Supporting carers to improve patient safety and maintain their well-being in transitions from mental health hospitals to the community: A prioritisation nominal group technique.

INTRODUCTION: Carers of people with mental illness may face distinct challenges, including navigating fragmented health and social services during discharge from mental health hospitals. Currently, limited examples of interventions that support carers of people with mental illness in improving patient safety during transitions of care exist. We aimed to identify problems and solutions to inform future carer-led discharge interventions, which is imperative for ensuring patient safety and the well-being of carers. METHODS: The nominal group technique was used which combines both qualitative and quantitative data collection methods in four distinct phases: (1) problem identification, (2) solution generation, (3) decision making and (4) prioritisation. The aim was to combine expertise from different stakeholder groups (patients, carers and academics with expertise in primary/secondary care, social care or public health) to identify problems and generate solutions. RESULTS: Twenty-eight participants generated potential solutions that were grouped into four themes. The most acceptable solution for each was as follows: (1) 'Carer Involvement and Improving Carer Experience' a dedicated family liaison worker, (2) 'Patient Wellness and Education' adapting and implementing existing approaches to help implement the patient care plan, (3) 'Carer Wellness and Education' peer/social support interventions for carers and (4) 'Policy and System Improvements' understanding the co-ordination of care. CONCLUSION: The stakeholder group concurred that the transition from mental health hospitals to the community is a distressing period, where patients and carers are particularly vulnerable to safety and well-being risks. We identified numerous feasible/acceptable solutions to enable carers to improve patient safety and maintain their own mental wellbeing. PATIENT AND PUBLIC CONTRIBUTION: Patient and public contributors were represented in the workshop and the focus of the workshop was to identify the problems they faced and co-design potential solutions. Patient and public contributors were involved in the funding application and study design.

A qualitative study on lived experience of self-harm in South Asians in the UK: From reasons to recovery.

OBJECTIVES: Self-harm rates and clinical presentations differ by ethnicity. South Asian women are at risk of self-harm. Previous research suggested investigating individuals' experiences with self-harm with qualitative studies in developing self-harm prevention strategies. This research aims to explore self-harm experiences among South Asians in the United Kingdom. DESIGN: Qualitative study. METHODS: Participants were recruited via third-sector organizations and online platforms. Semi-structured interviews were conducted with 11 South Asian individuals with a history of self-harm living in the United Kingdom. The data were analysed based on a reflective thematic analysis approach. RESULTS: Results revealed four main themes: (1) reasons for self-harm; (2) recovery journey; (3) culture and mental health; and (4) the transition to suicidal thoughts and behaviours. Reasons for self-harm included negative life circumstances, social life difficulties, challenges faced during COVID-19 and mental health problems. Participants described their recovery journey by acknowledging the role of professional help, self-care, psychoeducation and personal growth, improving social relationships, and faith and spirituality. Cultural factors included generational differences and stigma. Culturally adapted psychological interventions were perceived as promising. The reported transition from self-harm to suicidal behaviours was linked to experiencing major stressful life events and the use of severe methods of self-harm. CONCLUSIONS: The findings suggest that socio-cultural factors impact mental health and recovery processes among South Asians. Mental health services should consider improving culturally sensitive clinical practices in responding to self-harm among South Asian communities.

Understanding self-harm and suicidal behaviours in South Asian communities in the UK: systematic review and meta-synthesis.

BACKGROUND: Previous findings have indicated that self-harm and suicide are associated with different rates, and different risk and protective factors in South Asian people compared with White people in the UK. Substantial qualitative research has explored experiences of self-harm and suicide in South Asian people. AIMS: The study aims to review the existing qualitative evidence on self-harm and suicidal behaviours in South Asian communities in the UK. METHOD: Systematic searches were conducted on Medline, EMBASE, PsycINFO, CINAHL, Open Dissertations and the British Library Ethos databases. We selected qualitative studies from both journals and grey literature that included South Asian participants who were resident in the UK and presented perceptions or experiences of self-harm and/or suicidal behaviour. Analysis was undertaken based on the meta-ethnographic approach. RESULTS: Fifteen studies were included in the analysis. Experience of self-harm was discussed based on three aspects: behind self-harm, functions of self-harm and recovery from self-harm. 'Behind self-harm' refers to factors associated with self-harm and suicide. 'Functions of self-harm' captures the meaning attributed to self-harm and suicide. 'Recovery from self-harm' encapsulates personal and professional help, and practical suggestions for the improvement of mental health services. CONCLUSIONS: Although some similarities with the majority White population were present, there were also crucial differences that need consideration when shaping health policies, improving access to health services and developing culturally sensitive psychosocial interventions for self-harm and suicide specific to South Asian communities in the UK.

