Pre-implementation planning for a new personalised, dementia post-diagnostic support intervention: exploring the perspective of professional stakeholders.

BACKGROUND: Only a third of people with dementia receive a diagnosis and post-diagnostic support. An eight session, manualised, modular post-diagnostic support system (New Interventions for Independence in Dementia Study (NIDUS) - family), delivered remotely by non-clinical facilitators is the first scalable intervention to improve personalised goal attainment for people with dementia. It could significantly improve care quality. AIMS: We aimed to explore system readiness for NIDUS-family, a scalable, personalised post-diagnostic support intervention. METHOD: We conducted semi-structured interviews with professionals from dementia care services; the Consolidated Framework for Implementation Research guided interviews and their thematic analysis. RESULTS: From 2022 to 2023, we interviewed a purposive sample of 21 professionals from seven English National Health Service, health and social care services. We identified three themes: (1) potential value of a personalised intervention - interviewees perceived the capacity for choice and supporting person-centred care as relative advantages over existing resources; (2) compatibility and deliverability with existing systems - the NIDUS-family intervention model was perceived as compatible with service goals and clients' needs, but current service infrastructures, financing and commissioning briefs constraining resources to those at greatest need were seen as barriers to providing universal, post-diagnostic care; (3) fit with current workforce skills - the intervention model aligned well with staff development plans; delivery by non-clinically qualified staff was considered an advantage over current care options. CONCLUSIONS: Translating evidence for scalable and effective post-diagnostic care into practice will support national policies to widen access to support and upskill support workers, but requires a greater focus on prevention in commissioning briefs and resource planning.

New models of health and social care for people in later life: mapping of innovation in services in two regions of the United Kingdom using a mixed method approach.

BACKGROUND: Innovation for reforming health and social care is high on the policy agenda in the United Kingdom in response to the growing needs of an ageing population. However, information about new innovations of care being implemented is sparse. METHODS: We mapped innovations for people in later life in two regions, North East England and South East Scotland. Data collection included discussions with stakeholders (n = 51), semi-structured interviews (n = 14) and website searches that focused on technology, evaluation and health inequalities. We analysed qualitative data using framework and thematic analyses. Quantitative data were analysed descriptively. RESULTS: One hundred eleven innovations were identified across the two regions. Interviewees reported a wide range of technologies that had been rapidly introduced during the COVID-19 pandemic and many remained in use. Digital exclusion of certain groups of older people was an ongoing concern. Innovations fell into two groups; system-level ones that aimed to alleviate systems pressures such as preventing hospital (re)admissions, and patient-level ones which sought to enhance health and wellbeing directly. Interviewees were aware of the importance of health inequalities but lacked data to monitor the impact of innovations on these, and evaluation was challenging due to lack of time, training, and support. Quantitative findings revealed that two thirds of innovations (n = 74, 67%) primarily focused on the system level, whilst a third (n = 37, 33%) primarily focused on the patient-level. Overall, over half (n = 65, 59%) of innovations involved technologies although relatively few (n = 12, 11%) utilised advanced technologies. Very few (n = 16, 14%) focused on reducing health inequalities, and only a minority of innovations (n = 43, 39%) had undergone evaluation (most of which were conducted by the service providers themselves). CONCLUSIONS: We found a wide range of innovative care services being developed for people in later life, yet alignment with key policy priorities, such as addressing health inequalities, was limited. There was a strong focus on technology, with little consideration for the potential to widen the health inequality gap. The absence of robust evaluation was also a concern as most innovations were implemented without support to monitor effectiveness and/or without plans for sustainability and spread.

Comprehensive geriatric assessment for people with both COPD and frailty starting pulmonary rehabilitation: a mixed-methods feasibility trial.

