Patient safety in the NHS: now is the time for optimism.

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, considers the need for optimism about NHS patient safety.

Penicillin allergy status and its effect on antibiotic prescribing, patient outcomes and antimicrobial resistance (ALABAMA): protocol for a multicentre, parallel-arm, open-label, randomised pragmatic trial.

INTRODUCTION: Incorrect penicillin allergy records are recognised as an important barrier to the safe treatment of infection and affect an estimated 2.7 million people in England. Penicillin allergy records are associated with worse health outcome and antimicrobial resistance. The ALlergy AntiBiotics And Microbial resistAnce (ALABAMA) trial aims to determine if an intervention package, centred around a penicillin allergy assessment pathway (PAAP) initiated in primary care, is safe and effective in improving patient health outcomes and antibiotic prescribing. METHODS AND ANALYSIS: The ALABAMA trial is a multicentre, parallel-arm, open-label, randomised pragmatic trial with a nested pilot study. Adults (≥18 years) with a penicillin allergy record and who have received antibiotics in the previous 24 months will be eligible for participation. Between 1592 and 2090 participants will be recruited from participating National Health Service general practices in England. Participants will be randomised to either usual care or intervention to undergo a pre-emptive PAAP using a 1:1 allocation ratio. The primary outcome measure is the percentage of treatment response failures within 28 days of an index prescription. 2090 and 1592 participants are estimated to provide 90% and 80% power, respectively, to detect a clinically important absolute difference of 7.9% in primary outcome at 1 year between groups. The trial includes a mixed-methods process evaluation and cost-effectiveness evaluation. ETHICS AND DISSEMINATION: This trial has been approved by London Bridge Research Ethics Committee (ref: 19/LO/0176). It will be conducted in compliance with Good Clinical Practice guidelines according to the Declaration of Helsinki. Informed consent will be obtained from all subjects involved in the study. The primary trial results will be submitted for publication to an international, peer-reviewed journal. TRIAL REGISTRATION: ISRCTN20579216.

Intervention to reduce sedentary behaviour and improve outcomes after stroke (Get Set Go): a study protocol for the process evaluation of a pilot cluster randomised controlled trial (RECREATE).

INTRODUCTION: Stroke survivors spend long periods of time engaging in sedentary behaviour (SB) even when their functional recovery is good. In the RECREATE programme, an intervention aimed at reducing SB ('Get Set Go') will be implemented and evaluated in a pragmatic external pilot cluster randomised controlled trial with embedded process and economic evaluations. We report the protocol for the process evaluation which will address the following objectives: (1) describe and clarify causal assumptions about the intervention, and its mechanisms of impact; (2) assess implementation fidelity; (3) explore views, perceptions and acceptability of the intervention to staff, stroke survivors and their carers; (4) establish the contextual factors that influence implementation, intervention mechanisms and outcomes. METHODS AND ANALYSIS: This pilot trial will be conducted in 15 UK-based National Health Service stroke services. This process evaluation study, underpinned by the Medical Research Council guidance, will be undertaken in six of the randomised services (four intervention, two control). Data collection includes the following: observations of staff training sessions, non-participant observations in inpatient and community settings, semi-structured interviews with staff, patients and carers, and documentary analysis of key intervention components. Additional quantitative implementation data will be collected in all sites. Training observations and documentary analysis data will be summarised, with other observational and interview data analysed using thematic analysis. Relevant theories will be used to interpret the findings, including the theoretical domains framework, normalisation process theory and the theoretical framework of acceptability. Anticipated outputs include the following: recommendations for intervention refinements (both content and implementation); a revised implementation plan and a refined logic model. ETHICS AND DISSEMINATION: The study was approved by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (REC reference: 19/YH/0403). Findings will be disseminated via peer review publications, and national and international conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN82280581.

Study of How Adiposity in Pregnancy has an Effect on outcomeS (SHAPES): protocol for a prospective cohort study.

