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Patient and public involvement in research helps to make it more relevant and useful to the end-users. Involvement influences the design, delivery and dissemination of research, ultimately leading to better services, treatments and care. Researchers are therefore keen to involve patients, carers and public in their work, but are sometimes uncertain about who to involve. Some confusion may arise from the terms used. The UK’s catch-all term ‘patient and public involvement’ suggests this is a single activity, that perhaps both ‘patient’ and ‘public’ input are needed, or that either will do. The terms ‘patient’, ‘carer’ and ‘public’ have been defined, but are not used consistently. In fact there are many different contexts for involvement and many different kinds of decisions made, which then determine whose input will be most valuable. Clarity about the ‘why’ can help answer the ‘who’ question. However, not all researchers are clear about the purpose of involvement. While it is often understood to have a moral purpose, or to improve research quality, this doesn’t always identify who needs to be involved. When learning is understood to be the purpose of involvement, then the most appropriate people to involve are those with relevant experiential knowledge. In research projects, these are people with lived experience of the topic being investigated. This could be patients, carers, members of the public or health professionals. In this article we discuss how involving people who do not have the relevant experiential ‘lived’ knowledge may contribute to ineffective or tokenistic involvement. These people are as likely as researchers to make assumptions, risking missing key insights or resulting in outcomes that are off-putting or even harmful to research participants. We conclude that greater attention needs to be given to the question of who to involve. Raising awareness of the significance of experiential knowledge and the contextual factors that determine whose input will be most useful will help everyone to understand their roles and improve the quality of involvement. It will help to maximise the opportunities for learning, increasing the likelihood of impact, and helping to achieve the ultimate goal of improved health and services. Plain English summary Patient and public involvement in research helps to make it more relevant and useful to the end-users. Researchers are therefore keen to involve people but are sometimes uncertain about who to involve. Some confusion comes from the terms used. The UK’s term ‘patient and public involvement’ suggests there is only one activity and that both inputs are needed or either will do. The terms ‘patient’, ‘carer’ and ‘public’ are not used in the same way by everyone. Involvement happens in many different situations, influencing different kinds of decisions, which then determines whose input will be most valuable. Being clear about the ‘why’ can help answer the ‘who’ question. However, not all researchers are clear about the purpose of involvement. When learning is understood to be the purpose, the most appropriate people to involve are those with relevant experiential knowledge. They provide insights based on their lived experience. In research projects, this is experience of the topic being studied. This could be patients, carers, public or health professionals. We discuss how involving people who do not have relevant experiential knowledge may limit impact. These people may be as likely as researchers to make wrong assumptions. This risks missing key insights or making unhelpful decisions. We conclude that greater attention should be given to the question of who to involve. Raising awareness of the importance of relevant experiential knowledge and other factors that determine whose input will be most useful, will help maximise opportunities for learning and increase the potential for impact.

Plain English summary Researchers who conduct studies in health and social care are encouraged to involve the public as early as possible in the process of designing their studies. Before their studies are allowed to start researchers must seek approval from a Research Ethics Committee, which will assess whether the study is going to be safe and ethical for patients or healthy volunteers to take part in. The process of ethical review does not consider how researchers work with patients and the public early on to design their studies. Furthermore, there is no requirement for researchers to seek ethical approval for public involvement. However, in our work advising researchers about public involvement we have found that the ways in which researchers involve the public in the design of their studies are sometimes unintentionally unethical, and this is the focus of our paper. We have observed ten areas where ethical issues may arise because of the actions researchers may or may not take and which might consequently have a negative impact. Therefore, we have used these observations to develop a “framework” to help researchers and the public work together at the early design stage in ways that are ethical. Our intention for the framework is to help researchers be mindful of these ten areas and how easily ethical issues can arise. The framework suggests some ways to overcome the potential issues in each of the ten areas. The ten areas are: 1) Allocating sufficient time for public involvement; 2) Avoiding tokenism; 3) Registering research design stage public involvement work with NHS Research & Development Trust Office at earliest opportunity; 4) Communicating clearly from the outset; 5) Entitling public contributors to stop their involvement for any unstated reasons; 6) Operating fairness of opportunity; 7) Differentiating qualitative research methods and public involvement activities; 8) Working sensitively; 9) Being conscious of confidentiality and 10) Valuing, acknowledging and rewarding public involvement. We looked to see whether any other similar approaches to helping researchers address potential ethical issues when working with the public on designing studies have been published and to our knowledge none exist. Our framework is presented as a draft and believe that it would now benefit from input from researchers and the public to gauge how useful it is and whether there are any other possible situations that it might need to cover. The current paper highlights real life examples of how ethical issues can arise during public involvement activities at the research design stage. We refer to “the research design stage” as the time between the generation of the research ideas and when formal permissions to start the work including ethical approval are granted. We argue that although most researchers work ethically at this early stage, some may still benefit from being informed about ethically conscious approaches to involving the public. The paper highlights 10 ethical issues that we have observed with involving the public at the research design stage. We provide examples of these observed scenarios to illustrate the issues and make suggestions for how they can be avoided to help researchers become more ethically conscious when involving the public at the research design stage. Currently the draft framework comprises: 1) Allocating sufficient time for public involvement; 2) Avoiding tokenism; 3) Registering research design stage public involvement work with NHS Research & Development Trust Office at earliest opportunity; 4) Communicating clearly from the outset; 5) Entitling public contributors to stop their involvement for any unstated reasons; 6) Operating fairness of opportunity; 7) Differentiating qualitative research methods and public involvement activities; 8) Working sensitively; 9) Being conscious of confidentiality and 10) Valuing, acknowledging and rewarding public involvement. The draft framework will help researchers to recognise the ethical issues when involving the public and is intended to be used voluntarily in a self-regulatory way. We believe that the draft framework requires further consultation and input from the wider research community and the public before endorsement by national UK bodies such as INVOLVE and the Health Research Authority (HRA).