Introduction: Many people with COPD experience frailty. Frailty increases risk of poor health outcomes, including non-completion of pulmonary rehabilitation. Integrated approaches to support people with COPD and frailty throughout and following rehabilitation are indicated. The aim of the present study was to determine the feasibility of conducting a randomised controlled trial of integrating comprehensive geriatric assessment (CGA) for people with COPD and frailty starting pulmonary rehabilitation. Methods: A multicentre mixed-methods randomised controlled feasibility trial ("Breathe Plus"; ISRCTN13051922) was carried out. People with COPD, aged ≥50 years, Clinical Frailty Scale ≥5 and referred for pulmonary rehabilitation were randomised 1:1 to usual pulmonary rehabilitation, or pulmonary rehabilitation plus CGA. Remote intervention delivery was used during COVID-19 restrictions. Outcomes (physical, psychosocial, service use) were measured at baseline, 90 and 180 days, alongside process data and qualitative interviews. Results: Recruitment stopped at 31 participants (mean±sd age 72.4±10.1 years, 68% Medical Research Council Dyspnoea Scale 4-5), due to COVID-19-related disruptions. Recruitment (46% eligible recruited) and retention (87% at 90- and 180-day follow-up) were acceptable. CGAs occurred on average 60.5 days post-randomisation (range 8-129) and prompted 46 individual care recommendations (median 3 per participant, range 0-12), 65% of which were implemented during follow-up. The most common domains addressed during CGA were nutrition and cardiovascular health. Participants valued the holistic approach of CGA but questioned the optimal time to introduce it. Conclusion: Integrating CGA alongside pulmonary rehabilitation is feasible and identifies unmet multidimensional need in people with COPD and frailty. Given challenges around timing and inclusivity, the integration of geriatric and respiratory care should not be limited to rehabilitation services.

Using Palliative Care Needs Rounds in the UK for care home staff and residents: an implementation science study.

Background: Care home residents often lack access to end-of-life care from specialist palliative care providers. Palliative Care Needs Rounds, developed and tested in Australia, is a novel approach to addressing this. Objective: To co-design and implement a scalable UK model of Needs Rounds. Design: A pragmatic implementation study using the integrated Promoting Action on Research Implementation in Health Services framework. Setting: Implementation was conducted in six case study sites (England, n = 4, and Scotland, n = 2) encompassing specialist palliative care service working with three to six care homes each. Participants: Phase 1: interviews (n = 28 care home staff, specialist palliative care staff, relatives, primary care, acute care and allied health practitioners) and four workshops (n = 43 care home staff, clinicians and managers from specialist palliative care teams and patient and public involvement and engagement representatives). Phase 2: interviews (n = 58 care home and specialist palliative care staff); family questionnaire (n = 13 relatives); staff questionnaire (n = 171 care home staff); quality of death/dying questionnaire (n = 81); patient and public involvement and engagement evaluation interviews (n = 11); fidelity assessment (n = 14 Needs Rounds recordings). Interventions: (1) Monthly hour-long discussions of residents' physical, psychosocial and spiritual needs, alongside case-based learning, (2) clinical work and (3) relative/multidisciplinary team meetings. Main outcome measures: A programme theory describing what works for whom under what circumstances with UK Needs Rounds. Secondary outcomes focus on health service use and cost effectiveness, quality of death and dying, care home staff confidence and capability, and the use of patient and public involvement and engagement. Data sources: Semistructured interviews and workshops with key stakeholders from the six sites; capability of adopting a palliative approach, quality of death and dying index, and Canadian Health Care Evaluation Project Lite questionnaires; recordings of Needs Rounds; care home data on resident demographics/health service use; assessments and interventions triggered by Needs Rounds; semistructured interviews with academic and patient and public involvement and engagement members. Results: The programme theory: while care home staff experience workforce challenges such as high turnover, variable skills and confidence, Needs Rounds can provide care home and specialist palliative care staff the opportunity to collaborate during a protected time, to plan for residents' last months of life. Needs Rounds build care home staff confidence and can strengthen relationships and trust, while harnessing services' complementary expertise. Needs Rounds strengthen understandings of dying, symptom management, advance/anticipatory care planning and communication. This can improve resident care, enabling residents to be cared for and die in their preferred place, and may benefit relatives by increasing their confidence in care quality. Limitations: COVID-19 restricted intervention and data collection. Due to an insufficient sample size, it was not possible to conduct a cost-benefit analysis of Needs Rounds or calculate the treatment effect or family perceptions of care. Conclusions: Our work suggests that Needs Rounds can improve the quality of life and death for care home residents, by enhancing staff skills and confidence, including symptom management, communications with general practitioners and relatives, and strengthen relationships between care home and specialist palliative care staff. Future work: Conduct analysis of costs-benefits and treatment effects. Engagement with commissioners and policy-makers could examine integration of Needs Rounds into care homes and primary care across the UK to ensure equitable access to specialist care. Study registration: This study is registered as ISRCTN15863801. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR128799) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 19. See the NIHR Funding and Awards website for further award information.

