在内窥镜结直肠癌筛查的随机试验中，当黄金标准无法如黄金般可靠时：流行病学偏倚问题。
When gold standards are not so golden: prevalence bias in randomized trials on endoscopic colorectal cancer screening.
发表日期：2023 Aug 02
作者：
Hermann Brenner, Thomas Heisser, Rafael Cardoso, Michael Hoffmeister
来源：
EUROPEAN JOURNAL OF EPIDEMIOLOGY
摘要：
关于筛查内窥镜在降低结直肠癌（CRC）风险方面的有效性的随机试验已经报告了统计学上显著但相对较小的降低CRC风险的结果。然而，这些试验中的风险估计包括了相当比例的既往CRC病例，这些病例已经早期被检测到，但是根本无法通过筛查来预防。因此，违背了随机预防试验的一个关键原则，即只有尚未患有目标预防疾病的“处于风险中”的人可以包括在预防效果的测量中。以近期发表的Nordic-European Initiative on Colorectal Cancer（NordICC）试验数据为例，我们说明了旨在解决“患病率偏倚”问题的方法导致的效果估计值远大于试验中报告的值，并且更符合观察性研究和实际环境的结果。需要更严格的方法学工作来开发有效且用户友好的工具，以预防或调整患病率偏倚在未来的筛查研究中的影响。© 2023. 作者。
Randomized trials on the effectiveness of screening endoscopy in reducing colorectal cancer (CRC) risk have reported statistically significant, but rather modest reduction of CRC risk by the screening offer. However, risk estimates in these trials included substantial proportions of prevalent CRC cases which were early detected, but could not possibly have been prevented by screening. Thereby, a key principle of randomized prevention trials is violated that only "at risk" persons who do not yet have the disease one aims to prevent should be included in measures of preventive effects. Using recently published data from the Nordic-European Initiative on Colorectal Cancer (NordICC) trial as an example, we illustrate that approaches aimed to account for "prevalence bias" lead to effect estimates that are substantially larger than those reported in the trial and more in line with results from observational studies and real life settings. More rigorous methodological work is needed to develop effective and user-friendly tools to prevent or adjust for prevalence bias in future screening studies.© 2023. The Author(s).