Evaluating a co-designed care bundle to improve patient safety at discharge from adult and adolescent mental health services (SAFER-MH and SAFER-YMH): protocol for a non-randomised feasibility study.

INTRODUCTION: Patients being discharged from inpatient mental wards often describe safety risks in terms of inadequate information sharing and involvement in discharge decisions. Through stakeholder engagement, we co-designed, developed and adapted two versions of a care bundle intervention, the SAFER Mental Health care bundle for adult and youth inpatient mental health settings (SAFER-MH and SAFER-YMH, respectively), that look to address these concerns through the introduction of new or improved processes of care. METHODS AND ANALYSIS: Two uncontrolled before-and-after feasibility studies, where all participants will receive the intervention. We will examine the feasibility and acceptability of the SAFER-MH in inpatient mental health settings in patients aged 18 years or older who are being discharged and the feasibility and acceptability of the SAFER-YMH intervention in inpatient mental health settings in patients aged between 14 and 18 years who are being discharged. The baseline period and intervention periods are both 6 weeks. SAFER-MH will be implemented in three wards and SAFER-YMH in one or two wards, ideally across different trusts within England. We will use quantitative (eg, questionnaires, completion forms) and qualitative (eg, interviews, process evaluation) methods to assess the acceptability and feasibility of the two versions of the intervention. The findings will inform whether a main effectiveness trial is feasible and, if so, how it should be designed, and how many patients/wards should be included. ETHICS AND DISSEMINATION: Ethical approval was obtained from the National Health Service Cornwall and Plymouth Research Ethics Committee and Surrey Research Ethics Committee (reference: 22/SW/0096 and 22/LO/0404). Research findings will be disseminated with participating sites and shared in various ways to engage different audiences. We will present findings at international and national conferences, and publish in open-access, peer-reviewed journals.

Developing the Resident Measure of Safety in Care Homes (RMOS): A Delphi and Think Aloud Study.

OBJECTIVE: This study aimed to develop a measure of contributory factors to safety incidents in care homes to be completed by residents and/or their unpaid carers. INTRODUCTION: Care home residents are particularly vulnerable to patient safety incidents, due to higher likelihood of frailty, multimorbidity and cognitive decline. However, despite residents and their carers wanting to be involved in safety initiatives, there are few mechanisms for them to contribute and make meaningful safety improvements to practice. METHODS: We developed 73 evidence-based items from synthesis and existing measures, which we presented to a panel of stakeholders (residents/carers, health/social care professionals and researchers). We used two online rounds of Delphi to generate consensus (80%) on items important to include in the Resident Measure of Safety in Care Homes (RMOS); a consensus meeting was later held. The draft RMOS developed through the Delphi was presented to participants during 'Think Aloud' interviews using cognitive testing techniques. RESULTS: The 29-item RMOS was developed. Forty-three participants completed Delphi round 1, and 27 participants completed round 2, 11 participants attended the consensus meeting and 12 'Think Aloud' interviews were conducted. Of the 73 original items, 42 items that did not meet consensus in Delphi round 1 were presented in round 2. After the consensus meeting, it was agreed that 35 items would comprise the RMOS questionnaire and were presented in the 'Think Aloud' interviews. Participants suggested numerous changes to items mostly to improve comprehension and ability to answer. CONCLUSION: We have a developed an evidence-based RMOS, with good face validity, to assess contributory factors to safety in care homes from a resident/carer perspective. Future work will involve psychometrically testing the items in a pilot and developing a complementary simplified, dementia-friendly version to promote inclusivity. PATIENT OR PUBLIC INVOLVEMENT: Four patient and public contributors worked with researchers to develop the online questionnaires. Patients (residents) and carers participated on the consensus panel. One member of the research team is an expert by lived experience and was involved in design and analysis decisions. The item list and instructions for the questionnaires were reviewed for face validity, understanding and acceptability by a patient and public involvement group and modified.

