How can NHS trusts in England optimise strategies to improve the mental health and well-being of hospital doctors? The Care Under Pressure 3 (CUP3) realist evaluation study protocol.

INTRODUCTION: The growing incidence of mental ill health in doctors was a major issue in the UK and internationally, even prior to the COVID-19 pandemic. It has significant and far-reaching implications, including poor quality or inconsistent patient care, absenteeism, workforce attrition and retention issues, presenteeism, and increased risk of suicide. Existing approaches to workplace support do not take into account the individual, organisational and social factors contributing to mental ill health in doctors, nor how interventions/programmes might interact with each other within the workplace. The aim of this study is to work collaboratively with eight purposively selected National Health Service (NHS) trusts within England to develop an evidence-based implementation toolkit for all NHS trusts to reduce doctors' mental ill health and its impacts on the workforce. METHODS AND ANALYSIS: The project will incorporate three phases. Phase 1 develops a typology of interventions to reduce doctors' mental ill health. Phase 2 is a realist evaluation of the existing combinations of strategies being used by acute English healthcare trusts to reduce doctors' mental ill health (including preventative promotion of well-being), based on 160 interviews with key stakeholders. Phase 3 synthesises the insights gained through phases 1 and 2, to create an implementation toolkit that all UK healthcare trusts can use to optimise their strategies to reduce doctors' mental ill health and its impact on the workforce and patient care. ETHICS AND DISSEMINATION: Ethical approval has been granted for phase 2 of the project from the NHS Research Ethics Committee (REC reference number 22/WA/0352). As part of the conditions for our ethics approval, the sites included in our study will remain anonymous. To ensure the relevance of the study's outputs, we have planned a wide range of dissemination strategies: an implementation toolkit for healthcare leaders, service managers and doctors; conventional academic outputs such as journal manuscripts and conference presentations; plain English summaries; cartoons and animations; and a media engagement campaign.

Views and experiences of opioid access amongst palliative care providers and public representatives in a low-resource setting: A qualitative interview study.

Opioids (e.g. morphine) are affordable, effective interventions for cancer-related pain. However, equity of access to this key medication remains a global challenge, particularly in low- and middle-income countries. We aimed to explore views of palliative care providers and public-representatives about opioid analgesia access in two States in India. We conducted a qualitative study using semi-structured interviews. Transcribed audio-recordings were subjected to thematic analysis using a Framework Approach. Palliative care providers and public-representatives were purposively sampled from services reporting consistent opioid availability and prescribing (≥4kg per annum) from Karnataka and Kerala. Twenty participants (doctors (10), nurses (4), pharmacists (2), service managers (2) and public-representatives (2) were interviewed. Three themes were identified: 1) Attitudes and awareness: opioid treatments are perceived as end-of-life (last days/weeks) interventions; fears of addiction and misunderstanding of pain management goals limit access. 2) Expected and unexpected inequities: patients/carers from lower socioeconomic strata accept doctor recommendations if opioids are affordable, more educated patients/families have reservations about opioids, delay access and perceive expensive medicines as better. Non-palliative care specialist doctors have negative entrenched views and require specialist training. 3) Experiential learning-positive experiences can positively alter attitudes (e.g., participants in Kerala report improved attitudes, awareness and understanding influenced by exposure and community awareness, but experience can also reinforce perceptions as end-of-life care. Entrenched negative views are reinforced by poor experiences while positive experiences improve attitudes. To promote access, opioid prescribing must be needs-based rather than prognosis-based. Addressing the lack of training for non-palliative care workforce would help overcome a major barrier.

Evaluation of a complex intervention for prisoners with common mental health problems, near to and after release: the Engager randomised controlled trial.

