Title: Patient-centred trials: developing measures to improve the experience of people taking part in clinical trials
Funder: Department of Health and Social Care

Abstract: Research is fundamental to delivery of high quality NHS care, and helping people take part in research is critical. A key way to improve trials is through patient and public involvement (PPI) in their design. However, there is less focus on assessing peoples experience of actually taking part in trials, such as the process of informed consent, randomisation, interactions with trial staff, and levels of burden from the research. Many aspects of health care have been markedly improved by consistent measurement of patient experience, but our recent review suggests that routine assessment of patient experience in trials is uncommon. Routine measurement could allow stakeholders to assess patient experience in trials, explore aspects of trials that lead to positive and negative experiences and encourage better trials. If better measurement of experience leads to better trials, this could improve recruitment and retention. Aims Our aim is to work with patients and research staff to develop a measure of patient experience in trials that is useful, generates data that is valid and reliable and helps improve the quality of trials Methods We will conduct the work in 3 phases Phase 1 &ndash; Developing the measure (a) Defining the core domains of experience in trials We will synthesise findings from our previous work, including a review of patient experience measures in trials, workshops exploring patient experience, and our ongoing Delphi study. This will help us define key domains of patient experience in trials. We will search existing reviews to check if our list of domains is comprehensive. We will present this initial list of domains to patients and research staff to check they are comprehensive. We will then develop a list of statements relating to patient experience in trials that might be used in the measure. (b) Item selection and development Our list of candidate statements will be developed into a shorter list that is considered critical for any measurement of experience in a trial. We will also develop a longer list of candidate items that might be used in different types of trials or at different time points. We will explore the use of open ended questions. (c) Cognitive testing We will test these items using cognitive interviewing techniques to ensure the items are grounded in experience and comprehensible. We will recruit 20-30 people with varied characteristics and trial experience. People will be asked to read the statements with an interviewer, thinking aloud while they complete the measure. This will help us understand the ways in which people make judgements about their trial experience. Phase 2 &ndash; Piloting the measure We will pilot the measure on people taking part in ongoing trials. We will use our existing networks to identify at least 3 trials, and have our measure included in the trial. Piloting will assess acceptability of the measure, descriptive statistics and psychometrics. We will collect data from at least 500 people to provide a sufficient sample for psychometric analyses. We will also conduct interviews or focus groups with members from different trial teams to understand the barriers to the use of our measure, and how the data could best be used to improve trials for patients. Phase 3 - Developing a toolkit (including guidance and materials) We will develop a draft toolkit to enhance collection, analysis and presentation of patient experience data, drawing on our previous research and existing NIHR-funded studies of patient experience. We will co-produce the toolkit with trial staff, patient representatives on trials and funders, and expect it to include advice on collection of data; templates for data reporting; and advice on quality improvement and implementation.

Lay abstract: Research to discover which treatments are most effective is essential for the NHS to deliver high quality care. Comparing treatments is often done by clinical trials , which need a large number of participants for accurate results. However, trials sometimes have difficulty both in engaging enough participants ( recruitment ) and in keeping them in the trial until it ends ( retention ). If trials do not have the right number of people participating and finishing, they may take a lot longer, so they will cost more and there will be delay in patients receiving the best treatment. Involving patients and members of the public in designing trials helps to make them better and easier for those taking part, but we also need a way of finding out from the trial participants themselves how they found it. If they can tell us about their experiences throughout the trial, both good and bad, then this information can be used to improve the way future trials are delivered. We want develop a way to measure these patient experiences. We have already done some preliminary work and now need to flesh out details such as the right questions to ask and when and how to ask them. We will discuss these issues with members of the public and patients who have taken part or may in future take part in trials and also with research staff who run trials. When we have done this we will test our methods in different types of trials and use the results to refine our methods and develop further guidance. We hope the results will be used to improve future trials, to make the experience better and easier for people to participate. This may encourage people to join and stay in future trials, allowing quicker decisions about the best treatments

Research activity codes: 8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES);8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health categories: GENERIC HEALTH RELEVANCE