Justin Waring

Introduction: Early Intervention in Psychosis services were established throughout England over two decades ago, yet despite aiming to optimise care, less than 40% of patients achieve full clinical recovery and notable inequities persist in accessing NICE‐recommended treatments. Fragmented electronic health record systems and limited systematic data capture conceal how disparities in care delivery and effectiveness affect recovery and remission. The Early Psychosis Informatics into Care, EPICare, programme aims to develop a national, learning healthcare system incorporating a standardised core dataset and clinician dashboard to support equitable, data‐driven care. Methods: Our stakeholder co‐design approach comprised three interlinked work packages delivered between 2021 and 2022. Using participatory co‐design, we conducted four multi‐stakeholder workshops and preparatory lived experience sessions with people with lived experience, clinicians, informaticians, academics, and policymakers. We identified essential data elements using adapted “MoSCoW” card sort methodology, refined content, and developed dashboard requirements. Parallel informatics and implementation research assessed technical feasibility, data maturity, and harmonisation requirements and evaluated anticipated barriers and facilitators to future adoption. Results: Consensus was achieved on core EPICare dataset “must haves” including sociodemographic variables, routine treatment interventions, Patient‐ and Clinician‐Reported Outcome Measures, and longitudinal symptom data. Stakeholders defined key dashboard features, prioritising usability and alignment with clinical workflow. Substantial variation in Trust‐level data infrastructure informed flexible technical architecture to mitigate implementation risk. Conclusion: EPICare stakeholder engagement delivered the blueprint for a co‐designed, technically feasible and nationally scalable specification for a psychosis learning healthcare system, enabling progression to platform development and piloting across five Early Intervention in Psychosis services in the NHS.