BACKGROUND: Many male prisoners have significant mental health problems, including anxiety and depression. High proportions struggle with homelessness and substance misuse. AIMS: This study aims to evaluate whether the Engager intervention improves mental health outcomes following release. METHOD: The design is a parallel randomised superiority trial that was conducted in the North West and South West of England (ISRCTN11707331). Men serving a prison sentence of 2 years or less were individually allocated 1:1 to either the intervention (Engager plus usual care) or usual care alone. Engager included psychological and practical support in prison, on release and for 3-5 months in the community. The primary outcome was the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), 6 months after release. Primary analysis compared groups based on intention-to-treat (ITT). RESULTS: In total, 280 men were randomised out of the 396 who were potentially eligible and agreed to participate; 105 did not meet the mental health inclusion criteria. There was no mean difference in the ITT complete case analysis between groups (92 in each arm) for change in the CORE-OM score (1.1, 95% CI -1.1 to 3.2, P = 0.325) or secondary analyses. There were no consistent clinically significant between-group differences for secondary outcomes. Full delivery was not achieved, with 77% (108/140) receiving community-based contact. CONCLUSIONS: Engager is the first trial of a collaborative care intervention adapted for prison leavers. The intervention was not shown to be effective using standard outcome measures. Further testing of different support strategies for prison with mental health problems is needed.

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

INTRODUCTION: Delirium is a complex condition in which altered mental state and cognition causes severe distress and poor clinical outcomes for patients and families, anxiety and stress for the health professionals and support staff providing care, and higher care costs. Hospice patients are at high risk of developing delirium, but there is significant variation in care delivery. The primary objective of this study is to demonstrate the feasibility of an implementation strategy (designed to help deliver good practice delirium guidelines), participant recruitment and data collection. METHODS AND ANALYSIS: Three work packages in three hospices in the UK with public involvement in codesign, study management and stakeholder groups: (1) experience-based codesign to adapt an existing theoretically-informed implementation strategy (Creating Learning Environments for Compassionate Care (CLECC)) to implement delirium guidelines in hospices; (2) feasibility study to explore ability to collect demographic, diagnostic and delirium management data from clinical records (n=300), explanatory process data (number of staff engaged in CLECC activities and reasons for non-engagement) and cost data (staff and volunteer hours and pay-grades engaged in implementation activities) and (3) realist process evaluation to assess the acceptability and flexibility of the implementation strategy (preimplementation and postimplementation surveys with hospice staff and management, n=30 at each time point; interviews with hospice staff and management, n=15). Descriptive statistics, rapid thematic analysis and a realist logic of analysis will be used be used to analyse quantitative and qualitative data, as appropriate. ETHICS AND DISSEMINATION: Ethical approval obtained: Hull York Medical School Ethics Committee (Ref 21/23), Health Research Authority Research Ethics Committee Wales REC7 (Ref 21/WA/0180) and Health Research Authority Confidentiality Advisory Group (Ref 21/CAG/0071). Written informed consent will be obtained from interview participants. A results paper will be submitted to an open access peer-reviewed journal and a lay summary shared with study site staff and stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN55416525.

Housing as a Social Determinant of Health: Evidence from Singapore, the UK, and Kenya: the 3-D Commission.

Housing is a paradigmatic example of a social determinant of health, as it influences and is influenced by structural determinants, such as social, macroeconomic, and public policies, politics, education, income, and ethnicity/race, all intersecting to shaping the health and well-being of populations. It can therefore be argued that housing policy is critically linked to health policy. However, the extent to which this linkage is understood and addressed in public policies is limited and highly diverse across and within countries. This analysis seeks to describe the linkages between housing policies and health and well-being using examples from three countries at different levels of the wealth spectrum: Singapore, the UK, and Kenya.We conducted a comparative policy analysis across three country contexts (Singapore, the UK, and Kenya) to document the extent to which housing policies address health and well-being, highlighting commonalities and differences among them. To guide our analysis, we used the United Nations (UN) definition of adequate housing as it offers a broad framework to analyze the impact of housing on health and well-being.The anatomy of housing policies has a strong correlation to the provision of adequate housing across Singapore, the UK, and Kenya, especially for vulnerable groups. The paper demonstrates that contextual factors including population composition (i.e., aging versus youthful), political ideologies, legal frameworks (i.e., welfare versus market-based provision of housing), and presence (or absence) of adequate, quality, timely, reliable, robust data systems for decision-making, which are taken up by stakeholders/state, have strong implications of the type of housing policies developed and implemented, in turn directly and indirectly impacting the overall health and well-being of populations.This analysis demonstrates the value of viewing housing policies as public health policies that could significantly impact the health and well-being of populations, especially vulnerable groups. Moreover, the findings highlight the importance of the Health in All Policies approach to facilitate integrated policy responses to address social determinants of health such as housing. This is more critical than ever, given the context of the global pandemic that has led to worsening overall health and well-being.

