Contextualising and challenging under-representation in research in light of Cultural Trauma: a qualitative focus group and interview study.

BACKGROUND: Although underserved populations- including those from ethnic minority communities and those living in poverty-have worse health and poorer healthcare experiences, most primary care research does not fairly reflect these groups. Patient and public involvement (PPI) is usually embedded within research studies in the United Kingdom (UK), but often fails to represent underserved populations. This study worked with patient and public contributors and local community leaders, situated in a socio-economically deprived and ethnically diverse urban area, to explore under-representation in primary healthcare research. METHODS: We undertook a focus group with a purposive sample of 6 members of a Patient and Public Involvement Group (PPIG), and interviews with 4 community leaders (representing Black, South Asian, Roma and socio-economically deprived communities). An iterative analysis process based on template analysis was used. Focus group 1 was rapidly analysed, and a template created. Findings were presented in focus group 2, and the template further developed. The Cultural Trauma concept was than applied to the template to give a wider theoretical lens. In-depth analysis of focus groups and interviews was then performed based on the template. RESULTS: Wider societal and historical influences have degraded trust in academic and healthcare institutions within underserved populations. Along with more practical considerations, trust underpins personal motivations to engage with research. Researchers need to invest time and resources in prolonged, mutually beneficial engagement with communities of importance to their research, including sharing power and influence over research priorities. Researcher reflexivity regarding differential power and cultural competencies are crucial. Utilising participatory methodologies including co-production demonstrates a commitment to inclusive study design. CONCLUSIONS: Re-framing evidence-based medicine to be more useful and relevant to underserved populations with the highest burden of ill health is urgently needed. Lack of representation in primary healthcare research reflects wider societal inequalities, to which Cultural Trauma provides a useful lens. However, there are actions that researchers can take to widen representation. This will ultimately help achieve the goal of increased health equity by enhancing scientific rigour and research generalizability.

THE PROBLEM: People living in poverty, and people from ethnic minority communities may be referred to as 'underserved'. Underserved communities benefit less from health services, and along with other factors, this leads to health inequalities. Primary care research does not include enough people from these communities. This makes the health inequalities  worse. WHAT WE DID: This study looks at why people from underserved communities are not included in research. It also looks at what might help. We had focus group discussions with members of a Patient and Public Involvement Group (PPIG). These are individuals who do not have research expertise, but use their lived experience as patients to influence the research process. This group was formed in 2017, from areas where more people live with social disadvantage. We also interviewed local community leaders. Interviews and focus groups ask open questions, so are a good way to explore what people think about an issue. We found a useful theory about how cultural history affects what people can do. We used this to help us to understand how our findings could improve and widen participation in research within underserved communities. WHAT WE FOUND: We found that trust is very important. There needs to be trust between people and organisations. There are also practical reasons people from underserved communities might not be able to get involved in research. Researchers need to be aware of these things, and work with people from these communities throughout all stages of research. Long term relationships need to develop between institutions and people doing research. Understanding each other's culture and history makes it easier to work together.

Effectiveness of a symptom-clinic intervention delivered by general practitioners with an extended role for people with multiple and persistent physical symptoms in England: the Multiple Symptoms Study 3 pragmatic, multicentre, parallel-group, individually randomised controlled trial.

BACKGROUND: People with multiple and persistent physical symptoms have impaired quality of life and poor experiences of health care. We aimed to evaluate the effectiveness of a community-based symptom-clinic intervention in people with multiple and persistent physical symptoms, hypothesising that this symptoms clinic plus usual care would be superior to usual care only. METHODS: The Multiple Symptoms Study 3 was a pragmatic, multicentre, parallel-group, individually randomised controlled trial conducted in 108 general practices in the UK National Health Service in four regions of England between Dec 6, 2018, and June 30, 2023. Participants were individually randomised (1:1) to the symptom-clinic intervention plus usual care or to usual care only via a computer-generated, pseudo-random list stratified by trial centre. Allocation was done by the trial statistician and concealed with a centralised, web-based randomisation system; masking participants was not possible due to the nature of the intervention. The symptom-clinic intervention was a sequence of up to four medical consultations that aimed to elicit a detailed clinical history, fully hear and validate the participant, offer rational explanations for symptoms, and assist the participant to develop ways of managing their symptoms; it was delivered by general practitioners with an extended role. The primary outcome was Patient Health Questionnaire-15 (PHQ-15) score 52 weeks after randomisation, analysed by intention to treat. The trial is registered on the ISRCTN registry (ISRCTN57050216). FINDINGS: 354 participants were randomly assigned; 178 (50%) were assigned to receive the community-based symptoms clinic plus usual care and 176 (50%) were assigned to receive usual care only. At the primary-outcome point of 52 weeks, PHQ-15 scores were 14·1 (SD 3·7) in the group receiving usual care and 12·2 (4·5) in the group receiving the intervention. The adjusted between-group difference of -1·82 (95% CI -2·67 to -0·97) was statistically significantly in favour of the intervention group (p<0·0001). There were 39 adverse events in the group receiving usual care and 36 adverse events in the group receiving the intervention. There were no statistically significant between-group differences in the proportion of participants who had non-serious adverse events (-0·03, 95% CI -0·11 to 0·05) or serious adverse events (0·02, -0·02 to 0·07). No serious adverse event was deemed to be related to the trial intervention. INTERPRETATION: Our symptom-clinic intervention, which focused on explaining persistent symptoms to participants in order to support self-management, led to sustained improvement in multiple and persistent physical symptoms. FUNDING: UK National Institute for Health and Care Research.

