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Abstract Background Four out of five people living with osteoarthritis (OA) also suffer with at least one other long-term health condition. The complex interaction between OA and multiple long-term conditions (MLTCs) can result in difficulties with self-care, restricted mobility, pain, anxiety, depression and reduced quality of life. The aim of the MulTI-domain Self-management in Older People wiTh OstEoarthritis and Multi-Morbidities (TIPTOE) trial is to evaluate the clinical and cost-effectiveness of the Living Well self-management support intervention, co-designed with people living with OA, integrated into usual care, in comparison to usual care alone. Methods TIPTOE is a multi-centre, two-arm, individually randomised controlled trial where 824 individuals over 65 years old with knee and/or hip joint pain from their OA affected joint and at least one other long-term health condition will be randomised to receive either the Living Well Self-Management support intervention or usual care. Eligible participants can self-refer onto the trial via a website or be referred via NHS services across Wales and England. Those randomised to receive the Living Well support intervention will be offered up to six one-to-one coaching sessions with a TIPTOE-trained healthcare practitioner and a co-designed book. Participants will be encouraged to nominate a support person to assist them throughout the study. All participants will complete a series of self-reported outcome measures at baseline and 6- and 12-month follow-up. The primary outcome is symptoms and quality of life as assessed by the Musculoskeletal Health Questionnaire (MSK-HQ). Routine data will be used to evaluate health resource use. A mixed methods process evaluation will be conducted alongside the trial to inform future implementation should the TIPTOE intervention be found both clinically and cost-effective. An embedded ‘Study Within A Project’ (SWAP) will explore and address barriers to the inclusion of under-served patient groups (e.g. oldest old, low socioeconomic groups, ethnic groups). Discussion TIPTOE will evaluate the clinical and cost-effectiveness of a co-designed, living well personalised self-management support intervention for older individuals with knee and/or hip OA and MLTCs. The trial has been designed to maximise inclusivity and access. Trial registration ISRCTN 16024745 . Registered on October 16, 2023.

Background: Medication-related safety incidents (MSIs) are among the most frequent contributors to preventable harm in hospital patients. There is a paucity of research that explores the factors that contribute to MSIs across the departments of high-risk specialties such as surgery. Objectives: To characterize MSIs involving surgical patients across two secondary care sites at a University Health Board. Design: Retrospective cross-sectional convergent analysis of anonymous MSI reports extracted from the risk management system between 1st January 2017 and 31st October 2020 was undertaken. Methods: Incident reports contained categorical data pertaining to the type and nature of the incident as well as free-text reporter accounts. Categorical data were analyzed quantitatively, undergoing descriptive analysis using IBM SPSS Statistics © software (Version 26.0.01; 2019). Content analysis of free-text responses was undertaken using the Organizational Accident Causation model as the underpinning theoretical framework. Results: Of a total of 670 incidents, most MSIs did not result in harm ( n = 495, 73.9%). Most MSIs occurred during administration ( n = 439, 65.5%). Half of the incidents ( n = 335, 50%) were related to one of three medication types: opioids, antimicrobials, and antithrombotic agents. Communication failures were the most frequent error-producing condition ( n = 39, 5.8%) and drug omission was the most frequent active failure ( n = 156, 23.3%). Conclusion: To the knowledge of the authors, this is the first study in the United Kingdom that reports the medications most frequently involved in MSI reports for surgical patients. Staff in the surgical setting should be informed of the high frequency of incidents involving opioids, antimicrobials, heparin, and other antithrombotic agents as they appear in half of MSI reports in the surgical setting. Further research should explore administration error reduction strategies as well as tools to improve communication between staff to mitigate the risk of medicines-related harm associated with key medications.

Objective & Approach Demand for urgent eyecare exponentially outstrips public healthcare capacity in the United Kingdom. Such eye conditions, and related vision impairment, affect the lives of people everywhere. We aimed to quantify the burden of urgent eyecare on primary- and community-care providers in a national population using data produced by General Practitioner, Accident and Emergency, pharmacy and optometry services. A secondary aim was to characterise some drivers of this burden. We analysed data from the Secure Anonymised Information Linkage Databank (linked), Eye Health Examination Wales Service (unlinked) and Common Ailments Scheme (unlinked) during 2017-2018 to quantify burden. We applied generalised linear modelling and logistic regression to understand drivers. Results Of 365,044 episodes of care during the study, GPs and A&E managed 46.2% (168,877) and 1.4% (5,122) respectively while optometrists and pharmacists managed 51.8% (116,868) and 0.6% (2,635). Older females and infants of both sexes were more likely to use GP prescribing services, while adolescent and middle-aged males were more likely to visit A&E. GP prescribing burden was driven partially by economic deprivation, access to local services, and overall community health. Season, day of the week, and time of day were predictors of burden for GP and A&E services. Conclusion & Implications Acute eyecare continues to place considerable burden on primary care services in Wales, particularly in urban areas with greater deprivation. This is likely to increase with an ageing population. With ongoing pathway development to better utilise community care, there may be scope to change this trajectory.

Introduction At least 10% of hospital admissions in high-income countries, including Australia, are associated with patient safety incidents, which contribute to patient harm (‘adverse events’). When a patient is seriously harmed, an investigation or review is undertaken to reduce the risk of further incidents occurring. Despite 20 years of investigations into adverse events in healthcare, few evaluations provide evidence of their quality and effectiveness in reducing preventable harm.This study aims to develop consistent, informed and robust best practice guidance, at state and national levels, that will improve the response, learning and health system improvements arising from adverse events.Methods and analysis The setting will be healthcare organisations in Australian public health systems in the states of New South Wales, Queensland, Victoria and the Australian Capital Territory. We will apply a multistage mixed-methods research design with evaluation and in-situ feasibility testing. This will include literature reviews (stage 1), an assessment of the quality of 300 adverse event investigation reports from participating hospitals (stage 2), and a policy/procedure document review from participating hospitals (stage 3) as well as focus groups and interviews on perspectives and experiences of investigations with healthcare staff and consumers (stage 4). After triangulating results from stages 1–4, we will then codesign tools and guidance for the conduct of investigations with staff and consumers (stage 5) and conduct feasibility testing on the guidance (stage 6). Participants will include healthcare safety systems policymakers and staff (n=120–255) who commission, undertake or review investigations and consumers (n=20–32) who have been impacted by adverse events.Ethics and dissemination Ethics approval has been granted by the Northern Sydney Local Health District Human Research Ethics Committee (2023/ETH02007 and 2023/ETH02341).The research findings will be incorporated into best practice guidance, published in international and national journals and disseminated through conferences.

Abstract Background This study estimated the prevalence of evidence-based care received by a population-based sample of Australian residents in long-term care (LTC) aged ≥ 65 years in 2021, measured by adherence to clinical practice guideline (CPG) recommendations. Methods Sixteen conditions/processes of care amendable to estimating evidence-based care at a population level were identified from prevalence data and CPGs. Candidate recommendations (n = 5609) were extracted from 139 CPGs which were converted to indicators. National experts in each condition rated the indicators via the RAND-UCLA Delphi process. For the 16 conditions, 236 evidence-based care indicators were ratified. A multi-stage sampling of LTC facilities and residents was undertaken. Trained aged-care nurses then undertook manual structured record reviews of care delivered between 1 March and 31 May 2021 (our record review period) to assess adherence with the indicators. Results Care received by 294 residents with 27,585 care encounters in 25 LTC facilities was evaluated. Residents received care for one to thirteen separate clinical conditions/processes of care (median = 10, mean = 9.7). Adherence to evidence-based care indicators was estimated at 53.2% (95% CI: 48.6, 57.7) ranging from a high of 81.3% (95% CI: 75.6, 86.3) for Bladder and Bowel to a low of 12.2% (95% CI: 1.6, 36.8) for Depression. Six conditions (skin integrity, end-of-life care, infection, sleep, medication, and depression) had less than 50% adherence with indicators. Conclusions This is the first study of adherence to evidence-based care for people in LTC using multiple conditions and a standardised method. Vulnerable older people are not receiving evidence-based care for many physical problems, nor care to support their mental health nor for end-of-life care. The six conditions in which adherence with indicators was less than 50% could be the focus of improvement efforts.

