Changes in and impact of the death review process in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial

Anthony B. Miller, Ronald Feld, Robert Fontana, John K. Gohagan, Ismail Jatoi, Walter Lawrence, Amy Miller, Philip C. Prorok, Ashwani Rajput, Morris Sherman, Gilbert Welch, Patrick Wright, Susan Yurgalevitch, Peter Albertsen

Research output: Contribution to journalArticle

16 Scopus citations

Abstract

Death review was conducted for the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial to avoid the biases associated with causes of death entered on death certificates. An algorithm selected deaths for review. Records on diagnosis and terminal illness were perused in the coordinating center and by the chair of the death review committee (DRC). Identifying information and randomization arm was removed. Three reviewers independently determined the cause of death. Disagreement was resolved at a meeting of the DRC. This process was subsequently simplified. The cause of death was determined by one DRC member and compared to the death certificate. With agreement the case was finalized. When discordant, the records were sent to a second DRC member. If the reviewers agreed, the case was finalized. If not, a third member reviewed. If two of the three reviewers agreed, the case was sent back to the discordant reviewer. If the reviewer remained discordant the case was resolved by a conference call. Of the 4728 death reviews that were completed, the DRC confirmed the death certificate underlying cause for over 90%. Between 5% and 13% of the certified deaths were regarded as indirect causes of death, associated with the treatment of the ascertained cancer; differential for prostate cancer, 11% in the intervention arm and 6% in the control. Without review, between 1% and 6% of the deaths that occurred would not have been assigned to the relevant PLCO cancer. The DRC completed 76% of those requiring review before the process ceased.

Original languageEnglish (US)
Pages (from-to)206-211
Number of pages6
JournalReviews on Recent Clinical Trials
Volume10
Issue number3
DOIs
StatePublished - Sep 1 2015

Keywords

  • Colorectal cancer
  • Death certificates
  • Death review
  • Lung cancer
  • Ovarian cancer
  • Prostate cancer
  • Randomized screening trials

ASJC Scopus subject areas

  • Pharmacology

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