Safety-netting advice documentation out-of-hours: a retrospective cohort from 2013 to 2020.

BACKGROUND: Providing safety-netting advice (SNA) in out-of-hours primary care is a recognised standard of safe care but it is not known how frequently this occurs in practice. AIM: Assess the frequency and type of SNA documented in out-of-hours primary care and explore factors associated with its presence. DESIGN AND SETTING: Retrospective cohort using the Birmingham Out-of-hours General Practice Research Database. METHOD: A stratified sample of 30 adult consultation records per month from July 2013 to February 2020 were assessed using a safety-netting coding tool. Associations were tested using linear and logistic regression. RESULTS: The overall frequency of SNA per consultation was 78.0%, increasing from 75.7% (2014) to 81.5% (2019). The proportion of specific SNA and the average number of symptoms patients were told to look out for increased with time. The most common symptom to look out for was if the patients' condition worsened followed by if their symptoms persisted, but only one in five consultations included a time-frame to reconsult for persistent symptoms. SNA was more frequently documented in face-to-face treatment-centre encounters compared to telephone-consultations (Odds Ratio [OR]=1.77, p=0.02), for possible infections (OR=1.53, p=0.006), and less frequently for mental (vs. physical) health consultations (OR=0.33, p=0.002) and where follow-up was planned (OR=0.34, p<0.001). CONCLUSION: The frequency of SNA documented in OOH was higher than previously reported during in-hours care. Over time, the frequency of SNA and proportion that contained specific advice increased, however this study highlights potential consultations where SNA could be improved, such as mental health and telephone consultations.

Improving health system responses when patients are harmed: a protocol for a multistage mixed-methods study.

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.

Recommendations from evaluating the implementation of the 'GP Daffodil Standards' to support the provision of palliative and end-of-life care in primary care: a mixed-methods study.

BACKGROUND: The 'GP Daffodil Standards for Advanced Serious Illness and End of Life Care' was launched by the Royal College of General Practitioners and Marie Curie in 2019 to support improvement of end-of-life care activity in primary care. AIM: To undertake and independent evaluation of the implementation of the Daffodil Standards. METHOD: A multi-method evaluation, informed by Normalisation Process Theory. An online survey with GPs in the UK (Phase 1) and semi-structured interviews with a sub-sample of survey responders (Phase 2) were used to map end-of-life activities and understand the use of the standards. Illustrative case studies of good practice were used to outline recommendations to improve and sustain the implementation of the standards (Phase 3). Data were analysed both quantitatively (Phase 1: descriptive statistics) and qualitatively (Phases 2 and 3: framework analysis). RESULTS: For the Phase 1 survey (n = 82) and Phase 2 semi-structured interviews (n = 8), results demonstrated the motivation to undertake end-of-life care activities and active use of the standards. GPs find it difficult to take this further because of limitations in resources and capacity. There is the indication that a misperception exists for both the purpose and role of the standards. For Phase 3, two case studies are complete, providing more in-depth practical insights into the planning, use, and implementation of the standards. All data collection stopped in December 2023. CONCLUSION: Final results were reported and best practice shared, along with recommendations to sustain the ongoing implementation of the Daffodil Standards.

Evaluation of different models of general practitioners working in or alongside emergency departments: a mixed-methods realist evaluation.

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.

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 practitioner­emergency 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 practitioner­emergency 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 practitioner­emergency 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 practitioner­emergency department services and we have written easy-to-read summaries of all the articles we published.

Programme theories to describe how different general practitioner service models work in different contexts in or alongside emergency departments (GP-ED): realist evaluation.

