title: The National Lung Screening Trial's Endpoint Verification Process: determining the cause of death.
abstract: BACKGROUND
  Randomized 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.
  
  
  METHODS
  Deaths 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.
  
  
  CONCLUSIONS
  NLST's EVP is designed to produce a highly accurate count of lung cancer deaths.
authors.affiliation: Division of Cancer Prevention, National Cancer Institute, 6130 Executive Blvd., Bethesda, MD 20892-7354, USA. marcusp@mail.nih.gov
authors.forename: Pamela M
authors.initials: PM
authors.lastname: Marcus
authors.forename: Ilana F
authors.initials: IF
authors.lastname: Gareen
authors.forename: Anthony B
authors.initials: AB
authors.lastname: Miller
authors.forename: Jennifer
authors.initials: J
authors.lastname: Rosenbaum
authors.forename: Kristen
authors.initials: K
authors.lastname: Keating
authors.forename: Denise R
authors.initials: DR
authors.lastname: Aberle
authors.forename: Christine D
authors.initials: CD
authors.lastname: Berg
mesh_terms: D002423:Cause of Death; D003644:Death Certificates; D055088:Early Detection of Cancer / Q000379:methods*; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality*; D008403:Mass Screening / Q000379:methods*; D016032:Randomized Controlled Trials as Topic; D014481:United States / Q000453:epidemiology