Embedded recruitment trials: creating Russian dolls

If you fail to recruit, your clinical trial will fail. This harsh reality has led to an increased number of embedded recruitment trials, assessing which recruitment strategy works best in what context. Research最近出版试验概述了报告这些嵌入式招聘试验的指南,在这里,参与该项目的Shaun Treweek讨论了这些准则不仅如何影响报告,而且还应影响嵌入式招聘试验设计。

进行试验是艰苦的工作。

您需要一个很好的研究问题和一个愿意给您足够的钱来回答这个问题的资助者,您需要招募您统计学家所说的惊人的参与者,然后您必须将它们全部保留在接下来的五个年。您必须获得所有批准,准备数据收集表格,开发数据管理系统以支持这些表格,提供培训,处理物流,列表还在继续。

But really it’s recruitment that bothers you. Everyone connected with trials worries about recruitment and the reason is obvious: without participants you have no trial.

But really it’s recruitment that bothers you. Everyone connected with trials worries about recruitment and the reason is obvious: without participants you have no trial.

What’s more, you can burn your way through an awful lot of time and cash before the hopelessness of recruitment becomes clear.

Astudy of a single academic medical center in the US published in 2011looked at the cost of trials that were closed having recruited either zero or one participant. They found 260 trials in this category and estimated the costs at just under $1 million. That’s $1 million dollars for no scientific benefit.

在英国,Sully及其同事found that only 55% of trials funded by the Medical Research Council and the Health Technology Assessment program met their recruitment target, although to be fair, three-quarters did reach 80% of their target. Almost half of all trials received an extension of one kind or another; those that did were no more likely to have recruitment success.

鉴于它是estimated that around 25,000 trials are published every year and essentially all of them need to recruit participants, it’s strange that we are not better at it.

鉴于它是estimated that around 25,000 trials are published every year从本质上讲,他们所有人都需要招募参与者,这很奇怪,我们并没有更好。

In fact, despite trialists being a community of evaluators, we are remarkably poor at evaluating our own methods. The currentCochrane review of strategies to improve recruitment to trials也许有三件事可以合理地期望改善他们的招聘,这也许是三件事。几乎不是圣诞节。

Which is where the最近的文章试验by Vichithranie Madurasinghe, Sandra Eldridge, Gordon Forbes and colleagues (conflict of interest note: I am one of these colleagues) on the reporting of embedded recruitment trials comes in. What these authors want to do is:

  1. encourage trialists to evaluate their recruitment strategies by running embedded trials-within-trials
  2. 这样做后,请很好地报告他们的发现

正如您在试用报告指南中所期望的那样,作者大力倾向于配偶(报告试验的合并标准),并且该指南的开发过程和呈现将是任何熟悉Consort的人都熟悉的,如果您参与临床试验,这将是我想大多数人。

指导是明智的:看看,看看您的想法。不过,这篇论文有两种更大的图像要走。

Firstly, Madurasinghe and colleagues are imploring us to apply the same enthusiasm and methodological rigor to evaluating our own methods as we apply to the treatments, therapies and health care initiatives we evaluate together with our clinical and policy colleagues.

我们需要进行更多嵌入式试验,我们需要它们变得良好。

我们需要进行更多嵌入式试验,我们需要它们变得良好。最后一点通往我的第二个大图。

There is a not unreasonable tendency to look at reporting guidelines when you are, well, reporting. I think this is a mistake, or rather leaving it this late is a mistake.

The reporting standard presented by Madurasinghe and colleagues describes what an ideal report of the results of an embedded recruitment trial would look like.

It presents what others, such as other trialists and systematic reviewers, need to know to make judgments about your embedded recruitment trial and its relevance to their own context and work.

它不仅是描述如何报告的文档,而且是描述如何设计的文档。一开始考虑报告标准的时间是正确的:这些是​​您需要做的事情,然后描述他人考虑与他们相关的试验。

因此,如果您不确定自己的招聘策略,为什么不建立嵌入式招聘试验?我们当然需要更多。而且,如果您这样做,请在开始之前先查看Madurasinghe和同事的论文。

如果您真的想将樱桃放在上面,那就很棒Trial Forge team know too; there might be other trialists who would like to test the same recruitment intervention. All our trials need Russian dolls.

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