Data, Social Determinants, and Better Decision-making for Health: the 3-D Commission.

More than a decade after the World Health Organization Commission on the Social Determinants of Health (SDoH), it is becoming widely accepted that social and economic factors, including but not limited to education, energy, income, race, ethnicity, and housing, are important drivers of health in populations. Despite this understanding, in most contexts, social determinants are not central to local, national, or global decision-making. Greater clarity in conceptualizing social determinants, and more specificity in measuring them, can move us forward towards better incorporating social determinants in decision-making for health. In this paper, first, we summarize the evolution of the social framing of health. Second, we describe how the social determinants are conceptualized and contextualized differently at the global, national, and local levels. With this, we seek to demonstrate the importance of analyzing and understanding SDoH relative to the contexts in which they are experienced. Third, we problematize the gap in data across contexts on different dimensions of social determinants and describe data that could be curated to better understand the influence of social determinants at the local and national levels. Fourth, we describe the necessity of using data to understand social determinants and inform decision-making to improve health. Our overall goal is to provide a path for our collective understanding of the foundational causes of health, facilitated by advances in data access and quality, and realized through improved decision-making.

Implementation of geriatric assessment in oncology settings: A systematic realist review.

Older adults with cancer are more likely to have worse clinical outcomes than their younger counterparts, and shared decision-making can be difficult, due to both complexity from adverse ageing and under-representation in clinical trials. Geriatric assessment (GA) has been increasingly recognised as a predictive and prehabilitative tool for older adults with cancer. However, GA has been notoriously difficult to implement in oncological settings due to workforce, economic, logistical, and practical barriers. We aimed to review the heterogenous literature on implementation of GA in oncology settings to understand the different implementation context configurations of GA and the mechanisms they trigger to enable successful implementation. A systematic realist review was undertaken in two stages: i) systematic searches with structured data extraction combined with iterative key stakeholder consultations to develop programme theories for implementing GA in oncology settings; ii) synthesis to refine programme theories. Medline, Embase, PsycInfo, Cochrane Library, CINAHL, Web of Science, Scopus, ASSIA, Epistemonikos, JBI Database of Systematic Reviews and Implementation Reports, DARE and Health Technology Assessment were searched. Four programme theories were developed from 53 included articles and 20 key stakeholder consultations addressing the major barriers of GA implementation in oncology practice: time (leveraging non-specialists), funding (creating favourable health economics), practicalities (establishing the use of GA in cancer care), and managing limited resources. We demonstrate that a whole system approach is required to improve the implementation of GA in cancer settings. This review will help inform policy decisions regarding implementation of GA and provide a basis for further implementation research.

Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial.

INTRODUCTION: The 'Engager' programme is a 'through-the-gate' intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost-effectiveness of the Engager intervention. METHODS AND ANALYSIS: The study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either: (a) the Engager intervention plus standard care (intervention group) or (b) standard care alone (control group) across two investigation centres (South West and North West of England). Two hundred and eighty prisoners meeting eligibility criteria will take part. Engager is a person-centred complex intervention delivered by practitioners and aimed at addressing offenders' mental health and social care needs. It comprises one-to-one support for participants prior to release from prison and for up to 20 weeks postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness. ETHICS AND DISSEMINATION: This study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015-283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations. TRIAL REGISTRATION NUMBER: ISRCTN11707331; Pre-results.

'Care Under Pressure': a realist review of interventions to tackle doctors' mental ill-health and its impacts on the clinical workforce and patient care.