Care home residents often lack access to end-of-life care from hospice teams and so may experience distressing symptoms at end of life if care home staff cannot fully meet their needs. We examined how an approach which worked well in Australia called 'Palliative Care Needs Rounds' (or 'Needs Rounds') could be used in the United Kingdom. We interviewed 28 people (care home staff, hospice staff and other National Health Service/social care professionals in the community) about their understanding of the United Kingdom setting, what might help trigger change and what results they would want. We discussed these interviews at online workshops with 43 people, where we started to develop a theory of 'what would work, for whom, under what circumstances' and determine what United Kingdom Needs Rounds would look like. Six specialist palliative care services, each partnered with three to six local care homes, used Needs Rounds for a year. We collected information on care home residents, staff experiences of using Needs Rounds, relatives' perceptions of care quality, staff views of residents' quality of death, and on their ability to provide a palliative approach to residents. We found that Needs Rounds can provide care home staff and specialist palliative care staff the opportunity to work together during a protected time, to plan for residents' last months of life. Needs Rounds build care home staff confidence and can strengthen relationships and trust, while using each services' expertise. Needs Rounds strengthen understandings of dying, symptom management, advance/anticipatory care planning and communication between care home staff, families, specialist palliative care staff and primary care. This improves the quality of resident care, enabling residents to be cared for and die in their preferred place, and also benefits relatives by increasing their confidence in care quality.

Overarching Priorities for Health and Care Research in the United Kingdom: A Coproduced Synthesis of James Lind Alliance 'Top 10s'.

INTRODUCTION: James Lind Alliance (JLA) Priority Setting Partnerships (PSPs) produce 'Top 10' lists of health and care research priorities through a structured, shared decision-making process with patients or service users, carers and health or care professionals who identify questions that are most important to them. To date, over 150 PSPs in different areas of health and care have published research priorities. Some PSPs share similar priorities, which could be combined, promoted and addressed through collaborative research to increase value and reduce research waste. AIM: The aim of this study was to identify overarching themes common to JLA PSP priorities across different areas of health and care. METHODS: Our analysis included 'Top 10' research priorities produced by UK-based JLA PSPs between 2016 and 2020. The priorities were coded deductively by the Health Research Classification System (HRCS) health category and research activity. We then carried out online workshops with patients, service users and carers to generate new codes not already captured by this framework. Within each code, multistakeholder inductive thematic analysis was used to identify overarching themes, defined as encompassing priorities from three or more PSPs covering two or more health categories. We used codesign methods to produce an interactive tool for end users to navigate the overarching themes. RESULTS: Five hundred and fifteen research priorities from 51 PSPs were included in our analysis. The priorities together encompassed 20 of 21 HRCS health categories, the most common being 'generic health relevance' (22%), 'mental health' (18%) and 'musculoskeletal' (14%). We identified 89 overarching themes and subthemes, which we organised into a hierarchy with seven top-level themes: quality of life, caregivers and families, causes and prevention, screening and diagnosis, treatment and management, services and systems and social influences and impacts. CONCLUSION: There are many overarching themes common to research priorities across multiple areas of health and care. To facilitate new research and research funding, we have developed an interactive tool to help researchers, funders and patients or service users to explore these priority topics. This is freely available to download online. PATIENT OR PUBLIC CONTRIBUTION: Patients or service users and carers were involved throughout the study, including deciding the aims, designing the study, analysing priorities to identify themes, interpreting and reporting the findings.

GP workforce sustainability to maximise effective and equitable patient care: a realist review of what works, for whom and in what circumstances?

