Stopping anticoagulation for isolated or incidental pulmonary embolism: the STOPAPE RCT protocol.

Research question: Is withholding anticoagulation for patients with isolated or incidental subsegmental pulmonary embolism clinically and cost-effective compared with full anticoagulation for 3 months? Background: There has been an increase in the diagnosis of subsegmental pulmonary embolism since the advent of computed tomography pulmonary angiogram to investigate patients with suspected pulmonary embolism. Subsegmental pulmonary embolism is not often detectable with older nuclear medicine-based diagnostic imaging for ventilation/perfusion mismatch. The case fatality of pulmonary embolism has reduced as subsegmental pulmonary embolism diagnoses from computed tomography pulmonary angiogram have increased. There is growing equipoise about the optimal treatment for patients with subsegmental pulmonary embolism, given that full anticoagulation has significant risks of bleeding and subsegmental pulmonary embolism was not often diagnosed previously with ventilation/perfusion scanning and therefore most likely left predominantly untreated prior to the introduction of computed tomography pulmonary angiogram scanning. Objectives: Determine whether withholding anticoagulation for isolated or incidental subsegmental pulmonary embolism (i.e. subsegmental pulmonary embolism with no coexisting deep-vein thrombosis) reduces the harms of recurrent thromboembolism and major bleeding compared with 3 months of full anticoagulation at 3, 6 and 12 months. Determine the rate of complications of anticoagulation therapy (predominantly bleeding) in patients with isolated subsegmental pulmonary embolism. Determine whether not treating isolated subsegmental pulmonary embolism is acceptable to clinicians and patients. Determine the reclassification rate of subsegmental pulmonary embolism diagnoses made by general reporting radiologists when reviewed by specialist respiratory radiologists and develop a set of rules to improve general radiologists' diagnoses of subsegmental pulmonary embolism. Assess cost-effectiveness of not treating patients with isolated subsegmental pulmonary embolism with anticoagulation, taking a health service perspective. Methods: Prospective individually randomised open controlled trial with blinded end-point committee assessment for outcomes, powered for non-inferiority for recurrent venous thromboembolism and for superiority for bleeding events. An internal pilot phase is included for feasibility and acceptability of no anticoagulation. We planned to recruit 1466 patients from at least 50 acute hospital sites. Allowing for a dropout rate of 15%, this would have given us 90% power to detect a reduction in major and clinically relevant non-major bleeding from 7.3% in the anticoagulation arm to 3% in the intervention arm. We were powered to determine that a strategy of no anticoagulation was non-inferior to anticoagulation with an upper margin of a 2.3% increase in recurrent venous thromboembolism from an expected rate of 2% in those who receive full anticoagulation. We also planned to undertake a study comparing acute reporting radiologists' diagnoses of subsegmental pulmonary embolism from all computed tomography pulmonary angiograms with specialist respiratory radiologists. This would have allowed us to determine safety in the pilot study (i.e. patients with pulmonary embolism that was in fact larger than subsegmental would have been identified) and develop guidance for subsegmental pulmonary embolism diagnosis for general radiologists. Patients with lived experience of thrombosis contributed to all aspects of the trial design and were part of the Trial Management Group. Progress of study: The STOPAPE trial was stopped prematurely due to a low recruitment rate in the wake of the COVID pandemic and prioritisation of recovery of the National Institute for Health and Care Research research portfolio. There are no outcome data available for this trial. Separate NIHR Library publications will detail the linked qualitative study examining the views of patients and clinicians around withholding anticoagulation for isolated subsegmental pulmonary embolism as well as presenting all collected data of recruited patients. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR128073. A plain language summary of this research article is available on the NIHR Journals Library Website https://doi.org/10.3310/HRCW7937.

Pulmonary embolism is a potentially serious condition, whereby blood clots cause a blockage of the blood supply to the lungs. The diagnosis of pulmonary embolism is made with a scan of the lungs, by showing areas where blood cannot get through the vessels easily due to blood clots. The treatment of pulmonary embolism includes anticoagulant medication ('blood thinners') that is taken over months and includes warfarin, an injectable form of heparin and directly acting oral anticoagulants. These medications work by preventing new clots from forming while the body's own mechanisms break down the clots. As the scanning technology for pulmonary embolism has become more sensitive, smaller clots are being diagnosed. However, small pulmonary embolisms may not cause any symptoms and may be found incidentally on scans performed for other reasons. In these situations, it is unclear whether treatment is required for the pulmonary embolism. These clots in smaller blood vessels away from the centre of the lungs (subsegmental pulmonary embolism) may be removed by the body's own mechanisms for dissolving clots without needing medications. Anticoagulant medication can cause side effects in some patients such as bleeding. For the anticoagulant medication to be appropriate in these smaller pulmonary embolisms, the benefits from preventing future blood clots (pulmonary embolism and deep-vein thrombosis) would need to outweigh the potential risks from the medication side effects. The STOPAPE study aimed to answer this question by testing whether we can safely withhold anticoagulation from patients diagnosed with subsegmental pulmonary embolism. Although we aimed to enrol 1466 patients in the trial with half getting usual care of anticoagulation and half getting no anticoagulation, we could not recruit patients quickly enough to the trial and, as a result, we could not continue with the STOPAPE study. This study protocol is published to help future research teams that wish to answer this research question.

