Tabar Laszlo, Chen Tony Hsiu-Hsi, Hsu Chen-Yang, Wu Wendy Yi-Ying, Yen Amy Ming-Fang, Chen Sam Li-Sheng, Chiu Sherry Yueh-Hsia, Fann Jean Ching-Yuan, Beckmann Kerri, Smith Robert A, Duffy Stephen W
1 University of Uppsala, Uppsala, Sweden.
2 National Taiwan University, Taipei, Taiwan.
J Med Screen. 2017 Mar;24(1):27-33. doi: 10.1177/0969141316631375. Epub 2016 Jun 23.
Objectives To summarize debate and research in the Swedish Two-County Trial of mammographic screening on key issues of trial design, endpoint evaluation, and overdiagnosis, and from these to infer promising directions for the future. Methods A cluster-randomized controlled trial of the offer of breast cancer screening in Sweden, with a single screen of the control group at the end of the screening phase forms the setting for a historical review of investigations and debate on issues of design, analysis, and interpretation of results of the trial. Results There has been considerable commentary on the closure screen of the control group, ascertainment of cause of death, and cluster randomization. The issues raised were researched in detail and the main questions answered in publications between 1989 and 2003. Overdiagnosis issues still remain, but methods of estimation taking full account of lead time and of non-screening influences on incidence (taking place mainly before 2005) suggest that it is a minor phenomenon. Conclusion Despite resolution of issues relating to this trial in peer-reviewed publications dating from years, or even decades ago, issues that already have been addressed continue to be raised. We suggest that it would be more profitable to concentrate efforts on current research issues in breast cancer diagnosis, treatment, and prevention.
目的 总结瑞典双县乳腺钼靶筛查试验在试验设计、终点评估和过度诊断等关键问题上的争论与研究，并据此推断未来有前景的方向。方法 瑞典一项关于提供乳腺癌筛查的整群随机对照试验，在筛查阶段结束时对对照组进行一次筛查，以此作为对该试验设计、分析和结果解读等问题的调查与争论进行历史回顾的背景。结果 对于对照组的末次筛查、死因确定和整群随机化存在大量评论。所提出的问题得到了详细研究，主要问题在1989年至2003年期间的出版物中得到了解答。过度诊断问题仍然存在，但充分考虑领先时间和非筛查对发病率的影响（主要发生在2005年之前）的估计方法表明这是一个小现象。结论 尽管多年甚至几十年前的同行评议出版物中已解决了与该试验相关的问题，但已解决的问题仍不断被提出。我们建议将精力集中在乳腺癌诊断、治疗和预防的当前研究问题上会更有成效。