Involving patients and carers in patient safety in primary care: A qualitative study of a co-designed patient safety guide.

BACKGROUND: Involving patients is a key premise of national and international policies on patient safety, which requires understanding how patients or carers want to be involved and developing resources to support this. This paper examines patients' and carers' views of being involved in patient safety in primary care and their views of potentially using a co-designed patient safety guide for primary care (PSG-PC) to foster both involvement and their safety. METHODS: A qualitative study using semistructured face-to-face interviews with 18 patients and/or carers in primary care. Interviews were transcribed and analysis was conducted using an inductive thematic approach. RESULTS: Overall participants expressed enthusiasm for the PSG-PC as a tool to support patients and carers to be involved in patient safety in primary care. However, for some participants being involved in patient safety was seen as taking on the role of General Practitioner and had the potential to add an additional workload for patients. Participants' willingness or ability to be involved in patient safety was influenced by a range of factors including an invisible, often underacknowledged role of everyday safety for patients' interactions with primary care; the levels of involvement that patients wanted in their care and safety and the work of embedding the PSG-PC for patients into their routine interactions with primary care. Participants identified components of the PSG-PC that would be useful to them, in particular, if they had a responsibility for caring for a family member if they had more complex care or long-term conditions. CONCLUSION: Involving patients and carers in patient safety needs a tailored and personalized approach that enables patients and carers to use resources like the PSG-PC routinely and helps challenge assumptions about their willingness and ability to be involved in patient safety. Doing so would raise awareness of opportunities to be involved in safety in line with personal preference. PATIENT OR PUBLIC CONTRIBUTION: Patient and public involvement were central to the research study. This included working in partnership to develop the PSG-PC with patients and carers and throughout our study including in the design of the study, recruiting participants, interpretation of findings.

Predictors and population health outcomes of persistent high GP turnover in English general practices: a retrospective observational study.

OBJECTIVE: English primary care faces significant challenges, including 'persistent high turnover' of general practitioners (GPs) in some partnerships. It is unknown whether there are specific predictors of persistent high turnover and whether it is associated with poorer population health outcomes. DESIGN: A retrospective observational study. METHODS: We linked workforce data on individual GPs to practice-level data from Hospital Episode Statistics and the GP Patient Survey (2007-2019). We classified practices as experiencing persistent high turnover if more than 10% of GPs changed in at least 3 consecutive years. We used multivariable logistic or linear regression models for panel data with random effects to identify practice characteristics that predicted persistent high turnover and associations of practice outcomes (higher emergency hospital use and patient experience of continuity of care, access to care and overall patient satisfaction) with persistent high turnover. RESULTS: Each year, 6% of English practices experienced persistent high turnover, with a maximum of 9% (688/7619) in 2014. Larger practices, in more deprived areas and with a higher morbidity burden were more likely to experience persistent high turnover. Persistent high turnover was associated with 1.8 (95% CI 1.5 to 2.1) more emergency hospital attendances per 100 patients, 0.1 (95% CI 0.1 to 0.2) more admissions per 100 patients, 5.2% (95% CI -5.6% to -4.9%) fewer people seeing their preferred doctor, 10.6% (95% CI-11.4% to -9.8%) fewer people reporting obtaining an appointment on the same day and 1.3% (95% CI -1.6% to -1.1%) lower overall satisfaction with the practice. CONCLUSIONS: Persistent high turnover is independently linked to indicators of poorer service and health outcomes. Although causality needs to be further investigated, strategies and policies may be needed to both reduce high turnover and support practices facing challenges with high GP turnover when it occurs.

Patient safety, self-injection, and B12 deficiency: a UK cross-sectional survey.