General population screening for type 1 diabetes using islet autoantibodies at the preschool vaccination visit: a proof-of-concept study (the T1Early study).

OBJECTIVE: Type 1 diabetes (T1D) screening programmes testing islet autoantibodies (IAbs) in childhood can reduce life-threatening diabetic ketoacidosis. General population screening is required to detect the majority of children with T1D, since in >85% there is no family history. Age 3-5 years has been proposed as an optimal age for a single screen approach. DESIGN: Capillary samples were collected from children attending their preschool vaccination and analysed for IAbs to insulin, glutamic acid decarboxylase, islet antigen-2 and zinc transporter 8 using radiobinding/luciferase immunoprecipitation system assays. Acceptability was assessed using semistructured interviews and open-ended postcard questionnaires with parents. SETTING: Two primary care practices in Oxfordshire, UK. MAIN OUTCOME MEASURES: The ability to collect capillary blood to test IAbs in children at the routine preschool vaccination (3.5-4 years). RESULTS: Of 134 parents invited, 66 (49%) were recruited (median age 3.5 years (IQR 3.4-3.6), 26 (39.4%) male); 63 provided a sample (97% successfully), and one participant was identified with a single positive IAb. Parents (n=15 interviews, n=29 postcards) were uniformly positive about screening aligned to vaccination and stated they would have been less likely to take part had screening been a separate visit. Themes identified included preparedness for T1D and the long-term benefit outweighing short-term upset. The perceived volume of the capillary sample was a potential concern and needs optimising. CONCLUSIONS: Capillary IAb testing is a possible method to screen children for T1D. Aligning collection to the preschool vaccination visit can be convenient for families without the need for an additional visit.

Experiences and challenges of people living with multiple long-term conditions in managing their care in primary care settings in Kerala, India: A qualitative study.

BACKGROUND: Multimorbidity or multiple long-term conditions (MLTCs), the coexistence of two or more chronic conditions within an individual, presents a growing concern for healthcare systems and individuals' well-being. However, we know little about the experiences of those living with MLTCs in low- and middle-income countries (LMICs) such as India. We explore how people living with MLTCs describe their illness, their engagements with healthcare services, and challenges they face within primary care settings in Kerala, India. METHODS: We designed a qualitative descriptive study and conducted in-depth, semi-structured interviews with 31 people (16 males and 15 females) from family health centres (FHCs) in Kerala. Interview data were recorded, transcribed, and thematic analysis using the Framework Method was undertaken. FINDINGS: Two main themes and three sub-themes each were identified; (1) Illness impacts on life (a)physical issues (b) psychological difficulties (c) challenges of self-management and (2) Care-coordination maze (a)fragmentation and poor continuity of care (b) medication management; an uphill battle and (c) primary care falling short. All participants reported physical and psychological challenges associated with their MLTCs. Younger participants reported difficulties in their professional lives, while older participants found household activities challenging. Emotional struggles encompassed feelings of hopelessness and fear rooted in concerns about chronic illness and physical limitations. Older participants, adhering to Kerala's familial support norms, often found themselves emotionally distressed by the notion of burdening their children. Challenges in self-management, such as dietary restrictions, medication adherence, and physical activity engagement, were common. The study highlighted difficulties in coordinating care, primarily related to traveling to multiple healthcare facilities, and patients' perceptions of FHCs as fit for diabetes and hypertension management rather than their multiple conditions. Additionally, participants struggled to manage the task of remembering and consistently taking multiple medications, which was compounded by confusion and memory-related issues. CONCLUSION: This study offers an in-depth view of the experiences of individuals living with MLTCs from Kerala, India. It emphasizes the need for tailored and patient-centred approaches that enhance continuity and coordination of care to manage complex MLTCs in India and similar LMICs.

The Clinical Teaching Fellow role: exploring expectations and experiences.

