Severe mental illness, race/ethnicity, multimorbidity and mortality following COVID-19 infection: nationally representative cohort study.

BACKGROUND: The association of COVID-19 with death in people with severe mental illness (SMI), and associations with multimorbidity and ethnicity, are unclear. AIMS: To determine all-cause mortality in people with SMI following COVID-19 infection, and assess whether excess mortality is affected by multimorbidity or ethnicity. METHOD: This was a retrospective cohort study using primary care data from the Clinical Practice Research Database, from February 2020 to April 2021. Cox proportional hazards regression was used to estimate the effect of SMI on all-cause mortality during the first two waves of the COVID-19 pandemic. RESULTS: Among 7146 people with SMI (56% female), there was a higher prevalence of multimorbidity compared with the non-SMI control group (n = 653 024, 55% female). Following COVID-19 infection, the SMI group experienced a greater risk of death compared with controls (adjusted hazard ratio (aHR) 1.53, 95% CI 1.39-1.68). Black Caribbean/Black African people were more likely to die from COVID-19 compared with White people (aHR = 1.22, 95% CI 1.12-1.34), with similar associations in the SMI group and non-SMI group (P for interaction = 0.73). Following infection with COVID-19, for every additional multimorbidity condition, the aHR for death was 1.06 (95% CI 1.01-1.10) in the SMI stratum and 1.16 (95% CI 1.15-1.17) in the non-SMI stratum (P for interaction = 0.001). CONCLUSIONS: Following COVID-19 infection, patients with SMI were at an elevated risk of death, further magnified by multimorbidity. Black Caribbean/Black African people had a higher risk of death from COVID-19 than White people, and this inequity was similar for the SMI group and the control group.

Service user perspectives of community mental health services for people with complex emotional needs: a co-produced qualitative interview study.

BACKGROUND: There is consensus that services supporting people with complex emotional needs are part of a mental health care system in which change is needed. To date, service users' views and co-production initiatives have had little impact on the development of interventions and care. This needs to change, and our paper evidences the experiences and perspectives of a diverse range of people on how community services can best address the needs of people with complex emotional needs. METHODS: A co-produced qualitative research study. Lived experience researchers led data collection and analysis. Individual interviews were conducted with 30 people across England who had a diverse range of experiences and perspectives of using community services for complex emotional needs. Participants were asked about their experiences of using community services for their mental health, and views on how community services can best address their needs. Thematic analysis was used to analyse the data. RESULTS: Participants reported some experiences of good practice but also of experiences of severely stigmatising interventions, a lack of effective support and service fragmentation. Relational Practice was identified as the central overarching theme and describes how community services can best support people with complex emotional needs. This approach involves care delivered in a non-stigmatising, individualised and compassionate way and care that is trauma-informed. It involves care that is planned collaboratively with service users to ensure their multiple needs are addressed in a flexible, holistic and consistent way which accounts for the long-term and fluctuating nature of their needs. CONCLUSIONS: Relational practice approaches have potential to facilitate better community care for people with complex emotional needs. Research and service development are needed to examine how best to implement such approaches across the mental health service system. This work must be co-produced with people with relevant lived experience, their carers and the professionals who support them.

Experiences of living with mental health problems during the COVID-19 pandemic in the UK: a coproduced, participatory qualitative interview study.