Explanation for symptoms and biographical repair in a clinic for persistent physical symptoms.

Introduction: Biographical disruption describes the process by which illness impacts not just on a person's body and their participation in activities, but also on their sense of self. Biographical disruption is often followed by a process of biographical repair in which identity is reconstructed and a new normality is restored. People with persistent physical symptoms (sometimes referred to as medically unexplained symptoms) experience biographical disruption. This can be complicated by lack of explanation and the implication that if the problem is not medical, then it might be the person/psychological. We aimed to examine this tension in people attending a novel "Symptoms Clinic" for people with persistent physical symptoms. Methods: This study reports an embedded qualitative study in a UK based randomised controlled trial. Data were collected by audio recordings of consultations and semi-structured interviews with patients. We used theoretically informed thematic analysis with regular coding and discussion meetings of the analysis team. This analysis explores the role of intervention components in facilitating biographical repair. Results: The lack of acceptable explanation for persistent symptoms acted as a block to biographical repair. In the clinic, multi-layered explanations were offered and negotiated that viewed persistent symptoms as understandable entities rather than as indicators of something still hidden. These explanations allowed study participants to make sense of their symptoms and in turn opened new opportunities for self-management. The result was that participants were able to reframe their symptoms in a way that enabled them to see themselves differently. Even if symptoms had not yet improved, there was a sense of being better. This can be understood as a process of biographical repair. Conclusion: Explaining persistent physical symptoms enables biographical repair.

Integration of primary care and palliative care services to improve equality and equity at the end-of-life: Findings from realist stakeholder workshops.

BACKGROUND: Inequalities in access to palliative and end of life care are longstanding. Integration of primary and palliative care has the potential to improve equity in the community. Evidence to inform integration is scarce as research that considers integration of primary care and palliative care services is rare. AIM: To address the questions: 'how can inequalities in access to community palliative and end of life care be improved through the integration of primary and palliative care, and what are the benefits?' DESIGN: A theory-driven realist inquiry with two stakeholder workshops to explore how, when and why inequalities can be improved through integration. Realist analysis leading to explanatory context(c)-mechanism(m)-outcome(o) configurations(c) (CMOCs). FINDINGS: A total of 27 participants attended online workshops (July and September 2022): patient and public members (n = 6), commissioners (n = 2), primary care (n = 5) and specialist palliative care professionals (n = 14). Most were White British (n = 22), other ethnicities were Asian (n = 3), Black African (n = 1) and British mixed race (n = 1). Power imbalances and racism hinder people from ethnic minority backgrounds accessing current services. Shared commitment to addressing these across palliative care and primary care is required in integrated partnerships. Partnership functioning depends on trusted relationships and effective communication, enabled by co-location and record sharing. Positive patient experiences provide affirmation for the multi-disciplinary team, grow confidence and drive improvements. CONCLUSIONS: Integration to address inequalities needs recognition of current barriers. Integration grounded in trust, faith and confidence can lead to a cycle of positive patient, carer and professional experience. Prioritising inequalities as whole system concern is required for future service delivery and research.

An evaluation of a public partnership project between academic institutions and young people with Black African, Asian and Caribbean heritage.

