BACKGROUND: Often in randomized controlled trials of cancer screening, cause of death is determined by a mortality review committee. However, little is known regarding how findings from mortality review compare to those from death certificates alone. PURPOSE: To examine the results of four different U. S. trials of cancer screening when death certificate data only were used, as compared to results using all available mortality review information. METHODS: Trials included were the Health Insurance Plan of New York breast screening trial (HIP), the Minnesota trial of fecal occult blood testing, and the Johns Hopkins and Mayo Lung Projects, which each examined chest x-ray and sputum cytology. The sensitivity, specificity, positive and negative predictive values, and Cohen's kappa for death certificates were calculated for all arms of all trials. Separate intention-to-screen analyses were conducted for each trial using cause of death information from either death certificates alone or full mortality review data. RESULTS: Generally there was excellent agreement between the death certificates and the mortality review committee as to the underlying cause of death (kappa >0.85 in all cases); death certificate agreement was similar between arms in all trials. Modest changes in the screening effectiveness estimates were observed when mortality review information was utilized, ranging from a 9% decrease to a 2% increase in the calculated mortality rate ratios. However, in one instance (HIP) a statistically significant benefit of screening was observed when mortality review committee data were used (rate ratio (RR) 0.77, 95% confidence interval (CI) 0.62- 0.95) but not when death certificate data were used (RR 0.82, 95% CI 0.65-1.03). LIMITATIONS: Although considered to be the gold standard, even carefully conducted mortality review may result in errors in cause of death assignment. CONCLUSIONS: For each trial, results were similar regardless of the source of cause of death information.
BACKGROUND: Often in randomized controlled trials of cancer screening, cause of death is determined by a mortality review committee. However, little is known regarding how findings from mortality review compare to those from death certificates alone. PURPOSE: To examine the results of four different U. S. trials of cancer screening when death certificate data only were used, as compared to results using all available mortality review information. METHODS: Trials included were the Health Insurance Plan of New York breast screening trial (HIP), the Minnesota trial of fecal occult blood testing, and the Johns Hopkins and Mayo Lung Projects, which each examined chest x-ray and sputum cytology. The sensitivity, specificity, positive and negative predictive values, and Cohen's kappa for death certificates were calculated for all arms of all trials. Separate intention-to-screen analyses were conducted for each trial using cause of death information from either death certificates alone or full mortality review data. RESULTS: Generally there was excellent agreement between the death certificates and the mortality review committee as to the underlying cause of death (kappa >0.85 in all cases); death certificate agreement was similar between arms in all trials. Modest changes in the screening effectiveness estimates were observed when mortality review information was utilized, ranging from a 9% decrease to a 2% increase in the calculated mortality rate ratios. However, in one instance (HIP) a statistically significant benefit of screening was observed when mortality review committee data were used (rate ratio (RR) 0.77, 95% confidence interval (CI) 0.62- 0.95) but not when death certificate data were used (RR 0.82, 95% CI 0.65-1.03). LIMITATIONS: Although considered to be the gold standard, even carefully conducted mortality review may result in errors in cause of death assignment. CONCLUSIONS: For each trial, results were similar regardless of the source of cause of death information.
Authors: Michael Goodman; Robert H Fletcher; V Paul Doria-Rose; Christopher D Jensen; Alexis M Zebrowski; Tracy A Becerra; Virginia P Quinn; Ann G Zauber; Douglas A Corley; Chyke A Doubeni Journal: J Comp Eff Res Date: 2015-07-23 Impact factor: 1.744
Authors: Pamela M Marcus; Vincent Paul Doria-Rose; Ilana F Gareen; Brenda Brewer; Kathy Clingan; Kristen Keating; Jennifer Rosenbaum; Heather M Rozjabek; Joshua Rathmell; JoRean Sicks; Anthony B Miller Journal: Clin Trials Date: 2016-03-22 Impact factor: 2.486
Authors: Naomi J Williams; Elizabeth M Hill; Siaw Yein Ng; Richard M Martin; Chris Metcalfe; Jenny L Donovan; Simon Evans; Laura J Hughes; Charlotte F Davies; Freddie C Hamdy; David E Neal; Emma L Turner Journal: BMC Med Res Methodol Date: 2015-01-23 Impact factor: 4.615
Authors: Stephen D Walter; Harry J de Koning; Jonas Hugosson; Kirsi Talala; Monique J Roobol; Sigrid Carlsson; Marco Zappa; Vera Nelen; Maciej Kwiatkowski; Álvaro Páez; Sue Moss; Anssi Auvinen Journal: Br J Cancer Date: 2016-11-17 Impact factor: 7.640
Authors: Chloe J Bright; Adam R Brentnall; Kate Wooldrage; Jonathon Myles; Peter Sasieni; Stephen W Duffy Journal: Br J Cancer Date: 2020-02-10 Impact factor: 7.640