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Storytelling as an approach to understand how cultural activities support the well-being in older people from global majority groups
BACKGROUND: Social prescribing is increasingly used to support well-being through non-clinical, community-based interventions. However, there is limited understanding of how cultural activities can be tailored for older people from global majority groups. The TOUS study (Tailoring cultural Offers with and for diverse older Users of Social prescribing) explores how cultural offers can be adapted to meet the needs of these communities. AIM: This study aims to understand how storytelling can be used within a realist evaluation to explore the role of cultural activities in enhancing well-being among older adults from global majority groups. METHOD: Storytelling was used as a key method of data collection in two case studies. This approach involves four open-ended questions that allow participants to share experiences in their own words. Each transcript is condensed into a two-page narrative, approved by the participant, and used in collaborative discussions with stakeholders. This method aligns with the patient-centred ethos of social prescribing and complements realist evaluation by highlighting mechanisms of change and barriers to participation. RESULTS: Preliminary findings suggest cultural institutions can foster inclusion, connection, and identity among participants. Storytelling revealed the importance of culturally relevant, welcoming spaces and captured the nuanced experiences of individuals often overlooked in traditional research. CONCLUSION: Storytelling enriches realist evaluation by offering a participant-led, less extractive method of data collection. It bridges individual experiences with broader programme outcomes and provides a valuable approach for researchers aiming to centre voices from underrepresented communities in primary care research.
Factors associated with single, dual and poly combustible tobacco use among Emirati adults in the United Arab Emirates: The UAE Healthy Future and ITC Survey results (2016 - 2023).
INTRODUCTION: Forms of combustible tobacco, such as shisha and pipe tobacco, are popular in the Middle East. Poly use of combustible tobacco products increases exposure to the harmful toxicants in them. Little is known about patterns of tobacco use behaviors in Middle Eastern countries and the potential harms due to particular types and concurrent versus single-use. METHODS: We analyzed data on tobacco use from 7,535 Emirati adults as part of the UAE Healthy Future Study, a longitudinal cohort study in the United Arab Emirates. We examined associations between single, dual, or poly combustible tobacco use and sociodemographic and clinical factors, including markers of cardiovascular disease (CVD). We also examined associations between the type of tobacco used and markers of CVD. RESULTS: Age-adjusted prevalence of combustible tobacco use was 34%. Single, dual, and poly use were 47%, 35%, and 18%, respectively. Parental tobacco use was associated with any kind of combustible tobacco use, and was strongly associated with poly use (RRRp=4.4, 95% CI=1.2, 16.8). Those who used one or more combustible tobacco products had higher levels of some CVD markers, notably HDL and Apolipoprotein A. Use of any type of tobacco was associated with increased risk for markers of CVD. CONCLUSIONS: Any amount of tobacco used was associated with differences in CVD markers. Associations were strongest for poly tobacco users. Future studies are needed to understand relationships between single, dual and poly combustible tobacco use, different combustible tobacco types, and disease risk. IMPLICATIONS: All forms of tobacco were associated with markers of CVD, signaling that there is no safer form of combustible tobacco. The study is one of the largest to characterize tobacco use behaviors in a Middle Eastern population, and should provide an important benchmark for further research on different, and sometimes co-occurring, forms of tobacco use.
The consequences of micro-discretions and boundaries in the social prescribing link worker role in England: a realist evaluation.