BACKGROUND: This project (named Reinvent) aimed to promote Public Involvement (PI) in health research. Academics worked with a community group, the Eloquent Praise & Empowerment Dance Company, to develop a community partnership with young people from Black African, Asian and Caribbean heritage communities. The goal of this paper is to evaluate the Reinvent project for key learnings on how to engage and build partnerships with young people from Black African, Asian and Caribbean heritage communities. METHODS: Reinvent developed a steering group which consisted of five young people, one academic, a Race Equality Ambassador and the Director of Eloquent. The steering group co-produced an agenda for two workshops and the evaluation tools used. The content of the workshops included drama exercises, discussions on physical and mental health, nutrition and school-life, short introductions to the concepts of research and PI, and group work to critique and improve a video currently used to promote PI in health research to young people. The evaluation tools included using the 'Cube' evaluation framework, video-blogging and collecting anonymous feedback. Findings The responses to the 'Cube' evaluation framework were positive across all four domains (agenda, voice, contribute change) in both workshops. A few of the young people described having a better understanding of the meaning and practice of PI in a video-blog. The anonymous feedback suggested that the workshops had increased young people's confidence in sharing their thoughts and opinions about health and PI. CONCLUSION: Reinvent has shown that academic institutions and young people from an under-served community can partner to co-design workshops and apply evaluation tools. Working with young people in an environment in which they were comfortable, and by researchers joining in with the activities that the young people enjoyed (such as dance), enabled more informal and open conversations to develop. More work is needed to build upon this project so that young people can feel confident and supported to get involved in PI activities relating to research.

Identifying Preferred Features of Weight Loss Programs for Adults With or at Risk of Type 2 Diabetes: A Discrete Choice Experiment With 3,960 Adults in the U.K.

OBJECTIVE: To understand preferences for features of weight loss programs among adults with or at risk of type 2 diabetes in the U.K. RESEARCH DESIGN AND METHODS: We conducted a discrete choice experiment with 3,960 U.K. adults living with overweight (n = 675 with type 2 diabetes). Preferences for seven characteristics of weight loss programs were analyzed. Simulations from choice models using the experimental data predicted uptake of available weight loss programs. Patient groups comprising those who have experience with weight loss programs, including from minority communities, informed the experimental design. RESULTS: Preferences did not differ between individuals with and without type 2 diabetes. Preferences were strongest for type of diet. Healthy eating was most preferred relative to total diet replacement (odds ratio [OR] 2.24; 95% CI 2.04-2.44). Individual interventions were more popular than group interventions (OR 1.40; 95% CI 1.34-1.47). Participants preferred programs offering weight loss of 10-15 kg (OR 1.37; 95% CI 1.28-1.47) to those offering loss of 2-4 kg. Online content was preferred over in-person contact (OR 1.24; 95% CI 1.18-1.30). There were few differences in preferences by gender or ethnicity, although weight loss was more important to women than to men, and individuals from ethnic minority populations identified more with programs where others shared their characteristics. Modeling suggested that tailoring programs to individual preferences could increase participation by ∼17 percentage points (68% in relative terms). CONCLUSIONS: Offering a range of weight loss programs targeting the preferred attributes of different patient groups could potentially encourage more people to participate in weight loss programs and support those living with overweight to reduce their weight.

A framework for more equitable, diverse, and inclusive Patient and Public Involvement for palliative care research.

BACKGROUND: There are marked inequalities in palliative care provision. Research is needed to understand how such inequalities can be addressed, so that everyone living with advanced illness can receive the care they need, when they need it. Research into inequalities in palliative care should be guided by Patient and Public Involvement (PPI) that includes people from diverse backgrounds, who are less likely to receive specialist services. Multi-disciplinary research partnerships, bringing together primary care (the main providers of palliative care to diverse communities) and specialist palliative care, have the potential to work together in new ways to do research to address inequalities and improve palliative care in practice. This report describes a research partnership between primary care and palliative care that aimed to: (1) create opportunities for more inclusive PPI in palliative care research, (2) co-design new resources to support more equitable, diverse and inclusive PPI for palliative care, (3) propose a new framework for inclusive PPI in palliative care research. METHODS: PPI members were recruited via primary care and palliative care research networks from three diverse areas of the UK. A pragmatic, collaborative approach was taken to achieve the partnership aims. Online workshops were carried out to understand barriers to inclusive PPI in palliative care and to co-design resources. Evaluation included a "you said, we did" impact log and a short survey. The approach was informed by good practice principles from previous PPI, and existing theory relating to equity, equality, diversity, and inclusion. RESULTS: In total, 16 PPI members were recruited. Most were White British (n = 10), other ethnicities were Asian (n = 4), Black African (n = 1) and British mixed race (n = 1). The research team co-ordinated communication and activities, leading to honest conversations about barriers to inclusive PPI. Resources were co-designed, including a role description for an Equity, Equality, Diversity and Inclusion Champion, a "jargon buster", an animation and an online recipe book ( http://www.re-equipp.co.uk/ ) to inform future PPI. Learning from the partnership has been collated into a new framework to inform more inclusive PPI for future palliative care research. CONCLUSION: Collaboration and reciprocal learning across a multi-disciplinary primary care and palliative care research partnership led to the development of new approaches and resources. Research team commitment, shared vision, adequate resource, careful planning, relationship building and evaluation should underpin approaches to increase equality, diversity and inclusivity in future PPI for palliative care research.