INTRODUCTION: Mental ill-health is prevalent across all groups of health professionals and this is of great concern in many countries. In the UK, the mental health of the National Health Service (NHS) workforce is a major healthcare issue, leading to presenteeism, absenteeism and loss of staff from the workforce. Most interventions targeting doctors aim to increase their 'productivity' and 'resilience', placing responsibility for good mental health with doctors themselves and neglecting the organisational and structural contexts that may have a detrimental effect on doctors' well-being. There is a need for approaches that are sensitive to the contextual complexities of mental ill-health in doctors, and that do not treat doctors as a uniform body, but allow distinctions to account for particular characteristics, such as specialty, career stage and different working environments. METHODS AND ANALYSIS: Our project aims to understand how, why and in what contexts support interventions can be designed to minimise the incidence of doctors' mental ill-health. We will conduct a realist review-a form of theory-driven interpretative systematic review-of interventions, drawing on diverse literature sources. The review will iteratively progress through five steps: (1) locate existing theories; (2) search for evidence; (3) select articles; (4) extract and organise data and (5) synthesise evidence and draw conclusions. The analysis will summarise how, why and in what circumstances doctors' mental ill-health is likely to develop and what can remediate the situation. Throughout the project, we will also engage iteratively with diverse stakeholders in order to produce actionable theory. ETHICS AND DISSEMINATION: Ethical approval is not required for our review. Our dissemination strategy will be participatory. Tailored outputs will be targeted to: policy makers; NHS employers and healthcare leaders; team leaders; support organisations; doctors experiencing mental ill-health, their families and colleagues. PROSPERO REGISTRATION NUMBER: CRD42017069870.

Opportunities, challenges and concerns for the implementation and uptake of pelvic floor muscle assessment and exercises during the childbearing years: protocol for a critical interpretive synthesis.

BACKGROUND: Pregnancy and childbirth are important risk factors for urinary incontinence (UI) in women. Pelvic floor muscle exercises (PFME) are effective for prevention of UI. Guidelines for the management of UI recommend offering pelvic floor muscle training (PFMT) to women during their first pregnancy as a preventive strategy. The objective of this review is to understand the relationships between individual, professional, inter-professional and organisational opportunities, challenges and concerns that could be essential to maximise the impact of PFMT during childbearing years and to effect the required behaviour change. METHODS: Following systematic searches to identify sources for inclusion, we shall use a critical interpretive synthesis (CIS) approach to produce a conceptual model, mapping the relationships between individual, professional, inter-professional and organisational factors and the implementation, acceptability and uptake of PFME education, assessment and training during the childbearing years. Purposive sampling will be used to identify potentially relevant material relating to topics or areas of interest which emerge as the review progresses. A wide range of empirical and non-empirical sources will be eligible for inclusion to encompass the breadth of relevant individual, professional, inter-professional and organisational issues relating to PFME during childbearing years. Data analysis and synthesis will identify key themes, concepts, connections and relationships between these themes. Findings will be interpreted in relation to existing frameworks of implementation, attitudes and beliefs of individuals and behaviour change. We will collate examples to illustrate relationships expressed in the conceptual model and identify potential links between the model and drivers for change. DISCUSSION: The CIS review findings and resulting conceptual model will illustrate relationships between factors that might affect the implementation, acceptability and uptake of PFME education, assessment and training during the childbearing years. The model will inform the development and evaluation of a training package to support midwives with implementation and delivery of effective PFME during the antenatal period. The review forms part of the first phase of the United Kingdom National Institute for Health Research funded 'Antenatal Preventative Pelvic floor Exercises And Localisation (APPEAL)' programme (grant number: RP-PG-0514-20002) to prevent poor health linked to pregnancy and childbirth-related UI. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD42016042792.

The comparative diagnostic accuracy of the Mini Mental State Examination (MMSE) and the General Practitioner assessment of Cognition (GPCOG) for identifying dementia in primary care: a systematic review protocol.