PURPOSE: Research is beginning to quantify the impact of COVID-19 on people with pre-existing mental health conditions. Our paper addresses a lack of in-depth qualitative research exploring their experiences and perceptions of how life has changed at this time. METHODS: We used qualitative interviews (N = 49) to explore experiences of the pandemic for people with pre-existing mental health conditions. In a participatory, coproduced approach, researchers with lived experiences of mental health conditions conducted interviews and analysed data as part of a multi-disciplinary research team. RESULTS: Existing mental health difficulties were exacerbated for many people. People experienced specific psychological impacts of the pandemic, struggles with social connectedness, and inadequate access to mental health services, while some found new ways to cope and connect to the community. New remote ways to access mental health care, including digital solutions, provided continuity of care for some but presented substantial barriers for others. People from black and ethnic minority (BAME) communities experienced heightened anxiety, stigma and racism associated with the pandemic, further impacting their mental health. CONCLUSION: There is a need for evidence-based solutions to achieve accessible and effective mental health care in response to the pandemic, especially remote approaches to care. Further research should explore the long-term impacts of COVID-19 on people with pre-existing mental health conditions. Particular attention should be paid to understanding inequalities of impact on mental health, especially for people from BAME communities.

Exploring the theory, barriers and enablers for patient and public involvement across health, social care and patient safety: a systematic review of reviews.

BACKGROUND: The emergence of patient and public involvement (PPI) in healthcare in the UK can be traced as far back as the 1970s. More recently, campaigns by harmed patients have led to a renewed focus on strengthening PPI. There is a growing awareness of the benefits of PPI in research as well as a need to address power inequities and a lack of diversity and inclusion. This review was undertaken to look at evidence for theories, barriers and enablers in PPI across health, social care and patient safety that could be used to strengthen PPI and address a perceived knowledge and theory gap with PPI in patient safety. METHODS: We searched MEDLINE, EMBASE and PsycINFO from inception to August 2018, using both MeSH and free-text terms to identify published empirical literature. Protocols in PROSPERO were also searched to identify any systematic reviews in progress. The extracted information was analysed using a narrative approach, which synthesises data using a descriptive method. RESULTS: Forty-two reviews were identified and grouped by key outcomes. Twenty-two papers mentioned theory in some form, 31 mentioned equality and diversity (although with no theory mentioned in this area), and only 19 cited equality and diversity as a barrier or enabler. Thirty-four reviews identified barriers and enablers at different organisational levels: personal/individual; attitudes; health professional; roles and expectations; knowledge, information and communication; financing and resourcing; training; general support; recruitment and representation, PPI methods and working with communities and addressing power dynamics. CONCLUSIONS: The review findings suggest that a commitment to PPI and partnership working is dependent on taking a whole system approach. This needs to consider the complex individual and organisational enablers and constraints to this process and address imbalances of power experienced by different groups. Addressing equality and diversity and use of a theory-driven approach to guide PPI are neglected areas. The long tradition of involvement across health and social care can provide considerable expertise in thinking about ways to strengthen approaches to PPI. This is especially important in patient safety, with a much newer tradition of developing PPI than other areas of healthcare.

The importance of power, context and agency in improving patient experience through a patient and family centred care approach.

BACKGROUND: Research shows that the way that healthcare staff experience their job impacts on their individual performance, patient experience and outcomes as well as on the performance of organisations. This article builds on this literature by investigating, with multi-disciplinary clinical teams as well as patients and relatives, what factors help or hinder changes designed to improve patient experience. METHODS: Qualitative research looking at patient- and family-centred care (PFCC) on two care pathways (stroke and hip fracture) was conducted in England and Wales. A realist approach combined with participatory action research was used to account for the complexity of organisational context and power relations. Multiple methods were used, including documentary analysis, participatory steering groups with staff and patient representatives, observations of the care pathways (n = 7), staff and patient and relative focus groups (n = 8), and hospital staff, patient and PFCC staff interviews (n = 47). RESULTS: Findings highlight multiple factors that support and hinder good patient experiences. Within individual care, paternalistic values and a lack of shared decision-making and patient-centred care still exist. Supportive interdisciplinary teamwork is needed to address issues of hierarchy, power and authority amongst staff and managers. At the organisational level, key issues of waiting times, patient flow, organisational resources and timely discharge affect staff's time and capacity to deliver care. In addition, macro contextual factors, such as finance, policy, targets and measures, set particular limits for improvement projects. CONCLUSIONS: Given this context, improving patient experience needs to go well beyond small-scale projects at the micro and meso level to incorporate a more critical understanding of systems, the wider organisational context and how power operates at multiple levels to enable and constrain action. In order to more meaningfully understand and address the factors that can help or hinder activities to improve patient experiences, PFCC frameworks and methods need to account for how power inequities operate and require the adoption of more participatory co-produced and empowering approaches to involve patients, relatives, carers and staff in improving complex healthcare environments.