Research is needed to understand how inequalities in palliative care can be addressed, so that everyone living with advanced illness can receive the care they need. Research into inequalities in palliative care should be guided by Patient and Public Involvement (PPI) that includes people from diverse backgrounds, who are less likely to receive specialist palliative care. Primary care services are grounded in the community they serve and can be the main providers of palliative care, but this is rarely the focus of research. Primary care and palliative care researchers can work together in new ways to do research to address inequalities and improve palliative care in practice. This paper describes the work of the RE-EQUIPP (REducing inEQUalities through Integration of Primary and Palliative Care) Care Partnership. The partnership involved researchers from primary care and palliative care working with people with lived experience of serious illness as patient or carer from three diverse areas of the United Kingdom: (1) London, (2) inner-city Sheffield and (3) Worthing in Sussex, a rural, coastal setting. The project provided opportunity to develop new ways of working and resources for more inclusive and equitable PPI for future palliative care research. Sixteen PPI members from diverse backgrounds and with a range of experience joined the partnership. Workshops were held to understand the barriers to inclusive PPI. New roles and resources were developed, including an Equity, Equality, Diversity and Inclusion Champion role, a "jargon buster", an animation, and an online recipe book to inform future PPI. Learning from the partnership was used to develop a new framework, which is presented to inform inclusive PPI for palliative care research in the future. This outlines the need for research team commitment and shared vision, adequate resource, careful planning, relationship building and evaluation.

Recognition, explanation, action, learning: Teaching and delivery of a consultation model for persistent physical symptoms.

OBJECTIVE: To describe the teaching and delivery of an extended consultation model designed for clinicians to use with patients with persistent physical symptoms and functional disorders. The model is underpinned by current scientific knowledge about persistent physical symptoms and the communication problems that arise in dealing with them. METHODS: Process evaluation of training and delivery of the Recognition, Explanation, Action, Learning (REAL) model within the Multiple Symptoms Study 3: a randomised controlled trial of an extended-role GP "Symptoms Clinic". Evaluation used clinician and patient interviews and consultation transcripts. RESULTS: 7 GPs were trained in the intervention and 6 of them went on to deliver the REAL model in Symptoms Clinics either face-to-face or online. The Symptoms Clinic provided a set of 4 extended consultations to approximately 170 patients. Evaluation of training indicated that there was a considerable load in terms of new knowledge and skills. Evaluation of delivery found clinicians could adapt the model to individual patients while maintaining a high level of fidelity to its core components. CONCLUSION: REAL is a teachable consultation model addressing specific clinical communication issues for people with persistent physical symptoms. PRACTICE IMPLICATIONS: REAL enables clinicians to explain persistent physical symptoms in a beneficial way.

A qualitative study exploring the effect of communicating with partially intelligible speech.

Few studies have investigated how individuals with partially intelligible speech choose to communicate, including how, when, and why they might use a speech-generating device (SGD). This study aimed to add to the literature by exploring how this group of individuals use different communication strategies. Qualitative interviews were carried out with 10 participants with partially intelligible speech with the aim of investigating participants' perceptions of modes of communication and communication strategies. Transcripts were analyzed using Framework Analysis to investigate the role of SGDs alongside other communication strategies. Factors that influence why, when, and how a person chooses to communicate were identified and these were interpreted as an explanatory model of communication with partially intelligible speech. Participants described how they made the decision whether to attempt to communicate at all and then which communication method to use. Decision-making was influenced by the importance of the message, how much time is available, past experience, and the communication partner. Each communication attempt adds to an individuals' experience of communicating and influences subsequent decisions. This study suggests that individuals with partially intelligible speech are at risk of reduced communication environments and networks and that current SGDs may not be designed in a way that recognizes their particular needs.

Study protocol for the Multiple Symptoms Study 3: a pragmatic, randomised controlled trial of a clinic for patients with persistent (medically unexplained) physical symptoms.

