REporting recommendations for tumour MARKer prognostic studies (REMARK).

REporting recommendations for tumour MARKer prognostic studies (REMARK).
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DOI:
10.1038/sj.bjc.6602678
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发表时间:
2005-08-22
影响因子:
8.8
通讯作者:
--
中科院分区:
医学1区
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--
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尽管对肿瘤学中的肿瘤标志物进行了多年的研究和数百份报告,但在临床上有用的标志物的数量却少得可怜。通常,最初报道的标记研究显示出巨大的希望,但随后对相同或相关标记的研究得出不一致的结论或与有希望的结果直接矛盾。我们必须尝试理解对同一标记物的多项研究导致不同结论的原因。人们引用了各种方法论问题来解释这些差异。不幸的是,许多肿瘤标志物研究尚未以严格的方式进行报告,并且发表的文章往往缺乏足够的信息来充分评估研究的质量或研究结果的普遍性。制定肿瘤标志物研究报告指南是美国国家癌症研究所和欧洲癌症研究与治疗组织 (NCI-EORTC) 2000 年第一届国际癌症诊断会议的主要建议。与成功的随机试验 CONSORT 倡议和诊断研究 STARD 声明类似,我们建议指南提供有关研究设计、预先计划的假设、患者和样本特征、检测的相关信息。 方法和统计分析方法。此外,指南还建议对数据和讨论中包含的重要元素进行有用的介绍。这些指南的目标是鼓励透明和完整的报告,以便其他人可以获得相关信息,帮助他们判断数据的有用性并了解结论适用的背景。
Despite years of research and hundreds of reports on tumour 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 methodological problems have been cited to explain these discrepancies. Unfortunately, many tumour 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 generalisability of the study results. The development of guidelines for the reporting of tumour marker studies was a major recommendation of the US National Cancer Institute and the European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. Similar to the successful CONSORT initiative for randomised trials and the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned 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.
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