BACKGROUND: Many UK junior doctors are now taking a year out of the traditional training pathway, usually before specialty training, and some choose to work as a clinical teaching fellow (CTF). CTFs primarily have responsibility for delivering hospital-based teaching to undergraduate medical students. Only a very small amount of literature is available regarding CTF posts, none of which has explored why doctors choose to undertake the role and their expectations of the job. This study aimed to explore the expectations and experiences of CTFs employed at NHS hospital Trusts in the West Midlands. METHODS: CTFs working in Trusts in the West Midlands region registered as students on the Education for Healthcare Professionals Post Graduate Certificate course at the University of Birmingham in August 2019 took part in a survey and a focus group. RESULTS: Twenty-eight CTFs participated in the survey and ten participated in the focus group. In the survey, participants reported choosing a CTF role due to an interest in teaching, wanting time out of training, and being unsure of which specialty to choose. Expectations for the year in post were directly related to reasons for choosing the role with participants expecting to develop teaching skills, and have a break from usual clinical work and rotations. The focus group identified five main themes relating to experiences starting their job, time pressures and challenges faced in post, how CTF jobs differed between Trusts, and future career plans. Broadly, participants reported enjoying their year in a post at a mid-year point but identified particular challenges such as difficulties in starting the role and facing time pressures in their day-to-day work. CONCLUSION: This study has provided a valuable insight into the CTF role and why doctors choose a CTF post and some of the challenges experienced, adding to the sparse amount of literature. Understanding post holders' experiences may contribute to optimisation of the role. Those employing CTFs should consider ensuring a formal handover process is in place between outgoing and incoming CTFs, having a lead person at their Trust responsible for evaluating changes suggested by CTFs, and the balance of contractual duties and personal development time.

Self-monitoring blood pressure in Pregnancy: Evaluation of health professional experiences of the BUMP trials.

BACKGROUND: The BUMP trials evaluated a self-monitoring of blood pressure intervention in addition to usual care, testing whether they improved detection or control of hypertension for women at risk of hypertension or with hypertension during pregnancy. This process evaluation aimed to understand healthcare professionals' perspectives and experiences of the BUMP trials of self-monitoring of blood pressure during pregnancy. METHODS: Twenty-two in-depth qualitative interviews and an online survey with 328 healthcare professionals providing care for pregnant people in the BUMP trials were carried out across five maternity units in England. RESULTS: Analysis used Normalisation Process Theory to identify factors required for successful implementation and integration into routine practice. Healthcare professionals felt self-monitoring of blood pressure did not over-medicalise pregnancy for women with, or at risk of, hypertension. Most said self-monitored readings positively affected their clinical encounters and professional roles, provided additive information on which to base decisions and enriched their relationships with pregnant people. Self-monitoring of blood pressure shifts responsibilities. Some healthcare professionals felt women having responsibility to decide on timing of monitoring and whether to act on self-monitored readings was unduly burdensome, and resulted in healthcare professionals taking additional responsibility for supporting them. CONCLUSIONS: Despite healthcare professionals' early concerns that self-monitoring of blood pressure might over-medicalise pregnancy, our analysis shows the opposite was the case when used in the care of pregnant people with, or at higher risk of, hypertension. While professionals retained ultimate clinical responsibility, they viewed self-monitoring of blood pressure as a means of sharing responsibility and empowering women to understand their bodies, to make judgements and decisions, and to contribute to their care.

Perceptions on artificial intelligence-based decision-making for coexisting multiple long-term health conditions: protocol for a qualitative study with patients and healthcare professionals.

INTRODUCTION: Coexisting multiple health conditions is common among older people, a population that is increasing globally. The potential for polypharmacy, adverse events, drug interactions and development of additional health conditions complicates prescribing decisions for these patients. Artificial intelligence (AI)-generated decision-making tools may help guide clinical decisions in the context of multiple health conditions, by determining which of the multiple medication options is best. This study aims to explore the perceptions of healthcare professionals (HCPs) and patients on the use of AI in the management of multiple health conditions. METHODS AND ANALYSIS: A qualitative study will be conducted using semistructured interviews. Adults (≥18 years) with multiple health conditions living in the West Midlands of England and HCPs with experience in caring for patients with multiple health conditions will be eligible and purposively sampled. Patients will be identified from Clinical Practice Research Datalink (CPRD) Aurum; CPRD will contact general practitioners who will in turn, send a letter to patients inviting them to take part. Eligible HCPs will be recruited through British HCP bodies and known contacts. Up to 30 patients and 30 HCPs will be recruited, until data saturation is achieved. Interviews will be in-person or virtual, audio recorded and transcribed verbatim. The topic guide is designed to explore participants' attitudes towards AI-informed clinical decision-making to augment clinician-directed decision-making, the perceived advantages and disadvantages of both methods and attitudes towards risk management. Case vignettes comprising a common decision pathway for patients with multiple health conditions will be presented during each interview to invite participants' opinions on how their experiences compare. Data will be analysed thematically using the Framework Method. ETHICS AND DISSEMINATION: This study has been approved by the National Health Service Research Ethics Committee (Reference: 22/SC/0210). Written informed consent or verbal consent will be obtained prior to each interview. The findings from this study will be disseminated through peer-reviewed publications, conferences and lay summaries.