Developing a 'critical' approach to patient and public involvement in patient safety in the NHS: learning lessons from other parts of the public sector?

There has been considerable momentum within the NHS over the last 10 years to develop greater patient and public involvement (PPI). This commitment has been reflected in numerous policy initiatives. In patient safety, the drive to increase involvement has increasingly been seen as an important way of building a safety culture. Evidence suggests, however, that progress has been slow and even more variable than in health care generally. Given this context, the paper analyses some of the key underlying drivers for involvement in the wider context of health and social care and makes some suggestions on what lessons can be learned for developing the PPI agenda in patient safety. To develop PPI further, it is argued that a greater understanding is needed of the contested nature of involvement in patient safety and how this has similarities to the emergence of user involvement in other parts of the public services. This understanding has led to the development of a range of critical theories to guide involvement that also make more explicit the underlying factors that support and hinder involvement processes, often related to power inequities and control. Achieving greater PPI in patient safety is therefore seen to require a more critical framework for understanding processes of involvement that can also help guide and evaluate involvement practices.

Ethnic Disparities in Treatment of Chronic Pain in Individuals with Parkinson's Disease Living in the United Kingdom.

Background: Over 80% people with Parkinson's disease (PD; PwP) live with chronic pain. Objective: Whether ethnic disparities in receipt of appropriate analgesia exist among PwP with chronic pain living in the United Kingdom (UK). Methods: A retrospective datamining of an existing King's PD Pain Questionnaire validation study dataset enrolling 300 PwP. Results: 69 PwP: 23 Black (57% female), 23 Asian (57% female) and 23 White (65% female) had similar pain burden on the King's PD Pain Scale. Significantly more White PwP (83%) received pain relief compared to Black (48%) and Asian (43%) PwP (p = 0.016). The difference was most evident for opioid analgesics (White 43% vs. Black 4% vs. Asian 4%, p ≤ 0.001). Conclusions: Ethnic disparities in the analgesic use among PwP with chronic pain living in the UK are evident in this retrospective analysis, prompting large-scale studies and reinforcement of interventions to tackle the impact ethnicity might have on the successful analgesia.

Does Ethnicity Influence Recruitment into Clinical Trials of Parkinson's Disease?

BACKGROUND: Lack of participation of black and minority ethnic communities (BAME) in registered clinical trials is a concern as data emerging from these studies are used to licence new drugs or other interventions, even though findings made in such selected study populations have limited external validity in the aforesaid ethnic groups. OBJECTIVE: We used Parkinson's disease (PD), the fastest rising neurodegenerative disorder in the world, as an exemplar condition to test our hypothesis that participants from BAME communities are underrepresented in clinical trials. METHODS: A systematic search of clinical trials registered on a Clinicaltrials.gov database which queried for PD with racial distribution data from 2017 to 2021. RESULTS: Out of 266 trials considered, 54 trials were published in peer reviewed journals. Among these, only 23 (42.65%) publications reported data regarding the racial distribution of the participants. Out of these, five studies involved mixed racial participation and two trials included black subjects. CONCLUSION: We found that inclusion of under-represented BAME groups in recently published clinical trials is low, at only 21.57%, and is not even considered in most studies. Out of the reviewed trials, only 5 (21.75%) studies reported detailed demographic categories with black minorities enrolment. This constitutes a severe under-representation when compared to the proportion of Black or African American in the UK population (3%). Results of this study identified the need for better reporting of racial composition in clinical trials. We strongly recommend that future studies should consider ethnicity and other issues around diversity when designing and implementing the clinical trials, not only in the PD field but also beyond.