BACKGROUND: Addressing increasing patient demand and improving ED patient flow is a key ambition for NHS England. Delivering general practitioner (GP) services in or alongside EDs (GP-ED) was advocated in 2017 for this reason, supported by £100 million (US$130 million) of capital funding. Current evidence shows no overall improvement in addressing demand and reducing waiting times, but considerable variation in how different service models operate, subject to local context. METHODS: We conducted mixed-methods analysis using inductive and deductive approaches for qualitative (observations, interviews) and quantitative data (time series analyses of attendances, reattendances, hospital admissions, length of stay) based on previous research using a purposive sample of 13 GP-ED service models (3 inside-integrated, 4 inside-parallel service, 3 outside-onsite and 3 with no GPs) in England and Wales. We used realist methodology to understand the relationship between contexts, mechanisms and outcomes to develop programme theories about how and why different GP-ED service models work. RESULTS: GP-ED service models are complex, with variation in scope and scale of the service, influenced by individual, departmental and external factors. Quantitative data were of variable quality: overall, no reduction in attendances and waiting times, a mixed picture for hospital admissions and length of hospital stay. Our programme theories describe how the GP-ED service models operate: inside the ED, integrated with patient flow and general ED demand, with a wider GP role than usual primary care; outside the ED, addressing primary care demand with an experienced streaming nurse facilitating the 'right patients' are streamed to the GP; or within the ED as a parallel service with most variability in the level of integration and GP role. CONCLUSION: GP-ED services are complex . Our programme theories inform recommendations on how services could be modified in particular contexts to address local demand, or whether alternative healthcare services should be considered.

Validated medication deprescribing instruments for patients with palliative care needs: a systematic review / Instrumentos validados de desprescripción de medicamentos para los pacientes que reciben cuidados paliativos: una revisión sistemática

Objectives: Patients with life-limiting illnesses are prone to unnecessary polypharmacy. Deprescribing tools may contribute to minimizing negative outcomes. Thus, the aims of the study were to identify validated instruments for deprescribing inappropriate medications for patients with palliative care needs and to assess the impact on clinical, humanistic, and economic outcomes. Methods: A systematic review was conducted in LILACS, PUBMED, EMBASE, COCHRANE, and WEB OF SCIENCE databases (until May 2021). A manual search was performed in the references of enrolled articles. The screening, eligibility, extraction, and bias risk assessment were carried out by 2 independent researchers. Experimental and observational studies were eligible for inclusion. Results: Out of the 5791 studies retrieved, after excluding duplicates (n = 1050), conducting title/abstract screening (n = 4741), and full reading (n = 41), only 1 study met the inclusion criteria. In this included study, a randomized controlled trial was conducted, which showed a high level of bias risk overall. Adults 75 years or older (n = 130) with limited life expectancy and polypharmacy were allocated to 2 groups [intervention arm (deprescribing); and control arm (usual care)]. Deprescribing was performed with the aid of the STOPPFrail tool. The mean number of inappropriate medications and monthly medication costs were significantly lower in the intervention arm. No statistically significant differences were found in terms of unscheduled hospital presentations, falls, fractures, mortality, and quality of life. Conclusions: Despite the availability of several instruments to support deprescribing in patients with palliative care needs, only 1 of them has undergone validation and robust assessment for effectiveness in clinical practice. The STOPPFrail tool appears to reduce the number of inappropriate medications for older people with limited life expectancy (and probably palliative care needs)...(AU)

Objetivo: Los pacientes con enfermedades terminales son propensos a la polifarmacia innecesaria. Las herramientas de desprescripción pueden contribuir a minimizar los resultados negativos. Por lo tanto, los objetivos del estudio fueron identificar instrumentos validados para la desprescripción de medicamentos inapropiados en pacientes con necesidades de cuidados paliativos y evaluar el impacto en los resultados clínicos, humanísticos y económicos. Métodos: Se realizó una revisión sistemática en las bases de datos LILACS, PUBMED, EMBASE, COCHRANE y WEB OF SCIENCE (hasta mayo de 2021). Se realizó una búsqueda manual en las referencias de los artículos incluidos. La selección, elegibilidad, extracción y evaluación del riesgo de sesgo se llevaron a cabo por dos investigadores independientes. Se aceptó la inclusión de estudios observacionales y experimentales. Resultados: De los 5791 estudios recuperados, después de excluir duplicados (n = 1050), realizar la selección de títulos/resúmenes (n = 4741) y la lectura completa (n = 41), solo un estudio cumplió con los criterios de inclusión. En este estudio incluido, se realizó un ensayo controlado aleatorizado, que mostró un alto nivel de riesgo de sesgo en general. A los adultos de 75 años o más (n = 130) con esperanza de vida limitada y polifarmacia se les asignaron dos grupos [grupo de intervención (desprescripción) y grupo de control (atención habitual)]. Se realizó la desprescripción con la ayuda de la herramienta STOPPFrail. El número promedio de medicamentos inapropiados y los costos mensuales de los medicamentos fueron significativamente más bajos en el grupo de intervención. No se encontraron diferencias estadísticamente significativas en términos de presentaciones hospitalarias no programadas, caídas, fracturas, mortalidad y calidad de vida. Conclusiones: A pesar de la disponibilidad de varias herramientas para apoyar la deprescripción en pacientes con necesidades de cuidados paliativos...(AU)