Background Emergency healthcare services are under intense pressure to meet increasing patient demands. Many patients presenting to emergency departments could be managed by general practitioners in general practitioner–emergency department service models. Objectives To evaluate the effectiveness, safety, patient experience and system implications of the different general practitioner–emergency department models. Design Mixed-methods realist evaluation. Methods Phase 1 (2017–8), to understand current practice: rapid realist literature review, national survey and follow-up key informant interviews, national stakeholder event and safety data analysis. Phase 2 (2018–21), to collect and analyse qualitative (observations, interviews) and quantitative data (time series analysis); cost–consequences analysis of routine data; and case site data for ‘marker condition’ analysis from a purposive sample of 13 case sites in England and Wales. Phase 3 (2021–2), to conduct mixed-methods analysis for programme theory and toolkit development. Results General practitioners commonly work in emergency departments, but delivery models vary widely in terms of the scope of the general practitioner role and the scale of the general practitioner service. We developed a taxonomy to describe general practitioner–emergency department service models (Integrated with the emergency department service, Parallel within the emergency department, Outside the emergency department on the hospital site) and present a programme theory as principal output of the study to describe how these service models were observed to operate. Routine data were of variable quality, limiting our analysis. Time series analysis demonstrated trends across intervention sites for: increased time spent in the emergency department; increased emergency department attendances and reattendances; and mixed results for hospital admissions. Evidence on patient experience was limited but broadly supportive; we identified department-level processes to optimise the safety of general practitioner–emergency department models. Limitations The quality, heterogeneity and extent of routine emergency department data collection during the study period limited the conclusions. Recruitment was limited by criteria for case sites (time series requirements) and individual patients (with ‘marker conditions’). Pandemic and other pressures limited data collection for marker condition analysis. Data collected and analysed were pre pandemic; new approaches such as ‘telephone first’ and their relevance to our findings remains unexplored. Conclusion Findings suggest that general practitioner–emergency department service models do not meet the aim of reducing the overall emergency department waiting times and improving patient flow with limited evidence of cost savings. Qualitative data indicated that general practitioners were often valued as members of the wider emergency department team. We have developed a toolkit, based on our findings, to provide guidance for implementing and delivering general practitioner–emergency department services. Future work The emergency care data set has since been introduced across England to help standardise data collection to facilitate further research. We would advocate the systematic capture of patient experience measures and patient-reported outcome measures as part of routine care. More could be done to support the development of the general practitioner in emergency department role, including a core set of competencies and governance structure, to reflect the different general practitioner–emergency department models and to evaluate the effectiveness and cost effectiveness to guide future policy. Study registration This study is registered as PROSPERO CRD42017069741. 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: 15/145/04) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 10. See the NIHR Funding and Awards website for further award information. Plain language summary Hospital emergency departments are under huge pressure. Patients are waiting many hours to be seen, some with problems that general practitioners could deal with. To reduce waiting times and improve patient care, arrangements have been put in place for general practitioners to work in or alongside emergency departments (general practitioner–emergency department models). We studied the different ways of working to find out what works well, how and for whom. We brought together a lot of information. We reviewed existing evidence, sent out surveys to 184 emergency departments, spent time in the emergency departments observing how they operated and interviewing 106 staff in 13 hospitals and 24 patients who visited those emergency departments. We also looked at statistical information recorded by hospitals. Two public contributors were involved from the beginning, and we held two stakeholder events to ensure the relevance of our research to professionals and patients. Getting reliable figures to compare the various general practitioner–emergency department set-ups (inside, parallel to or outside the emergency department) was difficult. Our findings suggest that over time more people are coming to emergency departments and overall waiting times did not generally improve due to general practitioner–emergency department models. Evidence that general practitioners might admit fewer patients to hospital was mixed, with limited findings of cost savings. Patients were generally supportive of the care they received, although we could not speak to as many patients as we planned. The skills and experience of general practitioners were often valued as members of the wider emergency department team. We identified how the care provided was kept safe with: strong leaders, good communication between different types of staff, highly trained and experienced nurses responsible for streaming and specific training for general practitioners on how they were expected to work. We have produced a guide to help professionals develop and improve general practitioner–emergency department services and we have written easy-to-read summaries of all the articles we published. Scientific summary Background Emergency healthcare services are under intense pressure to meet the increasing patient demands. Many patients presenting to emergency departments (EDs) could be managed by general practitioners (GPs). We aimed to evaluate the effectiveness, safety, patient experience and system implications of the different models of GPs working in or alongside EDs (GP-ED). Objectives Identify which models are in place. Describe how the models work. Describe the outcomes of each model. Explain the relationships between contexts (C), mechanisms (M) and outcomes (O) to develop a programme theory to help inform service delivery in other settings. Design We conducted a mixed-methods realist evaluation to describe what works, for whom, in what circumstances and how over three phases. Phase 1: understanding current practice and which models are in place Rapid realist review Method We conducted a rapid realist review to develop initial theories about how different GP-ED models operate, supported by our co-applicants as an expert reference group. Results A total of 96 articles contributed to initial theories: how decisions on streaming patients to GP services are influenced; the role of GPs in EDs; patient satisfaction and safety concerns; the risk of provider-induced demand in highly visible services; and whether these services represent value for money. National survey and follow-up clinical director interviews Method We sent an online survey to 184 clinical directors (CDs) from Type 1 EDs in England and Wales to gather information on aims, implementation and delivering the GP-ED services. Thirty CDs who worked in services implemented since 2010 (a range of locations, models and sizes) were invited to take part in semistructured telephone interviews to explore: service operation, perceived successes and challenges. Results We received 77 responses out of 184 invitees (41.3%); 51 (66%) respondents used a GP-ED model. We interviewed 21 CDs. Findings were used to characterise and categorise GP-ED models to create a taxonomy, inform case study site selection and further theory development. National stakeholder event Method We held a National Stakeholder event in Bristol in 2018 (n = 48 attendees), to present findings from the review and survey, gather stakeholder feedback on a taxonomy of GP-ED models (in collaboration with researchers from the GP-ED team at the University of the West of England) and identify ‘marker conditions’ to guide data collection in Phase 2. Results The taxonomy included a description of the ‘form’ of the GP-ED models (inside the ED: Integrated with ED service delivery or a separate Parallel service; or Outside the ED: on or off the hospital site) and a description of how different constructs influence how the service may ‘function’ – as a traditional GP service or emergency medicine service. Five marker conditions were selected, including: child with a fever, cough/shortness of breath, abdominal pain, back pain and chest pain. (We added ‘headache’ as a further condition in Phase 2 of the study to enhance patient interview recruitment.) National patient safety data collection and analysis Method We searched Coroners’ Reports to Prevent Future Deaths (2013–8) and National Reporting and Learning System (NRLS) patient safety incident reports (2005–15) relating to diagnostic errors in GP-ED services. We coded these using the Patient Safety Classification System (PISA) framework and developed initial safety theories to inform data collection in Phase 2. Results We identified 9 relevant Coroners’ Reports and 217 NRLS reports. Initial theories were developed around: difficulty with triage and streaming processes; errors in clinical decision-making; and inadequate referral pathways and communication between services. Phase 2: case study mixed-methods data collection and analysis to describe how the general practitioner–emergency department models work and outcomes Qualitative data analysis Method We selected 13 case study sites reflecting different GP-ED models (3 Integrated, 4 Parallel, 3 Outside and 3 with no GP-ED model), different locations, sizes of ED and experience delivering the service. We visited all sites (2–4 days) and conducted observations and realist interviews with staff to refine initial theories. We requested local patient safety incident reports related to the GP-ED model and invited patients presenting with marker conditions for interviews to describe their experience. We analysed data from the multiple data sources and applied knowledge from conceptual frameworks and formal theories to refine our initial theories. We then mapped context–mechanism–outcome configurations against different GP-ED models to compare across different types of service. We presented findings at a second national event on 3 December 2019 (n = 70 attendees) for stakeholder feedback. Results Across all sites, we interviewed 106 staff members, collected 14 anonymised local patient safety incident reports, invited 748 patients to take part in telephone interviews and subsequently interviewed 24 patients. Theories were refined to describe: how streaming processes were influenced by nurse experience, guidance and overall operational and strategic management; how GPs found working in EDs influenced their clinical decision-making to maintain a usual GP approach or adopt an ED clinician approach, mitigating safety risks; factors that facilitate teamwork and communication between GP-ED services and the ED; how separate, visible GP-ED services are perceived to contribute to provider-induced demand; and patients’ expectations and experiences of using services. Routine data analysis Method We obtained patient-level data relating to ED attendances and subsequent hospital admissions from hospital episode statistics accident and emergency and admitted patient care (APC) data sets, via NHS Digital for study sites located in England; and from emergency department data set and patient episode database for Wales data sets (via secure anonymised information linkage) for one study site located in Wales. We summarised the attendance-level data as time series (per site, aggregating data for each study fortnight) for the following ED variables: Attendances; Reattendances; Hospital admissions (defined by patient record appearing in the APC data set); Investigations and Treatments; Time in ED; length of stay (LOS) of hospital admission. For all variables, we used standard time series analysis methods to assess the nature and extent of linear trends and seasonality in data before and after an intervention point at intervention sites. Results Data from 1 October 2010 to 30 September 2018 were eligible for inclusion and were of variable quality, tending to decrease as the level of integration between to GP-ED model and the ED decreased. We are more confident in the interpretations made about some outcomes (attendances, reattendances, admissions, LOS) than others (investigations, treatments, average time in ED) due to data quality. In general, at the GP-ED model sites, attendances increased over time. Reattendances within 28 days in the post-intervention period increased over that in the pre-intervention period in eight of the nine sites assessed. Overall, intervention sites also demonstrated a consistent trend of increasing average time in the ED across both the pre- and post-intervention phases. A mixed picture was seen in relation to hospital admissions in the Integrated and Parallel sites, with data quality issues at the Outside sites. Average length of hospital stay showed a mixed picture over all intervention sites. Cost–consequences analysis Method We conducted a cost–consequences analysis (CCA) using the routine data described above to consider the costs and resource consequences resulting from, or associated with, the use of the GP-ED model types compared to control sites. Results Negligible incremental ED attendance cost differences were observed between the model types and the control with an extremely small increased cost [£0.70, standard error (SE) £0.07] observed when looking at all models combined over control, though a saving of £72 (SE £3.18) when looking at inpatient admissions. When looking at ED visits by individual models, the Integrated model saw a small cost saving (£8.73, SE £0.07), but small cost increases were seen in the Parallel model (£9.51, SE £0.08) and the Outside model (£16.30, SE £0.16). With respect to inpatient admissions, all models saw small cost savings [£25 (SE £4.16) to £215 (SE £9.05)] with the Outside model showing the largest saving (£215, SE £9.05). Marker condition analysis Method We used a CCA as above to evaluate the management of six marker conditions at a Parallel GP-ED model as a case study site (the only site with data available during the pandemic period). Anonymised patient-level data were used to compare proportions of patients admitted to hospital (Pearson’s chi-squared test), and times (non-parametric Mann–Whitney U-test) for ED clinicians and GPs. A backward enter stepwise approach was taken with non-statistically significant variables (p > 0.05) removed. Results Emergency department clinicians saw most patients and those patients categorised as being more severely unwell. Across all marker conditions, GPs managed patients more quickly – the main driver being the time taken from treatment to discharge. Across all marker conditions, the trend was for GPs to admit fewer patients to inpatient care, compared with ED clinicians. This trend was more evident (and for some reaching statistical significance) among those requiring the lowest levels of intervention. Reattendance rates at 7 days were equal for both GPs and ED clinicians. Phase 3: mixed-method analysis, programme theory and toolkit development Mixed-methods analyses Method We conducted mixed-methods analyses to further refine our theories through two approaches: firstly, to identify questions raised through the qualitative data analysis to support, refute or refine through quantitative data analyses; then to identify noteworthy findings from the statistical analysis and cross-check with both the qualitative and marker conditions analyses. Results Streaming The marker condition and qualitative data analysis indicated the potential for GPs to improve the flow of the least unwell patients through the ED. However, at the whole ED level examined by the routine data, the analysis demonstrated increased time in the ED for patients at most sites. Therefore, our theories related to streaming and patient flow have limited support from quantitative data. General practitioner role Marker condition data from a single Parallel case study site showed that patients spent less time in the department and were less likely to be admitted, with no difference in reattendance rates at 7 days. Data on investigation use were of poor quality and not included in the analysis. Routine data for all intervention sites and three control sites also showed poor quality of investigation data. Any influence on time in the department and hospital admissions described in the marker condition data was not seen consistently in routine data analysis. While the marker conditions analysis supports the theory that a GP approach in an ED setting can be different to an ED clinician approach, it remains unclear whether this is due to individual clinicians’ management behaviours or service level differences in ways of working. The quantitative data did not identify particular GP-ED models associated with favourable outcomes potentially attributable to facilitating the ‘GP role’. Safety The routine data indicated increasing rates of reattendance at 28 days across most intervention and control sites. This may reflect changes in levels of morbidity among the population, public behaviours or service configurations (including availability of services elsewhere, notably in-hours primary care) rather than necessarily representing a change in the quality of the care provided at the ED. The marker condition data suggested that GP care in the ED appeared to be as safe as ED clinician care using reattendances within 7 days as a proxy. We have not identified data to develop our theory about strength of communication and teamworking within the ED. Patient experience While the marker conditions analysis indicated that patients attending ED who required the fewest investigations and treatments might be more satisfied by being seen by a GP due to a shorter ED stay, we could not identify any particular GP-ED model that appeared most likely to consistently decrease department stay. Demand Our theory about provider-induced demand in distinct and visible services is not supported by the data on ED attendances over the study period, but our qualitative findings suggest that there is a perceived additional demand for primary care at an ED in services where the primary care service is visible, easily accessible and more well known in the local area. Programme theory development We developed a programme theory, as the principal out of the research, presented as the patient journey through the three GP-ED models, to highlight similarities and differences. We recognise that each site had unique characteristics, so this represents a high-level summary of key features, rather than a description of every possible variation. At Integrated models, the streaming process is less influential. The ‘invisibility’ of the GP service means its impact on patient expectations is also more limited, but it allows for GPs to take on supervision of junior ED doctors, described positively at some sites. At Outside models, the process of ensuring that the right patient saw the GP was more complex, and open to potential problems. Their high visibility and accessibility were likely to have a greater impact on patients’ expectations and experiences. At these sites, GPs often took on a supervisory role for a wider primary care team. Parallel models showed the most variation in the way services were set up and the clarity of the GP role: some more like Integrated models others, Outside models. Toolkit We worked with study co-applicants and a stakeholder group of CDs to translate the research findings and programme theory into guidance for implementing and delivering GP-ED services. Some key points include: A culture including strong clinical leadership, encouraging mutual respect, interprofessional communication and teamworking is essential. To ensure that patients are efficiently and safely streamed, nurses should be highly trained and experienced; streaming pathways/protocols must be clear with senior oversight and include quality improvement systems. Training for GPs based on the type of GP-ED model in use and their intended role. Patients need to be informed about reasons for being streamed to different clinicians to help manage expectations. Conclusion General practitioners commonly work in EDs, but delivery models vary widely in terms of the scope of the GP role and the scale of the GP service. We developed a taxonomy to describe GP-ED models (Integrated, Parallel, Outside) and present a programme theory to describe how these models were observed to operate. Routine data were heterogeneous and of variable quality limiting analysis, including verification of the proposed theories, but trends were noted across intervention sites for: increased time spent in the ED, increased ED attendances and reattendances and mixed findings for hospital admissions. Findings suggest that GP-ED service models do not meet the aim of reducing ED waiting times and improving patient flow, with limited evidence of cost savings. Qualitative data indicated that GPs were often valued as members of the wider ED team, with significant appetite to utilise their specific skillset to provide care in the ED. We developed a toolkit, based on our findings, to provide guidance for implementing and delivering GP-ED services. Study registration This study is registered as PROSPERO CRD42017069741. 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: 15/145/04) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 10. See the NIHR Funding and Awards website for further award information.

