Clarke Mike, Hopewell Sally, Chalmers Iain
UK Cochrane Centre, NHS R&D Programme, Summertown Pavilion, Middle Way, Oxford OX2 7LG, UK.
J R Soc Med. 2007 Apr;100(4):187-90. doi: 10.1177/014107680710011415.
Scientific and ethical justification for new clinical trials requires them to have been designed in the light of scientifically defensible assessments of relevant previous research. Reliable interpretation of the results of new clinical trials entails setting them in the context of updates of the reviews upon which they were deemed scientifically and ethically justifiable. We have shown previously that most reports of randomized trials published in five general medical journals in May 1997 and in May 2001 failed to set their results in the context of the findings from similar research. In the current study, we assess whether there had been progress in this respect in 2005 and also investigate the extent to which reports begin by referring to systematic reviews providing the justification for the new research reported.
Assessment of the Introduction and Discussion sections in all reports of randomized trials published during May 2005 in five general medical journals.
Reports of randomized trials in five general medical journals.
Annals of Internal Medicine, BMJ, JAMA, Lancet and New England Journal of Medicine.
None.
The inclusion or mention of one or more systematic reviews in the Introduction or Discussion section of each report assessed.
We found 18 reports of randomized trials. The Introduction sections referred to systematic reviews in five (27%) of these reports. None of the discussion sections of the 15 reports of trials that were not the first published trials to address the question studied placed the results of the new trial in the context of an updated systematic review of other research. Although reference was made to relevant systematic reviews in five of these 15 reports, there was no integration - quantitative or qualitative - of the results of the new trials in an update of these reviews. In the remaining ten reports there was no evidence that any systematic attempt had been made to set the new results in the context of previous trials.
There is no evidence of progress between 1997 and 2005 in the proportion of reports of trials published in general medical journals which discussed new results within the context of up-to-date systematic reviews of relevant evidence from other controlled trials. Although the proportion of trials referring to systematic reviews in Discussion sections has increased, the majority of reports continued to fail even to do this. Similarly, most researchers appear not to have considered a systematic review when designing their trial. Researchers and journal editors do a disservice to the interests of the public and others involved in healthcare decision-making by acquiescing in this situation.
新的临床试验要具备科学和伦理依据，就需要依据对相关既往研究的科学合理评估来设计。对新临床试验结果进行可靠解读，需要将其置于综述更新的背景下，而这些综述正是新临床试验在科学和伦理方面具有合理性的依据。我们之前已经表明，1997年5月和2001年5月在五本综合医学期刊上发表的大多数随机试验报告，都未能将其结果置于类似研究结果的背景下。在当前研究中，我们评估2005年在这方面是否有进展，同时调查报告在开头提及为所报告的新研究提供依据的系统综述的程度。
对2005年5月期间在五本综合医学期刊上发表的所有随机试验报告的引言和讨论部分进行评估。
五本综合医学期刊上的随机试验报告。
《内科学年鉴》《英国医学杂志》《美国医学会杂志》《柳叶刀》和《新英格兰医学杂志》。
无。
在每份评估报告的引言或讨论部分是否纳入或提及一项或多项系统综述。
我们找到了18篇随机试验报告。其中五篇（27%）报告的引言部分提及了系统综述。在15篇并非首次发表的针对所研究问题的试验报告中，没有一篇在讨论部分将新试验结果置于对其他研究的更新系统综述背景下。虽然这15篇报告中有五篇提到了相关系统综述，但在这些综述的更新中，没有对新试验结果进行定量或定性的整合。在其余十篇报告中，没有证据表明曾有任何系统的尝试将新结果置于既往试验的背景下。
没有证据表明，在1997年至2005年期间，综合医学期刊上发表的试验报告中，在依据对其他对照试验相关证据的最新系统综述来讨论新结果方面取得了进展。虽然在讨论部分提及系统综述的试验比例有所增加，但大多数报告甚至连这一点都做不到。同样，大多数研究人员在设计试验时似乎也没有考虑进行系统综述。研究人员和期刊编辑默许这种情况，损害了公众以及其他参与医疗保健决策的人的利益。