Instrumentos validados de desprescripción de medicamentos para los pacientes que reciben cuidados paliativos: una revisión sistemática / Validated medication deprescribing instruments for patients with palliative care needs: a systematic review

Objectives: Patients with life-limiting illnesses are prone to unnecessary polypharmacy. Deprescribing tools may contribute to minimizing negative outcomes. Thus, the aims of the study were to identify validated instruments for deprescribing inappropriate medications for patients with palliative care needs and to assess the impact on clinical, humanistic, and economic outcomes. Methods: A systematic review was conducted in LILACS, PUBMED, EMBASE, COCHRANE, and WEB OF SCIENCE databases (until May 2021). A manual search was performed in the references of enrolled articles. The screening, eligibility, extraction, and bias risk assessment were carried out by 2 independent researchers. Experimental and observational studies were eligible for inclusion. Results: Out of the 5791 studies retrieved, after excluding duplicates (n = 1050), conducting title/abstract screening (n = 4741), and full reading (n = 41), only 1 study met the inclusion criteria. In this included study, a randomized controlled trial was conducted, which showed a high level of bias risk overall. Adults 75 years or older (n = 130) with limited life expectancy and polypharmacy were allocated to 2 groups [intervention arm (deprescribing); and control arm (usual care)]. Deprescribing was performed with the aid of the STOPPFrail tool. The mean number of inappropriate medications and monthly medication costs were significantly lower in the intervention arm. No statistically significant differences were found in terms of unscheduled hospital presentations, falls, fractures, mortality, and quality of life. Conclusions: Despite the availability of several instruments to support deprescribing in patients with palliative care needs, only 1 of them has undergone validation and robust assessment for effectiveness in clinical practice. The STOPPFrail tool appears to reduce the number of inappropriate medications for older people with limited life expectancy (and probably palliative care needs)...(AU)

Objetivo: Los pacientes con enfermedades terminales son propensos a la polifarmacia innecesaria. Las herramientas de desprescripción pueden contribuir a minimizar los resultados negativos. Por lo tanto, los objetivos del estudio fueron identificar instrumentos validados para la desprescripción de medicamentos inapropiados en pacientes con necesidades de cuidados paliativos y evaluar el impacto en los resultados clínicos, humanísticos y económicos. Métodos: Se realizó una revisión sistemática en las bases de datos LILACS, PUBMED, EMBASE, COCHRANE y WEB OF SCIENCE (hasta mayo de 2021). Se realizó una búsqueda manual en las referencias de los artículos incluidos. La selección, elegibilidad, extracción y evaluación del riesgo de sesgo se llevaron a cabo por dos investigadores independientes. Se aceptó la inclusión de estudios observacionales y experimentales. Resultados: De los 5791 estudios recuperados, después de excluir duplicados (n = 1050), realizar la selección de títulos/resúmenes (n = 4741) y la lectura completa (n = 41), solo un estudio cumplió con los criterios de inclusión. En este estudio incluido, se realizó un ensayo controlado aleatorizado, que mostró un alto nivel de riesgo de sesgo en general. A los adultos de 75 años o más (n = 130) con esperanza de vida limitada y polifarmacia se les asignaron dos grupos [grupo de intervención (desprescripción) y grupo de control (atención habitual)]. Se realizó la desprescripción con la ayuda de la herramienta STOPPFrail. El número promedio de medicamentos inapropiados y los costos mensuales de los medicamentos fueron significativamente más bajos en el grupo de intervención. No se encontraron diferencias estadísticamente significativas en términos de presentaciones hospitalarias no programadas, caídas, fracturas, mortalidad y calidad de vida. Conclusiones: A pesar de la disponibilidad de varias herramientas para apoyar la deprescripción en pacientes con necesidades de cuidados paliativos...(AU)

The burden of acute eye conditions on different healthcare providers: a retrospective population-based study.