BACKGROUND: UK general practice has been described as being in crisis. A shortage and exodus of GPs is an urgent and challenging problem, attracting significant media attention, widespread public debate, and policy action. AIM: Our review aims to examine which aspects of the healthcare system affect GP workforce sustainability, how, why, and for whom. METHOD: A realist review is an interpretive, theory-driven approach to evidence synthesis, that brings together data from quantitative, qualitative, mixed methods research, and the wider grey literature (e.g., policy documentation). Using this data allows us to examine a diverse range of evidence with a clear focus on understanding factors which support (or hinder) GP workforce sustainability, how these are shaped by contexts, and the mechanisms that underpin them. We identify important individual and system-level contexts that may be amenable to change. RESULTS: We present our emerging findings in the form of a programme theory which explores human connection with patients, colleagues, and across organisations, gaining intellectual enrichment and learning systems comprising socially-situated knowledge. Relational continuity is key across these, supporting GP workforce sustainability. Challenges include standardisation, alienation and professional loneliness, inflexible organisation, and restrictive technologies. CONCLUSION: Our research generates new knowledge about the interdependencies between contexts, mechanisms, and outcomes. The findings can inform strategies and interventions intended to support, facilitate, and assist the GP workforce in delivering equitable and effective patient care. We identify critical gaps in knowledge and prioritise the expectations for scope and nature of future GP work and retention strategies.

DECIDE (Diverse experiences of End-of-Life Care for Dementia) establishing consensus and capacity for future research through collaboration and co-production.

BACKGROUND: Dementia is a leading cause of death globally. However, end-of-life care is often poor or non-existent. People with dementia from ethnic minorities or socioeconomically deprived communities are even less likely to receive good palliative care. Despite this, research into end-of-life care often fails to include people from these populations. AIM: To find out what research is required to improve end-of-life care for everyone with dementia and how to facilitate inclusivity. METHOD: A scoping review of the academic literature (Medline, CINAHL, EMBASE, PsycInfo and Scopus databases) published between Jan 2000 and April 2023 was conducted. Findings were shared with diverse key stakeholders through a series of workshops. Conclusions were subsequently used to provide evidence-based recommendations for inclusive end-of-life care and future research. RESULTS: Themes from the literature were evident in the personal and professional experiences of key stakeholders. Palliative care providers are often ignorant of the needs of those dying in the margins. Support services are scarce and unequal geographically. There is a lack of personalised and culturally appropriate care for those with dementia and their families. Themes from the stakeholder groups included a need for better communication between services, and more investment into dementia as a palliative condition, with avenues created to increase trust and facilitate engagement with services. CONCLUSION: Future research should focus on educational strategies, including how optimal end-of-life care differs for those with dementia compared to other life-limiting conditions, with appropriate models of inclusive, appropriately funded care needed.

The cost-effectiveness of procalcitonin for guiding antibiotic prescribing in individuals hospitalized with COVID-19: part of the PEACH study.

BACKGROUND: Many hospitals introduced procalcitonin (PCT) testing to help diagnose bacterial coinfection in individuals with COVID-19, and guide antibiotic decision-making during the COVID-19 pandemic in the UK. OBJECTIVES: Evaluating cost-effectiveness of using PCT to guide antibiotic decisions in individuals hospitalized with COVID-19, as part of a wider research programme. METHODS: Retrospective individual-level data on patients hospitalized with COVID-19 were collected from 11 NHS acute hospital Trusts and Health Boards from England and Wales, which varied in their use of baseline PCT testing during the first COVID-19 pandemic wave. A matched analysis (part of a wider analysis reported elsewhere) created groups of patients whose PCT was/was not tested at baseline. A model was created with combined decision tree/Markov phases, parameterized with quality-of-life/unit cost estimates from the literature, and used to estimate costs and quality-adjusted life years (QALYs). Cost-effectiveness was judged at a £20 000/QALY threshold. Uncertainty was characterized using bootstrapping. RESULTS: People who had baseline PCT testing had shorter general ward/ICU stays and spent less time on antibiotics, though with overlap between the groups' 95% CIs. Those with baseline PCT testing accrued more QALYs (8.76 versus 8.62) and lower costs (£9830 versus £10 700). The point estimate was baseline PCT testing being dominant over no baseline testing, though with uncertainty: the probability of cost-effectiveness was 0.579 with a 1 year horizon and 0.872 with a lifetime horizon. CONCLUSIONS: Using PCT to guide antibiotic therapy in individuals hospitalized with COVID-19 is more likely to be cost-effective than not, albeit with uncertainty.