Abstract Background The EVITE Immunity study investigated the effects of shielding Clinically Extremely Vulnerable (CEV) people during the COVID-19 pandemic on health outcomes and healthcare costs in Wales, United Kingdom, to help prepare for future pandemics. Shielding was intended to protect those at highest risk of serious harm from COVID-19. We report the cost of implementing shielding in Wales. Methods The number of people shielding was extracted from the Secure Anonymised Information Linkage Databank. Resources supporting shielding between March and June 2020 were mapped using published reports, web pages, freedom of information requests to Welsh Government and personal communications (e.g. with the office of the Chief Medical Officer for Wales). Results At the beginning of shielding, 117,415 people were on the shielding list. The total additional cost to support those advised to stay home during the initial 14 weeks of the pandemic was £13,307,654 (£113 per person shielded). This included the new resources required to compile the shielding list, inform CEV people of the shielding intervention and provide medicine and food deliveries. The list was adjusted weekly over the 3-month period (130,000 people identified by June 2020). Therefore the cost per person shielded lies between £102 and £113 per person. Conclusion This is the first evaluation of the cost of the measures put in place to support those identified to shield in Wales. However, no data on opportunity cost was available. The true costs of shielding including its budget impact and opportunity costs need to be investigated to decide whether shielding is a worthwhile policy for future health emergencies.