BACKGROUND: Social prescribing addresses non-medical factors affecting health and well-being. Link workers are key to its delivery by connecting people to relevant support, often in the voluntary, community and social enterprise sector. Funding from the National Health Service means that link workers are becoming a common part of primary care in England. OBJECTIVE: To explore and understand the implementation of link workers in primary care in England. DESIGN: A realist evaluation addressed the question - When implementing link workers in primary care to sustain outcomes - what works, for whom, why and in what circumstances? SETTING: Link workers and staff associated with seven primary care sites across England. METHODS: Researchers spent 3 weeks with each link worker, going to meetings with them, watching them interact with patients, with healthcare staff and with voluntary, community and social enterprise organisations. In addition, interviews were conducted with 61 patients and 93 professionals (voluntary, community and social enterprise representatives and healthcare staff, including link workers). Follow-up interviews were conducted with 41 patients and with link workers 9-12 months later. Data were coded and developed into statements to identify how context around the link worker triggers mechanisms that lead to intended and unintended outcomes. RESULTS: We found that link workers exercise micro-discretions in their role - actions and advice-giving based on personal judgement of a situation, which may not always reflect explicit guidance or protocols. Our analysis highlighted that micro-discretions engender positive connections (with patients, healthcare staff, the voluntary, community and social enterprise sector) and promote buy-in to the link worker role in primary care. Micro-discretions supported delivery of person-centred care and enhanced job satisfaction. Data also highlighted that lack of boundaries could place link workers at risk of overstepping their remit. LIMITATIONS: Our research focused on link workers attached to primary care; findings may not be applicable to those working in other settings. Data were collected around seven link worker cases, who were selected purposively for variation in terms of geographical spread and how/by whom link workers were employed. However, these link workers were predominately white females. CONCLUSIONS: Enabling link workers to exercise micro-discretions allows for responsiveness to individual patient needs but can result in uncertainty and to link workers feeling overstretched. FUTURE WORK: Poor link worker retention may, in part, be associated with a lack of clarity around their role. Research to explore how this shapes intention to leave their job is being conducted by authors of this paper. FUNDING: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number NIHR130247.
Experiences of integrating social prescribing link workers into primary care in England — bolting on, fitting in, or belonging: a realist evaluation
Background Following the 2019 NHS Long Term Plan, link workers have been employed across primary care in England to deliver social prescribing. Aim To understand and explain how the link worker role is being implemented in primary care in England. Design and setting This was a realist evaluation undertaken in England, focusing on link workers based in primary care. Method The study used focused ethnographies around seven link workers from different parts of England. As part of this, we interviewed 61 patients and 93 professionals from health care and the voluntary, community, and social enterprise sector. We reinterviewed 41 patients, seven link workers, and a link worker manager 9–12 months after their first interview. Results We developed four concepts from the codes developed during the project on the topic around how link workers are integrated (or not) within primary care: (or not) within primary care: centralising or diffusing power; forging an identity in general practice; demonstrating effect; and building a facilitative infrastructure. These concepts informed the development of a programme theory around a continuum of integration of link workers into primary care — from being ‘bolted on’ to existing provision, without much consideration, to ‘fitting in’, shaping what is delivered to be accommodating, through to ‘belonging’, whereby they are accepted as a legitimate source of support, making a valued contribution to patients’ broader wellbeing. Conclusion Social prescribing was introduced into primary care to promote greater attention to the full range of factors affecting patients’ health and wellbeing, beyond biomedicine. For that to happen, our analysis highlights the need for a whole-system approach to defining, delivering, and maintaining this new part of practice.
Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)
Background: Improved blood-glucose control decreases the progression of diabetic microvascular disease, but the effect on macrovascular complications is unknown. There is concern that sulphonylureas may increase cardiovascular mortality in patients with type 2 diabetes and that high insulin concentrations may enhance atheroma formation. We compared the effects of intensive blood-glucose control with either sulphonylurea or insulin and conventional treatment on the risk of microvascular and macrovascular complications in patients with type 2 diabetes in a randomised controlled trial. Methods: 3867 newly diagnosed patients with type 2 diabetes, median age 54 years (IQR 48-60 years), who after 3 months' diet treatment had a mean of two fasting plasma glucose (FPG) concentrations of 6.1-15.0 mmol/L were randomly assigned intensive policy with a sulphonylurea (chlorpropamide, glibenclamide, or glipizide) or with insulin, or conventional policy with diet. The aim in the intensive group was FPG less than 6 mmol/L. In the conventional group, the aim was the best achievable FPG with diet alone; drugs were added only if there were hyperglycaemic symptoms or FPG greater than 15 mmol/L. Three aggregate endpoints were used to assess differences between conventional and intensive treatment: any diabetes-related endpoint (sudden death, death from hyperglycaemia or hypoglycaemia, fatal or non-fatal myocardial infarction, angina, heart failure, stroke, renal failure, amputation [of at least one digit], vitreous haemorrhage, retinopathy requiring photocoagulation, blindness in one eye, or cataract extraction); diabetes-related death (death from myocardial infarction, stroke, peripheral vascular disease, renal disease, hyperglycaemia or hypoglycaemia, and sudden death); all-cause mortality. Single clinical endpoints and surrogate subclinical endpoints were also assessed. All analyses were by intention to treat and frequency of hypoglycaemia was also analysed by actual therapy. Findings: Over 10 years, haemoglobin A(1c) (HbA(1c)) was 7.0% (6.2-8.2) in the intensive group compared with 7.9% (6.9-8.8) in the conventional group - an 11% reduction. There was no difference in HbA(1c) among agents in the intensive group. Compared with the conventional group, the risk in the intensive group was 12% lower (95% CI 1-21, p = 0.029) for any diabetes-related endpoint; 10% lower (-11 to 27, p = 0.34) for any diabetes-related death; and 6% lower (-10 to 20, p = 0.44) for all-cause mortality. Most of the risk reduction in the any diabetes-related aggregate endpoint was due to a 25% risk reduction (7-40, p = 0.0099) in microvascular endpoints, including the need for retinal photocoagulation. There was no difference for any of the three aggregate endpoints between the three intensive agents (chlorpropamide, glibenclamide, or insulin). Patients in the intensive group had more hypoglycaemic episodes than those in the conventional group on both types of analysis (both p < 0.0001). The rates of major hypoglycaemic episodes per year were 0.7% with conventional treatment, 1.0% with chlorpropamide, 1.4% with glibenclamide, and 1.8% with insulin. Weight gain was significantly higher in the intensive group (mean 2.9 kg) than in the conventional group (p < 0.001), and patients assigned insulin had a greater gain in weight (4.0 kg) than those assigned chlorpropamide (2.6 kg) or glibenclamide (1.7 kg). Interpretation: Intensive blood-glucose control by either sulphonylureas or insulin substantially decreases the risk of microvascular complications, but not macrovascular disease, in patients with type 2 diabetes. None of the individual drugs had an adverse effect on cardiovascular outcomes. All intensive treatment increased the risk of hypoglycaemia.
Clinical and cost-effectiveness of a personalised guided consultation versus usual physiotherapy care in people presenting with shoulder pain: a protocol for the PANDA-S cluster randomised controlled trial and process evaluation
Introduction Musculoskeletal shoulder pain is a common reason for people to be treated in physiotherapy services, but diagnosis can be difficult and often does not guide treatment or predict outcome. People with shoulder pain cite a need for clear information, and timely, tailored consultations for their pain. This trial will evaluate the introduction of a personalised guided consultation to help physiotherapists manage care for individuals with shoulder pain. Methods and analysis This is a cluster randomised controlled trial to evaluate the clinical and cost-effectiveness of introducing a personalised guided consultation compared with usual UK NHS physiotherapy care. Physiotherapy services (n=16) will be randomised in a 1:1 ratio to either intervention (physiotherapy training package and personalised guided consultation incorporating a new prognostic tool) or control (usual care); 832 participants (416 in each arm) identified from participating physiotherapy service waiting lists aged 18 years or over with shoulder pain will be enrolled. Follow-up will occur at 3 time points: 6 weeks, 6 months and 12 months. The primary outcome will be the Shoulder Pain and Disability Index (SPADI) score over 12 months. Secondary outcomes include global perceived change of the shoulder condition, sleep, work absence and the impact of shoulder pain on work performance, healthcare utilisation and health-related quality of life (using EuroQol 5 Dimension 5 Level (EQ-5D-5L)). A multimethod process evaluation will investigate views and experiences of participants and physiotherapists, assess uptake, facilitators and barriers to delivery, and changes in factors assumed to explain intervention outcomes. Primary analysis of effectiveness will be by intention-to-treat, and a health economic evaluation will assess cost-utility of introducing the personalised consultation. Ethics and dissemination The trial received ethics approval from the Yorkshire & The Humber (South Yorkshire) Research Ethics Committee (REC reference: 23/YH/0070). Findings will be shared through journal publications, media outlets and conference presentations. Supported by patient contributors and clinical advisors, we will communicate findings through a designated website, networks, newsletters, leaflets and in the participating physiotherapy services.