BACKGROUND: Individuals with vitamin B12 deficiency (including pernicious anaemia) often report being 'let down' or stigmatised by general practice systems and policy, and choose instead to self-medicate via injection; the association between this and perceptions of safe primary care in this group of people is unknown. AIM: To examine the association between self-medication for vitamin B12 deficiency and patient-reported safety in primary care. DESIGN AND SETTING: A UK cross-sectional online survey. METHOD: The survey consisted of the three components: demographics; the validated Primary Care Patient Measure of Safety; and questions about self-medication for vitamin B12 deficiency. Multivariable logistic regression analyses and thematic synthesis were undertaken. RESULTS: Responses from 1297 participants indicated 508 (39.2%) self-medicated via injection. Perceived primary care safety was low. Those who self-medicated via injection reported a significantly lower level of patient safety in primary care including adverse patient-related factors (odds ratio 0.82, 95% confidence interval = 0.73 to 0.92), and patients >34 years of age were significantly more likely to self-medicate via injection. Many reported that treatment under the guidance of a clinician was preferable to self-medication, but felt they had no other choice to regain quality of life. Almost half felt that the doctor did not always consider what they wanted for their care. CONCLUSION: To the authors' knowledge, this is the largest study to date examining patient safety and vitamin B12 deficiency. It found that four out of 10 patients with B12 deficiency self-medicate via injection. Patients who self-medicated perceived primary care as less safe. Providing patient-centred care and treating these patients with dignity and respect is a policy priority to reduce unsafe health behaviours.

Transitional Care Interventions for Older Residents of Long-term Care Facilities: A Systematic Review and Meta-analysis.

Importance: Residents of long-term care facilities (LTCFs) experience high hospitalization rates, yet little is known about the effects of transitional care interventions for these residents. Objective: To assess the association of transitional care interventions with readmission rates and other outcomes for residents of LTCFs who are 65 years and older and LTCF staff and to explore factors that potentially mitigate the association. Data Sources: MEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and Cumulative Index to Nursing and Allied Health Literature were searched for English-language studies published until July 21, 2021. Associated qualitative studies were identified using aspects of the CLUSTER (citations, lead authors, unpublished materials, searched Google Scholar, tracked theories, ancestry search for early examples, and follow-up of related projects) methodology. Study Selection: Controlled design studies evaluating transitional care interventions for residents of LTCFs 65 years and older were included. Records were independently screened by 2 reviewers; disagreements were resolved through discussion and involvement of a third reviewer. From 14 538 records identified, 15 quantitative and 4 qualitative studies met the eligibility criteria. Data Extraction and Synthesis: The study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Data were extracted by one reviewer and checked by a second reviewer. Fixed-effect and random-effects models were used according to the number of studies reporting the outcomes of interest. Main Outcomes and Measures: The primary outcome consisted of 30-, 60-, and 90-day readmission rates (hospital and emergency department [ED]). Other outcomes included length of stay, functional independence (Barthel score), and quality of life. The I2 statistic was used to quantify heterogeneity. Results: Of 14 538 records identified from searches, 15 quantitative studies (totaling 32 722 participants or records) and 4 qualitative studies were included. People allocated to transitional care interventions were 1.7 times less likely to be readmitted to the hospital or ED compared with those in control groups (14 studies; odds ratio, 1.66 [95% CI, 1.18-2.35]; I2 = 81% [95% CI, 70%-88%]). Length of stay in the ED was significantly decreased for intervention groups (3 studies; standardized mean difference, -3.00 [95% CI, -3.61 to -2.39]; I2 = 99% [95% CI, 98%-99%]). There were no significant differences for other outcomes. Factors associated with outcomes included communication and referral processes between health care professionals. Conclusions and Relevance: Emerging evidence suggests that transitional care interventions are associated with lower readmissions for residents of LTCFs 65 years and older. Despite this and with aging populations, investment in such interventions has been remarkably low across most countries.

Challenges and adaptations to public involvement with marginalised groups during the COVID-19 pandemic: commentary with illustrative case studies in the context of patient safety research.

Patient and public involvement (PPI) is integral to research on patient safety in the NIHR Greater Manchester Patient Safety Translational Research Centre (NIHR GMPSTRC), and is central to our patient safety research within our theme focusing on people in marginalised groups. Due to the impact of COVID-19, researchers had to adapt how they do PPI. For marginalised groups, remote working and digital adaptations (the key adaptations made in accessing and utilising health services in the United Kingdom during COVID-19) can potentially lead to further marginalisation of people already marginalised and provide new barriers to others. This editorial showcases three case examples of PPI with marginalised groups during COVID-19, these are with: (1) adults with vision impairments, (2) adults and carers with lived experience of self-harm and/ or suicide and (3) adults with lived experience of homelessness. In these case examples, we focus on challenges relating to key aspects of PPI during the pandemic. First, setting up a PPI advisory group and secondly maintaining relationships and effective PPI with a pre-existing advisory group. We contrast these examples using more traditional ways of 'doing PPI' i.e. involving public contributors in various stages of the research cycle, with a more fully 'co-produced' approach to research when developing a new patient safety intervention. Important considerations for PPI with marginalised groups during COVID-19 include: how to avoid exacerbating the digital divide when using video conferencing for PPI, the need for enhanced awareness around flexibility and resources, and the value of working closely with specialist charities to enable adaptations that are sensitive to the changed circumstances and needs of PPI contributors.