INTRODUCTION: Maternal obesity increases the risk of multiple maternal and infant pregnancy complications, such as gestational diabetes and pre-eclampsia. Current UK guidelines use body mass index (BMI) to identify which women require additional care due to increased risk of complications. However, BMI may not accurately predict which women will develop complications during pregnancy as it does not determine amount and distribution of adipose tissue. Some adiposity measures (eg, waist circumference, ultrasound measures of abdominal visceral fat) can better identify where body fat is stored, which may be useful in predicting those women who need additional care. METHODS AND ANALYSIS: This prospective cohort study (SHAPES, Study of How Adiposity in Pregnancy has an Effect on outcomeS) aims to evaluate the prognostic performance of adiposity measures (either alone or in combination with other adiposity, sociodemographic or clinical measures) to estimate risk of adverse pregnancy outcomes. Pregnant women (n=1400) will be recruited at their first trimester ultrasound scan (11+2-14+1 weeks') at Newcastle upon Tyne National Health Service Foundation Trust, UK. Early pregnancy adiposity measures and clinical and sociodemographic data will be collected. Routine data on maternal and infant pregnancy outcomes will be collected from routine hospital records. Regression methods will be used to compare the different adiposity measures with BMI in terms of their ability to predict pregnancy complications. If no individual measure performs better than BMI, multivariable models will be developed and evaluated to identify the most parsimonious model. The apparent performance of the developed model will be summarised using calibration, discrimination and internal validation analyses. ETHICS AND DISSEMINATION: Ethical favourable opinion has been obtained from the North East: Newcastle & North Tyneside 1 Research Ethics Committee (REC reference: 22/NE/0035). All participants provide informed consent to take part in SHAPES. Planned dissemination includes peer-reviewed publications and additional dissemination appropriate to target audiences, including policy briefs for policymakers, media/social-media coverage for public and conferences for research TRIAL REGISTRATION NUMBER: ISRCTN82185177.

Surgeon's narcissism, hostility, stress, bullying, meaning in life and work environment: a two-centered analysis.

INTRODUCTION: Disruptive physician behaviour can affect patients' safety. If surgical trainees throughout higher education experience disruptive behaviour, impaired work-life may follow. Therefore, we aimed to study surgeons' level of narcissism (N), hostility, and stress in relation to their work environment and potential experience of bullying. We also scrutinized search for or presence of meaning in life. METHODS: General surgeons in UK National Health Service from 2 hospitals participated with 3 levels of training: junior trainees (JT), senior trainees (ST), and consultants (CONS). Participants completed 52 VAS-formed questions plus demographics. Modified questionnaires were used for assessments of 'hostility', 'narcissism', meaning in life, quality of work-life, and bullying. RESULTS: Altogether 33% of surgeons displayed narcissism and 22% could exhibit disruptive behaviour. MANOVA significant differences between low, medium, and high narcissism groups were revealed in hostility (p<.01), perceived stress (p=.001), and presence of meaning in life (p<.05). Regression analyses explained hostility both by N-scale (p=.000) and 'being bullied during training'(p=.009) but negatively by 'presence of meaning in life'(p=.004). Surgeons' perceived stress was explained both by N-scale (p=.000) followed by 'seeing others bullied during training (p=.000) and negatively by 'working extra days beyond schedule' (p=.007). The presence of meaning in life was explained mostly by good beneficial stress (p= .000) but negatively both by 'doing extra work beyond schedule' (p= .016) and hostility (p= .003). CONCLUSION: Surgeons may exhibit disruptive behaviour in a challenging situation. The narcissim-scale was the best predictor of hostility and perceived stress. Being bullied during surgical training predicted hostility. Seeing others being bullied during surgical training predicted stress. Beneficial stress is explained best by surgeons' experience of the presence of meaning in life.

Modelling NHS England 111 demand for primary care services: a discrete event simulation.

