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BackgroundThe 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 analysisThis 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 disseminationEthical 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.

BackgroundFor 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.MethodsWe 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.ResultsTwenty-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.ConclusionWe 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.

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 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.

IntroductionPeople 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 analysisA 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 disseminationThe 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 numberCRD42024517124.

ObjectiveTo 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.DesignRealist 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 criteriaDocuments (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 sourcesEMBASE, 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.AnalysisData 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.Results566 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.ConclusionThe 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.

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. Plain language summary 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.

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) 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. This 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. A 24-month, multicenter, pragmatic, open-label, 2-arm, parallel-group, individually randomized group treatment trial will be conducted, with primary end point (glycated hemoglobin [HbA ]) 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). HbA , 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. Funding 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. The 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. ISRCTN 1434448; https://www.isrctn.com/ISRCTN14344948. DERR1-10.2196/71861.

Studies evaluating titration of antihypertensive medication using self-monitoring give contradictory findings and the precise place of telemonitoring over self-monitoring alone is unclear. The TASMINH4 trial aimed to assess the efficacy of self-monitored blood pressure, with or without telemonitoring, for antihypertensive titration in primary care, compared with usual care. This study was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group). Randomisation was by a secure web-based system. Neither participants nor investigators were masked to group assignment. The primary outcome was clinic measured systolic blood pressure at 12 months from randomisation. Primary analysis was of available cases. The trial is registered with ISRCTN, number ISRCTN 83571366. 1182 participants were randomly assigned to the self-monitoring group (n=395), the telemonitoring group (n=393), or the usual care group (n=394), of whom 1003 (85%) were included in the primary analysis. After 12 months, systolic blood pressure was lower in both intervention groups compared with usual care (self-monitoring, 137·0 [SD 16·7] mm Hg and telemonitoring, 136·0 [16·1] mm Hg vs usual care, 140·4 [16·5]; adjusted mean differences vs usual care: self-monitoring alone, −3·5 mm Hg [95% CI −5·8 to −1·2]; telemonitoring, −4·7 mm Hg [–7·0 to −2·4]). No difference between the self-monitoring and telemonitoring groups was recorded (adjusted mean difference −1·2 mm Hg [95% CI −3·5 to 1·2]). Results were similar in sensitivity analyses including multiple imputation. Adverse events were similar between all three groups. Self-monitoring, with or without telemonitoring, when used by general practitioners to titrate antihypertensive medication in individuals with poorly controlled blood pressure, leads to significantly lower blood pressure than titration guided by clinic readings. With most general practitioners and many patients using self-monitoring, it could become the cornerstone of hypertension management in primary care. National Institute for Health Research via Programme Grant for Applied Health Research (RP-PG-1209-10051), Professorship to RJM (NIHR-RP-R2-12-015), Oxford Collaboration for Leadership in Applied Health Research and Care, and Omron Healthcare UK.