A Smartphone App Designed to Empower Patients to Contribute Toward Safer Surgical Care: Qualitative Evaluation of Diverse Public and Patient Perceptions Using Focus Groups.

BACKGROUND: MySurgery is a smartphone app designed to empower patients and their caregivers to contribute toward safer surgical care by following practical advice to help reduce susceptibility to errors and complications. OBJECTIVE: The aim of this study is to evaluate service users' perceptions of MySurgery, including its perceived acceptability, the potential barriers and facilitators to accessing and using its content, and ideas about how to facilitate its effective implementation. The secondary aim is to analyze how the intended use of the app might differ for diverse patients, including seldom-heard groups. METHODS: We implemented a diversity approach to recruit participants from a range of backgrounds with previous experience of surgery. We aimed to achieve representation from seldom-heard groups, including those from a Black, Asian, and minority ethnic (BAME) background; those with a disability; and those from the lesbian, gay, bisexual, transgender, queer (LGBT+) community. A total of 3 focus groups were conducted across a 2-month period, during which a semistructured protocol was followed to elicit a rich discussion around the app. The focus groups were audio recorded, and thematic analysis was carried out. RESULTS: In total, 22 individuals participated in the focus groups. A total of 50% (n=11) of the participants were from a BAME background, 59% (n=13) had a disability, and 36% (n=8) were from the LGBT+ community. There was a strong degree of support for the MySurgery app. The majority of participants agreed that it was acceptable and appropriate in terms of content and usability, and that it would help to educate patients about how to become involved in improving safety. The checklist-like format was popular. There was rich discussion around the accessibility and inclusivity of MySurgery. Specific user groups were identified who might face barriers in accessing the app or acting on its advice, such as those with visual impairments or learning difficulties and those who preferred to take a more passive role (eg, some individuals because of their cultural background or personality type). The app could be improved by signposting further specialty-specific information and incorporating a calendar and notes section. With regard to implementation, it was agreed that use of the app should be signposted before the preoperative appointment and that training and education should be provided for clinicians to increase awareness and buy-in. Communication about the app should clarify its scientific basis in plain English and should stress that its use is optional. CONCLUSIONS: MySurgery was endorsed as a powerful tool for enhancing patient empowerment and facilitating the direct involvement of patients and their caregivers in maintaining patient safety. The diversity approach allowed for a better understanding of the needs of different population groups and highlighted opportunities for increasing accessibility and involvement in the app.

A Smartphone App Designed to Empower Patients to Contribute Toward Safer Surgical Care: Community-Based Evaluation Using a Participatory Approach.

BACKGROUND: MySurgery is a smartphone app designed to increase patient and carer involvement in behaviors that contribute toward safety in surgical care. OBJECTIVE: This study presents a pilot evaluation of MySurgery in which we evaluated surgical patients' perceptions of the app in terms of its content, usability, and potential impacts on communication and safety. METHODS: A participatory action research (PAR) approach was used to formulate a research steering group consisting of 5 public representatives and 4 researchers with equal decision-making input. Surgical patients were recruited from the community using multiple approaches, including Web based (eg, social media, recruitment websites, and charitable or voluntary organizations) and face to face (via community centers). Participants referred to MySurgery before, during, and after their surgery and provided feedback via an embedded questionnaire and using reflective notes. RESULTS: A diverse mix of 42 patients took part with good representation from 2 "seldom heard" groups: those with a disability and those from a black, Asian, or minority ethnic group. Most were very supportive of MySurgery, particularly those with previous experience of surgery and those who felt comfortable to be involved in conversations and decisions around their care. The app showed particular potential to empower patients to become involved in their care conversations and safety-related behaviors. Perceptions did not differ according to age, ethnicity, or length of hospital stay. Suggestions for improving the app included how to make it more accessible to certain groups, for example, those with a disability. CONCLUSIONS: MySurgery is a novel technology-driven approach for empowering patients to play a role in improving surgical safety that seems feasible for use within the United Kingdom's National Health Service. Adopting a PAR approach and the use of a diversity strategy considerably enhanced the research process in terms of gaining diverse participant recruitment and patient and public involvement. Further testing with stakeholder groups will follow.