OBJECTIVES: This feasibility study aimed to model in silico the current healthcare system for patients triaged to a primary care disposition following a call to National Health Service (NHS) 111 and determine the effect of reconfiguring the healthcare system to ensure a timely primary care service contact. DESIGN: Discrete event simulation. SETTING: Single English NHS 111 call centre in Yorkshire. PARTICIPANTS: Callers registered with a Bradford general practitioner who contacted the NHS 111 service in 2021 and were triaged to a primary care disposition. PRIMARY AND SECONDARY OUTCOME MEASURES: Face validity of conceptual model. Comparison between real and simulated data for quarterly counts (and 95% CIs) for patient contact with emergency ambulance (999), 111, and primary and secondary care services. Mean difference and 95% CIs in healthcare system usage between simulations and difference in mean proportion of avoidable admissions for callers who presented to an emergency department (ED). RESULTS: The simulation of the current system estimated that there would be 39 283 (95% CI 39 237 to 39 328) primary care contacts, 2042 (95% CI 2032 to 2051) 999 calls and 1120 (95% CI 1114 to 1127) avoidable ED attendances. Modifying the model to ensure a timely primary care response resulted in a mean percentage increase of 196.1% (95% CI 192.2% to 199.9%) in primary care contacts, and a mean percentage decrease of 78.0% (95% CI 69.8% to 86.2%) in 999 calls and 88.1% (95% CI 81.7% to 94.5%) in ED attendances. Avoidable ED attendances reduced by a mean of -26 (95% CI -35 to -17). CONCLUSION: In this simulated study, ensuring timely contact with a primary care service would lead to a significant reduction in 999 and 111 calls, and ED attendances (although not avoidable ED attendance). However, this is likely to be impractical given the need to almost double current primary care service provision. Further economic and qualitative research is needed to determine whether this intervention would be cost-effective and acceptable to both patients and primary care clinicians.

Protocol for the YORKSURe prospective multistage study testing the feasibility for early detection of bladder cancer in populations with high disease-specific mortality risk.

INTRODUCTION: Around 25% of patients with bladder cancer (BCa) present with invasive disease. Non-randomised studies of population-based screening have suggested reductions in BCa-specific mortality are possible through earlier detection. The low prevalence of lethal disease in the general population means screening is not cost-effective and there is no consensus on the best strategy. Yorkshire has some of the highest mortality rates from BCa in England. We aim to test whether population screening in a region of high mortality risk will lead to a downward stage-migration of aggressive BCa, improved survival and is cost-effective. METHODS AND ANALYSIS: YORKSURe is a tiered, randomised, multicohort study to test the feasibility of a large BCa screening randomised controlled trial. In three parallel cohorts, participants will self-test urine (at home) up to six times. Results are submitted via a mobile app or freephone. Those with a positive result will be invited for further investigation at community-based early detection clinics or within usual National Health Service (NHS) pathways. In Cohort 1, we will post self-testing kits to research engaged participants (n=2000) embedded within the Yorkshire Lung Screening Trial. In Cohort 2, we will post self-testing kits to 3000 invitees. Cohort 2 participants will be randomised between haematuria and glycosuria testing using a reveal/conceal design. In Cohort 3, we will post self-testing kits to 500 patients within the NHS pathway for investigation of haematuria. Our primary outcomes are rates of recruitment and randomisation, rates of positive test and acceptability of the design. The study is currently recruiting and scheduled to finish in June 2023. ETHICS AND DISSEMINATION: The study has received the following approvals: London Riverside Research Ethics Committee (22/LO/0018) and Health Research Authority Confidentiality Advisory Group (20/CAG/0009). Results will be made available to providers and researchers via publicly accessible scientific journals. TRIAL REGISTRATION NUMBER: ISRCTN34273159.

Did the evidence-based intervention (EBI) programme reduce inappropriate procedures, lessen unwarranted variation or lead to spill-over effects in the National Health Service?