Views of healthcare professionals on complementary and alternative medicine use by patients with diabetes: a qualitative study.

BACKGROUND: Recent estimates indicate that a significant proportion of diabetic patients globally, up to 51%, are utilizing complementary and alternative medicine (CAM). To improve patient-provider communication and optimize prescribed treatments, healthcare professionals (HCPs) must understand the factors associated with CAM use among diabetic patients. There is a dearth of literature on HCPs perspectives on CAM use by diabetic patients. This study explored HCPs knowledge, perspective, and views on their diabetic patients' use of CAM. METHODS: Qualitative study using one-to-one semi-structured interviews conducted with 22 HCPs involved in the care of diabetic patients (6 endocrinologists, 4 general practitioners, 4 nurses and 8 pharmacists). Participants were recruited through general practices, community pharmacies and a diabetic centre in Saudi Arabia. Data were analyzed using thematic analysis. RESULTS: Five key themes resulted from the analysis. HCPs generally demonstrated negative perceptions toward CAM, particularly regarding their evidence-based effectiveness and safety. Participants described having limited interactions with diabetic patients regarding CAM use due to HCPs' lack of knowledge about CAM, limited consultation time and strict consultation protocols. Participants perceived convenience as the reason why patients use CAM. They believed many users lacked patience with prescribed medications to deliver favourable clinical outcomes and resorted to CAM use. CONCLUSIONS: HCPs have noted inadequate engagement with diabetic patients regarding CAM due to a lack of knowledge and resources. To ensure the safe use of CAM in diabetes and optimize prescribed treatment outcomes, one must address the communication gap by implementing a flexible consultation protocol and duration. Additionally, culturally sensitive, and evidence-based information should be available to HCPs and diabetic patients.

Preparing for medical school selection: Exploring the complexity of disadvantage through applicant narratives.

Background: Despite a growing drive to improve diversity in medical schools, those from state schools and less-advantaged sociodemographic backgrounds remain underrepresented. We explore applicants' approaches to preparing for medical school selection, considering the complexity of sociodemographic disadvantage in this highly competitive process. Methods: Narrative interviews were undertaken with applicants to a United Kingdom medical school, exploring experiences of preparation for selection (n = 23). Participants were purposively sampled based on involvement in widening participation schemes, school background, gender, and ethnicity. Transcribed data were analyzed using Labov and Waletzky's analytic framework. Bourdieu's concepts of cultural capital and habitus provided a lens to constraints faced and variable experiences. This informed a consideration of the ways applicants approached and navigated their preparation, in the face of various constraints. Results: Constraints to resources and support were often apparent for those from state nonselective (SNS) schools. These applicants and those beginning their preparation later (12-18 months before application) appeared particularly vulnerable to myths and misunderstandings about the application process and appeared less confident and less discerning in their navigation of preparation. Some of the applicants, particularly those from independent and state selective schools, appeared confident and competent in navigating the complexities of the application process, while others (often from SNS schools) were more frequently lost or stressed by the process. Discussion: Those who lack particular preparatory tools or resources (materially, culturally, or perceptually) must "make do" as they prepare for medical school selection, In doing so, they may risk a haphazard, ill-informed or ill-equipped approach. Constraints to opportunities, more typically experienced by those from SNS schools, appeared to motivate the process of bricolage for a number of the applicants. Perversely, medical schools have introduced nonacademic requirements to level the playing field of disadvantage, yet applicants in this group appear to experience challenges as they prepare for selection.

"You're only a receptionist, what do you want to know for?": Street-level bureaucracy on the front line of primary care in the United Kingdom.

Introduction: In care settings across the globe non-clinical staff are involved in filtering patients to the most appropriate source of care. This includes primary care where general practice receptionists are key in facilitating access to individual surgeries and the wider National Health Service. Despite the complexity and significance of their role little is known of how the decision-making behaviors of receptionists impact policy implementation and service delivery. By combining the agent-based implementation theory of street-level bureaucracy with a tri-level analytical framework this work acknowledges the impact of the decisions made by receptionists as street-level bureaucrats and demonstrates the benefits of using the novel framework to provide practical insight of the factors influencing those decisions. Methods: A secondary analysis of qualitative data gathered from a series of semi-structured interviews conducted with 19 receptionists in the United Kingdom in 2019 was used to populate a tri-level framework: the micro-level relates to influences on decision making acting at an individual level, the meso-level influences at group and organizational levels, and the macro-level influences at a societal or policy level. Results: At the micro-level we determined how receptionists are influenced by the level of rapport developed with patients and would use common sense to interpret urgency. At the meso-level, influences included their position at the forefront of premises, the culture of the workplace, and the processes and protocols used by their practice. At the macro-level, participants described the impact of limited health service capacity, the lack of mandatory training, and the growth in the use of digital technologies. Conclusions: Street-level bureaucracy, complemented with a tri-level contextual analysis, is a useful theoretical framework to understand how health workers, such as receptionists, attempt to provide universality without sufficient resource, and could potentially be applied to other kinds of public service workers in this way. This theoretical framework also benefits from being an accessible foundation on which to base practice and policy changes.

