University of Bristol, UK.
Bristol NIHR Biomedical Research Centre, UK.
Autism. 2024 Jun;28(6):1540-1550. doi: 10.1177/13623613231202432. Epub 2023 Oct 26.
Large randomised controlled trials are used to test healthcare treatments. Yet there are no large randomised controlled trials on effective treatments for common mental health issues affecting autistic adults. The purpose of this study was to learn what autistic adults think about randomised controlled trials in preparation for a randomised controlled trial testing a medication for anxiety. This means we wanted to know their opinions about the way randomised controlled trials are done, such as how people are chosen to be in the study and how the study is carried out. We did this by talking to 49 autistic adults individually and asking them questions. We found that most of the people we talked to were okay with the way randomised controlled trials are done. They thought it was fair and they liked that it was based on evidence. However, some autistic people might find it hard to take part in randomised controlled trials. Some people did not like the uncertainty of not knowing what treatment they would receive in a randomised controlled trial. Others felt too vulnerable and may have had bad experiences with healthcare in the past. We found that it is important to involve autistic people early on and at every stage when designing a clinical trial. Care about how clear and precise the study communication is will build trust and improve access to research. Our study indicates that it is possible to conduct large randomised controlled trials with and for autistic people. This can ultimately contribute to the improvement of healthcare outcomes for this population.
大型随机对照试验用于测试医疗保健治疗方法。然而,目前针对影响成年自闭症患者的常见心理健康问题的有效治疗方法,尚无大型随机对照试验。本研究的目的是了解成年自闭症患者对随机对照试验的看法,为一项测试焦虑症药物的随机对照试验做准备。这意味着我们想了解他们对随机对照试验实施方式的意见,例如如何选择研究对象以及如何开展研究。我们通过与 49 名成年自闭症患者进行一对一访谈并提问来了解他们的看法。我们发现,我们访谈的大多数人对随机对照试验的实施方式表示认可。他们认为这种方式公平合理,而且基于证据。然而,一些自闭症患者可能难以参与随机对照试验。一些人不喜欢在随机对照试验中不知道自己将接受何种治疗的不确定性。还有一些人感到过于脆弱,并且过去可能在医疗保健方面有过不好的经历。我们发现,在设计临床试验时尽早并在每个阶段让自闭症患者参与非常重要。关注研究沟通的清晰和精准程度有助于建立信任,并提高参与研究的机会。我们的研究表明,为自闭症患者开展和进行大型随机对照试验是可行的。这最终有助于改善该人群的医疗保健结果。