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本刊统计学报告的新指南
New Guidelines for Statistical Reporting in the Journal


David Harrington ... 其他 • 2019.07.18
相关阅读
• 临床试验中的多重性考虑

本刊的一些读者可能已经注意到,在过去1年中,我们的研究论文报告的P值减少。例如,2018年11月,我们发表了维生素D和ω-3试验(Vitamin D and Omega-3 Trial,VITAL)的两份报告1,2,VITAL是一项2×2析因、安慰剂对照的随机试验,试验中评估了维生素D或海洋n-3(又名ω-3)脂肪酸可否预防心血管疾病或癌症。对于本试验的n-3部分,Manson等2报告了2项预设的主要结局及22个预设的和其他的次要结局,这样的报告在投入资金巨大的大规模随机研究或观察性研究中并不少见。n-3脂肪酸未显著降低主要心血管结局的发生率,也未显著降低癌症结局的发生率。如果作为独立结果报告,有两项次要结局的P值将小于0.05;然而,与本刊近期实施的在次要和其它比较中限制使用P值的指南相符,关于干预措施对这些次要结局产生的效应,文中仅报告了风险比和置信区间。





作者信息

David Harrington, Ph.D., Ralph B. D’Agostino, Sr., Ph.D., Constantine Gatsonis, Ph.D., Joseph W. Hogan, Sc.D., David J. Hunter, M.B., B.S., M.P.H., Sc.D., Sharon-Lise T. Normand, Ph.D., Jeffrey M. Drazen, M.D., and Mary Beth Hamel, M.D., M.P.H
From the Department of Data Sciences, Dana–Farber Cancer Institute (D.H.), Boston University (R.B.D.), Harvard T.H. Chan School of Public Health (D.H., D.J.H.), and the Department of Health Care Policy, Harvard Medical School, and the Department of Biostatistics, Harvard T.H. Chan School of Public Health (S.-L.T.N.) — all in Boston; the Department of Biostatistics and Center for Statistical Sciences, Brown University School of Public Health, Providence, RI (C.G., J.W.H.); and Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (D.J.H.).

 

参考文献

1. Manson JE, Cook NR, Lee I-M, et al. Vitamin D supplements and prevention of cancer and cardiovascular disease. N Engl J Med 2019;380:33-44.

2. Manson JE, Cook NR, Lee I-M, et al. Marine n−3 fatty acids and prevention of cardiovascular disease and cancer. N Engl J Med 2019;380:23-32.

3. Wasserstein RL, Lazar NA. The ASA’s statement on p-values: context, process, and purpose. Am Stat 2016;70:129-133.

4. Wasserstein RL, Schirm AL, Lazar NA. Moving to a world beyond “p<0.05.” Am Stat 2019;73:Suppl 1:1-19.

5. National Academies of Sciences, Engineering, and Medicine. Reproducibility and replicability in science. Washington, DC: National Academies Press, 2019.

6. Dmitrienko A, Bretz F, Westfall PH, et al. Multiple testing methodology. In: Dmitrienko A, Tamhane AC, Bretz F, eds. Multiple testing problems in pharmaceutical statistics. New York: Chapman and Hall/CRC Press, 2009:35-98.

7. Dmitrienko A, D’Agostino RB Sr. Multiplicity considerations in clinical trials. N Engl J Med 2018;378:2115-2122.

8. Rugo HS, Olopade OI, DeMichele A, et al. Adaptive randomization of veliparib–carboplatin treatment in breast cancer. N Engl J Med 2016;375:23-34.

9. Park JW, Liu MC, Yee D, et al. Adaptive randomization of neratinib in early breast cancer. N Engl J Med 2016;375:11-22.

10. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 2019;380:1706-1715.

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