BACKGROUND: Improved dementia identification is a global health priority, and general practitioners (GPs) are often the first point of contact for people with concerns about their cognition. However, GPs often express uncertainty in using assessment tools and the evidence based on which tests are most accurate in identifying dementia is unclear. In particular, there is little certainty around how the accuracy of available brief cognitive assessments compares within a clinical family practice setting.Grounded in existing brief cognitive assessment evidence, we will compare the diagnostic test accuracy of the Mini Mental State Examination (MMSE) to the General Practitioner Assessment of Cognition (GPCOG) against the best available reference standard when used within a family practice setting. METHODS: We will employ robust systematic review methods to assess studies of diagnostic accuracy where both the MMSE and GPCOG have been evaluated as direct comparisons, i.e. within the same study population. This approach will enable us to minimise between-study heterogeneity, to eliminate the risk of bias due to confounding and increase the opportunity to make clinically useful and useable comparisons of diagnostic accuracy across both the MMSE and GPCOG. This systematic review will be conducted using a pragmatic search strategy, refining searches that build upon studies identified as part of our overview of systematic reviews of the diagnostic accuracy of brief cognitive assessments for identifying dementia in primary care. DISCUSSION: Through this systematic review, we aim to improve existing evidence on how the diagnostic accuracy of MMSE and GPCOG compares when used to identify dementia within the family practice setting. We also aim to make clinical practice recommendations based upon the variations in diagnostic accuracy identified between the MMSE and GPCOG.

What approaches to social prescribing work, for whom, and in what circumstances? A protocol for a realist review.

BACKGROUND: The use of non-drug, non-health-service interventions has been proposed as a cost-effective alternative to help those with long-term conditions manage their illness and improve their health and well-being. Interventions typically involve accessing activities run by the third sector or community agencies and may also be described as non-medical referral, community referral or social prescribing. To be effective, patients need to be "transferred" from the primary care setting into the community and to maintain their participation in activities. However, it is not currently known how and why these approaches enable which people under what circumstances to reach community services that may benefit their health and well-being. METHODS: Database searches and extensive searching of grey sources will be carried out in an attempt to find evidence associated with referral and retention in social prescribing. After initial scoping searches, two main phases of searching will be conducted: (a) will focus on the identification of programme theories to illustrate how approaches to social prescribing work for different people and in different contexts and (b) will consist of targeted searches to locate evidence to refine these candidate theories into configurations of the contexts in which populations and the main mechanisms outcomes are achieved. Inclusion criteria will initially be broad in order to develop a clear picture of the ways in which social prescriptions might operate but may iteratively become more focused in response to initially identified evidence, for example, in terms of the population group. An expert advisory group consisting of professionals working in a range of organisations involved in social prescribing will be convened to check the approaches in the review and provide real-life experience of social prescribing. Findings from the review will be disseminated to commissioners, published in a peer-reviewed journal and used to help refine an intervention model for an outdoor nature-based group intervention. DISCUSSION: This realist review will explore why mechanisms of social prescribing work, for what groups of people and their impact on enrolment, attendance and adherence to programmes. The use of realist approaches to detail the social prescribing process is novel and will offer insights into effective transfer of patients. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016039491.

Interventions to improve antimicrobial prescribing of doctors in training: the IMPACT (IMProving Antimicrobial presCribing of doctors in Training) realist review.

