BACKGROUND:People from Black African Diaspora Communities (BAFDC) experience poorer health outcomes and are persistently under-represented in health and care research. There is limited understanding about how to support their greater inclusion and participation. OBJECTIVES:Explore secondary data providing insights for the co-development of a realist theory of inclusion and participation for people from BAFDC in health and care research in the United Kingdom. Drawing on these theories, co-produce a realist review with a diverse range of people from BAFDC. METHODS:A realist approach underpinned the study. Pawson's five steps to a realist approach were taken to shape the review, identify relevant sources, extract the data and then analyse and synthesise to inform an overarching programme theory. Initial programme theories (IPTs) were developed through context (C), mechanism (M), outcome (O) configurations (CMOCs). MAIN RESULTS:The review identified 43 relevant documents. Synthesis of evidence from the documents resulted in 8 IPTs and 17 CMOCs helping to understand and explain the inclusion and participation of people from BAFDC. Four key thematic clusters emerged: (1) Health and care research as a White space, (2) Trust deficit: the expansiveness of broken trust, (3) Implicit and complicit bias and (4) Processes that affect inclusion and participation. Findings were underpinned by five existing mid-range theories (MRTs) around central concepts of candidacy, social dominance, networks, narratives and racism that guided analysis and synthesis, supporting conceptualisation of CMOCs. An overarching programme theory was developed. CONCLUSION:The review identifies how the influence of perspectives, attitudes and beliefs held by individuals or groups about people from BAFDC operates in health and care research, resulting in exclusion, lack of trust and deficit thinking. The findings should be used to inform interventions aimed at increasing inclusion and participation of people from BAFDC. PATIENT OR PUBLIC CONTRIBUTION:The co-production group comprised a diverse range of individuals from within the health and care research system with different lived experiences of being Black. They contributed to the entire review process, including the development of initial programme theories and retroductive thinking and interpretation of the evidence. CLINICAL TRIAL REGISTRATION:Not applicable.

Background The work of receptionists in general practice is evolving rapidly and becoming more complex due to a number of changes within primary and community care services, such as increased digitalisation. In under-served areas, these changes have been further complicated by under-resourcing and workforce challenges around staff recruitment and retention. The National Health Service (NHS) 10-year health plan is set to accelerate further significant changes. There is limited understanding about how and why these changes and workforce challenges are impacting and will impact the future work of receptionists in general practice in under-served areas.Methods and analysis This realist review will build on an existing programme theory related to general practitioner workforce sustainability. The review will examine what works, for whom, how and under what circumstances for receptionist work in general practice, in under-served areas. For example, how influences such as the expectations of patients (in under-served communities), poor staffing or limited career progression. Key stakeholders, including public contributors and individuals from general practice settings, will inform the realist review.The review will be conducted using existing secondary and grey literature sources. The search strategy comprises five electronic databases: Medline, Embase, PsycINFO, CINAHL and Web of Science Core Collection (SCIE, SSCI, AHCI) with a date limit of 2015 applied to the search. The review 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 findings will be reported in accordance with the Realist and Meta-narrative Evidence Synthesis Evolving Standards.Ethics and dissemination Ethical approval is not needed for secondary analysis. The findings of this review will contribute to ongoing work as part of our ‘Workforce Voices’ programme of research. They will be disseminated to policymakers, commissioners, providers of health and social care and primary care and community healthcare teams through peer-reviewed publications, members of the public, conference presentations, social media and recommendations.

BackgroundPeople of Black African and Black Caribbean ethnicity experience higher rates and poorer outcomes of type 2 diabetes (T2D) than people of White European ethnicity; these inequalities are compounded by poor healthcare access. Cultural tailoring of diabetes self-management education and support (DSMES) programs has the potential to improve healthcare engagement and clinical outcomes for ethnic minority groups. Healthy Eating & Active Lifestyles for Diabetes (HEAL-D) is a co-designed, culturally tailored group-based DSMES program for adults of Black African and Black Caribbean ethnicity. ObjectiveThis trial aims to evaluate the clinical and cost effectiveness of the HEAL-D intervention, compared to standard DSMES programs, in Black African and Black Caribbean adults living with T2D. MethodsA 24-month, multicenter, pragmatic, open-label, 2-arm, parallel-group, individually randomized group treatment trial will be conducted, with primary end point (glycated hemoglobin [HbA1c]) assessment at 12 months. Black African and Black Caribbean adults with T2D (n=300), recruited from 3 to 5 centers in the United Kingdom (including London, West Midlands, and Greater Manchester), will be randomized in a 1:1 ratio to HEAL-D (intervention) or a standard DSMES program (control). HbA1c, blood lipids, anthropometric outcomes, blood pressure, physical activity, and patient-reported outcome measures relating to psychological well-being and self-management support, lifestyle behaviors, and health economics will be collected at baseline and follow-up visits (6, 12, and 24 months). Cost-effectiveness will be assessed through a cost-utility analysis conducted from a health and social care perspective. A mixed methods process evaluation will provide a formative evaluation of delivery, intervention fidelity, and implementation of HEAL-D, and an embedded study within a project will assess the impact of multiple long-term conditions on uptake of, and engagement with HEAL-D, and the impact of HEAL-D on multiple long-term conditions. The trial received Research Authority and Research Ethics Council approval on April 22, 2024. ResultsFunding began in August 2023. Site “green light” was received on August 15, 2024, for London; November 29, 2024, for Manchester; and January 31, 2025, for the West Midlands. Recruitment commenced in August 2024 and is due to run for 11 months. As of March 26, 2025, a total of 76 participants have consented. Last patient, last visit is expected in June 2027; primary data analysis is expected to begin in July 2027. Final results are anticipated to be available in September 2027, and publication is expected by the end of 2027. ConclusionsThe HEAL-D trial will address whether a culturally tailored DSMES program, provided in-person or via videoconferencing, is clinically and cost-effective compared to standard DSMES at improving diabetes management in Black African and Black Caribbean adults. If effective, this would provide an evidence-based model of equitable DSMES services and improve the implementation of healthcare programs for ethnic minority groups. Trial RegistrationISRCTN 1434448; https://www.isrctn.com/ISRCTN14344948 International Registered Report Identifier (IRRID)DERR1-10.2196/71861

