Literature DB >> 21047587

Blinded and uniform causes of death verification in cancer screening: a major influence on the outcome of a prostate cancer screening trial?

S J Otto1, P J van Leeuwen, J W Hoekstra, J W Merckelbach, J H M Blom, F H Schröder, M J Roobol, H J de Koning.   

Abstract

BACKGROUND: To assess the agreement between the causes of death assigned by a blinded and uniform review panel of the Rotterdam section of the European Randomised Study of Screening for Prostate Cancer and the official vital statistics and to explore the possible effect of the use of either of these two sources on the outcome of the screening trial.
METHODS: A total of 670 deaths amongst men with prostate cancer, reviewed by the causes of death committee (CODC) up to 31st December 2006 were included in this study. The kappa statistics with confidence intervals (CI), sensitivity and specificity of the official statistics were determined, with the CODC considered the gold standard. The rate ratio (RR) and 95% confidence intervals (95% CI) for prostate cancer mortality, official statistics relative to CODC, were calculated following the Mantel-Haenszel procedure.
RESULTS: The overall concordance and the kappa between official statistics and the CODC were 90.6% and 0.76 (0.71-0.82), remaining comparable when only the CODC category definitely prostate cancer was applied, with the sensitivity of official statistics increasing from 88.3% to 91.3% and specificity hardly changing (91.3% and 90.5%). High specificity and lower sensitivity is observed in the screening arm, whilst the opposite was seen in the control arm in men aged 55-69 and 70-74 years at entry. Considerable lower false positive rate was seen for both age groups in the screening arm (3.9% and 4.7%) compared to the control arm (8.4% and 14.3%). A statistically significant excess of prostate cancer death was observed for the official statistics in the age group 70-74 years, 1.53 (1.07-2.19), whilst it was not significant for men aged 55-69 at entry, 1.06 (0.83-1.36).
CONCLUSION: In the Rotterdam ERSPC section, official statistics tended to overreport prostate cancer as an underlying cause of death, particularly in the age group 70-plus in the control arm, which would overestimate the true effect in favour of screening.
Copyright © 2010 Elsevier Ltd. All rights reserved.

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Year:  2010        PMID: 21047587     DOI: 10.1016/j.ejca.2010.09.026

Source DB:  PubMed          Journal:  Eur J Cancer        ISSN: 0959-8049            Impact factor:   9.162


  5 in total

1.  Absolute Effect of Prostate Cancer Screening: Balance of Benefits and Harms by Center within the European Randomized Study of Prostate Cancer Screening.

Authors:  Anssi Auvinen; Sue M Moss; Teuvo L J Tammela; Kimmo Taari; Monique J Roobol; Fritz H Schröder; Chris H Bangma; Sigrid Carlsson; Gunnar Aus; Marco Zappa; Donella Puliti; Louis J Denis; Vera Nelen; Maciej Kwiatkowski; Marco Randazzo; Alvaro Paez; Marcos Lujan; Jonas Hugosson
Journal:  Clin Cancer Res       Date:  2015-08-19       Impact factor: 12.531

2.  Prostate cancer: net survival and cause-specific survival rates after multiple imputation.

Authors:  Adeline Morisot; Faïza Bessaoud; Paul Landais; Xavier Rébillard; Brigitte Trétarre; Jean-Pierre Daurès
Journal:  BMC Med Res Methodol       Date:  2015-07-28       Impact factor: 4.615

3.  Standardisation of information submitted to an endpoint committee for cause of death assignment in a cancer screening trial – lessons learnt from CAP (Cluster randomised triAl of PSA testing for Prostate cancer).

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

4.  Impact of cause of death adjudication on the results of the European prostate cancer screening trial.

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

5.  Intervention-related Deaths in the European Randomized Study of Screening for Prostate Cancer.

Authors:  Rebecka Arnsrud Godtman; Sebastiaan Remmers; Gunnar Aus; Vera Nelen; Liesbet van Eycken; Arnauld Villers; Xavier Rebillard; Maciej Kwiatkowski; Stephen Wyler; Donella Puliti; Giuseppe Gorini; Alvaro Paez; Marcos Lujan; Teuvo Tammela; Chris Bangma; Anssi Auvinen; Monique J Roobol
Journal:  Eur Urol Open Sci       Date:  2021-10-28
  5 in total

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