General practitioner workforce sustainability to maximise effective and equitable patient care: a realist review protocol.

INTRODUCTION: There are not enough general practitioners (GPs) in the UK National Health Service. This problem is worse in areas of the country where poverty and underinvestment in health and social care mean patients experience poorer health compared with wealthier regions. Encouraging more doctors to choose and continue in a GP career is a government priority. This review will examine which aspects of the healthcare system affect GP workforce sustainability, how, why and for whom. METHODS AND ANALYSIS: A realist review is a theory-driven interpretive approach to evidence synthesis, that brings together qualitative, quantitative, mixed-methods research and grey literature. We will use a realist approach to synthesise data from the available published literature to refine an evidence-based programme theory that will identify the important contextual factors and underlying mechanisms that underpin observed outcomes relating to GP workforce sustainability. Our review will follow Pawson's five iterative stages: (1) finding existing theories, (2) searching for evidence, (3) article selection, (4) data extraction and (5) synthesising evidence and drawing conclusions. We will work closely with key stakeholders and embed patient and public involvement throughout the review process to refine the focus of the review and enhance the impact and relevance of our research. ETHICS AND DISSEMINATION: This review does not require formal ethical approval as it draws on secondary data from published articles and grey literature. Findings will be disseminated through multiple channels, including publication in peer-reviewed journals, at national and international conferences, and other digital scholarly communication tools such as video summaries, X and blog posts. PROSPERO REGISTRATION NUMBER: CRD42023395583.

Negotiating pace, focus and identities: Patient/public involvement/engagement in a palliative care study.

Patient and public involvement and engagement (PPIE) is an increasingly important component of research conduct to enhance processes and potential for impact, yet is rarely critically interrogated. This paper draws on Foucauldian analysis to highlight the disciplinary powers and tensions arising in PPIE. The paper draws on a nested evaluation interview study with three PPIE members and eight academics, who had been involved in an implementation science study focused on palliative care. PPIE members were involved in the whole study and are co-authors of this article. Through shared values and commitments to the study, a team culture of equality was developed. Yet while power was dispersed and taken-up by all team members, in so doing a self-governance approach within the team was developed. The pace and focus of discussions was at times more subjugating than co-production. Identities and positions were porous; the simplistic division of 'academic' and 'PPIE' did not stand up to scrutiny, with an increasing blurring of boundaries as people's experiences and insights changed over time. Continual, subtle, negotiations of roles, inputs and identities were manifest throughout the project. PPIE in research involves subtle, complex and ongoing disciplinary practices enacted by all members of the team.

Improving the Detection, Assessment, Management and Prevention of Delirium in Hospices (the DAMPen-D study): Feasibility study of a flexible and scalable implementation strategy to deliver guideline-adherent delirium care.

BACKGROUND: Delirium is a complex condition, stressful for all involved. Although highly prevalent in palliative care settings, it remains underdiagnosed and associated with poor outcomes. Guideline-adherent delirium care may improve its detection, assessment and management. AIM: To inform a future definitive study that tests whether an implementation strategy designed to improve guideline-adherent delirium care in palliative care settings improves patient outcomes (reduced proportion of in-patient days with delirium). DESIGN: With Patient Involvement members, we conducted a feasibility study to assess the acceptability of and engagement with the implementation strategy by hospice staff (intervention), and whether clinical record data collection of process (e.g. guideline-adherent delirium care) and clinical outcomes (evidence of delirium using a validated chart-based instrument;) pre- and 12-weeks post-implementation of the intervention would be possible. SETTING/PARTICIPANTS: In-patient admissions in three English hospices. RESULTS: Between June 2021 and December 2022, clinical record data were extracted from 300 consecutive admissions. Despite data collection during COVID-19, target clinical record data collection (n = 300) was achieved. Approximately two-thirds of patients had a delirium episode during in-patient stay at both timepoints. A 6% absolute reduction in proportion of delirium days in those with a delirium episode was observed. Post-implementation improvements in guideline-adherent metrics include: clinical delirium diagnosis 15%-28%; delirium risk assessment 0%-16%; screening on admission 7%-35%. CONCLUSIONS: Collection of data on delirium outcomes and guideline-adherence from clinical records is feasible. The signal of patient benefit supports formal evaluation in a large-scale study.