Influence of external contextual factors on the implementation of health and social care interventions into practice within or across countries-a protocol for a 'best fit' framework synthesis.

BACKGROUND: The widespread implementation of interventions is often hindered by a decline and variability in effectiveness across implementation sites. It is anticipated that variations in the characteristics of the external context in different sites, such as the political and funding environment, socio-cultural context, physical environment or population demographics can influence implementation outcome. However, there is only a limited understanding about which and how external contextual factors influence implementation. We aim to develop a comprehensive framework conceptualising the influence of external contextual factors on implementation, particularly when spreading health and social care interventions within or across countries. METHODS: The review will use the 'best fit' framework synthesis approach. In the first stage of the review, we will examine existing frameworks, models, concepts and theories on external contextual factors and their influence on implementation from a variety of sectors and disciplines including health and social care, education, environmental studies and international development fields. The resulting a priori meta-framework will be tested and refined in the second review stage by analysing evidence from empirical studies focusing on the implementation of health and social care interventions within or across countries. Searches will be conducted in bibliographic databases such as MEDLINE, ERIC, HMIC and IBSS, grey literature sources and on relevant websites. We will also search reference lists, relevant journals, perform citation searches and ask experts in the field. There is no restriction to study type, setting, intervention type or implementation strategy to enable obtaining a broad and in-depth knowledge from various sources of evidence. DISCUSSION: The review will lead to a comprehensive framework for understanding the influence of external contextual factors on implementation, particularly when spreading health and social care interventions within or across countries. The framework is anticipated to help identify factors explaining the decline and variability in effectiveness of interventions and assessing the prospects of implementation effectiveness, when spreading interventions. We do not intend to only develop another stand-alone implementation framework but one that can be used in conjunction with existing frameworks. The framework can be honed and validated in future empirical research. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018084485.

Exploring the theory, barriers and enablers for patient and public involvement across health, social care and patient safety: a protocol for a systematic review of reviews.

INTRODUCTION: The emergence of patient and public involvement (PPI) in healthcare in the UK can be traced as far back as the 1970s. More recently, campaigns by harmed patients and their relatives have emerged as a result of clinical failings in the NHS, challenging paternalistic healthcare, which have led to a new focus on PPI in quality and safety, nationally and internationally. Evidence suggests that PPI within patient safety is often atheoretical and located within a biomedical discourse. This review will explore the literature on PPI across patient safety, healthcare and social care to identify theory, barriers and enablers that can be used to develop PPI in patient safety. METHODS AND ANALYSIS: Systematic searches of three electronic bibliographic databases will be conducted, using both MeSH and free-text terms to identify empirical literature published from database inception to May 2017. The screening process will involve input from at least two researchers and any disagreement will be resolved through discussion with a third reviewer. Initial inclusion and exclusion criteria have been developed and will be refined iteratively throughout the process. Data extraction from included articles will be conducted by at least two researchers using a data extraction form. Extracted information will be analysed using a narrative review approach, which synthesises data using a descriptive method. ETHICS AND DISSEMINATION: No ethical approval is required for this review as no empirical data were collected. We believe that the findings and recommendations from this review will be particularly relevant for an audience of academics and policymakers. The findings will, therefore, be written up and disseminated in international peer-reviewed journals and academic conferences with a health focus. They will also be disseminated to leading health policy organisations in the NHS, such as NHS England and NHS Improvement and national policy bodies such as the Health Foundation.

From tokenism to empowerment: progressing patient and public involvement in healthcare improvement.