Barriers and facilitators of people living with HIV receiving optimal care for hypertension and diabetes in Tanzania: a qualitative study with healthcare professionals and people living with HIV.

BACKGROUND: People living with HIV (PLWH) are at a higher risk for developing diabetes and hypertension. Often services are separate for HIV and non-communicable diseases (NCDs), but how this impacts NCD care among PLWH is unknown. We aimed to understand the barriers and facilitators for prevention, early diagnosis and safe effective care for diabetes and hypertension among PLWH. METHODS: Semi-structured interviews (SSIs) were conducted with 10 healthcare professionals (HCPs) that care for PLWH, 10 HCPs that care for people with diabetes and hypertension and 16 PLWH with a comorbidity of diabetes and/or hypertension. Participants were recruited from two healthcare facilities in Dodoma, Tanzania and purposively sampled based on age and sex. Interviews were conducted in Swahili using pre-developed topic guides, audio recorded then translated verbatim into English. An inductive thematic analysis was conducted using The Framework Method. RESULTS: Three themes were found: organisational/healthcare system factors, individual factors and syndemic factors. Organisational/healthcare system factors comprised the only facilitators for prevention (education on lifestyle behaviours and counselling on adherence), but included the most barriers overall: fragmented services, no protocol for NCD screening and lack of access to diagnostic equipment were barriers for early diagnosis whereas the former plus lack of continuity of NCD care were barriers for safe effective care. Individual factors comprised four sub-themes, three of which were considered facilitators: HCPs' knowledge of NCDs for early diagnosis, self-monitoring of NCDs for safe effective care and HCPs' personal practice for both early diagnosis and safe effective care. HCPs' knowledge was simultaneously a barrier for prevention and PLWH knowledge was a barrier for prevention and safe effective care. Syndemic factors comprised three sub-themes; all were barriers for prevention, early diagnosis and/or safe effective care: poverty and mental health of PLWH and HIV stigma. CONCLUSIONS: Organisational/healthcare system, individual and syndemic factors were found to be interlinked with barriers and facilitators that contribute to the prevention, early diagnosis and safe effective care of diabetes and hypertension among PLWH in Tanzania; these findings can inform future initiatives for making small and large health system changes to improve the health of aging PLWH.

Identifying and understanding the care pathway of patients with atrial fibrillation in Brazil and the impact of the COVID-19 pandemic: A mixed-methods study.

BACKGROUND: Atrial fibrillation (AF) is a major risk factor for stroke. To enable improvements to AF diagnosis and follow-up care, understanding current patient pathways and barriers to optimal care are essential. We investigated the patient care pathways and their drivers, and the impact of the COVID-19 pandemic on patient pathways in a middle-income country setting, Brazil. METHODS: This mixed-methods study in São Paulo, included adults (≥18y) with AF from 13 primary/secondary healthcare facilities. Surveys using baseline, follow-up (administered ≥two months after baseline) and COVID-19 questionnaires (quantitative), and three focus group discussions (FGDs) were conducted. Minimum sample size for the quantitative component was 236 and we aimed to reach saturation with at least three FGDs for the qualitative component. Descriptive statistics were used for quantitative data and a content analysis was used for qualitative data to identify themes related to AF diagnosis and follow-up care. RESULTS: 267 participants completed the baseline questionnaire: 25% were diagnosed in primary care, 65% in an emergency or inpatient department. At follow-up (n = 259), 31% visited more than one facility for AF care, and 7% had no follow-up. Intervals between international normalised ratio (INR) tests were increased during the pandemic, and the number of healthcare visits and availability of medication were reduced. Seventeen patients participated in three FGDs and revealed that AF diagnosis often occurred following a medical emergency and patients often delay care-seeking due to misconceptions about AF symptoms. Long waiting times, doctor/patient interactions and health system factors, such as doctor availability and the referral system, influence where participants visited for follow-up care. CONCLUSIONS: Lack of public awareness and underdeveloped primary healthcare lead to delayed diagnosis, which impacts clinical outcomes and excess patient and healthcare system costs. Health system, care-provider, and pandemic factors disrupt timely and effective continuity of care.

Promoting participation in physical activity through Snacktivity: A qualitative mixed methods study.