The National Institute of Health Research (NIHR) Greater Manchester Patient Safety Translational research Centre (GMPSTRC) carries out research to improve patient safety. We work in partnership with patients and members of the public to plan, manage, design, and carry out the research. This is labelled as patient and public involvement. A key area of GMPSTRC research focuses on people who may be marginalised from healthcare and potentially suffer increased patient safety risks relative to the general population. COVID-19 impacted on research in multiple ways, notably how researchers work with members of the public. Remote working via the use of internet enabled technology has now become more commonplace, although this raises concerns about digital exclusion and how to address barriers when face-to-face PPI is not possible. This article showcases three examples of how researchers and public contributors with lived experience have adapted to working together during the COVID-19 pandemic. These case examples are: (1) setting up a public involvement group for developing an intervention to reduce medication errors for adults with vision impairments; (2) working with a pre-existing group of public contributors who are adults and carers with lived experience of self-harm and/or suicide; and (3) working with a charity called Groundswell who train and support researchers with lived experience of homelessness. Challenges during COVID-19 have been making video conferencing meetings accessible to members who have a range of different needs, and addressing the digital divide by allowing members flexibility in how they contribute to research. The article provides examples of how these challenges were addressed.

Beyond the control of the care home: A meta-ethnography of qualitative studies of Infection Prevention and Control in residential and nursing homes for older people.

OBJECTIVE: This study aimed to develop interpretive insights concerning Infection Prevention and Control (IPC) in care homes for older people. DESIGN: This study had a meta-ethnography design. DATA SOURCES: Six bibliographic databases were searched from inception to May 2020 to identify the relevant literature. REVIEW METHODS: A meta-ethnography was performed. RESULTS: Searches yielded 652 records; 15 were included. Findings were categorized into groups: The difficulties of enacting IPC measures in the care home environment; workload as an impediment to IPC practice; the tension between IPC and quality of life for care home residents; and problems dealing with medical services located outside the facility including diagnostics, general practice and pharmacy. Infection was revealed as something seen to lie 'outside' the control of the care home, whether according to origins or control measures. This could help explain the reported variability in IPC practice. Facilitators to IPC uptake involved repetitive training and professional development, although such opportunities can be constrained by the ways in which services are organized and delivered. CONCLUSIONS: Significant challenges were revealed in implementing IPC in care homes including staffing skills, education, workloads and work routines. These challenges cannot be properly addressed without resolving the tension between the objectives of maintaining resident quality of life while enacting IPC practice. Repetitive staff training and professional development with parallel organisational improvements have prospects to enhance IPC uptake in residential and nursing homes. PATIENT OR PUBLIC CONTRIBUTION: A carer of an older person joined study team meetings and was involved in writing a lay summary of the study findings.

Developing Best Practice Guidance for Discharge Planning Using the RAND/UCLA Appropriateness Method.

Background: Discharge from acute mental health inpatient units is often a vulnerable period for patients. Multiple professionals and agencies are involved and processes and procedures are not standardized, often resulting in communication delays and co-ordination failures. Early and appropriate discharge planning and standardization of procedures could make inpatient care safer. Aim: To inform the development of a multi-component best practice guidance for discharge planning (including the 6 component SAFER patient flow bundle) to support safer patient transition from mental health hospitals to the community. Methods: Using the RAND/UCLA Appropriateness method, a panel of 10 professional stakeholders (psychiatrists, psychiatric nurses, clinical psychologists, pharmacists, academics, and policy makers) rated evidence-based statements. Six hundred and sixty-eight statements corresponding to 10 potential components of discharge planning best practice were rated on a 9-point integer scale for clarity, appropriateness and feasibility (median ≥ 7-9) using an online questionnaire then remote online face-to-face meetings. Results: Five of the six "SAFER" patient flow bundle components were appropriate and feasible for inpatient mental health. One component, "Early Flow," was rated inappropriate as mental health settings require more flexibility. Overall, 285 statements were rated as appropriate and feasible. Forty-four statements were considered appropriate but not feasible to implement. Discussion: This consensus study has identified components of a best practice guidance/intervention for discharge planning for UK mental health settings. Although some components describe processes that already happen in everyday clinical interactions (i.e., review by a senior clinician), standardizing such processes could have important safety benefits alongside a tailored and timely approach to post-discharge care.