Abstract Background The COVID-19 pandemic resulted in major disruption to healthcare delivery worldwide causing medical services to adapt their standard practices. Learning how these adaptations result in unintended patient harm is essential to mitigate against future incidents. Incident reporting and learning system data can be used to identify areas to improve patient safety. A classification system is required to make sense of such data to identify learning and priorities for further in-depth investigation. The Patient Safety (PISA) classification system was created for this purpose, but it is not known if classification systems are sufficient to capture novel safety concepts arising from crises like the pandemic. We aimed to review the application of the PISA classification system during the COVID-19 pandemic to appraise whether modifications were required to maintain its meaningful use for the pandemic context. Methods We conducted a mixed-methods study integrating two phases in an exploratory, sequential design. This included a comparative secondary analysis of patient safety incident reports from two studies conducted during the first wave of the pandemic, where we coded patient-reported incidents from the UK and clinician-reported incidents from France. The findings were presented to a focus group of experts in classification systems and patient safety, and a thematic analysis was conducted on the resultant transcript. Results We identified five key themes derived from the data analysis and expert group discussion. These included capitalising on the unique perspective of safety concerns from different groups, that existing frameworks do identify priority areas to investigate further, the objectives of a study shape the data interpretation, the pandemic spotlighted long-standing patient concerns, and the time period in which data are collected offers valuable context to aid explanation. The group consensus was that no COVID-19-specific codes were warranted, and the PISA classification system was fit for purpose. Conclusions We have scrutinised the meaningful use of the PISA classification system’s application during a period of systemic healthcare constraint, the COVID-19 pandemic. Despite these constraints, we found the framework can be successfully applied to incident reports to enable deductive analysis, identify areas for further enquiry and thus support organisational learning. No new or amended codes were warranted. Organisations and investigators can use our findings when reviewing their own classification systems.

Abstract Background Public involvement in health services research is encouraged. Descriptions of public involvement across the whole research cycle of a major study are uncommon and its effects on research conduct are poorly understood. Aim This study aimed to describe how we implemented public involvement, reflect on process and effects in a large‐scale multi‐site research study and present learning for future involvement practice. Method We recorded public involvement roles and activities throughout the study and compared these to our original public involvement plan included in our project proposal. We held a group interview with study co‐applicants to explore their experiences, transcribed the recorded discussion and conducted thematic analysis. We synthesized the findings to develop recommendations for future practice. Results Public contributors' activities went beyond strategic study planning and management to include active involvement in data collection, analysis and dissemination. They attended management, scrutiny, planning and task meetings. They also facilitated public involvement through annual planning and review sessions, conducted a Public Involvement audit and coordinated public and patient input to stakeholder discussions at key study stages. Group interview respondents said that involvement exceeded their expectations. They identified effects such as changes to patient recruitment, terminology clarification and extra dissemination activities. They identified factors enabling effective involvement including team and leader commitment, named support contact, building relationships and demonstrating equality and public contributors being confident to challenge and flexible to meet researchers' timescales and work patterns. There were challenges matching resources to roles and questions about the risk of over‐professionalizing public contributors. Conclusion We extended our planned approach to public involvement and identified benefits to the research process that were both specific and general. We identified good practice to support effective public involvement in health services research that study teams should consider in planning and undertaking research. Public Contribution This paper was co‐conceived, co‐planned and co‐authored by public contributors to contribute research evidence, based on their experiences of active involvement in the design, implementation and dissemination of a major health services research study.

Introduction There is an urgent need to determine the safety, effectiveness and cost-effectiveness of novel antiviral treatments for COVID-19 in vaccinated patients in the community at increased risk of morbidity and mortality from COVID-19.Methods and analysis PANORAMIC is a UK-wide, open-label, prospective, adaptive, multiarm platform, randomised clinical trial that evaluates antiviral treatments for COVID-19 in the community. A master protocol governs the addition of new antiviral treatments as they become available, and the introduction and cessation of existing interventions via interim analyses. The first two interventions to be evaluated are molnupiravir (Lagevrio) and nirmatrelvir/ritonavir (Paxlovid). Eligibility criteria: community-dwelling within 5 days of onset of symptomatic COVID-19 (confirmed by PCR or lateral flow test), and either (1) aged 50 years and over, or (2) aged 18–49 years with qualifying comorbidities. Registration occurs via the trial website and by telephone. Recruitment occurs remotely through the central trial team, or in person through clinical sites. Participants are randomised to receive either usual care or a trial drug plus usual care. Outcomes are collected via a participant-completed daily electronic symptom diary for 28 days post randomisation. Participants and/or their Trial Partner are contacted by the research team after days 7, 14 and 28 if the diary is not completed, or if the participant is unable to access the diary. The primary efficacy endpoint is all-cause, non-elective hospitalisation and/or death within 28 days of randomisation. Multiple prespecified interim analyses allow interventions to be stopped for futility or superiority based on prespecified decision criteria. A prospective economic evaluation is embedded within the trial.Ethics and dissemination Ethical approval granted by South Central–Berkshire REC number: 21/SC/0393; IRAS project ID: 1004274. Results will be presented to policymakers and at conferences, and published in peer-reviewed journals.Trial registration number ISRCTN30448031; EudraCT number: 2021-005748-31.

Introduction Shielding aimed to protect those predicted to be at highest risk from COVID-19 and was uniquely implemented in the UK during the first year of the pandemic from March 2020. As the first stage in the EVITE Immunity evaluation (Effects of shielding for vulnerable people during COVID-19 pandemic on health outcomes, costs and immunity, including those with cancer:quasi-experimental evaluation), we generated a logic model to describe the programme theory underlying the shielding intervention.Design and participants We reviewed published documentation on shielding to develop an initial draft of the logic model. We then discussed this draft during interviews with 13 key stakeholders involved in putting shielding into effect in Wales and England. Interviews were recorded, transcribed and analysed thematically to inform a final draft of the logic model.Results The shielding intervention was a complex one, introduced at pace by multiple agencies working together. We identified three core components: agreement on clinical criteria; development of the list of people appropriate for shielding; and communication of shielding advice. In addition, there was a support programme, available as required to shielding people, including food parcels, financial support and social support. The predicted mechanism of change was that people would isolate themselves and so avoid infection, with the primary intended outcome being reduction in mortality in the shielding group. Unintended impacts included negative impact on mental and physical health and well-being. Details of the intervention varied slightly across the home nations of the UK and were subject to minor revisions during the time the intervention was in place.Conclusions Shielding was a largely untested strategy, aiming to mitigate risk by placing a responsibility on individuals to protect themselves. The model of its rationale, components and outcomes (intended and unintended) will inform evaluation of the impact of shielding and help us to understand its effect and limitations.

