Evidence-informed decision aids for clinical trial participation: a methodological investigation of core components and outcome measures.

临床试验参与的循证决策辅助：核心组成部分和结果测量的方法学调查。

• 批准号: MR/L01193X/1
• 负责人: Kate Gillies
• 金额: $ 30.98万
• 依托单位: University of Aberdeen
• 依托单位国家: 英国
• 项目类别: Fellowship
• 财政年份: 2014
• 资助国家: 英国
• 起止时间: 2014 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FL01193X%2F1
• 关键词: Evidence; informed; decision; aids; clinical

This research aims to explore how to help people make a decision about taking part in a clinical trial. Other researchers have identified key aspects that are important for individuals when making decisions relating to their health and I wish to apply this to decisions about taking part in clinical trials.Clinical trials often compare one treatment to another and are interested in which is better. Trial treatments can range from an operation, to a drug, a device (e.g. catheter) or a certain type of therapy. Before making a decision about taking part in the trial, individuals are provided with an information leaflet describing the trial. This information leaflet will contain specific detail on the purpose of the trial, what will be expected from those taking part, the risks and benefits of taking part, and who to contact if there is a problem. Research has shown that there are several other influences on a person's decision to participate in a trial. Some of these reasons relate to misunderstanding the information they have been given and this can influence their decision to participate, or not, in the trial. I am going to undertake research to explore how to better support people to make a decision about whether or not to participate in a clinical trial, and specifically investigate the role of the tools, known as 'decision aids', to help with the decision making process.Decision aids are already sometimes used in the NHS to help patients decide which treatment to choose for a particular condition. These decision aids help people think about a healthcare decision and how it relates to them. The decision aid has written information that is accurate, lets the person think about how the treatment consequences might affect them, and summarises the person's reasons for choosing, or not choosing, an option. People who use decision aids say they understand the health problem and treatment choices more clearly, they understand why one treatment is better for them than another, and they can talk more confidently about the reasons for liking or not liking an option with others. Decision aids may also be useful to help people decide whether to take part in a trial. However, before we can start to use these decision aids to inform and support people about trial participation, there are specific aspects which require more research. First of all, some decision aids contain stories from other patients about their experiences. We currently do not know if other peoples' stories are helpful for people when considering trial participation and, if they are helpful, what kind of stories do people want to know about. Secondly, trials often have different risks and benefits relating to the treatments under investigation. There are established ways to present risk information in relation to treatment decisions that help to improve peoples' understanding and we wish to explore whether some of these methods can help people to understand the information in relation to trial participation. Last of all, it is important when we investigate whether these decision aids are effective, at improving decisions for trial participation, we know what outcomes are important. The last part of the research is interested in determining what we should measure (like peoples' understanding), when we are evaluating these decision aids and why. The project will work with a variety of people: people who have taken part in a trial; those who have not; the general public; researchers and doctors who are experts in some of the areas under investigation; and those involved with research governance. There is significant potential for the results of this research to improve the information and support provided to potential participants when considering taking part in a clinical trial. In addition to this, the research may improve the decision making process for potential trial participants and result in decisions being more informed.

这项研究旨在探讨如何帮助人们决定参加临床试验。其他研究人员已经确定了对个人做出与其健康有关的决定很重要的关键方面，我希望将其应用于有关参加临床试验的决策中。临床试验通常将一种治疗方法与另一种治疗方法进行比较，并且对更好的方法进行了兴趣。试验治疗的范围从手术到药物，设备（例如导管）或某种类型的治疗。在决定参加试验之前，为个人提供了描述试验的信息传单。此信息传单将包含有关试验目的的具体详细信息，从参与的人那里期望的是什么，参加问题的风险和好处以及如果存在问题，将与谁联系。研究表明，对一个人参加试验的决定还有其他几个影响。其中一些原因涉及误解他们所获得的信息，这可能会影响他们参与审判的决定。我将进行研究，以探索如何更好地支持人们，以决定是否参加临床试验，并特别研究工具（称为“决策艾滋病”）的作用，以帮助进行决策过程。有时在NHS中已经使用了Decision AIDS，以帮助患者确定哪种治疗方法来选择特定条件。这些决策辅助工具可帮助人们思考医疗保健决定及其与他们的关系。决策援助已经具有准确的书面信息，让该人考虑治疗后果如何影响它们，并总结了该人选择或不选择选项的原因。使用决策辅助工具的人说，他们更清楚地了解健康问题和治疗选择，他们了解为什么一种治疗对他们比另一种治疗更好，并且他们可以更自信地谈论喜欢或不喜欢与他人选择的原因。决策艾滋病也可能有助于帮助人们决定是否参加审判。但是，在我们开始使用这些决策辅助工具来告知和支持人们有关试验参与的情况之前，有一些需要更多研究的方面。首先，一些决策辅助工具包含其他患者的故事。我们目前不知道其他人的故事在考虑审判参与时是否对人们有帮助，如果他们有帮助，人们想知道什么样的故事。其次，试验通常具有与正在调查的治疗相关的风险和益处。有一些既定方法来提出与治疗决策有关的风险信息，从而有助于提高人们的理解，我们希望探索其中一些方法是否可以帮助人们了解与试验参与有关的信息。最后，当我们研究这些决策辅助工具是否有效，改善试验参与决策时，我们知道哪些结果很重要，这一点很重要。研究的最后一部分有兴趣确定我们应该衡量的内容（例如人民的理解），当我们评估这些决策辅助工具以及原因时。该项目将与各种各样的人合作：参加了审判的人；那些没有的人；公众；研究人员和医生是一些正在调查的领域的专家；以及参与研究治理的人。在考虑参加临床试验时，这项研究的结果具有很大的潜力，可以改善向潜在参与者提供的信息和支持。除此之外，研究还可以改善潜在试验参与者的决策过程，并导致决策更加明智。

项目成果

Surgeons' and methodologists' perceptions of utilising an expertise-based randomised controlled trial design: a qualitative study.

• DOI: 10.1186/s13063-018-2832-z
• 发表时间: 2018-09-06
• 期刊: Trials
• 影响因子: 2.5
• 作者: Cook JA;Campbell MK;Gillies K;Skea Z
• 通讯作者: Skea Z

Additional file 1 of Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review

向 III 期务实有效性 RCT 参与者提供试验结果的附加文件 1：范围界定审查

• DOI: 10.6084/m9.figshare.14670546
• 发表时间: 2021
• 作者: Bruhn H

What, how, when and who of trial results summaries for trial participants: stakeholder-informed guidance from the RECAP project.

• DOI: 10.1136/bmjopen-2021-057019
• 发表时间: 2022-03-25
• 期刊: BMJ open
• 影响因子: 2.9
• 作者: Bruhn H;Campbell M;Entwistle V;Humphreys R;Jayacodi S;Knapp P;Tizzard J;Gillies K
• 通讯作者: Gillies K

Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set.

• DOI: 10.1136/bmjopen-2020-045568
• 发表时间: 2021-06-24
• 期刊: BMJ open
• 影响因子: 2.9
• 作者: Cruickshank M;Newlands R;Blazeby J;Ahmed I;Bekheit M;Brazzelli M;Croal B;Innes K;Ramsay C;Gillies K
• 通讯作者: Gillies K

Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review.

• DOI: 10.1186/s13063-021-05300-x
• 发表时间: 2021-05-24
• 期刊: Trials
• 影响因子: 2.5
• 作者: Bruhn H;Cowan EJ;Campbell MK;Constable L;Cotton S;Entwistle V;Humphreys R;Innes K;Jayacodi S;Knapp P;South A;Gillies K
• 通讯作者: Gillies K