BACKGROUND: Health systems are under pressure to maintain services within limited resources. The Evidence-Based Interventions (EBI) programme published a first list of guidelines in 2019, which aimed to reduce inappropriate use of interventions within the NHS in England, reducing potential harm and optimising the use of limited resources. Seventeen procedures were selected in the first round, published in April 2019. METHODS: We evaluated changes in the trends for each procedure after its inclusion in the EBI's first list of guidelines using interrupted time series analysis. We explored whether there was any evidence of spill-over effects onto related or substitute procedures, as well as exploring changes in geographical variation following the publication of national guidance. RESULTS: Most procedures were experiencing downward trends in the years prior to the launch of EBI. We found no evidence of a trend change in any of the 17 procedures following the introduction of the guidance. No evidence of spill-over increases in substitute or related procedures was found. Geographic variation in the number of procedures performed across English CCGs remained at similar levels before and after EBI. CONCLUSIONS: The EBI programme had little success in its aim to further reduce the use of the 17 procedures it deemed inappropriate in all or certain circumstances. Most procedure rates were already decreasing before EBI and all continued with a similar trend afterwards. Geographical variation in the number of procedures remained at a similar level post EBI. De-adoption of inappropriate care is essential in maintaining health systems across the world. However, further research is needed to explore context specific enablers and barriers to effective identification and de-adoption of such inappropriate health care to support future de-adoption endeavours.

Hospital clinicians' perceptions and experiences of care pathways for chronic limb-threatening ischaemia: a qualitative study.

BACKGROUND: Chronic limb-threatening ischaemia (CLTI) is a condition associated with significant risks of lower limb loss and mortality, which increase with delays in management. Guidance recommends urgent referral and assessment, but delays are evident at every stage of the CLTI patient pathway. This study uses qualitative methods to explore hospital clinicians' experiences and perceptions of the existing CLTI pathway. METHODS: A qualitative interview study was conducted. Semi-structured interviews were undertaken with 13 clinicians involved in the assessment of patients referred to hospital with suspected CLTI, identified via purposive sampling from English vascular surgery units. Clinicians included podiatrists, vascular specialist nurses and doctors. Reflexive thematic analysis was performed on the data from a critical realist position. RESULTS: The need for speed was the single overarching theme identified. Four linked underlying themes were also identified; 1. Vascular surgery as the poor relation (compared to cancer and other specialties), with a sub-theme of CLTI being a challenging diagnosis. 2. Some patients are more equal than others, with sub-themes of diabetes vs. non-diabetes, hub vs. spoke and frailty vs. non-frail. 3. Life in the National Health Service (NHS) is tough, with sub-themes of lack of resource and we're all under pressure. 4. Non-surgeons can help. CONCLUSIONS: The underlying themes generated from the rich interview data describe barriers to timely referral, assessment and management of CLTI, as well as the utility of non-surgical roles such as podiatrists and vascular specialist nurses as a potential solution for delays. The overarching theme of the need for speed highlights the meaning given to adverse consequences of delays in management of CLTI by clinicians involved in its assessment. Future improvement projects aimed at the CLTI pathway should take these findings into account.

Codesigning a systemic discharge intervention for inpatient mental health settings (MINDS): a protocol for integrating realist evaluation and an engineering-based systems approach.

INTRODUCTION: Transition following discharge from mental health hospital is high risk in terms of relapse, readmission and suicide. Discharge planning supports transition and reduces risk. It is a complex activity involving interacting systemic elements. The codesigning a systemic discharge intervention for inpatient mental health settings (MINDS) study aims to improve the process for people being discharged, their carers/supporters and staff who work in mental health services, by understanding, co-designing and evaluating implementation of a systemic approach to discharge planning. METHODS AND ANALYSIS: The MINDS study integrates realist research and an engineering-informed systems approach across three stages. Stage 1 applies realist review and evaluation using a systems approach to develop programme theories of discharge planning. Stage 2 uses an Engineering Better Care framework to codesign a novel systemic discharge intervention, which will be subjected to process and economic evaluation in stage 3. The programme theories and resulting care planning approach will be refined throughout the study ready for a future clinical trial. MINDS is co-led by an expert by experience, with researchers with lived experience co-leading each stage. ETHICS AND DISSEMINATION: MINDS stage 1 has received ethical approval from Yorkshire & The Humber-Bradford Leeds (Research Ethics Committee (22/YH/0122). Findings from MINDS will be disseminated via high-impact journal publications and conference presentations, including those with service user and mental health professional audiences. We will establish routes to engage with public and service user communities and National Health Service professionals including blogs, podcasts and short videos. TRIAL REGISTRATION NUMBER: MINDS is funded by the National Institute of Health Research (NIHR 133013) https://fundingawards.nihr.ac.uk/award/NIHR133013. The realist review protocol is registered on PROSPERO. PROSPERO REGISTRATION NUMBER: CRD42021293255.

