SWATted away: the challenging experience of setting up a programme of SWATs in paediatric trials
SWATted away: the challenging experience of setting up a programme of SWATs in paediatric trials
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DOI：
10.1186/s13063-019-3236-4
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发表时间：
2019-02-19
期刊：
影响因子：
2.5
通讯作者：
Knapp, Peter
中科院分区：
文献类型：
--
作者：
Martin-Kerry, Jacqueline;Parker, Adwoa;Knapp, Peter
随机对照试验被认为是确定健康干预措施有效性和安全性的最佳方法。涉及儿童的试验对于确保治疗安全有效至关重要。然而，在成人和儿科人群中进行的许多试验没有达到招募目标和/或维持参与者的保留，这可能导致结果的内部和外部有效性降低。确定提高试验效率的方法对于增加试验的成功完成非常重要。主体“试验中的研究”（SWAT）是一项嵌入正在进行的试验中的独立研究，旨在建立证据以改善医疗保健试验的管理和交付。近年来，越来越多的SWAT已经进行，但在儿科试验中很少。在这里，我们描述了一些挑战，在英国的儿科临床试验中进行SWAT计划。TRECA（TRials Engagement in Children and Adolescents）研究涉及开发多媒体网站，用于儿科试验，为儿童，年轻人及其家人提供有关临床试验的招募信息。遇到的挑战包括治理问题，如主机试验批准程序和匿名数据的共享，主机试验的资金问题，医疗保健环境中的互联网质量和可访问性，以及与SWAT方法相关的伦理问题。我们认为，在儿科环境中的伦理问题更加突出，也许是因为更少的SWAT在这些环境中进行或更谨慎，风险规避的方法进行研究与children is taken. ConclusionSWAT正在变得越来越普遍，以提供一个证据基础的方法，以提高试验效率。然而，我们遇到了一些意想不到的挑战，嵌入TRECA，以前没有在科学文献中报道。我们相信，如果通过更广泛地宣传和解释涉及所有关键利益相关者的SWAT，以及探索SWAT的替代资金模式来解决这些问题，这将使SWAT的流程更加简化，适当和及时，并为提高试验效率提供更强大的证据基础。于2016年8月24日注册。
BackgroundRandomised controlled trials are considered the best method for determining the effectiveness and safety of health interventions. Trials involving children are essential to ensure that treatments are safe and effective. However, many trials, in both adult and paediatric populations, do not achieve recruitment targets and/or maintain retention of participants, which can lead to a reduction in the internal and external validity of the results. Identifying ways of improving trial efficiency are important in order to increase the successful completion of trials.Main bodyA Study Within A Trial' (SWAT) is a self-contained study embedded within an ongoing trial, which aims to establish evidence to improve the management and delivery of trials in healthcare. Increasing numbers of SWATs have been undertaken in recent years yet very few within paediatric trials. Herein, we describe some of the challenges with undertaking a programme of SWATs within paediatric clinical trials in the UK. The TRECA (TRials Engagement in Children and Adolescents) study involves developing multimedia websites for use within paediatric trials to provide recruitment information to children, young people and their families about the clinical trial. Challenges encountered included governance issues such as host trial approval processes and sharing of anonymised data, funding issues for host trials, internet quality and accessibility within the healthcare setting, and ethical concerns associated with SWAT methodology. We believe the ethical concerns are more pronounced in the paediatric setting, perhaps because of the fewer SWATs undertaken in these settings or that a more cautious, risk-averse approach to undertaking research with children is taken.ConclusionSWATs are becoming increasingly common to provide an evidence base for methods to improve trial efficiency. However, we encountered a number of unanticipated challenges to embedding TRECA that have not been previously reported within the scientific literature. We believe that, if these issues were addressed through wider promotion and explanation of undertaking SWATs involving all key stakeholders, as well as by exploration of alternative funding models for SWATs, this would enable more streamlined, appropriate and timely processes for SWATs and a stronger evidence base for what works to increase trial efficiency.Trial registrationThe TRECA study is registered on ISRCTN, ID 73136092. Registered on 24 August 2016.