Investigating the association between recorded smoking cessation interventions and smoking cessation in people living with cardiovascular disease using UK general practice data
Background: Smoking significantly increases the risk of cardiovascular diseases (CVD), yet quitting smoking after diagnosis of CVD can mitigate further negative impacts. However, encouraging smoking cessation remains a challenge for General Practitioners (GPs) with concerns regarding mental health. Since 2004, the UK’s Quality and Outcomes Framework (QOF) incentivises GP smoking cessation support. Despite this, a significant proportion of individuals diagnosed with CVD continue to smoke after diagnosis. This study aims to investigate the frequencies and types of smoking cessation interventions offered to people with CVD (defined as coronary heart disease (CHD) and stroke), with and without mental illness, and assess their association with successful cessation. Methods: This retrospective cohort study examined adults diagnosed with CHD or stroke using the QResearch general practice records database (1996–2019). We evaluated the frequency and types of smoking cessation interventions documented in patients’ records, including education, brief interventions, pharmacological support, referrals, and counselling. Logistic regression assessed the relationship between recorded interventions and smoking abstinence rates within the one-year post-index event, considering QOF incentives and mental illness presence. Results: While smoking cessation education was common in general practice settings, prescriptions for nicotine replacement therapy or other evidence-based interventions were comparatively low. CHD and stroke populations showed a significant association between any intervention and smoking cessation within one year (CHD: OR 1.41, 95% CI 1.36–1.45; stroke: OR 1.49, 95% CI 1.43–1.55). Education consistently correlated with higher cessation likelihoods, while other interventions were linked to lower rates. Individuals with common and serious mental illness were less likely to quit, irrespective of intervention. QOF implementation led to increased documentation of advice but not intensive support or treatment, with pre-QOF interventions associated with significantly increased abstinence likelihoods (CHD: OR 5.09, 95% CI 4.84–5.35; stroke: OR 4.44, 95% CI 4.07–4.86). Conclusions: Financial incentives for GP smoking cessation support outlined in QOF may not suffice to enhance methods that are more efficacious or improve cessation rates, especially among people with mental illness. Practical strategies that provide tangible support and treatment are needed for CVD patients, including those with mental illness, to facilitate successful cessation.
Impact of the COVID-19 pandemic on antidepressant prescribing with a focus on people with learning disability and autism: an interrupted time series analysis in England using OpenSAFELY-TPP.