Introduction Healthcare-associated harm is an international public health issue. Children are particularly vulnerable to this with 15%–35% of hospitalised children experiencing harm during medical care. While many factors increase the risk of adverse events, such as children’s dependency on others to recognise illness, children have a unique protective factor in the form of their family, who are often well placed to detect and prevent unsafe care. However, families can also play a key role in the aetiology of unsafe care.We aim to explore the role of families, guardians and parents in paediatric safety incidents, and how this may have changed during the pandemic, to learn how to deliver safer care and codevelop harm prevention strategies across healthcare settings.Methods and analysis This will be a retrospective study inclusive of an exploratory data analysis and thematic analysis of incident report data from the Learning from Patient Safety Events service (formerly National Reporting and Learning System), using the established PatIent SAfety classification system. Reports will be identified by using specific search terms, such as *parent* and *mother*, to capture narratives with explicit mention of parental involvement, inclusive of family members with parental and informal caregiver responsibilities.Paediatricians and general practitioners will characterise the reports and inter-rater reliability will be assessed. Exploratory descriptive analysis will allow the identification of types of incidents involving parents, contributing factors, harm outcomes and the specific role of the parents including inadvertent contribution to or mitigation of harm.Ethics and dissemination This study was approved by Cardiff University Research Ethics Committee (SMREC 22/32). Findings will be submitted to a peer-reviewed journal, presented at international conferences and presented at stakeholder workshops.

Introduction: Improving medication safety during transition of care is an international healthcare priority. While existing research reveals that medication-related incidents and associated harms may be common following hospital discharge, there is limited information about their nature and contributory factors at a national level which is crucial to inform improvement strategy. Aim: To characterise the nature and contributory factors of medication-related incidents during transition of care from secondary to primary care. Method: A retrospective analysis of medication incidents reported to the National Reporting and Learning System (NRLS) in England and Wales between 2015 and 2019. Descriptive analysis identified the frequency and nature of incidents and content analysis of free text data, coded using the Patient Safety Research Group (PISA) classification, examined the contributory factors and outcome of incidents. Results: A total of 1121 medication-related incident reports underwent analysis. Most incidents involved patients over 65 years old (55%, n = 626/1121). More than one in 10 (12.6%, n = 142/1121) incidents were associated with patient harm. The drug monitoring (17%) and administration stages (15%) were associated with a higher proportion of harmful incidents than any other drug use stages. Common medication classes associated with incidents were the cardiovascular ( n = 734) and central nervous ( n = 273) systems. Among 408 incidents reporting 467 contributory factors, the most common contributory factors were organisation factors (82%, n = 383/467) (mostly related to continuity of care which is the delivery of a seamless service through integration, co-ordination, and the sharing of information between different providers), followed by staff factors (16%, n = 75/467). Conclusion: Medication incidents after hospital discharge are associated with patient harm. Several targets were identified for future research that could support the development of remedial interventions, including commonly observed medication classes, older adults, increase patient engagement, and improve shared care agreement for medication monitoring post hospital discharge. Plain language summary Study using reports about unsafe or substandard care mainly written by healthcare professionals to better understand the type and causes of medication safety problems following hospital discharge Why was the study done? The safe use of medicines after hospital discharge has been highlighted by the World Health Organization as an important target for improvement in patient care. Yet, the type of medication problems which occur, and their causes are poorly understood across England and Wales, which may hamper our efforts to create ways to improve care as they may not be based on what we know causes the problem in the first place. What did the researchers do? The research team studied medication safety incident reports collected across England and Wales over a 5-year period to better understand what kind of medication safety problems occur after hospital discharge and why they happen, so we can find ways to prevent them from happening in future. What did the researchers find? The total number of incident reports studied was 1121, and the majority ( n = 626) involved older people. More than one in ten of these incidents caused harm to patients. The most common medications involved in the medication safety incidents were for cardiovascular diseases such as high blood pressure, conditions such as mental illness, pain and neurological conditions (e.g., epilepsy) and other illnesses such as diabetes. The most common causes of these incidents were because of the organisation rules, such as information sharing, followed by staff issues, such as not following protocols, individual mistakes and not having the right skills for the task. What do the findings mean? This study has identified some important targets that can be a focus of future efforts to improve the safe use of medicines after hospital discharge. These include concentrating attention on medication for the cardiovascular and central nervous systems (e.g., via incorporating them in prescribing safety indicators and pharmaceutical prioritisation tools), staff skill mix (e.g., embedding clinical pharmacist roles at key parts of the care pathway where greatest risk is suspected), and implementation of electronic interventions to improve timely communication of medication and other information between healthcare providers.

Abstract Background Patient experience is an important outcome and indicator of healthcare quality, and patient reported experiences are key to improving quality of care. While patient experience in emergency departments (EDs) has been reported in research, there is limited evidence about patients’ specific experiences with primary care services located in or alongside EDs. We aim to identify theories about patient experience and acceptability of being streamed to a primary care clinician in an ED. Methods Using theories from a rapid realist review as a basis, we interviewed 24 patients and 106 staff members to generate updated theories about patient experience and acceptability of streaming to primary care services in EDs. Feedback from 56 stakeholders, including clinicians, policymakers and patient and public members, as well as observations at 13 EDs, also contributed to the development of these theories, which we present as a programme theory. Results We found that patients had no expectations or preferences for which type of clinician they were seen by, and generally found being streamed to a primary care clinician in the ED acceptable. Clinicians and patients reported that patients generally found primary care streaming acceptable if they felt their complaint was dealt with suitably, in a timely manner, and when clinicians clearly communicated the need for investigations, and how these contributed to decision-making and treatment plans. Conclusions From our findings, we have developed a programme theory to demonstrate that service providers can expect that patients will be generally satisfied with their experience of being streamed to, and seen by, primary care clinicians working in these services. Service providers should consider the potential advantages and disadvantages of implementing primary care services at their ED. If primary care services are implemented, clear communication is needed between staff and patients, and patient feedback should be sought.

BackgroundReducing avoidable healthcare-associated harm is a global health priority. Progress in evaluating the burden and aetiology of avoidable harm in prisons is limited compared with other healthcare sectors. To address this gap, this study aimed to develop a definition of avoidable harm to facilitate future epidemiological studies in prisons.MethodsUsing a sequential mixed methods study design we first characterised and reached consensus on the types and avoidability of patient harm in prison healthcare involving analysis of 151 serious prison incidents reported to the Strategic Executive Information System (StEIS) followed by in-depth nominal group (NG) discussions with four former service users and four prison professionals. Findings of the NG discussions and StEIS analysis were then synthesised and discussed among the research team and study oversight groups to develop an operational definition of avoidable harm in prison healthcare which was subsequently tested and validated using prison patient safety incident report data derived from the National Reporting and Learning System (NRLS).ResultsAnalysis of StEIS incident reports and NG discussions identified important factors influencing avoidable harm which reflected the unique prison setting, including health care delivery issues and constraints associated with the secure environment which limited access to care. These findings informed the development of a new working two-tier definition of avoidable harm using appropriate and timely intervention, which included an additional assessment of harm avoidability taking into the account the prison regime and environment. The definition was compatible with the NRLS incident report narratives and illustrated how the prison environment may influence identification of avoidable harm and judgements of avoidability.ConclusionsWe have developed a working definition of avoidable harm in prison health care that enables consideration of caveats associated with prison environments and systems. Our definition enables future studies of the safety of prison healthcare to standardise outcome measurement.

Abstract Background Increasing demand on emergency healthcare systems has prompted introduction of new healthcare service models including the provision of GP services in or alongside emergency departments. In England this led to a policy proposal and £100million (US$130million) of funding for all emergency departments to have co-located GP services. However, there is a lack of evidence for whether such service models are effective and safe. We examined diagnostic errors reported in patient safety incident reports to develop theories to explain how and why they occurred to inform potential priority areas for improvement and inform qualitative data collection at case study sites to further refine the theories. Methods We used a mixed-methods design using exploratory descriptive analysis to identify the most frequent and harmful sources of diagnostic error and thematic analysis, incorporating realist methodology to refine theories from an earlier rapid realist review, to describe how and why the events occurred and could be mitigated, to inform improvement recommendations. We used two UK data sources: Coroners’ reports to prevent future deaths (30.7.13–14.08.18) and National Reporting and Learning System (NRLS) patient safety incident reports (03.01.05–30.11.15). Results Nine Coroners’ reports (from 1347 community and hospital reports, 2013–2018) and 217 NRLS reports (from 13 million, 2005–2015) were identified describing diagnostic error related to GP services in or alongside emergency departments. Initial theories to describe potential priority areas for improvement included: difficulty identifying appropriate patients for the GP service; under-investigation and misinterpretation of diagnostic tests; and inadequate communication and referral pathways between the emergency and GP services. High-risk presentations included: musculoskeletal injury, chest pain, headache, calf pain and sick children. Conclusion Initial theories include the following topics as potential priority areas for improvement interventions and evaluation to minimise the risk of diagnostic errors when GPs work in or alongside emergency departments: a standardised initial assessment with streaming guidance based on local service provision; clinical decision support for high-risk conditions; and standardised computer systems, communication and referral pathways between emergency and GP services. These theories require refinement and testing with qualitative data collection from case study (hospital) sites.

