Design and analysis of group-randomized trials in cancer: A review of current practices.
Design and analysis of group-randomized trials in cancer: A review of current practices.
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DOI：
10.1016/j.ypmed.2018.03.010
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发表时间：
2018-06
影响因子：
5.1
通讯作者：
Nelson SM
中科院分区：
文献类型：
--
作者：
Murray DM;Pals SL;George SM;Kuzmichev A;Lai GY;Lee JA;Myles RL;Nelson SM
本文的目的是总结目前的做法，设计和分析的组随机试验，涉及癌症相关的危险因素或结果，并提供建议，以改善未来的试验。我们检索了2011- 2015年在同行评议期刊上发表或在线发表的涉及癌症相关风险因素或结局的分组随机试验。在2016-17年期间，在马里兰州的贝塞斯达，我们审查了来自76种期刊的123篇文章，以描述其设计及其样本量估计和数据分析方法。只有66篇（53.7%）文章报告了样本量估计的适当方法。仅63例（51.2%）报告了完全适当的分析方法。这些发现表明，许多研究者没有充分注意到组随机试验中固有的方法学挑战。这些做法可能导致研究力度不足，导致第1类错误率膨胀，并导致误导读者的推论。研究者应与生物统计学家或其他熟悉这些问题的方法学家合作。资助者和编辑应确保对申请和手稿进行仔细的方法审查。评审员应确保研究得到适当的计划和分析。需要这些步骤来提高分组随机试验的严谨性和可重复性。美国国立卫生研究院（NIH）的疾病预防办公室（ODP）已经采取了几项措施来解决这些问题。ODP提供了一个关于分组随机试验设计和分析的在线课程。ODP正在努力增加在赠款审查小组中任职的方法学家的人数。ODP为申请指南和审查标准制定了标准语言，以提请调查人员注意这些问题。最后，ODP创建了一个新的研究方法资源网站，以帮助研究人员，评审员和NIH工作人员更好地了解这些问题。
The purpose of this paper is to summarize current practices for the design and analysis of group-randomized trials involving cancer-related risk factors or outcomes and to offer recommendations to improve future trials. We searched for group-randomized trials involving cancer-related risk factors or outcomes that were published or online in peer-reviewed journals in 2011–15. During 2016–17, in Bethesda MD, we reviewed 123 articles from 76 journals to characterize their design and their methods for sample size estimation and data analysis. Only 66 (53.7%) of the articles reported appropriate methods for sample size estimation. Only 63 (51.2%) reported exclusively appropriate methods for analysis. These findings suggest that many investigators do not adequately attend to the methodological challenges inherent in group-randomized trials. These practices can lead to underpowered studies, to an inflated type 1 error rate, and to inferences that mislead readers. Investigators should work with biostatisticians or other methodologists familiar with these issues. Funders and editors should ensure careful methodological review of applications and manuscripts. Reviewers should ensure that studies are properly planned and analyzed. These steps are needed to improve the rigor and reproducibility of group-randomized trials. The Office of Disease Prevention (ODP) at the National Institutes of Health (NIH) has taken several steps to address these issues. ODP offers an online course on the design and analysis of group-randomized trials. ODP is working to increase the number of methodologists who serve on grant review panels. ODP has developed standard language for the Application Guide and the Review Criteria to draw investigators’ attention to these issues. Finally, ODP has created a new Research Methods Resources website to help investigators, reviewers, and NIH staff better understand these issues.
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影响因子：
105.7
作者：
Campbell, MK;Elbourne, DR;Altman, DG
通讯作者：
Altman, DG
影响因子：
5
作者：
DONNER, A;BIRKETT, N;BUCK, C
通讯作者：
BUCK, C
DOI：
10.2307/2981943
发表时间：
1985-01-01
影响因子：
2
作者：
CLAYTON, D;CUZICK, J
通讯作者：
CUZICK, J
影响因子：
1.7
作者：
Ford, Whitney P.;Westgate, Philip M.
通讯作者：
Westgate, Philip M.
影响因子：
64.8
作者：
Collins, Francis S.;Tabak, Lawrence A.
通讯作者：
Tabak, Lawrence A.