Poor recruitment to, and retention in, clinical trials is a source of research waste that could be reduced by more informed choices about participation. Barriers to effective recruitment and retention can be wide-ranging but relevance of the questions being addressed by trials and the outcomes that they are assessing are key for potential participants. Decisions about trial participation should be informed by general and trial-specific information and by considering broader assessments of ‘informedness’ and how they impact on both recruitment and retention. We suggest that more informed decisions about trial participation should encourage personally appropriate decisions, increase recruitment and retention, and reduce research waste and increase its value.

Background One of the top three research priorities for the UK clinical trial community is to address the gap in evidence-based approaches to improving participant retention in randomised trials. Despite this, there is little evidence supporting methods to improve retention. This paper reports the PRioRiTy II project, a Priority Setting Partnership (PSP) that identified and prioritised unanswered questions and uncertainties around trial retention in collaboration with key stakeholders. Methods This PSP was conducted in collaboration with the James Lind Alliance, a non-profit making initiative, to support key stakeholders (researchers, patients, and the public) in jointly identifying and agreeing on priority research questions. There were three stages. (1) First an initial online survey was conducted consisting of six open-ended questions about retention in randomised trials. Responses were coded into thematic groups to create a longlist of questions. The longlist of questions was checked against existing evidence to ensure that they had not been answered by existing research. (2) An interim stage involved a further online survey where stakeholders were asked to select questions of key importance from the longlist. (3) A face-to-face consensus meeting was held, where key stakeholder representatives agreed on an ordered list of 21 unanswered research questions for methods of improving retention in randomised trials. Results A total of 456 respondents yielded 2431 answers to six open-ended questions, from which 372 questions specifically about retention were identified. Further analysis included thematically grouping all data items within answers and merging questions in consultation with the Steering Group. This produced 27 questions for further rating during the interim survey. The top 21 questions from the interim online survey were brought to a face-to-face consensus meeting in which key stakeholder representatives prioritised the order. The ‘Top 10’ of these are reported in this paper. The number one ranked question was ’What motivates a participant’s decision to complete a clinical trial?’ The entire list will be available at www.priorityresearch.ie . Conclusion The Top 10 list can inform the direction of future research on trial methods and be used by funders to guide projects aiming to address and improve retention in randomised trials.