Feasibility and acceptability of NIDUS-professional, a training and support intervention for homecare workers caring for clients living with dementia: a cluster-randomised feasibility trial.

INTRODUCTION: In the first randomised controlled trial of a dementia training and support intervention in UK homecare agencies, we aimed to assess: acceptability of our co-designed, manualised training, delivered by non-clinical facilitators; outcome completion feasibility; and costs for a future trial. METHODS: This cluster-randomised (2:1) single-blind, feasibility trial involved English homecare agencies. Intervention arm agency staff were offered group videocall sessions: 6 over 3 months, then monthly for 3 months (NIDUS-professional). Family carers (henceforth carers) and clients with dementia (dyads) were offered six to eight complementary, individual intervention sessions (NIDUS-Family). We collected potential trial measures as secondary outcomes remotely at baseline and 6 months: HCW (homecare worker) Work-related Strain Inventory (WRSI), Sense of Competence (SoC); proxy-rated Quality of Life (QOL), Disability Assessment for Dementia scale (DAD), Neuropsychiatric Inventory (NPI) and Homecare Satisfaction (HCS). RESULTS: From December 2021 to September 2022, we met agency (4 intervention, 2 control) and HCWs (n = 62) recruitment targets and recruited 16 carers and 16/60 planned clients. We met a priori progression criteria for adherence (≥4/6 sessions: 29/44 [65.9%,95% confidence interval (CI): 50.1,79.5]), HCW or carer proxy-outcome completion (15/16 (93.8% [69.8,99.8]) and proceeding with adaptation for HCWs outcome completion (46/63 (73.0% [CI: 60.3,83.4]). Delivery of NIDUS-Professional costs was £6,423 (£137 per eligible client). WRSI scores decreased and SoC increased at follow-up, with no significant between-group differences. For intervention arm proxy-rated outcomes, carer-rated QOL increased, HCW-rated was unchanged; carer and HCW-rated NPI decreased; DAD decreased (greater disability) and HCS was unchanged. CONCLUSION: A pragmatic trial is warranted; we will consider using aggregated, agency-level client outcomes, including neuropsychiatric symptoms.

Strategies used for childhood chronic functional constipation: the SUCCESS evidence synthesis.

