed by an Endpoint Verification Team (EVT) member. If concordance between the chair- and member-assigned cause of death is not achieved, the death is next reviewed by a group of at least three EVT members. Cause of death is assigned at the step in which concordance was achieved, or if necessary, at the team review.ConclusionsNLST's EVP is designed to produce a highly accurate count of lung cancer deaths. |
