The INVEST project: investigating the use of evidence synthesis in the design and analysis of clinical trials.
The INVEST project: investigating the use of evidence synthesis in the design and analysis of clinical trials.
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DOI：
10.1186/s13063-017-1955-y
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发表时间：
2017-05-15
期刊：
影响因子：
2.5
通讯作者：
Jones HE
中科院分区：
文献类型：
--
作者：
Clayton GL;Smith IL;Higgins JPT;Mihaylova B;Thorpe B;Cicero R;Lokuge K;Forman JR;Tierney JF;White IR;Sharples LD;Jones HE
在设计和分析临床试验时，使用以前的相关信息，可能以证据综合的形式，可以减少研究浪费。我们进行了INVEST（调查在临床试验设计和分析中使用证据合成）调查，以总结目前在试验设计和分析中使用证据合成的情况，收集试验者和方法学家对此类使用的意见，并了解任何障碍。我们的抽样框架是参加2015年11月国际临床试验方法学会议的所有代表。受访者被要求指出（1）他们对在试验设计和分析中使用证据综合的看法，（2）他们自己在过去10年中的使用情况，（3）在实践中使用的三个最大障碍。在大约638名与会者中，106人（17%）完成了调查，其中一半是统计学家。在试验设计中使用既往证据描述、系统性综述或荟萃分析的支持率通常较高。一般来说，受访者似乎没有像他们认为应该的那样经常使用证据综合。例如，只有50%（42/84相关受访者）使用荟萃分析来告知是否需要进行试验，而74%（62/84）表示这是可取的。只有6%（5/81的相关受访者）使用了信息分析的价值来告知样本量计算，而22%（18/81）表示支持这一点。令人惊讶的是，大量的参与者表示支持和以前使用的证据综合试验分析。例如，79%（79/100）的受访者表示，应使用有关治疗效果的外部信息为分析提供信息。在试验设计或分析中使用证据综合方法的最大障碍是时间限制，其次是认为新试验是该领域的第一次。证据综合可能是资源密集型的，但它们在为临床试验的设计、实施和分析提供信息方面的使用被广泛认为是可取的。我们主张进行更多的研究、培训和资源投资，致力于更有效地进行证据综合，从而提供长期节省成本的潜力。本文的在线版本（doi：10.1186/s13063-017-1955-y）包含补充材料，可供授权用户使用。
When designing and analysing clinical trials, using previous relevant information, perhaps in the form of evidence syntheses, can reduce research waste. We conducted the INVEST (INVestigating the use of Evidence Synthesis in the design and analysis of clinical Trials) survey to summarise the current use of evidence synthesis in trial design and analysis, to capture opinions of trialists and methodologists on such use, and to understand any barriers. Our sampling frame was all delegates attending the International Clinical Trials Methodology Conference in November 2015. Respondents were asked to indicate (1) their views on the use of evidence synthesis in trial design and analysis, (2) their own use during the past 10 years and (3) the three greatest barriers to use in practice. Of approximately 638 attendees of the conference, 106 (17%) completed the survey, half of whom were statisticians. Support was generally high for using a description of previous evidence, a systematic review or a meta-analysis in trial design. Generally, respondents did not seem to be using evidence syntheses as often as they felt they should. For example, only 50% (42/84 relevant respondents) had used a meta-analysis to inform whether a trial is needed compared with 74% (62/84) indicating that this is desirable. Only 6% (5/81 relevant respondents) had used a value of information analysis to inform sample size calculations versus 22% (18/81) indicating support for this. Surprisingly large numbers of participants indicated support for, and previous use of, evidence syntheses in trial analysis. For example, 79% (79/100) of respondents indicated that external information about the treatment effect should be used to inform aspects of the analysis. The greatest perceived barrier to using evidence synthesis methods in trial design or analysis was time constraints, followed by a belief that the new trial was the first in the area. Evidence syntheses can be resource-intensive, but their use in informing the design, conduct and analysis of clinical trials is widely considered desirable. We advocate additional research, training and investment in resources dedicated to ways in which evidence syntheses can be undertaken more efficiently, offering the potential for cost savings in the long term. The online version of this article (doi:10.1186/s13063-017-1955-y) contains supplementary material, which is available to authorized users.