Transition Support Award CSF Chris Gale

英国每11个婴儿中就有一个是早产的；其中许多婴儿需要新生儿护理，这涉及到婴儿护理的每一个部分的医疗决定。许多需要新生儿护理的婴儿都有影响他们一生的医疗和神经问题；这些问题可能会受到他们在新生儿住院期间所做决定的影响。找出哪个临床决定是最好的理想方法是通过随机试验。在这里，每个婴儿都有平等的机会获得每种治疗选项，这是偶然选择的，就像扔硬币一样。通过纳入大量的婴儿，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重。因此，只有一小部分新生儿治疗方案在随机试验中进行了测试，因此大多数决定都只是有根据的猜测。我想让随机临床试验更便宜、更容易，这样所有日常新生儿的决定都可以基于最好的研究-随机临床试验。我计划要做的是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)中获得所有信息，EHR是医疗记录的计算机版本。来自这些EHR系统的信息已经用于很多目的，我想将其用于随机试验，使它们更便宜、更容易，以便更多地进行，更简单、更容易。我们已经完成了以下工作，以证明内置到EHR系统中的大型简单新生儿试验是可行的：1.我们与医生、护士、父母、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，比如婴儿在家中是否需要氧气。我们已经证明了进行嵌入新生儿EHR的中等规模、新颖和开创性的试验是可能的，并测量了这是如何准确、简单和廉价的3。我们让父母、医生和护士参与进来，使大型简单新生儿试验的同意变得更容易、更直接，并表明这是可以接受的4。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、轻松地从EHR向父母提供关于他们婴儿的信息。这项完成的工作表明，大型简单新生儿试验是可行的，但也发现了一些问题--特别是一些信息的准确性和完整性。这项工作还表明，另一种使新生儿随机试验变得更容易和更简单的方法是使用“集群试验”，即每个婴儿接受的治疗不是随机决定的，而是整个新生儿单元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改善新生儿EHR数据，并看看是否有可能使用新生儿EHR系统进行大型简单的‘集群试验’。我们计划通过以下方式做到这一点：1.测试通过移动应用程序快速、轻松地从EHR向父母提供关于他们婴儿的信息是否会在新生儿EHR系统中提供更完整和准确的数据。看看不同的大型简单新生儿EHR试验和集群试验需要多么准确和完整的新生儿EHR数据才能发挥作用3.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EHR数据中确定的‘结果’最后，我们希望确保来自大型简单新生儿试验的知识可以在NHS中快速有效地交流，以改善照顾婴儿的方式，因此我们将学习美国其他卫生系统已经使用EHR系统做到这一点的成功和错误。我们将与新生儿医生、护士和研究人员以及EHR公司合作，在NHS找到做到这一点的最佳方法。

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.