Understanding the inclusion and participation of adults from Black African Diaspora Communities (BAFDC) in health and care research in the UK: a realist review protocol.

INTRODUCTION: People from Black African Diaspora Communities (BAFDC) experience poorer health outcomes, have many long-term conditions and are persistently under-represented in health and care research. There is limited focus on programmes, or interventions that support inclusion and participation of people from BAFDC in research. Through coproduction, this realist review seeks to provide a programme theory explaining what context and mechanisms may be required, to produce outcomes that facilitate inclusion and participation for people from BAFDC in health and care research, in the UK. METHODS AND ANALYSIS: A group of people from BAFDC with lived and professional experience, representing all levels of the health and care research system, will coproduce a realist review with a team of African-Caribbean, white British and white British of Polish origin health and care researchers. They will follow Pawson's five steps: (1) shaping the scope of the review; (2) searching for evidence; (3) document selection and appraisal; (4) data extraction and (5) data synthesis. The coproduction group will help to map the current landscape, identifying key issues that may inhibit or facilitate inclusion. Data will be extracted, analysed and synthesised following realist logic analysis, identifying and explaining how context and mechanisms are conceptualised in the literature and the types of contextual factors that exist and impact on inclusion and participation. Findings will be reported in accordance with Realist and Meta-narrative Evidence Synthesis Evolving Standards . ETHICS AND DISSEMINATION: The coproduction group will agree an ethical approach considering accountability, responsibility and power dynamics, by establishing a terms of reference, taking a reflexive approach and coproducing an ethical framework. Findings will be disseminated to BAFDC and the research community through arts-based methods, peer-reviewed publications and conference presentations, agreeing a coproduced strategy for dissemination. Ethical review is not required. PROSPERO REGISTRATION NUMBER: CRD42024517124.

Co-producing an online patient public community research hub: a qualitative study exploring the perspectives of national institute for health research (NIHR) research champions in England.

BACKGROUND: Patient and Public Involvement and Engagement (PPIE) should be embedded as part of researchers' everyday practice. However, this can be challenging. Creating a digital presence for PPIE as part of Higher Education Institutes' (HEIs) infrastructure may be one way of supporting this. This can support how information is made available to patients and members of the public, but relatively little is known about how HEIs can best do this. Our aim was to develop a university website for patients and members of the public to learn about ways to get actively involved in research and be able to access the results of health and social care research. METHODS: This project involved working as partners with five National Institute for Health and Care Research (NIHR) Research Champions. NIHR Research Champions are volunteers who raise awareness and share experiences about health and social care research. Content of a prototype Patient Public Community Research Hub website was co-produced with the Research Champions, and then 15 NIHR Research Champions from across England were asked for their views about the website. FINDINGS: The information collected told us that the Patient Public Community Research Hub was viewed as being beneficial for increasing visibility of PPIE opportunities and sharing the findings of studies though needs further work: to make the information more user-friendly; to improve the methods for directing people to the site and to create new ways of connecting with people. It provides a foundation for further co-development and evaluation. A set of recommendations has been developed that may be of benefit to other HEIs and organisations who are committed to working with patients and members of the public.

Sharing the results of health and care research studies with patients and members of the public could be improved. In many cases, patients and members of the public do not receive the results of studies they have taken part in. As well, it should also be easy for patients and members of the public to find out about opportunities to get involved with researchers in the development of their research. Universities have an important role to play in providing opportunities for patients and members of the public to be involved in the development of research studies, as well as sharing the findings of their studies. Creating an online patient public community research hub for this purpose was co-produced with National Institute for Health and Care Research (NIHR) Research Champions. The aims of this research were to find out what research volunteers within the National Institute for Health Research (NIHR), in the UK, would like to find on a university website about health and care research. This research aimed to understand how best to raise awareness about how people can get involved in research. It also aimed to understand how best to share information about research, with patients and members of the public, from a university website. Five NIHR Research Champions from diverse ethnic and cultural backgrounds (including younger and older people) helped to develop a set of webpages on a university website, called the Patient Public Community Research Hub. Once the initial online hub was created, online interviews were held with another 15 NIHR Research Champions. The interviews were to help the researcher to understand what they thought about the Patient Public Community Research Hub. The results from the interviews were analysed and grouped into themes. The themes helped to tell us what NIHR Research Champions felt patients and members of the public would want to see on the Patient Public Community Research Hub and what areas needed improving. A co-produced set of recommendations was created with the NIHR Research Champions who helped to shape the Patient Public Community Research Hub. The recommendations are for researchers, other organisations, or services to use. These recommendations along with the findings may help to improve how information gets shared about the results of research and ways in which patients and members of the public can get involved.

Factors influencing decisions about whether to participate in health research by people of diverse ethnic and cultural backgrounds: a realist review.