Visual impairment and medication safety: a protocol for a scoping review.

BACKGROUND: The number of individuals with a visual impairment in the UK was estimated a few years ago to be around 1.8 million. People can be visually impaired from birth, childhood, early adulthood or later in life. Those with visual impairment are subject to health inequities and increased risk for patient safety incidents in comparison to the general population. They are also known to be at an increased risk of experiencing medication errors compared to those without visual impairment. In view of this, this review aims to understand the issues of medication safety for VI people. METHODS/DESIGN: Four electronic bibliographic databases will be searched: MEDLINE, Embase, PsycInfo and CINAHL. Our search strategy will include search combinations of two key blocks of terms. Studies will not be excluded based on design. Included studies will be empirical studies. They will include studies that relate to both medication safety and visual impairment. Two reviewers (SG and LR) will screen all the titles and abstracts. SG, LR, RM, SCS and PL will perform study selection and data extraction using standard forms. Disagreements will be resolved through discussion or third party adjudication. Data to be collected will include study characteristics (year, objective, research method, setting, country), participant characteristics (number, age, gender, diagnoses), medication safety incident type and characteristics. DISCUSSION: The review will summarise the literature relating to medication safety and visual impairment.

Rates of turnover among general practitioners: a retrospective study of all English general practices between 2007 and 2019.

OBJECTIVE: To quantify general practitioners' (GPs') turnover in England between 2007 and 2019, describe trends over time, regional differences and associations with social deprivation or other practice characteristics. DESIGN: A retrospective study of annual cross-sectional data. SETTING: All general practices in England (8085 in 2007, 6598 in 2019). METHODS: We calculated turnover rates, defined as the proportion of GPs leaving a practice. Rates and their median, 25th and 75th percentiles were calculated by year and region. The proportion of practices with persistent high turnover (>10%) over consecutive years were also calculated. A negative binomial regression model assessed the association between turnover and social deprivation or other practice characteristics. RESULTS: Turnover rates increased over time. The 75th percentile in 2009 was 11%, but increased to 14% in 2019. The highest turnover rate was observed in 2013-2014, corresponding to the 75th percentile of 18.2%. Over time, regions experienced increases in turnover rates, although it varied across English regions. The proportion of practices with high (10% to 40%) turnover within a year almost doubled from 14% in 2009 to 27% in 2019. A rise in the number of practices with persistent high turnover (>10%) for at least three consecutive years was also observed, from 2.7% (2.3%-3.1%) in 2007 to 6.3% (5.7%-6.9%) in 2017. The statistical analyses revealed that practice-area deprivation was moderately associated with turnover rate, with practices in the most deprived area having higher turnover rates compared with practices in the least deprived areas (incidence rate ratios 1.09; 95% CI 1.06 to 1.13). CONCLUSIONS: GP turnover has increased in the last decade nationally, with regional variability. Greater attention to GP turnover is needed, in the most deprived areas in particular, where GPs often need to deal with more complex health needs. There is a large cost associated with GP turnover and practices with very high persistent turnover need to be further researched, and the causes behind this identified, to allow support strategies and policies to be developed.

Theorizing Factors Mediating With the Implementation of a Patient Feedback on Safety Intervention Implemented in the Primary Care Setting.

Developing safety interventions using patient feedback is valuable for creating safer systems of health care. A qualitative process evaluation of a patient feedback on safety intervention was undertaken in six primary care practices. The purpose was to theorize factors mediating with the implementation of the intervention using existing theories. The intervention required practices to obtain patient feedback on safety using a validated tool and respond using quality improvement methods. Multiple methods of qualitative data collection were used, including interviews and overt observation. Abductive reasoning informed the iterative process of analysis that examined theories relevant to the intervention and setting. A theoretical framework was developed, which encompassed mediating factors grouped under three concepts: practice readiness, utilization of problem-solving skills, and agency. Theorizing mediating factors was necessary to understand the complexities of primary care practices, and to identify the essential components for implementation of the intervention on a larger scale.

