Altman D G, Lyman G H
Imperial Cancer Research Fund Medical Statistics Group, Centre for Statistics in Medicine, Institute of Health Sciences, Oxford, UK.
Breast Cancer Res Treat. 1998;52(1-3):289-303. doi: 10.1023/a:1006193704132.
Many studies are carried out in an effort to find factors that help explain the large unexplained variation in prognosis of breast cancer patients. The principles of good study design and analysis are less well appreciated for prognostic factor studies than for therapeutic trials. The oncology literature is full of results from studies of varying quality, often with conflicting findings. As a consequence, despite the large number of studies, there is still uncertainty about the importance of most prognostic factors. Few recently proposed prognostic factors for breast cancer have become widely accepted. This paper reviews the important methodological issues underlying such research. These issues are illustrated with examples from published studies and recent reviews of papers published in cancer journals. Guidelines are proposed for conducting and evaluating prognostic factor studies which should improve the quality of research in this important area.
许多研究致力于寻找有助于解释乳腺癌患者预后存在大量无法解释的差异的因素。与治疗试验相比，预后因素研究对良好研究设计和分析原则的重视程度较低。肿瘤学文献充斥着质量参差不齐的研究结果，常常相互矛盾。因此，尽管研究数量众多，但大多数预后因素的重要性仍存在不确定性。最近提出的乳腺癌预后因素很少被广泛接受。本文回顾了此类研究背后的重要方法学问题。通过已发表研究的实例以及癌症期刊近期发表论文的综述来说明这些问题。提出了进行和评估预后因素研究的指南，这应能提高这一重要领域的研究质量。