Background Public and patient involvement aims to improve research quality, relevance, and appropriateness. Despite an increasing evidence base on the influence of public involvement in health research, the role of involvement in methodology research (i.e. research that aims to enhance the quality and rigour of research) is less clear. Using a qualitative case study, we explored public involvement in a research priority-setting partnership in rapid review methodology (Priority III) to give practical insights to inform public involvement in priority-setting for future methodological research. Methods Participant observation, documentary analysis, interviews and focus groups were used to explore the processes of Priority III and identify the views and experiences of the participants of a steering group ( n  = 26) regarding public involvement in Priority III. We used a case study research design and conducted two focus groups with five public partners; one focus group with four researchers; and seven one-to-one interviews with researchers and public partners. Nine episodes of participant observation of meetings were conducted. All data were analysed using template analysis. Results The findings of this case study present three themes and six subthemes: Theme 1 We all bring unique qualities to the table. Subtheme 1.1—Coming from different perspectives towards shared-decision making; Subtheme 1.2—Public partners bring pragmatism and grounding in reality; Theme 2 We need support and space at the table. Subtheme 2.1—Define and develop support needed for meaningful involvement; Subtheme 2.2—Creating safe space to listen, challenge and learn; Theme 3 We all benefit from working together. Subtheme 3.1—Reciprocity in mutual learning and capacity building; Subtheme 3.2—Relationships as partners in research, with a feeling of togetherness. Communication and trust, as inclusive ways of working, underpinned the partnership approach to involvement. Conclusions This case study contributes to knowledge on public involvement in research by explaining the supportive strategies, spaces, attitudes and behaviours that enabled a productive working partnership to develop between a team of researchers and public partners in this research context. Plain English summary Public and patient involvement is well known in research where patients share their lived experience for a health-related study. However, the role of public and patients in methodology research (research that aims to improve the quality of research) is not clear. A priority-setting partnership brings patients, carers, clinicians and other stakeholders together to jointly identify priorities for research. We looked at public involvement in a priority-setting partnership in how we plan, do, and share the results of rapid reviews—the Priority III project. We wanted to do this to better support public involvement in future research. We explored the processes of Priority III and asked the members of the Priority III steering group for their views and experiences of public involvement in the project. We found three themes: 1: We all bring unique qualities to the table. 2: We need support and space at the table. 3: We all benefit from working together. Communication and trust were found to be important across all themes. Even though public partners felt outside of their comfort zones when starting the project, they significantly helped the project, brought unique views, ideas and practical solutions. Support and safe spaces were needed to help overcome challenges due to the complex methodological concepts. Researchers and public partners learned from one another, and developed relationships with a feeling of being “partners in research”. Our findings offer insight into what helped public involvement in this research context. We give examples of practical actions and suggestions for future research.

Background A failure of clinical trials to retain participants can influence the trial findings and significantly impact the potential of the trial to influence clinical practice. Retention of participants involves people, often the trial participants themselves, performing a behaviour (e.g. returning a questionnaire or attending a follow-up clinic as part of the research). Most existing interventions that aim to improve the retention of trial participants fail to describe any theoretical basis for the potential effect (on behaviour) and also whether there was any patient and/or participant input during development. The aim of this study was to address these two problems by developing theory- informed, participant-centred, interventions to improve trial retention. Methods This study was informed by the Theoretical Domains Framework and Behaviour Change Techniques Taxonomy to match participant reported determinants of trial retention to theoretically informed behaviour change strategies. The prototype interventions were described and developed in a co-design workshop with trial participants. Acceptability and feasibility (guided by (by the Theoretical Framework of Acceptability) of two prioritised retention interventions was explored during a focus group involving a range of trial stakeholders (e.g. trial participants, trial managers, research nurses, trialists, research ethics committee members). Following focus group discussions stakeholders completed an intervention acceptability questionnaire. Results Eight trial participants contributed to the co-design of the retention interventions. Four behaviour change interventions were designed: (1) incentives and rewards for follow-up clinic attendance, (2) goal setting for improving questionnaire return, (3) participant self-monitoring to improve questionnaire return and/or clinic attendance, and (4) motivational information to improve questionnaire return and clinic attendance. Eighteen trial stakeholders discussed the two prioritised interventions. The motivational information intervention was deemed acceptable and considered straightforward to implement whilst the goal setting intervention was viewed as less clear and less acceptable. Conclusions This is the first study to develop interventions to improve trial retention that are based on the accounts of trial participants and also conceptualised and developed as behaviour change interventions (to encourage attendance at trial research visit or return a trial questionnaire). Further testing of these interventions is required to assess effectiveness.