INTRODUCTION: Antimicrobial resistance has been described as a global crisis-more prudent prescribing is part of the solution. Behaviour change interventions are needed to improve prescribing practice. Presently, the literature documents that context impacts on prescribing decisions, yet insufficient evidence exists to enable researchers and policymakers to determine how local tailoring should take place. Doctors in training are an important group to study, being numerically the largest group of prescribers in UK hospitals. Unfortunately very few interventions specifically targeted this group. METHODS AND ANALYSIS: Our project aims to understand how interventions to change antimicrobial prescribing behaviours of doctors in training produce their effects. We will recruit a project stakeholder group to advise us throughout. We will synthesise the literature using the realist review approach-a form of theory-driven interpretive systematic review approach often used to make sense of complex interventions. Interventions to improve antimicrobial prescribing behaviours are complex-they are context dependent, have long implementation chains, multiple non-linear interactions, emergence and depend on human agency. Our review will iteratively progress through 5 steps: step 1--Locate existing theories; step 2--Search for evidence; step 3--Article selection; step 4--Extracting and organising data; and step 5--Synthesising the evidence and drawing conclusions. Data analysis will use a realist logic of analysis to describe and explain what works, for whom, in what circumstances, in what respects, how and why to improve antimicrobial prescribing behaviour of doctors in training. ETHICS AND DISSEMINATION: Ethical approval was not required for our review. Our dissemination strategy will be participatory and involve input from our stakeholder group. Tailored project outputs will be targeted at 3 audiences: (1) doctors in training; (2) clinical supervisors/trainers and medical educators; and (3) policy, decision makers, regulators and royal societies.

The effectiveness and cost-effectiveness of shared care: protocol for a realist review.

BACKGROUND: Shared care (an enhanced information exchange over and above routine outpatient letters) is commonly used to improve care coordination and communication between a specialist and primary care services for people with long-term conditions. Evidence of the effectiveness and cost-effectiveness of shared care is mixed. Informed decision-making for targeting shared care requires a greater understanding of how it works, for whom it works, in what contexts and why. This protocol outlines how realist review methods can be used to synthesise evidence on shared care for long-term conditions.A further aim of the review is to explore economic evaluations of shared care. Economic evaluations are difficult to synthesise due to problems in accounting for contextual differences that impact on resource use and opportunity costs. Realist review methods have been suggested as a way to overcome some of these issues, so this review will also assess whether realist review methods are amenable to synthesising economic evidence. METHODS/DESIGN: Database and web searching will be carried out in order to find relevant evidence to develop and test programme theories about how shared care works. The review will have two phases. Phase 1 will concentrate on the contextual conditions and mechanisms that influence how shared care works, in order to develop programme theories, which partially explain how it works. Phase 2 will focus on testing these programme theories. A Project Reference Group made up of health service professionals and people with actual experience of long-term conditions will be used to ground the study in real-life experience. Review findings will be disseminated through local and sub-national networks for integrated care and long-term conditions. DISCUSSION: This realist review will explore why and for whom shared care works, in order to support decision-makers working to improve the effectiveness of care for people outside hospital. The development of realist review methods to take into account cost and cost-effectiveness evidence is particularly innovative and challenging, and if successful will offer a new approach to synthesising economic evidence. This systematic review protocol is registered on the PROSPERO database (registration number: CRD42012002842).

The challenge of external validity in policy-relevant systematic reviews: a case study from the field of substance misuse.

AIM: To critically evaluate the methods utilized in the conduct of a systematic review in the field of substance misuse. DESIGN: Participant-observation in the review process, semi-structured interviews with review team members and management and structured observation of the process of guidance development. SETTING: An 'arm's-length' government body. PARTICIPANTS: Review team members, management and the committee responsible for producing evidence-based guidance for policy and practice. MEASUREMENTS: Data from interviews and (participant-)observation were reflected upon critically in order to increase understanding of the systematic review process. FINDINGS: The application of systematic review methods produced an evidence base that did not inform the development of guidance to the extent that it could have done: (i) an emphasis upon internal research validity produced an evidence base with an emphasis on short-term interventions at the level of the individual; (ii) criteria for appraising the external validity of studies were not developed sufficiently; and (iii) the systematic review of evidence and development of guidance are strongly reliant upon the judgement of reviewers and committee members. CONCLUSIONS: Prioritizing internal validity in a systematic review risks producing an evidence base that is not informed adequately by the wider determinants of health and which does not give sufficient consideration to external validity. The use of appropriate methods requires that commissioners of systematic reviews are clear at the outset how the review is proposed to be utilized. Review methods such as meta-ethnography and realist synthesis could contribute to making the frameworks within which judgements are made more explicit.