Assessing the severity of cardiovascular disease in 213 088 patients with coronary heart disease: a retrospective cohort study.

OBJECTIVE: Most current cardiovascular disease (CVD) risk stratification tools are for people without CVD, but very few are for prevalent CVD. In this study, we developed and validated a CVD severity score in people with coronary heart disease (CHD) and evaluated the association between severity and adverse outcomes. METHODS: Primary and secondary care data for 213 088 people with CHD in 398 practices in England between 2007 and 2017 were used. The cohort was randomly divided into training and validation datasets (80%/20%) for the severity model. Using 20 clinical severity indicators (each assigned a weight=1), baseline and longitudinal CVD severity scores were calculated as the sum of indicators. Adjusted Cox and competing-risk regression models were used to estimate risks for all-cause and cause-specific hospitalisation and mortality. RESULTS: Mean age was 64.5±12.7 years, 46% women, 16% from deprived areas, baseline severity score 1.5±1.2, with higher scores indicating a higher burden of disease. In the training dataset, 138 510 (81%) patients were hospitalised at least once, and 39 944 (23%) patients died. Each 1-unit increase in baseline severity was associated with 41% (95% CI 37% to 45%, area under the receiver operating characteristics (AUROC) curve=0.79) risk for 1 year for all-cause mortality; 59% (95% CI 52% to 67%, AUROC=0.80) for cardiovascular (CV)/diabetes mortality; 27% (95% CI 26% to 28%) for any-cause hospitalisation and 37% (95% CI 36% to 38%) for CV/diabetes hospitalisation. Findings were consistent in the validation dataset. CONCLUSIONS: Higher CVD severity score is associated with higher risks for any-cause and cause-specific hospital admissions and mortality in people with CHD. Our reproducible score based on routinely collected data can help practitioners better prioritise management of people with CHD in primary care.

Nature and type of patient-reported safety incidents in primary care: cross-sectional survey of patients from Australia and England.

BACKGROUND: Patient engagement in safety has shown positive effects in preventing or reducing adverse events and potential safety risks. Capturing and utilising patient-reported safety incident data can be used for service learning and improvement. OBJECTIVE: The aim of this study was to characterise the nature of patient-reported safety incidents in primary care. DESIGN: Secondary analysis of two cross sectional studies. PARTICIPANTS: Adult patients from Australian and English primary care settings. MEASURES: Patients' self-reported experiences of safety incidents were captured using the validated Primary Care Patient Measure of Safety questionnaire. Qualitative responses to survey items were analysed and categorised using the Primary Care Patient Safety Classification System. The frequency and type of safety incidents, contributory factors, and patient and system level outcomes are presented. RESULTS: A total of 1329 patients (n=490, England; n=839, Australia) completed the questionnaire. Overall, 5.3% (n=69) of patients reported a safety incident over the preceding 12 months. The most common incident types were administration incidents (n=27, 31%) (mainly delays in accessing a physician) and incidents involving diagnosis and assessment (n=16, 18.4%). Organisation of care accounted for 27.6% (n=29) of the contributory factors identified in the safety incidents. Staff factors (n=13, 12.4%) was the second most commonly reported contributory factor. Where an outcome could be determined, patient inconvenience (n=24, 28.6%) and clinical harm (n=21, 25%) (psychological distress and unpleasant experience) were the most frequent. CONCLUSIONS: The nature and outcomes of patient-reported incidents differ markedly from those identified in studies of staff-reported incidents. The findings from this study emphasise the importance of capturing patient-reported safety incidents in the primary care setting. The patient perspective can complement existing sources of safety intelligence with the potential for service improvement.

Public Perspectives of Using Social Media Data to Improve Adverse Drug Reaction Reporting: A Mixed-Methods Study.

