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.

本研究旨在探讨如何帮助人们做出参加临床试验的决定。其他研究人员已经确定了在做出与健康相关的决定时对个人重要的关键因素，我希望将其应用于参与临床试验的决定。临床试验经常比较一种治疗方法与另一种治疗方法，并对哪种治疗方法更好感兴趣。试验治疗的范围可以从手术到药物，设备（例如导管）或某种类型的治疗。在决定参加试验之前，向个人提供一份描述试验的信息传单。本信息手册将包含有关试验目的、对参与者的期望、参与的风险和获益以及出现问题时联系人的具体细节。研究表明，一个人决定参加试验还有其他几个影响因素。其中一些原因与误解他们所获得的信息有关，这可能会影响他们参与或不参与试验的决定。我将进行研究，探索如何更好地支持人们做出是否参加临床试验的决定，并特别调查的工具，被称为“决策辅助”的作用，以帮助决策过程。决策辅助有时已经在NHS中使用，以帮助患者决定选择哪种治疗方法来治疗特定的疾病。这些决策辅助工具帮助人们思考医疗保健决策以及它与他们的关系。决策辅助工具包含准确的书面信息，让患者思考治疗结果可能会如何影响他们，并总结患者选择或不选择某个选项的原因。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，他们明白为什么一种治疗方法比另一种更好，他们可以更自信地与他人谈论喜欢或不喜欢一种选择的原因。决策辅助工具也可能有助于帮助人们决定是否参加试验。然而，在我们开始使用这些决策辅助工具来告知和支持人们参与试验之前，还有一些具体方面需要更多的研究。首先，一些决策辅助工具包含其他患者关于他们经历的故事。我们目前不知道其他人的故事在考虑参与试验时是否对人们有帮助，如果有帮助，人们想知道什么样的故事。其次，试验通常具有与所研究的治疗相关的不同风险和益处。有既定的方法来提供与治疗决策相关的风险信息，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理解与试验参与相关的信息。最后，重要的是，当我们调查这些决策辅助工具是否有效时，在改善参与试验的决策时，我们知道什么结果是重要的。研究的最后一部分感兴趣的是确定我们应该测量什么（比如人们的理解），当我们评估这些决策辅助工具时，以及为什么。该项目将与各种各样的人合作：参加过试验的人;没有参加试验的人;公众;在某些调查领域是专家的研究人员和医生;以及参与研究管理的人。本研究的结果有很大的潜力，可以改善在考虑参加临床试验时向潜在参与者提供的信息和支持。除此之外，该研究还可以改善潜在试验参与者的决策过程，并使决策更加知情。

项目成果

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

外科医生和方法学家对利用基于专业知识的随机对照试验设计的看法：一项定性研究。

• 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

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

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

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