BACKGROUND: There have been repeated calls to better involve patients and the public and to place them at the centre of healthcare. Serious clinical and service failings in the UK and internationally increase the urgency and importance of addressing this problem. Despite this supportive policy context, progress to achieve greater involvement is patchy and slow and often concentrated at the lowest levels of involvement. METHODS: A selective narrative literature search was guided by the authors' broad expertise, covering a range of disciplines across health and social care, policy and research. Published systematic literature reviews were used to identify relevant authors and publications. Google and hand searches of journal articles and reference lists and reports augmented identification of recent evidence. RESULTS: Patients and the wider public can be involved at most stages of healthcare, and this can have a number of benefits. Uncertainty persists about why and how to do involvement well and evaluate its impact, how to involve and support a diversity of individuals, and in ways that allow them to work in partnership to genuinely influence decision-making. This exposes patient and public involvement (PPI) to criticisms of exclusivity and tokenism. CONCLUSIONS: Current models of PPI are too narrow, and few organisations mention empowerment or address equality and diversity in their involvement strategies. These aspects of involvement should receive greater attention, as well as the adoption of models and frameworks that enable power and decision-making to be shared more equitably with patients and the public in designing, planning and co-producing healthcare.

Empowerment or rhetoric? Investigating the role of NHS Foundation Trust governors in the governance of patient safety.

OBJECTIVES: Involving patients and the public in patient safety is seen as central to health reform internationally. In England, NHS Foundation Trusts are seen as one way to achieve inclusive governance by involving local communities. We analysed these arrangements by studying lay governor involvement in the formal governance structures to improve patient safety. METHODS: Interviews with key informants, observations of meetings and documentary analysis were conducted at a case study site. A national survey was conducted with all acute Foundation Trusts (n=90), with a response rate of 40% (n=36). Follow up telephone interviews were conducted with seven of these. RESULTS: The case-study revealed a complex governance context for patient safety involving board, safety and various sub-committees. Governors were mainly not involved in these formal mechanisms, with participation being seen to pose a conflict of interest with the governors' role. Findings from the survey showed some involvement of governors in the governance of patient safety. CONCLUSIONS: This study revealed a lack of inclusivity by Foundation Trusts of lay governors in patient safety governance. It suggests action is needed to empower governors to undertake their statutory duties more effectively and particularly through clarification of their role and the provision of targeted training and support to facilitate their involvement in the governance of patient safety.

Harmed patients gaining voice: challenging dominant perspectives in the construction of medical harm and patient safety reforms.

Patient safety is a central issue in healthcare. In the United Kingdom, where there is more accurate information on National Health Service (NHS) hospitals than on primary care or the private sector, the evidence on adverse incidents shows that avoidable medical harm is a major concern. This paper looks at the occurrence of medical harm and argues that in the construction of patient safety reforms, it is important to be aware of alternative narratives about issues of power and accountability from harmed patients and self-help groups, that challenge dominant perspectives on the issues. The paper draws upon evidence from two sources. First, the paper draws on experiences of self-help groups set up as a result of medical harm and part of a campaigning network, where evidence was gathered from 14 groups over more than 2 years. In addition, data were obtained from 21 individuals affected by harm that attended a residential workshop called the Break Through Programme; 18 questionnaires were completed from participants and a written narrative account of their experiences and observational data were gathered from a range of workshop sessions. Looking at the issues from harmed patients' perspectives, the research illustrates that a model of medical harm focussing predominantly upon the clinical markers and individual agency associated with a medical model operates to obscure a range of social processes. These social processes, connected to the power and dominance of the medical profession and the activities of a wider state, are seen to be a major part of the construction of harm that impacts upon patients, which is further compounded by its concealment. Understanding the experiences of harmed patients is therefore seen as an important way of generating knowledge about the medical and social processes involved in harm, that can lead to a broader framework for addressing patient safety.