BACKGROUND: Public health guidance acknowledges the benefits of physical activity of any duration. We have proposed a whole-day approach to promoting physical activity called Snacktivity™, which encourages frequent 2-5 minute 'activity snacks' of moderate-to-vigorous intensity. METHODS: Using repeated semi-structured interviews and a think aloud protocol, this study aimed to understand participants' experiences of integrating Snacktivity™ into daily life, to provide insights to refine the delivery of Snacktivity™ interventions. Physically inactive adults recruited via primary care and a community health service engaged with an intervention to encourage Snacktivity™ over three weeks, which included using a Fitbit and linked mobile phone app (SnackApp). Participants took part in semi-structured interviews on two occasions during the intervention, with a sub-group participating in a think aloud study. Three study data sets were generated and independently explored using inductive thematic analysis, with findings combined into a single set of themes. RESULTS: Eleven adults participated in the interview study who were interviewed twice (total interviews completed n = 21, 1 participant declined the second interview), of whom six completed the think aloud study (total voice recordings n = 103). Three main themes emerged from the combined data; lived experience of participating in Snacktivity™, motivation for Snacktivity™ and experiences with the Snacktivity™ technology. Participants undertook a variety of activity snacks, utilising their environment, which they believed improved their psychological wellbeing. Participants were enthusiastic about Snacktivity™, with some stating that activity snacks were more accessible than traditional exercise, but perceived they were often prevented from doing so in the presence of others. Participants were mostly enthusiastic about using the Snacktivity™ technology. CONCLUSION: Participants were able to incorporate Snacktivity™ into their lives, particularly at home, and found this approach acceptable. Participants felt they experienced health benefits from Snacktivity™ although barriers to participation were reported. This study offers insights for translating guidance into practice and supporting people to become more physically active.

Current evidence for designing self-management support for underserved populations: an integrative review using the example of diabetes.

AIMS: With numerous and continuing attempts at adapting diabetes self-management support programmes to better account for underserved populations, its important that the lessons being learned are understood and shared. The work we present here reviews the latest evidence and best practice in designing and embedding culturally and socially sensitive, self-management support programmes. METHODS: We explored the literature with regard to four key design considerations of diabetes self-management support programmes: Composition - the design and content of written materials and digital tools and interfaces; Structure - the combination of individual and group sessions, their frequency, and the overall duration of programmes; Facilitators - the combination of individuals used to deliver the programme; and Context - the influence and mitigation of a range of individual, socio-cultural, and environmental factors. RESULTS: We found useful and recent examples of design innovation within a variety of countries and models of health care delivery including Brazil, Mexico, Netherlands, Spain, United Kingdom, and United States of America. Within Composition we confirmed the importance of retaining best practice in creating readily understood written information and intuitive digital interfaces; Structure the need to offer group, individual, and remote learning options in programmes of flexible duration and frequency; Facilitators where the benefits of using culturally concordant peers and community-based providers were described; and finally in Context the need to integrate self-management support programmes within existing health systems, and tailor their various constituent elements according to the language, resources, and beliefs of individuals and their communities. CONCLUSIONS: A number of design principles across the four design considerations were identified that together offer a promising means of creating the next generation of self-management support programme more readily accessible for underserved communities. Ultimately, we recommend that the precise configuration should be co-produced by all relevant service and patient stakeholders and its delivery embedded in local health systems.

Views of children with diabetes from underserved communities, and their families on diabetes, glycaemic control and healthcare provision: A qualitative evidence synthesis.

AIMS: Children and young people with diabetes (CYPD) from socio-economically deprived and/or ethnic minority groups tend to have poorer glucose control and greater risk of diabetes-related complications. In this systematic review of qualitative evidence (qualitative evidence synthesis, QES), we aimed to explore the experiences and views of clinical encounters in diabetes care from the perspectives of CYPD and their family/carers from underserved communities and healthcare professionals in diabetes care. METHODS: We searched 6 databases to March 2022 with extensive search terms, and used a thematic synthesis following methods of Thomas and Harden. RESULTS: We identified 7 studies and described 11 descriptive themes based on primary and secondary constructs. From these, three "analytical themes" were developed. (1) "Alienation of CYPD" relates to their social identity and interaction with peers, family and health service practitioners in the context of diabetes self- and family/carer management and is impacted by communication in the clinical encounter. (2) "Empowerment of CYPD and family/carers" explores families' understanding of risks and consequences of diabetes and taking responsibility for self- and family/carer management in the context of their socio-cultural background. (3) "Integration of diabetes (into self and family)" focuses on the ability to integrate diabetes self-management into the daily lives of CYPD and family/carers beyond the clinical consultation. CONCLUSIONS: The analytical themes are interdependent and provide a conceptual framework from which to explore and strengthen the therapeutic alliance in clinical encounters and to foster greater concordance with treatment plans. Communicating the biomedical aspects of managing diabetes in the clinical encounter is important, but should be balanced with addressing socio-emotional factors important to CYPD and family/carers.

