EVIDENCE-INFORMED DECISION AIDS FOR CLINICAL TRIAL PARTICIPATION: A METHODOLOGICAL INVESTIGATION OF CORE COMPONENTS AND OUTCOME MEASURES.

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

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.