OBJECTIVE: To develop and refine a programme theory that explains factors that influence decisions to take part in health research by people of diverse ethnic and cultural backgrounds. DESIGN: Realist review following a sequence of five steps: (a) scoping search and identification of programme theory; (b) evidence searching; (c) critical appraisal and data extraction; (d) organisation of evidence and (e) refinement of programme theory. ELIGIBILITY CRITERIA: Documents (including peer-reviewed articles, grey literature, websites, reports and conference papers) either full text, or a section of relevance to the overarching research question were included. DATA SOURCES: EMBASE, Medline, Web of Science, Psych Info, Google and Google Scholar were searched iteratively between May and August 2020. Search strategy was refined for each database providing a broad enough review for building of programme theory. ANALYSIS: Data from eligible documents was extracted to build understanding of the factors that influence decision-making. Data were mapped to create a data matrix according to context (C), mechanism (M), outcome (O), configurations (C) (CMOCs) for the process of informed consent, to aid interpretation and produce final programme theory. RESULTS: 566 documents were screened and 71 included. Final programme theory was underpinned by CMOCs on processes influencing decisions to take part in research. Key findings indicate the type of infrastructure required, for example, resources, services and policies, to support inclusion in health research, with a greater need to increase the social presence of researchers within communities, improve cultural competency of individuals and organisations, reduce the complexity of participant information, and provide additional resources to support adaptive processes and shared decision making. CONCLUSION: The review indicates the need for a more inclusive research infrastructure that facilitates diverse participation in health research through incorporating adaptive processes that support shared decision making within the informed consent process and in the conduct of research projects.

The informed consent process in health research with under-served populations: a realist review protocol.

BACKGROUND: The informed consent process aims to provide potential participants with information about health research that enables them to make an informed decision as to whether they choose to participate, or not. However, it remains unclear as to whether the process is effective for those who are under-served in health research. It is a pivotal issue within health research that the diversity of people who participate is broadened. The National Institute for Health Research (NIHR) pledges to support equality, diversity and inclusion, actively creating opportunities for all citizens whom are eligible, to take part in health research. METHODS: In order to understand how the informed consent process for under-served populations in health research works, under what circumstances and in what respects, a realist review approach will be undertaken. Searches will be carried out using electronic databases (EMBASE, MEDLINE, Web of Science and PsycINFO), along with selected websites and grey literature. Development of initial rough programme theory(ies) will lead to a more refined programme theory that will provide an explanation of context, mechanism and outcomes. Stakeholder involvement by NIHR (Public) Research Champions, health professionals and clinical academics will provide expert opinion about concepts and programme theory. DISCUSSION: Findings of this realist review will highlight how the informed consent process in health research affects the experience and decision-making process of potential participants from under-served populations. They will be written up in accordance with RAMESES guidelines and disseminated to patients and the public, health researchers, health professionals and policymakers through peer-reviewed publication, presentations and discussions. The review will contribute to our understanding of the mechanisms that cause both positive and negative outcomes in the informed consent process for those whom are often under-represented in health research to inform policy, study design and delivery.

Development and validation of a telephone classification interview for common chronic headache disorders.

BACKGROUND: For a trial of supportive self-management for people with chronic headache we needed to develop and validate a telephone classification interview that can be used by a non-headache specialist to classify common chronic headache types in primary care. We aimed to specifically: exclude secondary headaches other than medication overuse, exclude primary headache disorders other than migraine and tension type headache (TTH), distinguish between chronic migraine and chronic TTH, and identify medication overuse headache. METHODS: We held a headache classification consensus conference to draw on evidence and expertise to inform the content of a logic model underpinning the classification interview. Nurses trained to use the logic model did telephone classification interviews with participants recruited from primary care. Doctors specialising in headache did a second validation interview. RESULTS: Twenty-six delegates attended the headache classification conference including headache specialist doctors, nurses and lay representatives (with chronic headache). We trained six nurses to do the classification interviews and completed 107 paired interviews, median days between interviews was 32 days (interquartile range 21-48 days). We measured level of agreement between the nurse and doctor interviews using proportion of concordance, simple kappa and prevalence-adjusted bias-adjusted kappa (PABAK). Proportion of concordance of agreement between nurse and doctor interviews was 0.76, simple kappa coefficient κ 0.31 (95% CI, 0.09 to 0.52), and PABAK 0.51 (95% CI, 0.35 to 0.68), a moderate agreement. In a sensitivity test following review of headache characteristics recorded, concordance was 0.91, κ = 0.53 (95% CI, 0.28 to 0.79), and PABAK = 0.81 (95% CI, 0.70 to 0.92), a very good agreement. CONCLUSION: We developed and validated a new evidence-based telephone classification interview that can be used by a non-headache specialist to classify common chronic headache types in primary care.