Background: Up to 30% of children have constipation at some stage in their life. Although often short-lived, in one-third of children it progresses to chronic functional constipation, potentially with overflow incontinence. Optimal management strategies remain unclear. Objective: To determine the most effective interventions, and combinations and sequences of interventions, for childhood chronic functional constipation, and understand how they can best be implemented. Methods: Key stakeholders, comprising two parents of children with chronic functional constipation, two adults who experienced childhood chronic functional constipation and four health professional/continence experts, contributed throughout the research. We conducted pragmatic mixed-method reviews. For all reviews, included studies focused on any interventions/strategies, delivered in any setting, to improve any outcomes in children (0-18 years) with a clinical diagnosis of chronic functional constipation (excluding studies of diagnosis/assessment) included. Dual reviewers applied inclusion criteria and assessed risk of bias. One reviewer extracted data, checked by a second reviewer. Scoping review: We systematically searched electronic databases (including Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature) (January 2011 to March 2020) and grey literature, including studies (any design) reporting any intervention/strategy. Data were coded, tabulated and mapped. Research quality was not evaluated. Systematic reviews of the evidence of effectiveness: For each different intervention, we included existing systematic reviews judged to be low risk of bias (using the Risk of Bias Assessment Tool for Systematic Reviews), updating any meta-analyses with new randomised controlled trials. Where there was no existing low risk of bias systematic reviews, we included randomised controlled trials and other primary studies. The risk of bias was judged using design-specific tools. Evidence was synthesised narratively, and a process of considered judgement was used to judge certainty in the evidence as high, moderate, low, very low or insufficient evidence. Economic synthesis: Included studies (any design, English-language) detailed intervention-related costs. Studies were categorised as cost-consequence, cost-effectiveness, cost-utility or cost-benefit, and reporting quality evaluated using the consensus health economic criteria checklist. Systematic review of implementation factors: Included studies reported data relating to implementation barriers or facilitators. Using a best-fit framework synthesis approach, factors were synthesised around the consolidated framework for implementation research domains. Results: Stakeholders prioritised outcomes, developed a model which informed evidence synthesis and identified evidence gaps. Scoping review: 651 studies, including 190 randomised controlled trials and 236 primary studies, conservatively reported 48 interventions/intervention combinations. Effectiveness systematic reviews: studies explored service delivery models (n = 15); interventions delivered by families/carers (n = 32), wider children's workforce (n = 21), continence teams (n = 31) and specialist consultant-led teams (n = 42); complementary therapies (n = 15); and psychosocial interventions (n = 4). One intervention (probiotics) had moderate-quality evidence; all others had low to very-low-quality evidence. Thirty-one studies reported evidence relating to cost or resource use; data were insufficient to support generalisable conclusions. One hundred and six studies described implementation barriers and facilitators. Conclusions: Management of childhood chronic functional constipation is complex. The available evidence remains limited, with small, poorly conducted and reported studies. Many evidence gaps were identified. Treatment recommendations within current clinical guidelines remain largely unchanged, but there is a need for research to move away from considering effectiveness of single interventions. Clinical care and future studies must consider the individual characteristics of children. Study registration: This study is registered as PROSPERO CRD42019159008. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 128470) and is published in full in Health Technology Assessment; Vol. 28, No. 5. See the NIHR Funding and Awards website for further award information.

Between 5% and 30% of children experience constipation at some stage. In one-third of these children, this progresses to chronic functional constipation. Chronic functional constipation affects more children with additional needs. We aimed to find and bring together published information about treatments for chronic functional constipation, to help establish best treatments and treatment combinations. We did not cover assessment or diagnosis of chronic functional constipation. This project was guided by a 'stakeholder group', including parents of children with constipation, people who experienced constipation as children, and healthcare professionals/continence experts. We carried out a 'scoping review' and a series of 'systematic reviews'. Our 'scoping review' provides an overall picture of research about treatments, with 651 studies describing 48 treatments. This helps identify important evidence gaps. 'Systematic reviews' are robust methods of bringing together and interpreting research evidence. Our stakeholder group decided to structure our systematic reviews to reflect who delivered the interventions. We brought together evidence about how well treatments worked when delivered by families/carers (32 studies), the wider children's workforce (e.g. general practitioner, health visitor) (21 studies), continence teams (31 studies) or specialist consultant-led teams (42 studies). We also considered complementary therapies (15 studies) and behavioural strategies (4 studies). Care is affected by what is done and how it is done. We brought together evidence about different models of delivering care (15 studies), barriers and facilitators to implementation of treatments (106 studies) and costs (31 studies). Quality of evidence was mainly low to very low. Despite numerous studies, there was often insufficient information to support generalisable conclusions. Our findings generally agreed with current clinical guidelines. Management of childhood chronic functional constipation should be child-centred, multifaceted and adapted according to the individual child, their needs, the situation in which they live and the health-care setting in which they are looked after. Research is needed to address our identified evidence gaps.

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.

A psychosocial goal-setting and manualised support intervention for independence in dementia (NIDUS-Family) versus goal setting and routine care: a single-masked, phase 3, superiority, randomised controlled trial.

