癌症筛查中盲法和统一死因验证：对前列腺癌筛查试验结果的重大影响？

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

机构信息

Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.

出版信息

Eur J Cancer. 2010 Nov;46(17):3061-7. doi: 10.1016/j.ejca.2010.09.026.

DOI:10.1016/j.ejca.2010.09.026

PMID:21047587

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.

摘要

背景

评估由鹿特丹欧洲前列腺癌筛查随机研究分部的盲法和统一审查小组分配的死因与官方生命统计数据之间的一致性，并探讨使用这两个来源中的任何一个对筛查试验结果的可能影响。

方法

本研究共纳入了截至 2006 年 12 月 31 日由死因委员会（CODC）审查的 670 例前列腺癌死亡患者。使用 Kappa 统计量（置信区间[CI]）、敏感性和特异性来确定官方统计数据的一致性，将 CODC 视为金标准。使用 Mantel-Haenszel 程序计算相对于 CODC 的官方统计数据的前列腺癌死亡率的率比（RR）和 95%置信区间（95%CI）。

结果

官方统计数据与 CODC 之间的总体一致性和 Kappa 值分别为 90.6%和 0.76（0.71-0.82），当仅应用 CODC 确定的前列腺癌类别时，结果仍然相似，官方统计数据的敏感性从 88.3%增加到 91.3%，特异性几乎没有变化（91.3%和 90.5%）。在年龄为 55-69 岁和 70-74 岁的入组人群中，筛查组的特异性较高而敏感性较低，而对照组则相反。在筛查组中，两个年龄组的假阳性率均显著低于对照组（分别为 3.9%和 4.7%）（分别为 8.4%和 14.3%）。在年龄组为 70-74 岁的人群中，官方统计数据显示前列腺癌死亡的超额风险显著增加，为 1.53（1.07-2.19），而在年龄组为 55-69 岁的人群中，该风险不显著，为 1.06（0.83-1.36）。