Bentzen S M
Department of Experimental Clinical Oncology, University of Aarhus, Denmark.
Radiother Oncol. 1998 Jan;46(1):5-18. doi: 10.1016/s0167-8140(97)00226-0.
Although a substantial number of randomized clinical trials (RCTs) with a radiotherapy component have been conducted over time, it turns out that many of the trials have serious methodological flaws. What is even more frustrating is the circumstance that many RCTs, in radiotherapy as well as in other medical fields, are so heterogeneous in their reporting, that it is virtually impossible to judge their quality and thereby to judge the reliability of their conclusions. Recently, a new set of guidelines for reporting of RCTs has been proposed. These CONSORT (Consolidation of Standards for Reporting Trials) guidelines have now been accepted by a large number of medical journals. The present review presents the background for the CONSORT guidelines. Substantial research has been done on the methodological quality of RCTs reported in the literature and some of this will be reviewed here. Specific areas discussed include definition of endpoints, Type I and II errors, use of confidence intervals rather than P-values, randomization procedures, multiple significance tests, the intention-to-treat principle, and publication bias. Special concerns in relation to the reporting of radiotherapy RCTs are discussed as well. The conclusion is that we need to improve the quality of RCTs in terms of their design, conduct, analysis and reporting. As a step in that direction, a new set of guidelines for reports on treatment outcome in Radiotherapy and Oncology are presented. These guidelines meet the minimum criteria for reporting of RCTs as stated in the CONSORT guidelines.
虽然随着时间的推移已经进行了大量包含放射治疗部分的随机临床试验（RCT），但事实证明，其中许多试验存在严重的方法学缺陷。更令人沮丧的是，许多放射治疗以及其他医学领域的随机临床试验在报告方面差异极大，以至于几乎不可能判断其质量，从而无法判断其结论的可靠性。最近，有人提出了一套新的随机临床试验报告指南。这些CONSORT（统一临床试验报告标准）指南现已被大量医学期刊所接受。本综述介绍了CONSORT指南的背景。已对文献中报道的随机临床试验的方法学质量进行了大量研究，这里将对其中一些研究进行综述。讨论的具体领域包括终点的定义、I型和II型错误、使用置信区间而非P值、随机化程序、多重显著性检验、意向性分析原则以及发表偏倚。还讨论了与放射治疗随机临床试验报告相关的特殊问题。结论是，我们需要在随机临床试验的设计、实施、分析和报告方面提高其质量。作为朝着这个方向迈出的一步，本文提出了一套关于放射治疗与肿瘤学治疗结果报告的新指南。这些指南符合CONSORT指南中规定的随机临床试验报告的最低标准。