BACKGROUND: COVID-19 restrictions led to increased reports of depressive symptoms in the general population and impacted health and social care services. We explored whether these changes affected antidepressant prescribing trends in the general population and those with learning disability or autism. METHODS: With the approval of NHS England, we used >24 million patients' primary care data from the OpenSAFELY-TPP platform. We used interrupted time series analysis to quantify trends in those prescribed and newly prescribed an antidepressant across key demographic and clinical subgroups, comparing pre-COVID-19 (January 2018-February 2020), COVID-19 restrictions (March 2020-February 2021) and recovery (March 2021-December 2022) periods. RESULTS: Prior to COVID-19 restrictions, antidepressant prescribing was increasing in the general population and in those with learning disability or autism. We did not find evidence that the pandemic was associated with a change in antidepressant prescribing trend in the general population (relative risk (RR) 1.00 (95% CI 0.97 to 1.02)), in those with autism (RR 0.99 (95% CI 0.97 to 1.01)) or in those with learning disability (RR 0.98 (95% CI 0.96 to 1.00)).New prescribing post restrictions was 13% and 12% below expected had COVID-19 not happened in both the general population and those with autism (RR 0.87 (95% CI 0.83 to 0.93), RR 0.88 (95% CI 0.83 to 0.92)), but not learning disability (RR 0.96 (95% CI 0.87 to 1.05)). CONCLUSIONS AND IMPLICATIONS: In this England study, we did not see an impact of COVID-19 on overall antidepressant prescribing, although unique trends were noted, such as trends in new antidepressant prescriptions which increased in care homes over the pandemic and decreased in the general population and those with autism since recovery.
Clinical Study Reports-a systematic review with thematic synthesis: Part 2. Studying benefits, harms, and the benefit to harm balance of pharmacological interventions.
BACKGROUND: We define clinical study reports (CSRs) as standardized full reports of the protocols, results, and other pertinent details of clinical studies that are typically submitted by pharmaceutical companies to regulatory authorities when they apply for marketing authorization. METHODS: In this systematic review we searched various databases (Clarivate Web of Science, EMBASE and Ovid Medline, Google Scholar, and PubMed) for publications containing the term "clinical study report/s", without restrictions. THEMATIC SYNTHESIS: In the first part of this review we discussed the history of CSRs, their contents and structure, definitions, and relevant terminology. In this second part we discuss the uses of CSRs, concentrating on the individual benefits and harms of pharmacological interventions, and thus the benefit to harm balance. We also discuss adherence to interventions, prepublication of protocols of clinical trials, and how CSRs are written, factors that can all affect estimation of the benefit-harm balance. CONCLUSIONS: When clinical trial data from CSRs are compared with the data in published trial reports, the apparent benefits of pharmacological interventions are less impressive, and more information emerges about harms they can cause. Both of these effects change how the benefit-harm balance of a pharmacological intervention is estimated, generally making it less favourable than was otherwise thought. For more accurate assessment of the benefit-harm balance of an intervention, full, not abbreviated or synoptic, clinical study reports should continue to be made publicly available by regulatory authorities and manufacturers. Authorities that do not currently make them available should do so. CSRs should be introduced for assessment of surgical operations, therapeutic devices, and other non-pharmacological interventions in clinical trials.
Clinical Study Reports-a systematic review with thematic synthesis: Part 1. History, contents and structure, definitions, and terminology.
BACKGROUND: Clinical study reports (CSRs) are standardized full reports of the protocols, results, and other pertinent details of clinical studies that are typically submitted by pharmaceutical companies to regulatory authorities, as part of the drug approval process. Their recommended contents and structure were described in 1995 in a document of the International Conference on Harmonisation, ICH E3, although companies can choose how to present the data. Until 2015, such reports were not readily available to the public, but since then some regulatory authorities have made them available, as have some pharmaceutical companies, albeit often in abbreviated or redacted versions. The apparent benefits of pharmacological interventions are not as impressive when they are calculated using data from clinical study reports compared with published trial reports, and more information emerges about harms the interventions can cause. RESULTS: Our methods are described in Part 2 of this systematic review with thematic synthesis, in which we have summarized the uses of CSRs, as described in 349 publications of various sorts, including analyses of clinical trials, data analyses, commentaries, and official documents. We have specifically concentrated on how CSRs affect assessments of benefits, harms, and the benefit-to-harm balance, and other factors that affect it. In Part 1, we discuss the history of the development of CSRs, their contents and structure, definitions of CSRs and qualifying terms, and relevant terminology (including the availability of CSRs, data sharing systems, and transparency and confidentiality). CONCLUSIONS: Our conclusions are listed in Part 2 of this review.