Introduction Shielding aimed to protect those predicted to be at highest risk from COVID-19 and was uniquely implemented in the UK during the COVID-19 pandemic. Clinically extremely vulnerable people identified through algorithms and screening of routine National Health Service (NHS) data were individually and strongly advised to stay at home and strictly self-isolate even from others in their household. This study will generate a logic model of the intervention and evaluate the effects and costs of shielding to inform policy development and delivery during future pandemics.Methods and analysis This is a quasiexperimental study undertaken in Wales where records for people who were identified for shielding were already anonymously linked into integrated data systems for public health decision-making. We will: interview policy-makers to understand rationale for shielding advice to inform analysis and interpretation of results; use anonymised individual-level data to select people identified for shielding advice in March 2020 and a matched cohort, from routine electronic health data sources, to compare outcomes; survey a stratified random sample of each group about activities and quality of life at 12 months; use routine and newly collected blood data to assess immunity; interview people who were identified for shielding and their carers and NHS staff who delivered healthcare during shielding, to explore compliance and experiences; collect healthcare resource use data to calculate implementation costs and cost–consequences. Our team includes people who were shielding, who used their experience to help design and deliver this study.Ethics and dissemination The study has received approval from the Newcastle North Tyneside 2 Research Ethics Committee (IRAS 295050). We will disseminate results directly to UK government policy-makers, publish in peer-reviewed journals, present at scientific and policy conferences and share accessible summaries of results online and through public and patient networks.

Abstract Background Compared to the rest of Europe, the UK has relatively poor cancer outcomes, with late diagnosis and a slow referral process being major contributors. General practitioners (GPs) are often faced with patients presenting with a multitude of non-specific symptoms that could be cancer. Safety netting can be used to manage diagnostic uncertainty by ensuring patients with vague symptoms are appropriately monitored, which is now even more crucial due to the ongoing COVID-19 pandemic and its major impact on cancer referrals. The ThinkCancer! workshop is an educational behaviour change intervention aimed at the whole general practice team, designed to improve primary care approaches to ensure timely diagnosis of cancer. The workshop will consist of teaching and awareness sessions, the appointment of a Safety Netting Champion and the development of a bespoke Safety Netting Plan and has been adapted so it can be delivered remotely. This study aims to assess the feasibility of the ThinkCancer! intervention for a future definitive randomised controlled trial. Methods The ThinkCancer! study is a randomised, multisite feasibility trial, with an embedded process evaluation and feasibility economic analysis. Twenty-three to 30 general practices will be recruited across Wales, randomised in a ratio of 2:1 of intervention versus control who will follow usual care. The workshop will be delivered by a GP educator and will be adapted iteratively throughout the trial period. Baseline practice characteristics will be collected via questionnaire. We will also collect primary care intervals (PCI), 2-week wait (2WW) referral rates, conversion rates and detection rates at baseline and 6 months post-randomisation. Participant feedback, researcher reflections and economic costings will be collected following each workshop. A process evaluation will assess implementation using an adapted Normalisation Measure Development (NoMAD) questionnaire and qualitative interviews. An economic feasibility analysis will inform a future economic evaluation. Discussion This study will allow us to test and further develop a novel evidenced-based complex intervention aimed at general practice teams to expedite the diagnosis of cancer in primary care. The results from this study will inform the future design of a full-scale definitive phase III trial. Trial registration ClinicalTrials.gov NCT04823559 .

Background The COVID-19 pandemic has resulted in the rapid reorganisation of health and social care services. Patients are already at significant risk of healthcare-associated harm and the wholesale disruption to service delivery during the pandemic stood to heighten those risks. Objectives We explored the type and nature of patient safety incidents in French primary care settings during the COVID-19 first wave to make tentative recommendations for improvement. Methods A national patient safety incident reporting survey was distributed to General Practitioners (GPs) in France on 28 April 2020. Reports were coded using a classification system aligned to the WHO International Classification for Patient Safety (incident types, contributing factors, incident outcomes and severity of harm). Analysis involved data coding, processing, iterative generation of data summaries using descriptive statistical analysis. Clinicaltrials.gov: NCT04346121. Results Of 132 incidents, 58 (44%) related to delayed diagnosis, assessments and referrals. Cancellations of appointments, hospitalisations or procedures was reported in 22 (17%) of these incidents. Home confinement-related incidents accounted for 13 (10%) reports and inappropriate medication stopping for five (4%). Patients delayed attending or did not consult their general practitioner or other healthcare providers due to their fear of contracting COVID-19 infection at an in-person visit in 26 (10%) incidents or fear of burdening their GPs in eight (3%) incidents. Conclusion Constraints from the first wave of the COVID-19 pandemic have contributed to patient safety incidents during non-COVID-19 care. Lessons from these incidents pinpoint where primary care services in France can focus resources to design safer systems for patients.

Abstract Background To manage increasing demand for emergency and unscheduled care NHS England policy has promoted services in which patients presenting to Emergency Departments (EDs) with non-urgent problems are directed to general practitioners (GPs) and other primary care clinicians working within or alongside emergency departments. However, the ways that hospitals have implemented primary care services in EDs are varied. The aim of this study was to describe ED clinical leads’ experiences of implementing and delivering ‘primary care services’ and ‘emergency medicine services’ where GPs were integrated into the ED team. Methods We conducted interviews with ED clinical leads in England (n = 19) and Wales (n = 2). We used framework analysis to analyse interview transcripts and explore differences across ‘primary care services’, ‘emergency medicine services’ and emergency departments without primary care services. Results In EDs with separate primary care services, success was reported when having a distinct workforce of primary care clinicians, who improved waiting times and flow by seeing primary care-type patients in a timely way, using fewer investigations, and enabling ED doctors to focus on more acutely unwell patients. Some challenges were: trying to align their service with the policy guidance, inconsistent demand for primary care, accessible community primary care services, difficulties in recruiting GPs, lack of funding, difficulties in agreeing governance protocols and establishing effective streaming pathways. Where GPs were integrated into an ED workforce success was reported as managing the demand for both emergency and primary care and reducing admissions. Conclusions Introducing a policy advocating a preferred model of service to address primary care demand was not useful for all emergency departments. To support successful and sustainable primary care services in or alongside EDs, policy makers and commissioners should consider varied ways that GPs can be employed to manage variation in local demand and also local contextual factors such as the ability to recruit and retain GPs, sustainable funding, clear governance frameworks, training, support and guidance for all staff. Whether or not streaming to a separate primary care service is useful also depended on the level of primary care demand.

Abstract Background At times of increasing pressure on emergency departments, and the need for research into different models of service delivery, little is known about how to recruit patients for qualitative research in emergency departments. We report from one study which aimed to collect evidence on patients’ experiences of attending emergency departments with different models of using general practitioners, but faced challenges in recruiting patients. This paper aims to identify and reflect on the challenges faced at all stages of patient recruitment, from identifying and inviting eligible patients, consenting them for participation and finally to engaging them in interviews, and make recommendations based on our learning. Methods A thematic analysis was carried out on field-notes taken during research visits and meeting minutes of discussions to review and improve patient recruitment throughout the study. Results The following factors influenced the success of patient recruitment in the emergency department setting: complicated or time-consuming electronic health record systems for identifying patients; narrow participant eligibility criteria; limited research nurse support; and lack of face-to-face communication between researchers and eligible patients. Conclusions This paper adds to the methodological evidence for improving patient recruitment in different settings, with a focus on qualitative research in emergency departments. Our findings have implications for future studies attempting to recruit patients in similar settings.

