Research ethics and collaborative research in health and social care: Analysis of UK research ethics policies, scoping review of the literature, and focus group study.

Current research ethics frameworks were developed on the footprint of biomedical, experimental research and present several pitfalls when applied to non-experimental social sciences. This work explores how the normative principles underpinning policy and regulatory frameworks of research ethics and the related operational processes work in practice in the context of collaborative health and social care research. The work was organised in three phases. First, UK research ethics policy documents were analysed thematically, with themes further organised under the categories of 'Principles' and 'Processes'. Next, we conducted a scoping review of articles about research ethics in the context of collaborative health and social care research, published in English between 2010 and 2022. We then held an exploratory focus group with ten academic researchers with relevant experience to gather their views on how the research ethics system works in practice in England (UK). The thematic framework developed in the first phase supported the analysis of the articles included in the scoping review and of focus group data. The analysis of policy documents identified twelve themes. All were associated to both a principle and a related operational process. The scoping review identified 31 articles. Across these, some themes were barely acknowledged (e.g., Compliance with legislation). Other themes were extensively covered (e.g., The working of Research Ethics Committees), often to discuss issues and limitations in how, in practice, the research ethics system and its processes deal with collaborative research and to suggest options for improvement. Focus group data were largely consistent with the findings of the scoping review. This work provides evidence of the poor alignment between how the research ethics system is normatively expected to work and how it works in practice and offers options that could make research ethics more fit for purpose when addressing collaborative research in health and social care.

Pathways to care for people with dementia in India: An exploratory study using case vignettes.

BACKGROUND: Limited evidence exists on how people living with dementia and their family/unpaid carers navigate care and support in India. AIM: This study used case vignettes to illustrate likely pathways to care for dementia, from receiving a diagnosis to long-term support, in India and to highlight gaps and challenges associated with current care provision for persons living with dementia. METHODS: As part of the Strengthening Responses to Dementia in Developing Countries (STRiDE) project, and to contribute to an analysis of dementia care policies and systems in India, case vignettes were used to illustrate the diverse situations that people with dementia and their families may experience when seeking care in the Indian context. Eight hypothetical, but realistic cases of people with dementia were created by a multi-disciplinary team with experience in dementia care in India, to map out the likely care journeys of each case. RESULTS: Investigating eight diverse care trajectories of people living with dementia highlighted important patterns relevant to the Indian context. We identified delays in dementia diagnosis to be attributed to low awareness of dementia among the general public and medical professionals in addition to a critical shortage of specialist services involved in facilitating dementia diagnosis. Post-diagnosis, support was recognized as limited and associated with considerable out-of-pocket (OOP) costs. Families primarily provide long-term care for people with dementia till end of life. CONCLUSIONS AND RECOMMENDATIONS: Several steps need to be taken in order to improve dementia care in India. Increasing dementia awareness among both medical professionals and general public is essential. Shortages in dementia specialists can be addressed in part through appropriate task shifting. Lastly, more research is needed to develop evidence-based community interventions to support informal care provision for persons with dementia in India.

Accessing Dementia Care in Brazil: An Analysis of Case Vignettes.

BACKGROUND AND OBJECTIVES: Despite the rapid increase in the number of people living with dementia in Brazil, dementia care is limited. This study describes how people living with dementia and their carers access care, treatment, and support, and identifies what characteristics are likely to enable or prevent access. RESEARCH DESIGN AND METHODS: We created 10 vignettes to illustrate fictitious but realistic scenarios involving people living with dementia in Brazil. The vignettes explore a combination of socioeconomic and demographic variables. They were completed using an in-depth desk review of the dementia care landscape in Brazil; a Strengths, Opportunities, Weaknesses, and Threats (SWOT) analysis of the desk review; and expert knowledge. The analysis focused on identifying common sources of service provision, barriers of access to care and support, and specific issues experienced by some population groups. FINDINGS: Access to a dementia diagnosis, care, and support for people living with dementia in Brazil is limited. Demographic and socio-economic circumstances play a role in determining the type of services to which a person might have access. Poor knowledge about dementia, lack of capacity in the health system, and lack of formal long-term care support are among the identified barriers to accessing timely diagnosis, care, and support in the country. DISCUSSION AND IMPLICATIONS: Understanding the barriers and facilitators of access to diagnosis, treatment, and support for people with dementia and families with different demographic and socioeconomic characteristics is crucial for designing dementia policies that are context-specific and responsive to the care needs of different socioeconomic groups in Brazil.