BACKGROUND: The demand for acute eyecare exponentially outstrips capacity. The public lacks awareness of community eyecare services. AIM: To quantify the burden of acute eyecare on different healthcare service providers in a national population through prescribing and medicines provision by GPs, optometrists, and pharmacists, and provision of care by accident and emergency (A&E) services. A secondary aim was to characterise some of the drivers of this burden. DESIGN AND SETTING: A retrospective data-linkage study set in Wales, UK. METHOD: Analysis of datasets was undertaken from the Secure Anonymised Information Linkage Databank (GP and A&E), the Eye Health Examination Wales service (optometry), and the Common Ailments Scheme (pharmacy) during 2017-2018. RESULTS: A total of 173 999 acute eyecare episodes delivered by GPs (168 877 episodes) and A&E services (5122) were identified during the study. This resulted in 65.4 episodes of care per 1000 people per year. GPs prescribed a total of 87 973 653 prescriptions within the general population. Of these, 820 693 were related to acute eyecare, resulting in a prescribing rate of 0.9%. A total of 5122 eye-related and 905 224 general A&E attendances were identified, respectively, resulting in an A&E attendance rate of 0.6%. Optometrists and pharmacists managed 51.8% (116 868) and 0.6% (2635) of all episodes, respectively. 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 services, and health score. Season, day of the week, and time of day were predictors of burden in GP and A&E. CONCLUSION: Acute eyecare continues to place considerable burden on GP and A&E services in Wales, particularly in urban areas with greater economic deprivation and lower overall health. This is likely to increase with a rapidly ageing population. With ongoing pathway development to better utilise optometry and pharmacy, and improved public awareness, there may be scope to change this trajectory.

Cost-utility analysis of molnupiravir for high-risk, community-based adults with COVID-19: an economic evaluation of the PANORAMIC trial.

BACKGROUND: The cost-effectiveness of molnupiravir, an oral antiviral for early treatment of SARS-CoV-2, has not been established in vaccinated populations. AIM: To evaluate the cost-effectiveness of molnupiravir relative to usual care alone among mainly vaccinated community-based people at higher risk of severe outcomes from COVID-19 over 6 months. DESIGN AND SETTING: An economic evaluation of the PANORAMIC trial in the UK. METHOD: A cost-utility analysis that adopted a UK NHS and personal social services perspective and a 6-month time horizon was performed using PANORAMIC trial data. Cost-effectiveness was expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. Sensitivity and subgroup analyses assessed the impacts of uncertainty and heterogeneity. Threshold analysis explored the price for molnupiravir consistent with likely reimbursement. RESULTS: In the base-case analysis, molnupiravir had higher mean costs of £449 (95% confidence interval [CI] = 445 to 453) and higher mean QALYs of 0.0055 (95% CI = 0.0044 to 0.0067) than usual care (mean incremental cost per QALY of £81 190). Sensitivity and subgroup analyses showed similar results, except for those aged ≥75 years, with a 55% probability of being cost-effective at a £30 000 per QALY threshold. Molnupiravir would have to be priced around £147 per course to be cost-effective at a £15 000 per QALY threshold. CONCLUSION: At the current cost of £513 per course, molnupiravir is unlikely to be cost-effective relative to usual care over a 6-month time horizon among mainly vaccinated patients with COVID-19 at increased risk of adverse outcomes, except those aged ≥75 years.

The quality of care delivered to residents in long-term care in Australia: an indicator-based review of resident records (CareTrack Aged study).

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.

Validated medication deprescribing instruments for patients with palliative care needs palliative care: A systematic review. / [Artículo traducido] Instrumentos validados de desprescripción de medicamentos para los pacientes con necesidades de cuidados paliativos: una revisión sistemática.

OBJECTIVES: Patients with life-limiting illnesses are prone to unnecessary polypharmacy. Deprescribing tools may contribute to minimizing negative outcomes. Thus, the aims of the study were to identify validated instruments for deprescribing inappropriate medications for patients with palliative care needs and to assess the impact on clinical, humanistic, and economic outcomes. METHODS: A systematic review was conducted in LILACS, PUBMED, EMBASE, COCHRANE, and WEB OF SCIENCE databases (until May 2021). A manual search was performed in the references of enrolled articles. The screening, eligibility, extraction, and bias risk assessment were carried out by two independent researchers. Experimental and observational studies were eligible for inclusion. RESULTS: Out of the 5,791 studies retrieved, after excluding duplicates (n = 1,050), conducting title/abstract screening (n = 4,741), and full reading (n = 41), only one study met the inclusion criteria. In this included study, a randomized controlled trial was conducted, which showed a high level of bias risk overall. Adults 75 years or older (n = 130) with limited life expectancy and polypharmacy were allocated to two groups [intervention arm (deprescribing); and control arm (usual care)]. Deprescribing was performed with the aid of the STOPPFrail tool. The mean number of inappropriate medications and monthly medication costs were significantly lower in the intervention arm. No statistically significant differences were found in terms of unscheduled hospital presentations, falls, fractures, mortality, and quality of life. CONCLUSIONS: Despite the availability of several instruments to support deprescribing in patients with palliative care needs, only one of them has undergone validation and robust assessment for effectiveness in clinical practice. The STOPPFrail tool appears to reduce the number of inappropriate medications for older people with limited life expectancy (and probably palliative care needs) and decrease the monthly costs of pharmacotherapy. Nevertheless, the impact on patient safety and humanistic outcomes remain unclear.

