Transition Support Award CSF Chris Gale

在英国，每11个婴儿中就有一个早产；其中许多需要新生儿护理，涉及婴儿护理的每个部分的医疗决策。许多需要新生儿护理的婴儿都有影响其一生的医疗和神经问题；这些可能受到新生儿住院期间所作决定的影响。找出最佳临床决策的理想方法是通过随机试验。在这里，每个婴儿都有同等的机会接受每种治疗方案，这是随机选择的，就像扔硬币一样。通过纳入大量婴儿，我们可以找出哪种治疗方案效果最好。不幸的是，随机试验往往非常昂贵和繁琐。因此，只有少数新生儿治疗方案在随机试验中进行了测试，因此大多数决定只是有根据的猜测。我想让随机临床试验更便宜、更容易，这样所有日常的新生儿决策都可以基于最好的研究——随机临床试验。我的计划是通过去掉一个非常昂贵的部分——数据收集，直接从婴儿的电子健康记录（EHR）中获取所有信息，这是一种计算机化的医疗记录。来自这些电子病历系统的信息已经用于很多目的，我想把它用于随机试验，使它们更便宜、更容易，这样就可以进行更多的试验，更简单、更容易。我们已经完成了以下工作，以证明在电子病历系统中建立大型简单新生儿试验是可行的：我们与医生、护士、家长、患者和研究人员合作，确定大型简单新生儿试验最重要的“结果”是什么。“结果”是一项试验的结果，比如婴儿在家是否需要氧气。我们已经证明，在新生儿电子病历中进行中等规模的、新颖的、开拓性的试验是可能的，并且已经测量了这是多么准确、简单和廉价3。我们让父母、医生和护士参与进来，让大型简单的新生儿试验更容易、更直接地获得同意，并表明这是可以接受的。我们与父母合作开发了一个系统，通过移动应用程序（BUDS应用程序）快速方便地从电子病历中向父母提供有关婴儿的信息。这项完成的工作表明，大型简单的新生儿试验是可行的，但也发现了一些问题——特别是在一些信息的准确性和完整性方面。这项工作还表明，另一种使新生儿随机试验更容易、更简单的方法是使用“集群试验”，在这种试验中，每个婴儿接受的治疗不是随机决定的，而是整个新生儿单位使用的治疗是随机决定的。我们希望在这项工作的基础上，看看我们是否可以通过让父母参与来更好地获得新生儿电子病历数据，并看看是否有可能使用新生儿电子病历系统进行大型简单的“群集试验”。我们计划这样做：1。测试是否通过移动应用程序快速方便地向父母提供电子病历中关于婴儿的信息，从而在新生儿电子病历系统中获得更完整和准确的数据。观察不同的大型简单新生儿电子病历试验和群集试验需要的新生儿电子病历数据的准确性和完整性。表明我们可以衡量父母、患者、医生、护士和研究人员从新生儿电子病历数据中确定的重要“结果”。最后，我们希望确保从大型简单新生儿试验中获得的知识能够在整个NHS中快速有效地沟通，以改善婴儿的照顾方式，因此我们将从美国其他卫生系统的成功和错误中学习，这些系统已经使用电子病历系统做到了这一点。我们将与新生儿医生、护士、研究人员以及电子病历公司合作，寻找在NHS中实现这一目标的最佳方式。

1 in 11 UK babies are born prematurely; many of these need neonatal care that involves medical decisions about every part of a baby's care. Many babies who require neonatal care have medical and neurological problems that affect them throughout their lives; these may be influenced by decisions made during their neonatal stay.The ideal way to work out which clinical decision is the best is through a randomised trial. Here each baby has an equal chance of being given each treatment option and this is chosen by chance, like tossing a coin. By including lots of babies we can work out which treatment option works best. Unfortunately, randomised trials are often very expensive and burdensome. As a result, only a small number of neonatal treatment options have been tested in randomised trials and so most decisions are only educated guesses.I want to make randomised clinical trials cheaper and easier so all day-to-day neonatal decisions can be based on the best research - randomised clinical trials. I plan to do this is by getting rid of one very expensive part, data collection, by getting all the information straight from a baby's electronic health record (EHR), a computerised version of the medical notes. Information from these EHR systems is already used for lots of purposes, I want to use it for randomised trials to make them much cheaper and easier so more can be carried out, more simply and easily.We have already completed the following work to show that large simple neonatal trials built into EHR systems are feasible:1. We have worked with doctors, nurses, parents, patients and researchers to determine what the most important "outcomes" for large simple neonatal trials are. An "outcome" is a result of a trial, like whether a baby needs oxygen at home2. We have shown it is possible to carry out a moderately large, novel and pioneering trial embedded within the neonatal EHR, and have measured how accurate, simple and inexpensive this is3. We have involved parents, doctors and nurse to make taking consent for large simple neonatal trials easier and more straightforward, and have shown that this is acceptable 4. We have worked with parents to develop a system to give parents information from the EHR about their baby rapidly and easily through a mobile app (the BUDS app)This completed work has shown that large simple neonatal trials are feasible, but also identified some problems - particularly around how accurate and complete some information is. This work has also shown that another way to make neonatal randomised trials easier and simpler is by using 'cluster trials' where instead of the treatment each baby receives being decided by chance, the treatment a whole neonatal unit uses is decided by chance. We want to build on this work to see if we can make neonatal EHR data better by involving parents, and to see whether large simple 'cluster trials' are possible using the neonatal EHR system. We plan to do this by:1. Testing to see whether giving parents information from the EHR about their baby rapidly and easily through a mobile app leads to more complete and accurate data in the neonatal EHR system2. Looking at how accurate and complete neonatal EHR data need to be for different large simple neonatal EHR trials and cluster trials to work 3. Showing that we can measure the 'outcomes' that parents, patients, doctors, nurses and researchers identified as important from neonatal EHR data Finally we want to make sure that knowledge from large simple neonatal trials can be quickly and effectively communicated across the NHS to improve the way babies are looked after, so we will learn from the successes and mistakes of other health systems in the USA that already do this using EHR systems. We will work with neonatal doctors, nurses and researchers and with EHR companies to find the best way of doing this in the NHS.