Pamela Marcus

PhD

NCI/DCCPS

Epidemiologist

NLST (Learn more about this study)

201202-0032

Feb 27, 2012

Did death certificates and a mortality review committee agree on lung cancer cause of death in the National Lung Screening Trial?

Randomized controlled trials (RCTs) frequently use mortality review committees to assign a cause of death (COD) rather than relying on COD assignments on death certificates (DCs). The National Lung Screening Trial (NLST), an RCT of lung cancer screening with low dose radiation computed tomography versus chest x-ray among heavy and/or long-term smokers, used a committee blinded to arm assignment to determine whether COD was due to lung cancer.

NLST’s committee reviewed a subset of deaths, chosen by a pre-determined algorithm. The algorithm selected deaths with a DC COD that were most likely to represent a death due to lung cancer (either directly or indirectly) and deaths that might have been erroneously assigned a DC lung cancer COD. Also included were deaths within six months of a screen suspicious for lung cancer and within 60 days of certain lung cancer diagnostic evaluation procedures. Using the committee assignment as the gold standard and a lung cancer COD as the outcome of interest, we will calculate sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the death certificate COD assignment (lung cancer vs. non-lung cancer). We will also run the final interim analysis using death certificate data only.