INTRODUCTION: Information on suspected adverse drug reactions (ADRs) voluntarily submitted by patients can be a valuable source of information for improving drug safety; however, public awareness of reporting mechanisms remains low. Whilst methods to automatically detect ADR mentions from social media posts using text mining techniques have been proposed to improve reporting rates, it is unclear how acceptable these would be to social media users. OBJECTIVE: The objective of this study was to explore public opinion about using automated methods to detect and report mentions of ADRs on social media to enhance pharmacovigilance efforts. METHODS: Users of the online health discussion forum HealthUnlocked participated in an online survey (N = 1359) about experiences with ADRs, knowledge of pharmacovigilance methods, and opinions about using automated data mining methods to detect and report ADRs. To further explore responses, five qualitative focus groups were conducted with 20 social media users with long-term health conditions. RESULTS: Participant responses indicated a low awareness of pharmacovigilance methods and ADR reporting. They showed a strong willingness to share health-related social media data about ADRs with researchers and regulators, but were cautious about automated text mining methods of detecting and reporting ADRs. CONCLUSIONS: Social media users value public-facing pharmacovigilance schemes, even if they do not understand the current framework of pharmacovigilance within the UK. Ongoing engagement with users is essential to understand views, share knowledge and respect users' privacy expectations to optimise future ADR reporting from online health communities.

Protocol for a non-randomised feasibility study evaluating a codesigned patient safety guide in primary care.

INTRODUCTION: Patients and carers should be active partners in patient safety with healthcare professionals and be empowered to use personalised approaches to identify safety concerns and work together to prevent them. This protocol paper details a study to examine the feasibility of a multicomponent intervention to involve patients and/or carers in patient safety in primary care in the UK. METHODS AND ANALYSIS: This is a two-phase, non-randomised feasibility mixed methods pragmatic study of a patient safety guide for primary care (PSG-PC). 8 general practices will recruit 120 patient and/or carer participants. All patient and/or carer participants will receive the PSG-PC. It will examine the feasibility and acceptability of the PSG-PC in primary care settings in patients aged 18 years or older who attend appointments at general practice with health professionals four or more times per year as either patients or carers. It will identify secondary outcomes for improving patient safety, health status and patient empowerment, and reducing health service utilisation over 6 months between baseline and 6-month follow-ups. The findings will inform whether a main effectiveness trial is feasible and, if so, how it should be designed, and how many patients and practices will be needed. The study will be undertaken between January 2020 and September 2021. ETHICS AND DISSEMINATION: Ethical approval was obtained from the National Health Service London-West London and Gene Therapy Advisory Committee Research Ethics Committee (reference: 19/LO/1289). Research findings will be disseminated with participating general practices and shared in a range of different ways to engage different audiences, including presenting at international and national conferences, publishing in open-access, peer-reviewed journals and facilitating dissemination workshops within local communities with patients, carers and healthcare professionals. TRIAL REGISTRATION NUMBER: ISRCTN90222092.

A patient and public involvement workshop using visual art and priority setting to provide patients with a voice to describe quality and safety concerns: Vitamin B12 deficiency and pernicious anaemia.

BACKGROUND: Patient and public involvement and engagement (PPIE) is recognized as important for improved quality in health service provision and research. Vitamin B12 deficiency is one area where PPIE has potential to benefit patients, as patients often report sub-optimal care due to diagnostic delay, insufficient treatment and poor relationships with health professionals. OBJECTIVE: In an effort to engage an understudied patient population in health-care quality and safety discussions, and provide patients with an opportunity to have a voice, contribute to research priorities and express their current quality and safety concerns, we hosted a PPIE workshop. METHODS: One researcher (with lived experience) facilitated a one day workshop with 12 patients with varied demographics. The workshop had four components (a) one-to-one sessions with an artist, (b) quality and safety research/education priority setting, (c) comments on research proposals, and (d) development of a PPIE group for future research. RESULTS: All elements of the workshop elicited a number of quality and safety priorities for the group. Priority setting highlighted issues with interpretation of test results, symptom-based treatment, self-medication and relationship with primary care health-care professionals. One of the major safety issues highlighted in the visual art element was feeling ignored, silenced or not listened too by health-care professionals. DISCUSSION: Visual art methods to express experiences of health, and research priority setting tasks achieved the aim of providing patients with an opportunity to have a voice and express concerns about health-care quality and safety issues. The addition of visual art allowed patients to articulate emotions and impacts on everyday life associated with quality and safety. PATIENT OR PUBLIC CONTRIBUTION: A public contributor was involved in preparation of this manuscript. The event aimed to enable PPIE contribution in future research.