Yoga Programme for Type 2 Diabetes Prevention (YOGA-DP): A Qualitative Study Exploring the Trial Team's Facilitators and Challenges in Conducting a Feasibility Trial in India.

BACKGROUND: In India, around 77 million people are at high risk of developing type 2 diabetes mellitus (T2DM). Yoga interventions can be effective in preventing T2DM. We conducted a feasibility randomized controlled trial (RCT) in India, and the intervention was the Yoga Programme for T2DM Prevention (YOGA-DP). This study aimed to identify and explore the facilitators and challenges in conducting the feasibility trial in India, and more specifically, to explore the perceptions and experiences of trial staff in relation to running the feasibility trial and Yoga instructors in relation to delivering the intervention. METHODS: An exploratory qualitative study was conducted at two trial sites in India (Yoga centers in New Delhi and Bengaluru). Semi-structured interviews were conducted with ten participants (six trial staff and four Yoga instructors) to explore their perceptions and experiences related to the study's aim. Data were analyzed using deductive as well as inductive logic and an interpretative phenomenological approach. RESULTS: Feasibility-trial-related facilitators were useful participant recruitment strategies and help and support received from the trial coordination center. Intervention-related facilitators were strengths of the intervention content, structure, and delivery (including materials) and competencies of Yoga instructors. Feasibility-trial-related challenges were lack of awareness about T2DM among potential participants, stigma and fear associated with T2DM among potential participants, difficulties in explaining the research and obtaining written informed consent from potential participants, expectations and demands of potential participants and control-group participants, gender and language issues in participant recruitment, other participant recruitment-related challenges, issues in participant follow-up, and issues in data collection and trial documentation. Intervention-related challenges were the limited interest of participants in Yoga, participants' time constraints on practicing Yoga, participants' health issues hindered Yoga practice, beginners' difficulties with practicing Yoga, participants' demotivation to practice Yoga at home, issues with the Yoga practice venue, confusion regarding the intervention structure, issues with intervention materials, and the incompetence of Yoga instructors. CONCLUSIONS: The perceptions and experiences of trial staff and Yoga instructors helped us to understand the facilitators and challenges in running a feasibility trial and delivering the intervention for T2DM prevention, respectively. These findings and their suggestions will be used when designing the definitive RCT for evaluating YOGA-DP's effectiveness, and may be helpful to researchers planning similar trials. TRIAL REGISTRATION NUMBER: India (CTRI) CTRI/2019/05/018893.

What does social cognition look like in everyday social functioning in Huntington's disease? A protocol for a scoping review to explore and synthesise knowledge about social cognition alongside day-to-day social functioning of people with Huntington's disease.

INTRODUCTION: Social cognition is problematic in Huntington's disease (HD). Despite the observations of clinicians and families, there is minimal empirical literature about how it presents in daily life and the impact on social functioning. This protocol forms the basis of a scoping review to synthesise both the quantitative knowledge and qualitative experiences of the HD community so that a visual and narrative map can address what is known and what is not known for the benefit of the community and clinicians and academics alike. METHODS AND ANALYSES: An umbrella scoping review of previous work and a scoping review of newer studies of social cognition and social functioning will be undertaken. The electronic databases PubMed, Medline, PsycINFO, Web of Science, Scopus, Embase and CINAHL will be searched to identify eligible studies from starting from 2003 to June 2023. A grey literature search and grey data search will also be undertaken. Quality appraisal of the included documents will use the Critical Appraisal Skills Programme and Authority, Accuracy, Coverage, Objectivity, Date, Significance checklists. A data charting table will be used for data extraction, with analysis of qualitative data using the framework method. The review findings will be presented in a visual form and in a narrative summary. ETHICS AND DISSEMINATION: Ethical review is not usually required as scoping reviews are produced via secondary data analysis, however, this protocol includes the use of grey data from a charity web forum and so in line with best practice for internet mediated research ethical review was sought and approved (STEM Ethical Review Committee, University of Birmingham-ERN_21-1028A). Review findings will be shared with service users and disseminated through a peer-reviewed publications, conference presentations and hosted via the website of the patient association charity the HD Association.

General population screening for paediatric type 1 diabetes-A qualitative study of UK professional stakeholders.

