Did death certificates and a mortality review committee agree on lung cancer cause of death in the National Lung Screening Trial?
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1 Did death certificates and a mortality review committee agree on lung cancer cause of death in the National Lung Screening Trial? Pamela Marcus, PhD National Cancer Institute May 22, 2012
2 Cause of death in cancer screening RCTs Primary outcome in cancer screening RCTs is disease-specific mortality Accurate assignment of underlying cause of death (COD) is critical Two options for COD assignment Mortality review committee (aka death review) More resource-intensive but thought to be more accurate Death certificates (DC) Less resource-intensive but thought to be less accurate
3 Death review Most cancer screening RCTs have used some form of death review Is it worth the effort? Doria-Rose et al (Clin Trials, 2010) Compared DCs to death review Dichotomous* underlying COD for 4 cancer screening RCTs (lung (2), breast, colorectal) l) Kappa >= 0.85 for all *Example: lung cancer versus not lung cancer
4 National Lung Screening Trial (NLST) RCT of lung cancer screening with low dose CT versus chest x-ray Heavy and/or long-term smokers Significant 20% lung cancer mortality reduction Death review committee 5 MDs, including an MD-epidemiologist Members blinded to arm assignment Determined whether underlying COD was lung cancer (versus not lung cancer)
5 Selection for death review Subset of deaths Selected by apredetermined pre-determined algorithm
6 Deaths selected for review by algorithm Deaths with any DC COD that were most likely to represent a death due to lung cancer (either directly or indirectly) Deaths that might have been erroneously assigned a DC lung cancer COD Deaths within six months of a screen suspicious for lung cancer Deaths within 60 days of certain lung cancer diagnostic evaluation procedures
7 Death review e steps Records only, no DC Records and DC With respect to LC dx With respect to LC dx (versus non-lc dx)
8 Analyses Gold standard: death review Outcome of interest: lung cancer COD Versus COD other than lung cancer Performance characteristics of the death certificate COD assignment Re-ran final interim analysis Published findings used best available information Would use of DC data only change the conclusion of the study?
9 Agreement and kappa Death certificate Death review Lung cancer Not lung cancer Lung 855 (52) 19 (2) cancer Not lung 84 (5) 685 (42) cancer Agreement: 94% Kappa: 87% 1643 (42% of all deaths)
10 Performance characteristics Death review Death certificate Lung cancer Not lung cancer Lung 855 (52) 19 (2) cancer Not lung 84 (5) 685 (42) cancer Sensitivity: 91% Specificity: 98% PPV: 98% NPV*: 89% 1643 (42% of all deaths) *DC appears to have missed 9% of lung cancer deaths (adverse effects of diagnosis or treatment?)
11 Difference by study arm? LDCT (n=825) Chest x ray (n=818) Agreement Kappa Sensitivity Specificity PPV NPV
12 Lung cancer mortality reduction (Final interim analysis) Best available information* DC only 20.0% 0% 18.0% 95% CI: % CI: *Death review COD for those reviewed; ed DC COD for others
13 Limitations About 75% of deaths with a DC COD other than lung cancer (~2079) were not reviewed COD was considered (by the algorithm) unlikely to have been in error with respect to lung cancer death If these deaths had been reviewed and assigned a COD other than lung cancer: Specificity would have been 99% NPV would have been 97%
14 Limitations Generalizability of these findings is limited to Generalizability of these findings is limited to lung cancer in persons who meet NLST eligibility criteria
15 Conclusion When assigning lung cancer COD among When assigning lung cancer COD among heavy/long-term smokers, death certificates provide sufficiently accurate information
16 Acknowledgements My co-authors Ilana F. Gareen, V. Paul Doria-Rose, Jennifer Rosenbaum, Kathy Clingan, Kristen Keating, Brenda Brewer, Heather Rozjabek, Joshua Rathmell, Tony Miller The Endpoint Verification Team Tony Miller (Chair), Martin Edelman, Bill Evans, Bob Fontana, Mitch Machtay
17 Thank you!
18 DC lung cancer deaths reassigned to other COD by death review N=19 Reassigned to: Other malignancies: 8 Respiratory: 6 CVD: 3 Pneumonia: 1 Dementia: 1
19 DC non-lung-cancer deaths reassigned to lung cancer COD by death review N=84 Reassigned to: Other malignancies: 32 CVD: 22 Respiratory: 13 Other: 13 Complications of medical or surgical care: 3 Pending at close of study: 1
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