Validated medication deprescribing instruments for patients with palliative care needs: a systematic review.

OBJECTIVES: Patients with life-limiting illnesses are prone to unnecessary polypharmacy. Deprescribing tools may contribute to minimizing negative outcomes. Thus, the aims of the study were to identify validated instruments for deprescribing inappropriate medications for patients with palliative care needs and to assess the impact on clinical, humanistic, and economic outcomes. METHODS: A systematic review was conducted in LILACS, PUBMED, EMBASE, COCHRANE, and WEB OF SCIENCE databases (until May 2021). A manual search was performed in the references of enrolled articles. The screening, eligibility, extraction, and bias risk assessment were carried out by 2 independent researchers. Experimental and observational studies were eligible for inclusion. RESULTS: Out of the 5791 studies retrieved, after excluding duplicates (n = 1050), conducting title/abstract screening (n = 4741), and full reading (n = 41), only 1 study met the inclusion criteria. In this included study, a randomized controlled trial was conducted, which showed a high level of bias risk overall. Adults 75 years or older (n = 130) with limited life expectancy and polypharmacy were allocated to 2 groups [intervention arm (deprescribing); and control arm (usual care)]. Deprescribing was performed with the aid of the STOPPFrail tool. The mean number of inappropriate medications and monthly medication costs were significantly lower in the intervention arm. No statistically significant differences were found in terms of unscheduled hospital presentations, falls, fractures, mortality, and quality of life. CONCLUSIONS: Despite the availability of several instruments to support deprescribing in patients with palliative care needs, only 1 of them has undergone validation and robust assessment for effectiveness in clinical practice. The STOPPFrail tool appears to reduce the number of inappropriate medications for older people with limited life expectancy (and probably palliative care needs) and decrease the monthly costs of pharmacotherapy. Nevertheless, the impact on patient safety and humanistic outcomes remain unclear.

Methods for studying medication safety following electronic health record implementation in acute care: a scoping review.

OBJECTIVES: The objective of this scoping review is to map methods used to study medication safety following electronic health record (EHR) implementation. Patterns and methodological gaps can provide insight for future research design. MATERIALS AND METHODS: We used the Joanna Briggs Institute scoping review methodology and a custom data extraction table to summarize the following data: (1) study demographics (year, country, setting); (2) study design, study period, data sources, and measures; (3) analysis strategy; (4) identified limitations or recommendations; (5) quality appraisal; and (6) if a Safety-I or Safety-II perspective was employed. RESULTS: We screened 5879 articles. One hundred and fifteen articles met our inclusion criteria and were assessed for eligibility by full-text review. Twenty-seven articles were eligible for extraction. DISCUSSION AND CONCLUSION: We found little consistency in how medication safety following EHR implementation was studied. Three study designs, 7 study settings, and 10 data sources were used across 27 articles. None of the articles shared the same combination of design, data sources, study periods, and research settings. Outcome measures were neither defined nor measured consistently. It may be difficult for researchers to aggregate and synthesize medication safety findings following EHR implementation research. All studies but one used a Safety-I perspective to study medication safety. We offer a conceptual model to support a more consistent approach to studying medication safety following EHR implementation.

