McShane Lisa M, Altman Douglas G, Sauerbrei Willi, Taube Sheila E, Gion Massimo, Clark Gary M
Biometric Research Branch, DCTD, National Cancer Institute, Room 8126, Executive Plaza North, 6130 Executive Boulevard, Bethesda, MD 20892-7434, USA.
Breast Cancer Res Treat. 2006 Nov;100(2):229-35. doi: 10.1007/s10549-006-9242-8. Epub 2006 Aug 24.
Despite years of research and hundreds of reports on tumor markers in oncology, the number of markers that have emerged as clinically useful is pitifully small. Often initially reported studies of a marker show great promise, but subsequent studies on the same or related markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons that multiple studies of the same marker lead to differing conclusions. A variety of methodologic problems have been cited to explain these discrepancies. Unfortunately, many tumor marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalizability of study results. The development of guidelines for the reporting of tumor marker studies was a major recommendation of the National Cancer Institute-European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, pre-planned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines suggest helpful presentations of data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.
尽管肿瘤学领域对肿瘤标志物进行了多年研究并发表了数百份报告，但已证明具有临床实用价值的标志物数量却少得可怜。通常，最初关于某种标志物的研究报告显示出巨大的前景，但随后对相同或相关标志物的研究却得出不一致的结论，或者与那些前景良好的结果直接矛盾。我们必须尝试去理解为何对同一标志物的多项研究得出不同结论。人们列举了各种方法学问题来解释这些差异。不幸的是，许多肿瘤标志物研究的报告并不严谨，发表的文章往往缺乏足够信息，无法对研究质量或研究结果的可推广性进行充分评估。制定肿瘤标志物研究报告指南是美国国立癌症研究所 - 欧洲癌症研究与治疗组织（NCI - EORTC）2000年首届癌症诊断国际会议的一项主要建议。如同针对随机试验的成功的CONSORT倡议以及针对诊断性研究的STARD声明一样，我们建议制定指南，以提供有关研究设计、预先设定的假设、患者和标本特征、检测方法以及统计分析方法的相关信息。此外，该指南还建议以有益的方式呈现数据以及在讨论中应包含的重要内容。这些指南的目标是鼓励透明且完整的报告，以便其他人能够获取相关信息，帮助他们判断数据的有用性，并理解结论适用的背景。