Effectiveness-implementation hybrid type 2 study evaluating an intervention to support 'information work' in dementia care: an implementation study protocol.

INTRODUCTION: Patients with long-term conditions consistently report a lack of information around services and support available to them. This unmet need for information is significant among people with dementia and family carers. A quality improvement intervention is being carried out to tackle this issue as part of a co-creation initiative in the North East of England (UK). The intervention consists of the dissemination (via the local Community Mental Health Services for Older People) of a leaflet about services available to people with dementia and their family carers in the study site. This protocol is reported in accordance with the Standards for Reporting Implementation Studies. METHODS AND ANALYSIS: This effectiveness-implementation hybrid type 2 study aims at understanding (1) the unfolding and outcomes of the implementation strategy, (2) the outcomes of the intervention (for people with dementia and family carers, staff implementing the intervention and local service providers) and (3) the contribution of co-creation to the design and implementation of the intervention and its outcomes. The prospective theory of change of the intervention articulated by local stakeholders is used as a reference framework against which to assess the implementation and outcomes of the intervention. Evaluation data will be collected through in-depth interviews with people with dementia and family carers receiving the intervention, staff implementing the intervention and managers from local service providers. Referral data from local service providers will be collected to triangulate the interview data. A focus group with key stakeholders will support the sense-making of findings. The realist configuration of mechanism-context-outcome, operationalised using an information behaviour model, will inform data analysis and interpretation. ETHICS AND DISSEMINATION: Ethical and research governance approvals have been obtained from the West Midlands-South Birmingham Research Ethics Committee. The results of the study will be submitted for publication in peer-reviewed journals and disseminated through conferences.

A need-based, multi-level, cross-sectoral framework to explain variations in satisfaction of care needs among people living with dementia.

BACKGROUND: Provision of care and support for people with dementia and family carers is complex, given variation in how dementia manifests, progresses and affects people, co-morbidities associated with ageing, as well as individual preferences, needs, and circumstances. The traditional service-led approach, where individual needs are assessed against current service provision, has been recognised as unfit to meet such complexity. As a result, people with dementia and family members often fail to receive adequate support, with needs remaining unmet. Current research lacks a conceptual framework for explaining variation in satisfaction of care needs. This work develops a conceptual framework mapped onto the care delivery process to explain variations in whether, when and why care needs of people with dementia are met and to expose individual-, service-, system-level factors that enable or hinder needs satisfaction. METHODS: Data collected through 24 in-depth interviews and two focus groups (10 participants) with people with dementia and family carers living in the North East of England (UK) were analysed thematically to develop a typology of care needs. The need most frequently reported for people with dementia (i.e. for support to go out and about) was analysed using themes stemming from the conceptual framework which combined candidacy and discrepancy theories. RESULTS: The operationalisation of the framework showed that satisfaction of the need to go out was first determined at the point of service access, affected by issues about navigation, adjudication, permeability, users' resistance to offers, users' appearance, and systems-level operating conditions, and, subsequently, at the point of service use, when factors related to service structure and care process determined (dis)satisfaction with service and, hence, further contributed to met or unmet need. CONCLUSION: The conceptual framework pinpoints causes of variations in satisfaction of care needs which can be addressed when designing interventions and service improvements.

How valid are projections of the future prevalence of diabetes? Rapid reviews of prevalence-based and Markov chain models and comparisons of different models' projections for England.

