Bailey K R
Section of Biostatistics, Mayo Clinic, Rochester, Minnesota.
Control Clin Trials. 1994 Feb;15(1):15-23. doi: 10.1016/0197-2456(94)90024-8.
Many scientific and statistical issues are involved in generalizing the results of randomized clinical trials. This paper examines the issues of heterogeneity of risk and heterogeneity of effect, as well as quantitative vs. qualitative heterogeneity. Generalization of quantitative results to populations at different risk is shown to be problematic, independent of any other considerations. Issues of heterogeneity as they relate to target population and choice of therapy are discussed. A few proposals are offered regarding the design and report of trials.
随机临床试验结果的推广涉及许多科学和统计学问题。本文探讨了风险异质性、效应异质性以及定量与定性异质性等问题。结果表明，将定量结果推广到不同风险的人群存在问题，且与任何其他因素无关。文中还讨论了与目标人群和治疗选择相关的异质性问题。并针对试验的设计和报告提出了一些建议。
