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.

When invited to participate in a clinical trial people are provided with an information leaflet and given the opportunity to have any questions answered. Despite this, there is evidence that some trial participants misunderstand the trial rationale and/or procedures, putting into question the adequacy of the informed consent process. Although provision of information aimed at improving knowledge may assist decision making, other factors, including the influence of others, have been shown to be important. In work on treatment decision making, there has been development of tools ("decision aids") for patients. Decision aids are designed to promote a deliberative process of decision making allowing people to make choices by determining what matters most to them. Preliminary studies have explored a possible role of decision aids to facilitate the informed consent process for trials. However, there is a lack of evidence about content, delivery and evaluation of these tools in the context of trial participation.

This research aims to inform the design and assessment of trial participation decision aids by answering the following research questions:
1. What are the potential implications of including patient stories in trial decision aids? This will be explored using interviews to develop vignettes followed by think aloud analysis.
2. What are effective methods for presenting probabilistic trial information within trial decision aids? This will be investigated using questionnaires alongside think aloud analysis.
3. Which outcomes should be considered 'core' for the evaluation of trial decision aids? This will be determined using a systematic review of process outcomes of interventions to improve informed consent for trials. Followed by a Delphi process to determine stakeholders' views of outcome measurements appropriate in this context.
Finally, guidance documents will be developed on key content and outcome measures of trial participation decision aids.

Who will benefit from this research?
In addition to academic beneficiaries there are several parties who will benefit from this research. People involved in clinical trials, including the general public in their potential role as trial participants, are likely to receive immediate benefit. In addition to this, individuals working in the delivery of clinical trials in public and private sectors, such as research nurses and clinicians, may also receive direct benefits from this research. Other public sector beneficiaries who will directly benefit are the NRES and associated Research Ethics Committees. There may also be direct benefit to the commercial private sector, in particular pharmaceutical companies and clinical research organisations, who are running clinical trials. Some third sector organisations, such as disease specific charities, may use the results of the research in the longer term. The general public, including those who may never participate in clinical trials, will also be longer term beneficiaries.

How will they benefit from this research?
The general public will benefit from this research. This work will be directly recognised, and findings incorporated punctually into, the NRES guidance document on participant information. This guidance is used by those involved in clinical trials, in both public and private sectors, when developing information for potential trial participants. Moreover, several disease specific charities write guidance for participants about clinical trial participation. These organisations could also benefit from guidance on how to facilitate better decision making with regard to trial participation. As such, the findings from this research will provide an evidence base on which to influence public policies. Moreover, the research findings have the potential to change practices with regard to participation in clinical trials, facilitating a more supportive decision making process for those involved. As such, we anticipate that these findings will allow reflection on the research governance framework and may enhance the processes involved in RCT participation across the NHS.

This project would complement the Department of Health's policy paper 'Liberating the NHS: No decision about me, without me'. This document discusses a requirement to move towards a mutual NHS, in which patients and clinicians reach decisions about treatment (of which participation in a trial may be an option) together, with a shared understanding of the options available and the associated risks and benefits. The MRC ethics series document 'Good research practice: Principles and guidelines' states that 'Where practicable, consent that is freely given and informed should be sought from all competent participants. Guidance on writing participant information is available from the National Research Ethics Service' p7. This research project aims to augment the informed decision-making process with respect to RCT participation and findings will feed directly into the NRES guidance (currently being updated by a committee of which I am a member) and therefore complements this MRC document.

The research proposed in this methodology fellowship has the potential to contribute to the nation's health over the longer term. Specifically, this work will better inform how to support potential participants to make a decision about participation in clinical trials. Patients would be provided with benefit from information that would allow them to make a more informed decision about trial entry. As many of the treatments currently used within the NHS have been implemented due to results from clinical trials, any process that can enhance decisions about trial participation would also lead to beneficial results for the NHS in terms of putting trial interventions into practice in a more effective and timely manner, ultimately increasing the effectiveness of the public service.