Validated medication deprescribing instruments for patients with palliative care needs: a systematic review

Objectives Patients with life-limiting illnesses are prone to unnecessary polypharmacy. Deprescribing tools may contribute to minimizing negative outcomes. Thus, the aims of the study were to identify validated instruments for deprescribing inappropriate medications for patients with palliative care needs and to assess the impact on clinical, humanistic, and economic outcomes. Methods A systematic review was conducted in LILACS, PUBMED, EMBASE, COCHRANE, and WEB OF SCIENCE databases (until May 2021). A manual search was performed in the references of enrolled articles. The screening, eligibility, extraction, and bias risk assessment were carried out by 2 independent researchers. Experimental and observational studies were eligible for inclusion. Results Out of the 5791 studies retrieved, after excluding duplicates (n = 1050), conducting title/abstract screening (n = 4741), and full reading (n = 41), only 1 study met the inclusion criteria. In this included study, a randomized controlled trial was conducted, which showed a high level of bias risk overall. Adults 75 years or older (n = 130) with limited life expectancy and polypharmacy were allocated to 2 groups [intervention arm (deprescribing); and control arm (usual care)]. Deprescribing was performed with the aid of the STOPPFrail tool. The mean number of inappropriate medications and monthly medication costs were significantly lower in the intervention arm. No statistically significant differences were found in terms of unscheduled hospital presentations, falls, fractures, mortality, and quality of life. Conclusions Despite the availability of several instruments to support deprescribing in patients with palliative care needs, only 1 of them has undergone validation and robust assessment for effectiveness in clinical practice. The STOPPFrail tool appears to reduce the number of inappropriate medications for older people with limited life expectancy (and probably palliative care needs) and decrease the monthly costs of pharmacotherapy. Nevertheless, the impact on patient safety and humanistic outcomes remain unclear.

The cost of implementing the COVID-19 shielding policy in Wales.

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.

Analysis of applying a patient safety taxonomy to patient and clinician-reported incident reports during the COVID-19 pandemic: a mixed methods study.

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.

Unsafe care in residential settings for older adults: a content analysis of accreditation reports.

Residents of aged care services can experience safety incidents resulting in preventable serious harm. Accreditation is a commonly used strategy to improve the quality of care; however, narrative information within accreditation reports is not generally analysed as a source of safety information to inform learning. In Australia, the Aged Care Quality and Safety Commission (ACQSC), the sector regulator, undertakes over 500 accreditation assessments of residential aged care services against eight national standards every year. From these assessments, the Aged Care Quality and Safety Commission generates detailed Site Audit Reports. In over one-third (37%) of Site Audit Reports, standards relating to Personal and Clinical Care (Standard 3) are not being met. The aim of this study was to identify the types of resident Safety Risks that relate to Personal and Clinical Care Standards not being met during accreditation or re-accreditation. These data could inform priority setting at policy, regulatory, and service levels. An analytical framework was developed based on the World Health Organization's International Classification for Patient Safety and other fields including Clinical Issue (the issue related to the incident impacting the resident, e.g. wound/skin or pain). Information relating to safety incidents in the Site Audit Reports was extracted, and a content analysis undertaken using the analytical framework. Clinical Issue and the International Classification for Patient Safety-based classification were combined to describe a clinically intuitive category ('Safety Risks') to describe ways in which residents could experience unsafe care, e.g. diagnosis/assessment of pain. The resulting data were descriptively analysed. The analysis included 65 Site Audit Reports that were undertaken between September 2020 and March 2021. There were 2267 incidents identified and classified into 274 types of resident Safety Risks. The 12 most frequently occurring Safety Risks account for only 32.3% of all incidents. Relatively frequently occurring Safety Risks were organisation management of infection control; diagnosis/assessment of pain, restraint, resident behaviours, and falls; and multiple stages of wounds/skin management, e.g. diagnosis/assessment, documentation, treatment, and deterioration. The analysis has shown that accreditation reports contain valuable data that may inform prioritization of resident Safety Risks in the Australian residential aged care sector. A large number of low-frequency resident Safety Risks were detected in the accreditation reports. To address these, organizations may use implementation science approaches to facilitate evidence-based strategies to improve the quality of care delivered to residents. Improving the aged care workforces' clinical skills base may address some of the Safety Risks associated with diagnosis/assessment and wound management.

Platform adaptive trial of novel antivirals for early treatment of COVID-19 In the community (PANORAMIC): protocol for a randomised, controlled, open-label, adaptive platform trial of community novel antiviral treatment of COVID-19 in people at increased risk of more severe disease.

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.

Rationale for the shielding policy for clinically vulnerable people in the UK during the COVID-19 pandemic: a qualitative study.

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.

Family role in paediatric safety incidents: a retrospective study protocol.

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.