The role of Mayors in protecting citizens' health: a brief report from Italy.

The World Health Organization has identified urbanization as one of the most important public health challenges of our century. Nowadays, about half of the world's population live in urban areas, thus municipal authorities can influence multiple determinants of health through Urban Health strategies. However, the health policies and welfare systems are usually managed by multi-level political governments. The aim of this report is to describe the legal and operational competences attributed to mayors and municipal councils with reference to health, taking Italy as case study. Our report summarises and analyses the national, regional, and local Italian legislations. Our results identified the mayors as the highest local health authorities. Indeed, the mayor can issue specific regulations for their local area or order contingent and urgent measures for preventing or delimiting serious health hazards for the safety of their citizens. Moreover, among their duties, municipalities play a crucial role in social care. Hence, municipalities are expected to cooperate with National Health Service at the regional level, to integrate their contributions in a single welfare system. In conclusion, mayors represent the institutional figures closest to the citizens. Municipalities and regional governments should coordinate and integrate their strategies and policies to meet health and social needs of citizens, providing easy access to shared pathways. Municipalities also regulate autonomously fundamental aspects related to the urban environment and can promote and protect health and improve the quality of life for citizens.

Genesis and prospects of the shortage of specialist physicians in Italy and indicators of the 39 schools of hygiene and preventive medicine.

BACKGROUND AND AIM: In Italy, the number of physicians decreased in recent years due to retirements not being replaced by young specialists. To address this shortage of medical personnel, proper planning is needed, taking into consideration the number of accesses in medical schools and residency contracts. The main objective of this study is to deepen the data on the number of physicians, provide a prospective picture and make some suggestions for future planning.  Materials and Methods: Estimates of the number of physicians, contracts, assignments, and abandonments for specialist schools are based on data from the General Medical Council, the Ministry of University and Research, Eurostat and the "Associazione Liberi Specializzandi".    Results: Estimates of the number of physicians for the period 2023-2032 predict the minimum availability of active doctors between 2028 and 2029. While there has been an increase in the number of contracts for residents in recent years, there are concurrently high dropout rates and non-assignment of contracts, varying across Schools of Specialization. An examination of the available data for the 39 Schools of Specialization in Hygiene and Preventive Medicine shows lower than-average abundance rates.  Conclusions: In recent decades, poor planning and early retirement have led to a shortage of doctors, particularly specialists, that will not be resolved until after 2030. Proposed solutions to this 'health emergency' include importing doctors from abroad, delaying the retirement age, recruiting junior doctors to the National Health Service and changing the distribution of junior doctor contracts.

Overview of trials on artificial intelligence algorithms in breast cancer screening - A roadmap for international evaluation and implementation.

Accumulating evidence from retrospective studies demonstrate at least non-inferior performance when using AI algorithms with different strategies versus double-reading in mammography screening. In addition, AI algorithms for mammography screening can reduce work load by moving to single human reading. Prospective trials are essential to avoid unintended adverse consequences before incorporation of AI algorithms into UK's National Health Service (NHS) Breast Screening Programme (BSP). A stakeholders' meeting was organized in Newnham College, Cambridge, UK to undertake a review of the current evidence to enable consensus discussion on next steps required before implementation into a screening programme. It was concluded that a multicentre multivendor testing platform study with opt-out consent is preferred. AI thresholds from different vendors should be determined while maintaining non-inferior screening performance results, particularly ensuring recall rates are not increased. Automatic recall of cases using an agreed high sensitivity AI score versus automatic rule out with a low AI score set at a high sensitivity could be used. A human reader should still be involved in decision making with AI-only recalls requiring human arbitration. Standalone AI algorithms used without prompting maintain unbiased screening reading performance, but reading with prompts should be tested prospectively and ideally provided for arbitration.