Background: Hazardous prescribing is an important and expensive preventable cause of patient harm, which can be identified using electronic healthcare records. In our Programme Grant we investigated the large-scale roll-out of a type of clinical decision support called OptimiseRx ^® (First Databank, Hearst Health, Exeter, United Kingdom) (which had not been independently evaluated previously) and two large-scale roll-outs of pharmacist-led IT-based intervention (an intervention that had been shown to reduce hazardous prescribing in a cluster randomised trial). Objectives: To estimate harm and economic impact of specific hazardous prescribing events. To investigate whether a clinical decision support intervention (OptimiseRx) was associated with reduction in hazardous prescribing. To investigate whether a pharmacist-led IT-based intervention was associated with reduction in hazardous prescribing. To undertake economic and process evaluations of both interventions. Design and methods: The harm and economic impact of hazardous prescribing events were investigated using data from published sources to generate estimates of patient outcomes and cost associated with 11 prescribing safety indicators. An incomplete (not randomised) stepped-wedge design study with control groups was used to investigate the effectiveness of OptimiseRx (409 general practices). Incremental cost-effectiveness ratios were generated for OptimiseRx compared with standard care (cost per hazardous prescribing event prevented), subgroup analysis: cost per quality-adjusted life-year. Incomplete stepped-wedge design studies [East Midlands study (343 and 115 general practices); whole of England study (725 and 179 general practices)] investigated the effectiveness of pharmacist-led IT-based intervention. Incremental cost-effectiveness ratios were generated for pharmacist-led IT-based intervention compared with standard care (cost per hazardous prescribing event prevented, cost per quality-adjusted life-year). Data from interviews, focus groups, a survey and stakeholder events were analysed qualitatively to identify factors influencing the sustained implementation and operation of OptimiseRx or pharmacist-led IT-based intervention. Setting and participants: The interventions took place in general practices in England. The process evaluation involved clinicians, patients and other stakeholders in England. Interventions: Clinical decision support intervention (OptimiseRx). Pharmacist-led IT-based intervention. Main outcome measures: Changes in hazardous prescribing rates. Cost per quality-adjusted life-year. Data sources: Clinical Practice Research Datalink. ResearchOne. General practice clinical records. Process evaluation with clinicians, patients and other stakeholders. Results: All the hazardous prescribing events studied were associated with loss of quality-adjusted life-years. The costliest for the National Health Service were prescriptions of antipsychotics to patients with dementia (£1168 per patient) and anticoagulants in combination with nonsteroidal anti-inflammatory drugs (£1020 per patient). Of 409 practices included in the clinical decision support study, 227 (56%) were intervention practices. Deployment of OptimiseRx was associated with a 10% reduction in exposure to hazardous prescribing after 2 years (odds ratio 0.90, 95% confidence interval 0.88 to 0.92). OptimiseRx costs £14–48 per hazardous prescribing event prevented, depending on time point and patient volume. Based on two indicators only, OptimiseRx costs £236 per quality-adjusted life-year gained at 6 months and becomes dominant (quality-adjusted life-year increasing; cost saving) at 24 months. Of 343 general practices included in the East Midlands pharmacist-led IT-based intervention evaluation, we completed further data extraction for 115 (33.5%) of these. Pharmacist-led IT-based intervention was associated with a decrease in hazardous prescribing of 18% (adjusted odds ratio 0.82, 95% confidence interval 0.78 to 0.86) at 6 months, and 22% (adjusted odds ratio 0.78, 95% confidence interval 0.73 to 0.84) at 24 months post intervention. Pharmacist-led IT-based intervention generates approximately 0.15 quality-adjusted life-years per practice extra compared with no intervention. Expected savings do not fully offset delivery costs, so pharmacist-led IT-based intervention costs just over £1000 per practice. Pharmacist-led IT-based intervention was estimated to be £7449. With 12- and 24-month intervention effects, health gains rise to over 0.2 quality-adjusted life-years and net expenditure falls to < £800 per practice; around £3500 per quality-adjusted life-year gained. Of 725 practices that implemented pharmacist-led IT-based intervention nationally, we had usable data for only 179 because of the COVID-19 pandemic. For these practices, pharmacist-led IT-based intervention was associated with a reduction in hazardous prescribing of 11% (adjusted odds ratio 0.89, 95% confidence interval 0.86 to 0.92) at 6 months post intervention. The process evaluation studies demonstrated the importance of collaboration and system-level support for the clinical decision support and pharmacist-led IT-based interventions. Limitations: The main limitation was that we could not robustly evaluate the impact of OptimiseRx on serious harm outcomes and the analysis was limited for pharmacist-led IT-based intervention because of the COVID-19 pandemic. Future work: Further research is needed to determine whether interventions that reduce hazardous prescribing, also reduce serious harm to patients. Conclusions: Large-scale implementation of OptimiseRx was associated with reduced hazardous prescribing, at less than £50 per hazardous prescribing event avoided. Large-scale implementation of pharmacist-led IT-based intervention was also associated with reduced hazardous prescribing with a cost per quality-adjusted life-year of £7449. It should be noted, however, that these were quasi-experimental studies using observational data and so the findings may have been affected by unknown confounding. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1214-20012) and is published in full in Programme Grants for Applied Research ; Vol. 14, No. 15. See the NIHR Funding and Awards website for further award information.

The concept of ‘health systems’ is pervasive in contemporary public health policy and scholarship. Health systems are invoked as objects that can be strengthened, made resilient or reformed through better design, improved governance arrangements or more rational use of evidence. Yet, as much work in critical public health has shown, health systems are not neutral, coherent or stable entities. They are made and remade through the actions of situated actors, drawing on particular historical trajectories, ideas and interests, and they routinely reproduce social and health inequalities. This Special Issue of Journal of Critical Public Health brings interpretive and decentred approaches on public governance to bear on a set of empirical cases that span European economic governance, European Union (EU) meta-regulation, multistakeholder food policy partnerships, housing policy, place-based public health, integrated care reforms and healthcare within prisons. Collectively, the papers ask: what happens when we stop treating health systems as unitary structures or technocratic projects and instead treat them as contingent, contested practices? In doing so, they invite us to rethink how we conceptualise ‘systems’, and what it might mean to pursue more just and inclusive forms of public health.