BACKGROUND: Although national guidelines recommend that everyone with dementia receives personalised post-diagnostic support, few do. Unlike previous interventions that improved personalised outcomes in people with dementia, the NIDUS-Family intervention is fully manualised and deliverable by trained and supervised, non-clinical facilitators. We aimed to investigate the effectiveness of home-based goal setting plus NIDUS-Family in supporting the attainment of personalised goals set by people with dementia and their carers. METHODS: We did a two-arm, single-masked, multi-site, randomised, clinical trial recruiting patient-carer dyads from community settings. We randomly assigned dyads to either home-based goal setting plus NIDUS-Family or goal setting and routine care (control). Randomisation was blocked and stratified by site (2:1; intervention to control), with allocations assigned via a remote web-based system. NIDUS-Family is tailored to goals set by dyads by selecting modules involving behavioural interventions, carer support, psychoeducation, communication and coping skills, enablement, and environmental adaptations. The intervention involved six to eight video-call or telephone sessions (or in person when COVID-19-related restrictions allowed) over 6 months, then telephone follow-ups every 2-3 months for 6 months. The primary outcome was carer-rated goal attainment scaling (GAS) score at 12 months. Analyses were done by intention to treat. This trial is registered with the ISRCTN registry, ISRCTN11425138. FINDINGS: Between April 30, 2020, and May 9, 2021, we assessed 1083 potential dyads for eligibility, 781 (72·1%) of whom were excluded. Of 302 eligible dyads, we randomly assigned 98 (32·4%) to the control group and 204 (67·5%) to the intervention group. The mean age of participants with dementia was 79·9 years (SD 8·2), 169 (56%) were women, and 133 (44%) were men. 247 (82%) dyads completed the primary outcome, which favoured the intervention (mean GAS score at 12 months 58·7 [SD 13·0; n=163] vs 49·0 [14·1; n=84]; adjusted difference in means 10·23 [95% CI 5·75-14·71]; p<0·001). 31 (15·2%) participants in the intervention group and 14 (14·3%) in the control group experienced serious adverse events. INTERPRETATION: To our knowledge, NIDUS-Family is the first readily scalable intervention for people with dementia and their family carers that improves attainment of personalised goals. We therefore recommend that it be implemented in health and care services. FUNDING: UK Alzheimer's Society.

Developing a model for decision-making around antibiotic prescribing for patients with COVID-19 pneumonia in acute NHS hospitals during the first wave of the COVID-19 pandemic: qualitative results from the Procalcitonin Evaluation of Antibiotic use in COVID-19 Hospitalised patients (PEACH Study).

OBJECTIVE: To explore and model factors affecting antibiotic prescribing decision-making early in the pandemic. DESIGN: Semistructured qualitative interview study. SETTING: National Health Service (NHS) trusts/health boards in England and Wales. PARTICIPANTS: Clinicians from NHS trusts/health boards in England and Wales. METHOD: Individual semistructured interviews were conducted with clinicians in six NHS trusts/health boards in England and Wales as part of the Procalcitonin Evaluation of Antibiotic use in COVID-19 Hospitalised patients study, a wider study that included statistical analysis of procalcitonin (PCT) use in hospitals during the first wave of the pandemic. Thematic analysis was used to identify key factors influencing antibiotic prescribing decisions for patients with COVID-19 pneumonia during the first wave of the pandemic (March to May 2020), including how much influence PCT test results had on these decisions. RESULTS: During the first wave of the pandemic, recommendations to prescribe antibiotics for patients with COVID-19 pneumonia were based on concerns about secondary bacterial infections. However, as clinicians gained more experience with COVID-19, they reported increasing confidence in their ability to distinguish between symptoms and signs caused by SARS-CoV-2 viral infection alone, and secondary bacterial infections. Antibiotic prescribing decisions were influenced by factors such as clinician experience, confidence, senior support, situational factors and organisational influences. A decision-making model was developed. CONCLUSION: This study provides insight into the decision-making process around antibiotic prescribing for patients with COVID-19 pneumonia during the first wave of the pandemic. The importance of clinician experience and of senior review of decisions as factors in optimising antibiotic stewardship is highlighted. In addition, situational and organisational factors were identified that could be optimised. The model presented in the study can be used as a tool to aid understanding of the complexity of the decision-making process around antibiotic prescribing and planning antimicrobial stewardship support in the context of a pandemic. TRIAL REGISTRATION NUMBER: ISRCTN66682918.