INTRODUCTION: Persistent physical symptoms (which cannot be adequately attributed to physical disease) affect around 1 million people (2% of adults) in the UK. They affect patients' quality of life and account for at least one third of referrals from General Practitioners (GPs) to specialists. These referrals give patients little benefit but have a real cost to health services time and diagnostic resources. The symptoms clinic has been designed to help people make sense of persistent physical symptoms (especially if medical tests have been negative) and to reduce the impact of symptoms on daily life. METHODS AND ANALYSIS: This pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of the symptoms clinic intervention plus usual care compared with usual care alone. Patients were identified through GP searches and mail-outs and recruited by the central research team. 354 participants were recruited and individually randomised (1:1). The primary outcome is the self-reported Physical Health Questionnaire-15 at 52 weeks postrandomisation. Secondary outcome measures include the EuroQol 5 dimension 5 level and healthcare resource use. Outcome measures will also be collected at 13 and 26 weeks postrandomisation. A process evaluation will be conducted including consultation content analysis and interviews with participants and key stakeholders. ETHICS AND DISSEMINATION: Ethics approval has been obtained via Greater Manchester Central Research Ethics Committee (Reference 18/NW/0422). The results of the trial will be submitted for publication in peer-reviewed journals, presented at relevant conferences and disseminated to trial participants and patient interest groups. TRIAL REGISTRATION NUMBER: ISRCTN57050216.

Rehabilitation of older patients: day hospital compared with rehabilitation at home. Clinical outcomes.

OBJECTIVES: to test the hypothesis that older people and their informal carers are not disadvantaged by home-based rehabilitation (HBR) relative to day hospital rehabilitation (DHR). DESIGN: pragmatic randomised controlled trial. SETTING: four geriatric day hospitals and four home rehabilitation teams in England. PARTICIPANTS: eighty-nine patients referred for multidisciplinary rehabilitation. The target sample size was 460. INTERVENTION: multidisciplinary rehabilitation either in the home or in the day hospital. MEASUREMENTS: the primary outcome measure was the Nottingham extended activities of daily living scale (NEADL). Secondary outcome measures included EQ-5D, hospital anxiety and depression scale, therapy outcome measures, hospital admissions and the General Health Questionnaire for carers. RESULTS: at the primary end point of 6 months NEADL scores were not significantly in favour of HBR cf. DHR; mean difference -2.139 (95% confidence interval -6.87 to 2.59, P = 0.37). A post hoc analysis suggested non-inferiority for HBR for NEADL but there was considerable statistical uncertainty. CONCLUSION: taken together the statistical analyses and lack of power of the trial outcomes do not provide sufficient evidence to conclude that patients in receipt of HBR are disadvantaged compared with those receiving DHR.

The clients' perspective on change during treatment for an alcohol problem: qualitative analysis of follow-up interviews in the UK Alcohol Treatment Trial.

AIM: To develop a model of change during and following professional treatment for drinking problems, grounded in clients' accounts. PARTICIPANTS: Subsets of consecutively selected clients of the UK Alcohol Treatment Trial (UKATT), followed-up at 3 months (n = 211) and 12 months (n = 198) after randomization. Location Five statutory and non-statutory alcohol problems treatment agencies in three areas of England and Wales. Data Open-ended interviews conducted according to a brief interview guide, leading to 400-800-word post-interview reports used for analysis (tape-recordings used for auditing purposes). ANALYSIS: Reports analysed by a team according to grounded theory principles, involving an iterative process with successive refinement of interviewing and analysis with each successive batch of data. FINDINGS: A model of change from the clients' perspective was developed. Treatment was seen by clients as facilitating various changes in ways of thinking and/or increased support of various kinds from family and friends, along with new ways of acting in relation to drinking or more generally. For many those changes had led to an appreciation of the benefits accruing to them. Treatment was seen as part of a broader treatment system which included pretreatment assessment, forms of help additional to the trial treatment, plus an element of self-directed change during and following treatment. Taken with awareness of worsening alcohol-related harms, triggering events and external influence to seek treatment (the catalyst system), to which clients continued to refer following treatment, the change process is depicted as a complex, ongoing set of systems in which a trial treatment is embedded. CONCLUSIONS: Models of change should be broadened so that treatment is seen as a complex system of parts, facilitating a nexus of cognitive, social and behavioural changes, embedded within a broader system of events and processes catalysing change. Such a model helps explain the relative absence of between-treatments outcome differences in UKATT and in the alcohol problems treatment and more general psychotherapy research literatures.