Plain English summary Researchers carrying out research in the NHS in England have to obtain approval for their study from an NHS Research Ethics Committee (REC). Involving the public in research helps to ensure studies are ethically acceptable to the people taking part, and therefore supports the REC review. The form used by RECs asks researchers to describe any involvement that has taken place before the review or any planned for the future. We analysed researchers’ reports of involvement in 2748 applications to RECs in 2014, to assess how well their approaches to involvement are informing the review process. We found that researchers rarely describe involvement in enough detail to help REC members. It is difficult to judge whether previous involvement has shaped the research design in any way, and whether plans for future involvement are meaningful. It also seems that some researchers remain unclear about involvement and its purpose at different stages. This may be severely limiting its impact. So that public involvement can usefully inform REC reviews in future, the Health Research Authority, which oversees RECs, will carry out further work to find out what information RECS need about involvement. This information will be used to change the application form and to develop guidance and training for REC members and the wider research community. Researchers may also benefit from clearer guidance on the value and purpose of involvement at key research stages: early design, data collection and the dissemination of results. Background Researchers conducting research in the NHS in England are required to submit their study for approval by an NHS Research Ethics Committee (REC). Public involvement in research prior to REC review helps to ensure studies are ethically acceptable to participants, thus informing the review process. The Integrated Research Application System (IRAS) used by RECs, asks researchers to describe any involvement in the development of their project, and in its delivery and dissemination. We analysed researchers’ reports of involvement to assess how well current approaches to involvement are supporting REC review. Methods We used a mixed methods approach. The anonymised free-text data from all 2748 non-educational applications submitted to RECs in 2014 were analysed using NVivo. Themes were developed from the data and used to summarise and categorise the different types of reports of involvement. The frequency of common types of report was analysed using simple statistics. Results In general, researchers rarely describe any prior involvement in sufficient detail to know what was done and what difference this made. This makes it difficult to judge whether the involvement shaped the research design in any way to make it more ethically acceptable. Similarly, researchers’ plans for future involvement are not clear enough to enable RECs to make a proper assessment of whether this involvement will be meaningful, or whether potential ethical concerns raised by involvement have been addressed. This analysis also shows there is still considerable misunderstanding amongst researchers around what involvement means, and its purpose at different stages of a project. This may be severely limiting the potential for impact. Conclusions So that public involvement can usefully inform REC review in future, the HRA is undertaking a collaborative exercise to understand what information RECS need about involvement, and what changes need to be made to the IRAS form. At the same time it will develop guidance and training for REC members and the wider research community about how public involvement can support ethical review. Researchers may also benefit from guidance on the value and purpose of involvement at the research stages: design, data collection and dissemination of results.

Background The publication of the United Kingdom (UK) Standards for Public Involvement (PI) (UK Standards) in research drew a clear line in the sand regarding the importance of utilising the unique experience, skills and expertise that lay people may offer to the development, conduct and dissemination of clinical research. The UK Standards provide a benchmark which researchers should aim to achieve, yet its implementation continues to be a step wise iterative process of change management. A recent evaluation by a regional research group has suggested that our understanding of PI is enhanced through reflection on the UK Standards. We report on the utility of PI in the design, conduct and dissemination of the HIDDen study, a national, multicentre clinical study based across three UK centres. Methods A retrospective review of PI within the HIDDen study was conducted using field notes taken by the lead author from interactions throughout their involvement as a lay representative on the study. Key members of the HIDDen study were interviewed and data analysed to explore adherence to the UK Standards. Results There was universal support for PI across the study management group with genuine inclusivity of lay members of the committee. All six of the UK Standards were met to varying degrees. The greatest opportunities lay in ‘working together’ and ‘support and learning’. There were challenges meeting ‘governance’ with evidence of participation in decision making but less evidence of opportunities in management, regulation, leadership. Conclusion This study concurs with previous research supporting the utility of the Standards in the conduct and evaluation of PI in clinical research. To our knowledge this is the first multi-national study to be evaluated against the UK Standards.

Background Non-retention of participants seriously affects the credibility of clinical trial results and significantly reduces the potential of a trial to influence clinical practice. Non-retention can be defined as instances where participants leave the study prematurely. Examples include withdrawal of consent and loss to follow-up and thus outcome data cannot be obtained. The majority of existing interventions targeting retention fail to describe any theoretical basis for the observed improvement, or lack of improvement. Moreover, most of these interventions lack involvement of participants in their conception and/or design, raising questions about their relevance and acceptability. Many of the causes of non-retention involve people performing a behaviour (e.g. not returning a questionnaire). Behaviour change is difficult, and the importance of a strong theoretical basis for interventions that aim to change behaviour is increasingly recognised. This research aims to develop and pilot theoretically informed, participant-centred, evidence-based behaviour change interventions to improve retention in trials. Methods This research will generate data through semi-structured interviews on stakeholders’ perspectives of the reasons for trial non-retention. It will identify perceived barriers and enablers to trial retention using the Theoretical Domains Framework. The intervention development work will involve identification of behaviour change techniques, using recognised methodology, and co-production of retention interventions through discussion groups with end-users. An evaluation of intervention acceptability and feasibility will be conducted in focus groups. Finally, a ready-to-use evaluation framework to deploy in Studies Within A Trial as well as an explanatory retention framework will be developed for identifying and tackling modifiable issues to improve trial retention. Discussion We believe this to be one of the first studies to apply a theoretical lens to the development of interventions to improve trial retention that have been informed by, and are embedded within, participants’ experiential accounts. By developing and identifying priority interventions this study will support efforts to reduce research waste.