OBJECTIVES: To examine validity of prevalence-based models giving projections of prevalence of diabetes in adults, in England and the UK, and of Markov chain models giving estimates of economic impacts of interventions to prevent type 2 diabetes (T2D). METHODS: Rapid reviews of both types of models. Estimation of the future prevalence of T2D in England by Markov chain models; and from the trend in the prevalence of diabetes, as reported in the Quality and Outcomes Framework (QOF), estimated by ordinary least squares regression analysis. SETTING: Adult population in England and UK. MAIN OUTCOME MEASURE: Prevalence of T2D in England and UK in 2025. RESULTS: The prevalence-based models reviewed use sample estimates of past prevalence rates by age and sex and projected population changes. Three most recent models, including that of Public Health England (PHE), neither take account of increases in obesity, nor report Confidence Intervals (CIs). The Markov chain models reviewed use transition probabilities between states of risk and death, estimated from various sources. None of their accounts give the full matrix of transition probabilities, and only a minority report tests of validation. Their primary focus is on estimating the ratio of costs to benefits of preventive interventions in those with hyperglycaemia, only one reported estimates of those developing T2D in the absence of a preventive intervention in the general population.Projections of the prevalence of T2D in England in 2025 were (in millions) by PHE, 3.95; from the QOF trend, 4.91 and by two Markov chain models, based on our review, 5.64 and 9.07. CONCLUSIONS: To inform national policies on preventing T2D, governments need validated models, designed to use available data, which estimate the scale of incidence of T2D and survival in the general population, with and without preventive interventions.

A scoping review protocol to map the evidence on interventions to prevent overweight and obesity in children.

INTRODUCTION: Obesity has become one of the biggest public health problems of the 21st century. Prevalence of obesity in children and adolescents has increased dramatically worldwide over the last 20 years, and this trend is expected to continue. Obesity in childhood is concerning as it predicts obesity in adulthood, a common risk factor for a wide array of chronic diseases and poor health outcomes. Obesity is preventable and a vast but fragmented body of evidence on preventative interventions is now available. This article outlines the protocol for a scoping review of published literature reviews on interventions to prevent obesity in children. The scoping review addresses the broad research question 'What is the evidence on interventions to prevent childhood obesity?'. It aims to give an overview of the various interventions available, understand those which are effective and identify barriers and facilitators to their effectiveness. METHODS AND ANALYSIS: The six-staged Arksey and O'Malley methodology framework is used to guide the scoping review process: following the definition of the research questions (stage 1); the eligibility criteria and search strategy are defined (stage 2); the study selection process based on the eligibility criteria identified will follow (stage 3); a framework developed for this review will then inform the extraction and charting of data from the included reviews (stage 4); results will be aggregated and summarised with criteria relevant for health professionals and policy-makers (stage 5); and the optional consultation (stage 6) exercise is not planned. ETHICS AND DISSEMINATION: Since the scoping review methodology aims at synthetising information from available publications, this study does not require ethical approval. An article reporting the results of the scoping review will be submitted for publication to a scientific journal, presented at relevant conferences and disseminated as part of future workshops with professionals involved in obesity prevention.

Using an epidemiological model to investigate unwarranted variation: the case of ventilation tubes for otitis media with effusion in England.

OBJECTIVES: To investigate unwarranted variation in ventilation tube insertions for otitis media with effusion in children in England. This procedure is known to be 'overused' from clinical audits, as only one in three ventilation tube insertions conforms to the appropriateness criteria of the National Institute for Health and Care Excellence (NICE); but audits cannot identify the scale of 'underuse' - i.e. patients who would benefit but are not treated. METHODS: To explore both 'underuse' and 'overuse' of ventilation tubes for otitis media with effusion, we developed an epidemiological model based on: definitions of children with otitis media with effusion expected to benefit from ventilation tubes according to NICE guidance; epidemiological and clinical information from a systematic review; and expert judgement. A range of estimates was derived using Monte Carlo simulation and compared with the number of ventilation tubes provided in the English National Health Service in 2010. RESULTS: About 32,200 children in England would be expected to benefit from ventilation tubes for otitis media with effusion per year (between 20,411 and 45,231 with 90% certainty). The observed number of ventilation tubes for otitis media with effusion-associated diagnoses was 16,824. CONCLUSIONS: The expected population capacity to benefit from ventilation tubes for otitis media with effusion based on NICE guidance appeared to exceed, by far, the number of ventilation tubes provided in the English National Health Service. So, while there is known 'overuse', there also may be substantial 'underuse' of ventilation tubes for otitis media with effusion if NICE criteria were applied. Future investigations of unwarranted variation should, therefore, not only focus on the patients who are treated but also consider the potential for benefit at the population level.