Abstract Background Diagnostic error occurs more frequently in the emergency department than in regular in-patient hospital care. We sought to characterise the nature of reported diagnostic error in hospital emergency departments in England and Wales from 2013 to 2015 and to identify the priority areas for intervention to reduce their occurrence. Methods A cross-sectional mixed-methods design using an exploratory descriptive analysis and thematic analysis of patient safety incident reports. Primary data were extracted from a national database of patient safety incidents. Reports were filtered for emergency department settings, diagnostic error (as classified by the reporter), from 2013 to 2015. These were analysed for the chain of events, contributory factors and harm outcomes. Results There were 2288 cases of confirmed diagnostic error: 1973 (86%) delayed and 315 (14%) wrong diagnoses. One in seven incidents were reported to have severe harm or death. Fractures were the most common condition (44%), with cervical-spine and neck of femur the most frequent types. Other common conditions included myocardial infarctions (7%) and intracranial bleeds (6%). Incidents involving both delayed and wrong diagnoses were associated with insufficient assessment, misinterpretation of diagnostic investigations and failure to order investigations. Contributory factors were predominantly human factors, including staff mistakes, healthcare professionals’ inadequate skillset or knowledge and not following protocols. Conclusions Systems modifications are needed that provide clinicians with better support in performing patient assessment and investigation interpretation. Interventions to reduce diagnostic error need to be evaluated in the emergency department setting, and could include standardised checklists, structured reporting and technological investigation improvements.

Abstract Background Health care-related harm is an internationally recognized threat to public health. The United Kingdom’s national health services demonstrate that upwards of 90% of health care encounters can be delivered in ambulatory settings. Other countries are transitioning to more family practice-based health care systems, and efforts to understand avoidable harm in these settings is needed. Methods We developed 100 scenarios reflecting a range of diseases and informed by the World Health Organization definition of ‘significant harm’. Scenarios included different types of patient safety incidents occurring by commission and omission, demonstrated variation in timeliness of intervention, and conditions where evidence-based guidelines are available or absent. We conducted a two-round RAND / UCLA Appropriateness Method consensus study with a panel of family practitioners in England to define “avoidable harm” within family practice. Panelists rated their perceptions of avoidability for each scenario. We ran a k-means cluster analysis of avoidability ratings. Results Panelists reached consensus for 95 out of 100 scenarios. The panel agreed avoidable harm occurs when a patient safety incident could have been probably, or totally, avoided by the timely intervention of a health care professional in family practice (e.g. investigations, treatment) and / or an administrative process (e.g. referrals, alerts in electronic health records, procedures for following up results) in accordance with accepted evidence-based practice and clinical governance. Fifty-four scenarios were deemed avoidable, whilst 31 scenarios were rated unavoidable and reflected outcomes deemed inevitable regardless of family practice intervention. Scenarios with low avoidability ratings (1 s or 2 s) were not represented by the categories that were used to generate scenarios, whereas scenarios with high avoidability ratings (7 s 8 s or 9 s) were represented by these a priori categories. Discussion The findings from this RAND/UCLA Appropriateness Method study define the characteristics and conditions that can be used to standardize measurement of outcomes for primary care patient safety. Conclusion We have developed a definition of avoidable harm that has potential for researchers and practitioners to apply across primary care settings, and bolster international efforts to design interventions to target avoidable patient safety incidents that cause the most significant harm to patients.

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.

BackgroundNurse-led monitoring of patients for signs and symptoms associated with documented 'undesirable effects' of medicines has potential to prevent avoidable harm, and optimise prescribing.InterventionThe Adverse Drug Reaction Profile for polypharmacy (ADRe-p) identifies and documents putative adverse effects of medicines commonly prescribed in primary care. Nurses address some problems, before passing ADRe-p to pharmacists and prescribers for review, in conjunction with prescriptions.ObjectivesWe investigated changes in: the number and nature of residents' problems as recorded on ADRe-p; prescription regimens; medicines optimisation: and healthcare costs. We explored aetiologies of problems identified and stakeholders' perspectives.Setting and participantsIn three UK care homes, 19 residents completed the study, December 2018 to May 2019. Two service users, three pharmacists, six nurses gave interviews.MethodsThis mixed-method process evaluation integrated data from residents' ADRe-ps and medicines charts, at the study's start and 5-10 weeks later.ResultsWe recruited three of 27 homes approached and 26 of 45 eligible residents; 19 completed ADRe-p at least twice. Clinical gains were identified for 17/19 residents (mean number of symptoms 3 SD 1.67, range 0-7). Examples included management of: pain (six residents), seizures (three), dyspnoea (one), diarrhoea (laxatives reduced, two), falls (two of five able to stand). One or more medicine was de-prescribed or dose reduced for 12/19 residents. ADRe administration and review cost ~£30 in staff time. ADRe-p helped carers and nurses bring residents' problems to the attention of prescribers.ImplicationsADRe-p relieved unnecessary suffering. It supported carers and nurses by providing a tool to engage with pharmacists and prescribers, and was the only observable strategy for multidisciplinary team working around medicines optimisation. ADRe-p improved care by: a) regular systematic checks and problem documentation; b) information transfer from care home staff to prescribers and pharmacists; c) recording changes.RegistrationNLM Identifier NCT03955133; ClinicalTrials.gov.

Background: Lithium is a drug with a narrow therapeutic range and has been associated with a number of serious adverse effects. This study aimed to characterise primary care lithium-related patient safety incidents submitted to the National Reporting and Learning System (NRLS) database with respect to incident origin, type, contributory factors and outcome. The intention was to identify ways to minimise risk to future patients by examining incidents with a range of harm outcomes. Methods: A mixed methods analysis of patient safety incident reports related to lithium was conducted. Data from healthcare organisations in England and Wales were extracted from the NRLS database. An exploratory descriptive analysis was undertaken to characterise the most frequent incident types, the associated chain of events and other contributory factors. Results: A total of 174 reports containing the term ‘lithium’ were identified. Of these, 41 were excluded and, from the remaining 133 reports, 138 incidents were identified and coded. Community pharmacies reported 100 incidents (96 dispensing related, two administration, two other), general practitioner (GP) practices filed 22 reports and 16 reports originated from other sources. A total of 99 dispensing-related incidents were recorded, 39 resulted from the wrong medication dispensed, 31 the wrong strength, 8 the wrong quantity and 21 other. A total of 128 contributory factors were identified overall; for dispensing incidents, the most common related to medication storage/packaging ( n = 41), and ‘mistakes’ ( n = 22), whereas no information regarding contributory factors was provided in 41 reports. Conclusion: Despite the established link between medication packaging and the risk of dispensing errors, our study highlighted storage and packaging as the most commonly described contributory factors to dispensing errors. The absence of certain relevant data limited the ability to fully characterise a number of reports. This highlighted the need to include clear and complete information when submitting reports. This, in turn, may help to better inform the further development of interventions designed to reduce the risk of incidents and improve patient safety. Lay Summary A characterisation of lithium-related patient safety incidents in primary care Lithium is an effective treatment for certain mental illnesses, but has a number of harmful side effects. Safety incidents related to medicines in the UK are reported to the National Reporting and Learning System database (NRLS), and concerns relating to lithium have previously been highlighted. This study aimed to characterise lithium incidents reported to the NRLS that occurred in a primary care setting. Reports relating to lithium and submitted between 2002 and 2013 were reviewed, and the information coded. A total of 174 reports containing the term ‘lithium’ were identified. Of these, 41 were excluded and, from the remaining 133 reports, 138 incidents were identified and coded with respect to incident origin, type, contributory factors and outcome. A total of 100 incidents were reported by community pharmacies (96 of which related to medicine dispensing), general practitioner (GP) practices filed 22 reports and 16 reports originated from other sources. Of the dispensing-related incidents, 39 resulted from the wrong medication dispensed, 31 the wrong strength, 8 the wrong quantity and 21 other. A total of 128 contributory factors were identified overall; for dispensing incidents, the most common related to medication storage/packaging ( n = 41), and ‘mistakes’ ( n = 22) whereas no information regarding contributory factors was provided in 41 reports. Despite the established link between medication packaging and the risk of dispensing errors, our study highlighted storage and packaging as the most commonly cited contributory factors to dispensing errors. The absence of certain relevant data limited the ability to fully characterise a number of reports. This highlighted the need to include clear and complete information when submitting reports. This, in turn, may help to better inform the further development of interventions designed to reduce incident numbers and improve patient safety.