People of black African and black Caribbean ethnicity experience higher rates and poorer outcomes of type 2 diabetes (T2D) than people of white European ethnicity; these inequalities are compounded by poor healthcare access. Cultural tailoring of diabetes self-management education and support (DSMES) programmes has the potential to improve healthcare engagement and clinical outcomes for minority ethnic groups. Healthy Eating & Active Lifestyles for Diabetes (HEAL-D) is a co-designed culturally tailored DSMES programme for adults of black African and black Caribbean ethnicity. HEAL-D provides group-based education, behaviour change support and participatory physical activity sessions, delivered either face-to-face (F2F) or online. Initial assessments of HEAL-D have demonstrated patient acceptability, but the clinical and cost effectiveness of HEAL-D have yet to be examined. To evaluate the effectiveness of the HEAL-D intervention, compared to standard DSMES programmes, on glycaemic control (assessed via HbA1c) at 12-months in black African and black Caribbean adults living with T2D. A 24-month, multi-centre, open-label, 2-arm, parallel-group, individually randomised group treatment trial will be conducted, with primary endpoint (HbA1c) assessment at 12-months. Black African and black Caribbean adults with T2D (n=300), recruited from 3-5 centres in the UK (including London, West Midlands and Greater Manchester), will be randomised in a 1:1 ratio to HEAL-D (intervention) or a standard DSMES programme (control). Baseline and follow-up visits (6, 12 and 24-months) will involve collection/measurement of HbA1c, blood lipids, anthropometric outcomes, blood pressure, physical activity, and patient reported outcome measures relating to psychological wellbeing and self-management support, lifestyle behaviours, and health economics. An internal feasibility assessment of recruitment, allocation and treatment engagement will occur in the first 6 months. Cost-effectiveness will be assessed through a cost-utility analysis conducted from a health and social care perspective. A mixed methods process evaluation will provide a formative evaluation of delivery, intervention fidelity and implementation of HEAL-D, and an embedded study within a project (SWAP) will assess the impact of multiple long-term conditions (MLTC) on uptake of HEAL-D, engagement with HEAL-D, and the impact of HEAL-D on MLTC. The trial received Health Research Authority approval on 22 April 2024. Site ‘green light’ was received on 15 August 2024 for London and 29 November 2024 for Manchester; approvals in the West Midlands are expected January 2025. Recruitment commenced in August 2024 and is due to complete by May 2025. As of 28 January 2025, 36 participants have consented. Last patient, last visit is expected in June 2027; final results are anticipated to be available in September 2027, and publication is expected by the end of 2027. The HEAL-D trial will address whether a culturally tailored DSMES programme, provided in-person or online, is clinically and cost-effective compared to standard DSMES at improving diabetes management in black African and black Caribbean adults. If effective, this would provide an evidence-based model of equitable DSMES services and improve the implementation of healthcare programmes for minority ethnic groups. ISCRTN 45319 (24/05/2024).

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.

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 HEI’s and organisations who are committed to working with patients and members of the public.

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Background COVID-19 has led to rapid changes in healthcare delivery, raising concern that these changes may exacerbate existing inequalities in patient outcomes. Aim To understand how patients’ help-seeking experiences in primary care for colorectal cancer symptoms during COVID-19 were affected by their socioeconomic status (SES). Design and setting Qualitative semi-structured interviews with males and females across the UK, recruited using purposive sampling by SES. Method Interviews were carried out with 39 participants (20 higher SES; 19 lower SES) who contacted primary care about possible symptoms of colorectal cancer during COVID-19. Data were analysed using framework analysis followed by comparative thematic analysis to explore differences between groups. Results Three themes were identified with differences between SES groups: 1) how people decided to seek medical help through appraisal of symptoms; 2) how people navigated services; and 3) impact of COVID-19 on how patients interacted with healthcare professionals. The lower SES group expressed uncertainty appraising symptoms and navigating services (in terms of new processes resulting from COVID-19 and worries about infection). There was also potential for increased disparity in diagnosis and management, with other methods of getting in touch (for example, email or 111) taken up more readily by higher SES patients. Conclusion The findings suggest that COVID-19 exacerbated disparities between higher and lower SES participants. This study raises awareness around challenges in help seeking in the context of the pandemic, which are likely to persist (post-COVID-19) as healthcare systems settle on new models of care (for example, digital). Recommendations are provided to reduce inequalities of care.

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.

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.