Background: The National Health Service in England is piloting an extension of access to its Digital Weight Management Programme, a digital service to support behavioural and lifestyle changes for weight loss. Access is being piloted to include referrals for patients with a body mass index above a threshold level set by the National Health Service England and who either have a diagnosis of osteoarthritis of the knee or hip (musculoskeletal referrals – 11 pilot sites) or are on elective surgical care waiting lists (elective care referrals – 10 pilot sites). There is a marked variation across sites in the number of patients referred. Objectives: To understand reasons for variation (local implementation, barriers and facilitators) and experiences of the implementation and functioning of referral pathways for musculoskeletal and elective surgical care patients into the National Health Service Digital Weight Management Programme. Design and methods: A comparative case study ( n = 7 sites) methodology was used, employing a mixed-methods approach following a sequential explanatory design: descriptive analysis of quantitative referral data from National Health Service England; staff ( n = 25) and patient ( n = 18) interviews and online workshops. Thematic analysis was conducted. Setting: Osteoarthritis treatment and elective surgery providers in the National Health Service in England. Participants: Interviews: staff and patients at three musculoskeletal and four elective care pilot sites. Workshops: staff at all pilot sites. Intervention: Referral of osteoarthritis and elective surgery patients to the National Health Service Digital Weight Management Programme. Main outcome measures: Patients’ and staff’s views. Results: Sites that created referral processes that optimised clinical staff time (e.g. automation and use of administrative staff) and involved ways to capture body mass index if missing from patient records were more likely to have a higher number of referrals. Despite generally positive attitudes towards the Programme, many staff felt they had insufficient information to describe it accurately to patients, which may impact both offering and acceptance of referrals. Strong leadership and personal staff motivation are also likely to impact referral offers. Similarly, patients were more likely to accept a referral if it aligned with their attitudes towards weight management and was offered at a time where they felt they could engage with the Programme. Limitations: Data were available on numbers of patients referred but not on numbers of eligible patients not referred. All patients interviewed had accepted referral to the Programme: we were unsuccessful in our attempts to recruit patients who had declined referral. No patients from minority ethnic groups volunteered to be interviewed. Conclusions: There is a considerable variation between case study sites in the details of how they have implemented new pathways for referring patients to the National Health Service Digital Weight Management Programme. These differences likely reflect varying local contexts. No single best model for the referral pathways has been identified. Future work: It would be desirable to capture the experiences of patients from diverse ethnic backgrounds and from patients who declined referral. Larger, longitudinal and observational studies could help understand the specifics of referral conversations as well as the effectiveness and cost-effectiveness of these referral pathways against other pathways to the Programme to aid decision-making and development of support materials for staff. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number NIHR167932.

Objectives: In care homes, safety incident reporting, and the policy framework that surrounds safety incident reporting, is not well understood. This study aims to review safety incident reporting and safety policies in residential and nursing care homes in England. It aims to better understand safety incident reporting practices and identify lessons for the sector regarding approaches to safety incident reporting to improve safety. The objectives were to investigate what policies exist, identify the methods and any technology used for safety incident reporting and consider the data captured in safety incident reports. It aims to contribute to discussions regarding developing systems-based approaches to safety management in care homes. Methods: A qualitative documentary analysis of safety incident reporting policies in residential and nursing care homes in England was undertaken. Policies were collected from 23 organisations whose staff participated in interviews (n = 75) regarding safety incident reporting between January 2021 until June 2022 and from a structured internet search using specified search terms between April 2022 and May 2022. To be included, a policy needed to refer to safety incident reporting in any capacity and be partially or wholly related to care homes or nursing homes in England. Safety incidents could include staff, residents, contractors, and visitors to the home. Data, extracted using a bespoke framework based on study objectives, were tabulated and analysed deductively and inductively. For the selected policies, the Care Quality Commission website was searched for the latest inspection report and the overall rating was extracted. Results: Forty-one policy documents were retrieved and screened for inclusion. Twenty-five policies (from 23 organisations) were reviewed. Three were from the internet search and 22 were obtained from interview participants. There was considerable variability in the length and comprehensiveness of the policies, with some homes using untailored, ‘off-the-shelf’ standardised policies produced by a specialist company. Twenty-two (88%) referred to other policy and legislative documents important to safety incident reporting and all but three (12%) policies identified a designated person or role with responsibility for the reports. Only one policy incorporated resident accounts and views into the incident report. Two policies referred exclusively to electronic recording systems with most (n = 19) referring to paper-based reporting systems. Conclusions: The study identified the extent of, and gaps, in safety incident reporting policies, with reporting practices situated within a broad framework of governance. Incident reporting is as much a matter of governance as practice and there may be a greater opportunity to learn from incident reports than there is currently. Further research about how staff navigate multiple risks, develop adaptive approaches for the contextual conditions, and use safety incident reporting mechanisms within and across care homes to minimise harm may help improve standards, practices and safety in care homes, along with a greater understanding of how policy is utilised in practice.