Abstract Background Ensuring effective identification and management of sepsis is a healthcare priority in many countries. Recommendations for sepsis management in primary care have been produced, but in complex healthcare systems, an in-depth understanding of current system interactions and functioning is often essential before improvement interventions can be successfully designed and implemented. A structured participatory design approach to model a primary care system was employed to hypothesise gaps between work as intended and work delivered to inform improvement and implementation priorities for sepsis management. Methods In a Scottish regional health authority, multiple stakeholders were interviewed and the records of patients admitted from primary care to hospital with possible sepsis analysed. This identified the key work functions required to manage these patients successfully, the influence of system conditions (such as resource availability) and the resulting variability of function output. This information was used to model the system using the Functional Resonance Analysis Method (FRAM). The multiple stakeholder interviews also explored perspectives on system improvement needs which were subsequently themed. The FRAM model directed an expert group to reconcile improvement suggestions with current work systems and design an intervention to improve clinical management of sepsis. Results Fourteen key system functions were identified, and a FRAM model was created. Variability was found in the output of all functions. The overall system purpose and improvement priorities were agreed. Improvement interventions were reconciled with the FRAM model of current work to understand how best to implement change, and a multi-component improvement intervention was designed. Conclusions Traditional improvement approaches often focus on individual performance or a specific care process, rather than seeking to understand and improve overall performance in a complex system. The construction of the FRAM model facilitated an understanding of the complexity of interactions within the current system, how system conditions influence everyday sepsis management and how proposed interventions would work within the context of the current system. This directed the design of a multi-component improvement intervention that organisations could locally adapt and implement with the aim of improving overall system functioning and performance to improve sepsis management.

Who could disagree with the seemingly common-sense reasoning that: “We must learn from the things that go wrong.”? Despite major investments to improve patient safety, relatively few evaluations demonstrate convincing reductions in risk, harm, serious error or death. This disappointing trajectory of improvement from learning from errors or Safety-I as it is sometimes known has led some researchers to argue that there is more to be gained by learning from the majority of healthcare episodes: the things that go right. Based on this premise, socalled Safety-II has emerged as a new paradigm. In this commentary, we consider the ongoing value of Safety-I based approaches and explore whether now is the time to abandon learning from “the bad” and re-energise data collection and analysis by focusing on “the good.”

Background: GPs can play an important role in achieving earlier cancer diagnosis to improve patient outcomes, for example through prompt use of the urgent suspected cancer referral pathway. Barriers to early diagnosis include individual practitioner variation in knowledge, attitudes, beliefs, professional expectations, and norms. Aim: This programme of work (Wales Interventions and Cancer Knowledge about Early Diagnosis [WICKED]) will develop a behaviour change intervention to expedite diagnosis through primary care and contribute to improved cancer outcomes. Design & setting: Non-experimental mixed-method study with GPs and primary care practice teams from Wales. Method: Four work packages will inform the development of the behaviour change intervention. Work package 1 will identify relevant evidence-based interventions (systematic review of reviews) and will determine why interventions do or do not work, for whom, and in what circumstances (realist review). Work package 2 will assess cancer knowledge, attitudes, and behaviour of GPs, as well as primary care teams’ perspectives on cancer referral and investigation (GP survey, discrete choice experiment [DCE], interviews, and focus groups). Work package 3 will synthesise findings from earlier work packages using the behaviour change wheel as an overarching theoretical framework to guide intervention development. Work package 4 will test the feasibility and acceptability of the intervention, and determine methods for measuring costs and effects of subsequent behaviour change in a randomised feasibility trial. Results: The findings will inform the design of a future effectiveness trial, with concurrent economic evaluation, aimed at earlier diagnosis. Conclusion: This comprehensive, evidence-based programme will develop a complex GP behaviour change intervention to expedite the diagnosis of symptomatic cancer, and may be applicable to countries with similar healthcare systems.

BackgroundThe UK performs poorly relative to other economically developed countries on numerous indicators of care quality for children. The contribution of iatrogenic harm to these outcomes is unclear. As primary care is the first point of healthcare contact for most children, we sought to investigate the safety of care provided to children in this setting.Methods and findingsWe undertook a mixed methods investigation of reports of primary care patient safety incidents involving sick children from England and Wales' National Reporting and Learning System between 1 January 2005 and 1 December 2013. Two reviewers independently selected relevant incident reports meeting prespecified criteria, and then descriptively analyzed these reports to identify the most frequent and harmful incident types. This was followed by an in-depth thematic analysis of a purposive sample of reports to understand the reasons underpinning incidents. Key candidate areas for strengthening primary care provision and reducing the risks of systems failures were then identified through multidisciplinary discussions. Of 2,191 safety incidents identified from 2,178 reports, 30% (n = 658) were harmful, including 12 deaths and 41 cases of severe harm. The children involved in these incidents had respiratory conditions (n = 387; 18%), injuries (n = 289; 13%), nonspecific signs and symptoms, e.g., fever (n = 281; 13%), and gastrointestinal or genitourinary conditions (n = 268; 12%), among others. Priority areas for improvement included safer systems for medication provision in community pharmacies; triage processes to enable effective and timely assessment, diagnosis, and referral of acutely sick children attending out-of-hours services; and enhanced communication for robust safety netting between professionals and parents. The main limitations of this study result from underreporting of safety incidents and variable data quality. Our findings therefore require further exploration in longitudinal studies utilizing case review methods.ConclusionsThis study highlights opportunities to reduce iatrogenic harm and avoidable child deaths. Globally, healthcare systems with primary-care-led models of delivery must now examine their existing practices to determine the prevalence and burden of these priority safety issues, and utilize improvement methods to achieve sustainable improvements in care quality.

Background: There is an emerging interest in the inadvertent harm caused to patients by the provision of primary health-care services. To date (up to 2015), there has been limited research interest and few policy directives focused on patient safety in primary care. In 2003, a major investment was made in the National Reporting and Learning System to better understand patient safety incidents occurring in England and Wales. This is now the largest repository of patient safety incidents in the world. Over 40,000 safety incident reports have arisen from general practice. These have never been systematically analysed, and a key challenge to exploiting these data has been the largely unstructured, free-text data. Aims: To characterise the nature and range of incidents reported from general practice in England and Wales (2005–13) in order to identify the most frequent and most harmful patient safety incidents, and relevant contributory issues, to inform recommendations for improving the safety of primary care provision in key strategic areas. Methods: We undertook a cross-sectional mixed-methods evaluation of general practice patient safety incident reports. We developed our own classification (coding) system using an iterative approach to describe the incident, contributory factors and incident outcomes. Exploratory data analysis methods with subsequent thematic analysis was undertaken to identify the most harmful and most frequent incident types, and the underlying contributory themes. The study team discussed quantitative and qualitative analyses, and vignette examples, to propose recommendations for practice. Main findings: We have identified considerable variation in reporting culture across England and Wales between organisations. Two-thirds of all reports did not describe explicit reasons about why an incident occurred. Diagnosis- and assessment-related incidents described the highest proportion of harm to patients; over three-quarters of these reports (79%) described a harmful outcome, and half of the total reports described serious harm or death (n = 366, 50%). Nine hundred and ninety-six reports described serious harm or death of a patient. Four main contributory themes underpinned serious harm- and death-related incidents: (1) communication errors in the referral and discharge of patients; (2) physician decision-making; (3) unfamiliar symptom presentation and inadequate administration delaying cancer diagnoses; and (4) delayed management or mismanagement following failures to recognise signs of clinical (medical, surgical and mental health) deterioration. Conclusions: Although there are recognised limitations of safety-reporting system data, this study has generated hypotheses, through an inductive process, that now require development and testing through future research and improvement efforts in clinical practice. Cross-cutting priority recommendations include maximising opportunities to learn from patient safety incidents; building information technology infrastructure to enable details of all health-care encounters to be recorded in one system; developing and testing methods to identify and manage vulnerable patients at risk of deterioration, unscheduled hospital admission or readmission following discharge from hospital; and identifying ways patients, parents and carers can help prevent safety incidents. Further work must now involve a wider characterisation of reports contributed by the rest of the primary care disciplines (pharmacy, midwifery, health visiting, nursing and dentistry), include scoping reviews to identify interventions and improvement initiatives that address priority recommendations, and continue to advance the methods used to generate learning from safety reports. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

Using a modified Delphi exercise, Aziz Sheikh and colleagues identify research priorities for patient safety research in primary care contexts. Please see later in the article for the Editors' Summary.