AIMS: Identifying children at risk of type 1 diabetes allows education for symptom recognition and monitoring to reduce the risk of diabetic ketoacidosis at presentation. We aimed to explore stakeholder views towards paediatric general population screening for type 1 diabetes in the United Kingdom (UK). METHODS: Qualitative interviews were undertaken with 25 stakeholders, including diabetes specialists, policymakers and community stakeholders who could be involved in a future type 1 diabetes screening programme in the UK. A thematic framework analysis was performed using the National Screening Committee's evaluative criteria as the overarching framework. RESULTS: Diabetic ketoacidosis prevention was felt to be a priority and proposed benefits of screening included education, monitoring and helping the family to better prepare for a future with type 1 diabetes. However, diabetes specialists were cautious about general population screening because of lack of evidence for public acceptability. Concerns were raised about the harms of living with risk, provoking health anxiety and threatening the child's right to an 'open future'. Support systems that met the clinical and psychological needs of the family living with risk were considered essential. Stakeholders were supportive of research into general population screening and acknowledged this would be a priority if an immunoprevention agent were licensed in the UK. CONCLUSIONS: Although stakeholders suggested the harms of UK paediatric general population screening currently outweigh the benefits, this view would potentially be altered if prevention therapies were licensed. In this case, an evidence-based screening strategy would need to be formulated and public acceptability explored.

The Clinical Teaching Fellow role: views of the Heads of Academy in the West Midlands.

BACKGROUND: Increasingly junior doctors are taking a year out of the traditional training pathway, and some opt to spend a year in a clinical teaching fellow (CTF) post. The CTF post mainly involves delivering hospital-based teaching to undergraduate medical students. In NHS hospital Trusts in the West Midlands, Heads of Academy (HoAs) have oversight of medical education at each Trust and therefore have responsibility for employing and directing the work of CTFs. Currently, only limited literature exists about the CTF role and exploring this from the point of view of different stakeholders in medical education is important in terms of contributing towards development of the role. This study aimed to explore the views of HoAs in the West Midlands region regarding CTFs employed at their Trusts. METHODS: All HoAs at the NHS Trust/teaching hospitals associated with the University of Birmingham were invited to take part in an in-depth interview about CTFs at their Trusts. Interviews were held via Zoom recorded using Zoom's recording functionality. Interview transcripts were then coded and analysed using thematic analysis. RESULTS: Seven out of 11 HoAs participated in an interview. Seven themes were identified: CTF duties/Job role, Relationship with students, Benefits of having CTFs, Challenges associated with CTFs, Popularity of the role, What Trust offers CTFs, and Future of the role. Primarily it was felt that having CTFs at their Trust was beneficial in terms of the amount of teaching they provide for medical students. The HoAs were keen to ensure the CTF posts were of maximum benefit to both the post holders and to the Trusts where they were based. The CTF role is one that they felt would continue and develop in the future. CONCLUSION: This study has provided the first insight into the CTF role from the point of view of senior doctors with responsibility for delivery of undergraduate medical education. The consistency and reliability of teaching provided by the CTFs was identified as a key benefit of the role. Future work exploring the role from the point of view of post holders themselves would be beneficial to contribute to development of the role.

Snacktivity™ to promote physical activity and reduce future risk of disease in the population: protocol for a feasibility randomised controlled trial and nested qualitative study.

BACKGROUND: Many people do not regularly participate in physical activity, which may negatively impact their health. Current physical activity guidelines are focused on promoting weekly accumulation of at least 150 min of moderate to vigorous intensity physical activity (MVPA). Whilst revised guidance now recognises the importance of making small changes to physical activity behaviour, guidance still focuses on adults needing to achieve at least 150 min of MVPA per week. An alternative 'whole day' approach that could motivate the public to be more physically active, is a concept called Snacktivity™. Instead of focusing on achieving 150 min per week of physical activity, for example 30 min of MVPA over 5 days, Snacktivity™ encourages the public to achieve this through small, but frequent, 2-5 min 'snacks' of MVPA throughout the whole day. METHODS: The primary aim is to undertake a feasibility trial with nested qualitative interviews to assess the feasibility and acceptability of the Snacktivity™ intervention to inform the design of a subsequent phase III randomised trial. A two-arm randomised controlled feasibility trial aiming to recruit 80 inactive adults will be conducted. Recruitment will be from health and community settings and social media. Participants will be individually randomised (1:1 ratio) to receive either the Snacktivity™ intervention or usual care. The intervention will last 12 weeks with assessment of outcomes completed before and after the intervention in all participants. We are interested in whether the Snacktivity™ trial is appealing to participants (assessed by the recruitment rate) and if the Snacktivity™ intervention and trial methods are acceptable to participants (assessed by Snacktivity™/physical activity adherence and retention rates). The intervention will be delivered by health care providers within health care consultations or by researchers. Participants' experiences of the trial and intervention, and health care providers' views of delivering the intervention within health consultations will be explored. DISCUSSION: The development of physical activity interventions that can be delivered at scale are needed. The findings from this study will inform the viability and design of a phase III trial to assess the effectiveness and cost-effectiveness of Snacktivity™ to increase physical activity. TRIAL REGISTRATION: ISRCTN: 64851242.