Background: There are multiple reasons for involving patients and families in incident investigations. Fiscally, costs due to clinical negligence claims approximate £4 billion annually. Logically, patients and families provide important information about patient safety incidents. Morally, involving harmed patients and families helps address their concerns. However, little United Kingdom-based evidence was available to support systematic involvement. Objective: To co-design processes and resources to guide the involvement of patients and families in incident investigations at a national and local level, and to test these processes to understand their impact upon experience, learning and likelihood of litigation. Design and methods: A mixed-methods programme of research was undertaken. Stage 1 comprised a scoping review of evidence for the experience of patients/families in incident investigations, and a documentary analysis of 43 National Health Service Trust incident investigation policies. Stage 2A extended this with 41 qualitative interviews with patients/families, healthcare staff and investigators. Stage 2B synthesised previous data to develop common principles and programme theory. Stage 3 involved a 6-month co-design phase with a ‘co-design community’ of > 50 stakeholders. In stages 4 and 5, co-designed guidance was evaluated in a 15-month ethnography, within four National Health Service Trusts and the national independent investigatory body. Twenty-nine investigations were followed in real time, including 127 interviews and 45 hours of observation. Four final co-design workshops supported iterations to the final guidance and website. A substudy explored meaningful involvement in, and learning from, investigations following suicide via interviews and a qualitative survey involving 32 people (healthcare staff, policy-makers and managers; people bereaved by suicide). Findings: Stage 1 found stakeholders valued involvement, but it was not well supported by local policy, even though it likely reduces litigation. Stage 2A found a need for navigational support, and support for other needs. In stage 2B, 10 common principles and a programme theory were developed, emphasising the aim of reducing compounded harm, alongside promoting organisational learning. In stage 3, four draft guidance booklets and a training session were developed. Stage 4 found these to be feasible, with stakeholders positive about involvement, and generally agreed that it aided organisational learning. The guidance supported systematisation of involvement and encouraged relational working, but wider organisational challenges were highlighted. The substudy found that suicide was regarded as somewhat different to other safety events. Meaningful involvement was complicated by a range of factors and should be decoupled from postvention support. Limitations: Undertaking research during the pandemic may have impacted sample representativeness in stage 2A. Ethnically minoritised and lower socioeconomic groups were under-represented across the programme. Future research: Research should explore how people from minoritised groups experience investigations and any required adaptations to the approach. Research should also explore the possibilities for ‘harm-centred’ rather than ‘incident-centred’ responses to safety. Conclusions: Investigations are complex, relational processes. Our guidance was found to be feasible, with stakeholders being positive about involvement and the impact on organisational learning. It may help to reduce the significant and long-lasting experience of compounded harm for patients and families. However, involvement may always be challenging due to the divergent needs of patients/families and organisations. Study registration: This study is registered as Current Controlled Trials ISRCTN14463242. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 18/10/02) and is published in full in Health and Social Care Delivery Research; Vol. 13, No. 18. See the NIHR Funding and Awards website for further award information.

Across high income countries, policy makers seek to reform their health systems to promote public health, address long-term care needs, and reduce the burden on acute care. Policy narratives articulate a model of health system governance premised on multi-agency collaboration and service integration. Combining decentred theory with the negotiated order thesis, this paper examines how local policy actors interpret and negotiate the dilemmas presented by such reform in the context of their customary ways of working. Reporting on the findings of a three-year study of the introduction of Sustainability and Transformation Partnerships in the English health and care system, we focus on how policy actors negotiate the dilemmas manifest around the vision and priorities for, and the governance of, health system change. In each area, we show that structural interests and governing traditions shape actors’ orientation towards system change. This results in tensions that are resolved (or not) through localised negotiations between policy actors, which vary according to whether they were open or closed, structured or emergent, and whether they had a significant or limited impact on system governance. The paper shows that health systems reform is contingent upon how local policy actors translate and negotiate policy narratives.