Background and objective There is currently no standardised way to share information across disciplines about initiatives, including fields such as health, environment, basic science, manufacturing, media and international development. All problems, including complex global problems such as air pollution and pandemics require reliable data sharing between disciplines in order to respond effectively. Current reporting methods also lack information about the ways in which different people and organisations are involved in initiatives, making it difficult to collate and appraise data about the most effective ways to involve different people. The objective of STARDIT ( Sta nda r dised D ata on I ni t iatives) is to address current limitations and inconsistencies in sharing data about initiatives. The STARDIT system features standardised data reporting about initiatives, including who has been involved, what tasks they did, and any impacts observed. STARDIT was created to help everyone in the world find and understand information about collective human actions, which are referred to as ‘initiatives’. STARDIT enables multiple categories of data to be reported in a standardised way across disciplines, facilitating appraisal of initiatives and aiding synthesis of evidence for the most effective ways for people to be involved in initiatives. This article outlines progress to date on STARDIT; current usage; information about submitting reports; planned next steps and how anyone can become involved. Method STARDIT development is guided by participatory action research paradigms, and has been co-created with people from multiple disciplines and countries. Co-authors include cancer patients, people affected by rare diseases, health researchers, environmental researchers, economists, librarians and academic publishers. The co-authors also worked with Indigenous peoples from multiple countries and in partnership with an organisation working with Indigenous Australians. Results and discussion Over 100 people from multiple disciplines and countries have been involved in co-designing STARDIT since 2019. STARDIT is the first open access web-based data-sharing system which standardises the way that information about initiatives is reported across diverse fields and disciplines, including information about which tasks were done by which stakeholders. STARDIT is designed to work with existing data standards. STARDIT data will be released into the public domain (CC0) and integrated into Wikidata; it works across multiple languages and is both human and machine readable. Reports can be updated throughout the lifetime of an initiative, from planning to evaluation, allowing anyone to be involved in reporting impacts and outcomes. STARDIT is the first system that enables sharing of standardised data about initiatives across disciplines. A working Beta version was publicly released in February 2021 (ScienceforAll.World/STARDIT). Subsequently, STARDIT reports have been created for peer-reviewed research in multiple journals and multiple research projects, demonstrating the usability. In addition, organisations including Cochrane and Australian Genomics have created prospective reports outlining planned initiatives. Conclusions STARDIT can help create high-quality standardised information on initiatives trying to solve complex multidisciplinary global problems. Plain English Summary All major problems, including complex global problems such as air pollution and pandemics, require reliable data sharing between disciplines in order to respond effectively. Such problems require evidence-informed collaborative methods, multidisciplinary research and interventions in which the people who are affected are involved in every stage. However, there is currently no standardised way to share information about initiatives and problem-solving across and between fields such as health, environment, basic science, manufacturing, education, media and international development. A multi-disciplinary international team of over 100 citizens, experts and data-users has been involved in co-creating STARDIT to help everyone in the world share, find and understand information about collective human actions, which are referred to as ‘initiatives’. STARDIT is an open access data-sharing system to standardise the way that information about initiatives is reported, including information about which tasks were done by different people. Reports can be updated at all stages, from planning to evaluation, and can report impacts in many languages, using Wikidata. STARDIT is free to use, and data can be submitted by anyone. Report authors can be verified to improve trust and transparency, and data checked for quality. STARDIT can help create high-quality standardised information on initiatives trying to solve complex multidisciplinary global problems. Among its main benefits, STARDIT offers those carrying out research and interventions access to standardised information which enables well-founded comparisons of the effectiveness of different methods. This article outlines progress to date; current usage; information about submitting reports; planned next steps and how anyone can become involved.