Patient and caregiver characteristics associated with differential use of primary care for children and young people in the UK: a scoping review.

OBJECTIVE: To systematically map evidence to answer the research question: What is the relationship between the characteristics of children and young people (CYP) or their caregivers and primary care service use in the UK, taking into account underlying healthcare needs? DESIGN: Scoping review. SETTING: Primary care. ELIGIBILITY CRITERIA: English-language quantitative or mixed-methods studies published between 2012 and 2022. DATA SOURCES: Medline, Embase, Scopus and Web of Science Social Sciences Citation Index, and grey literature. RESULTS: 22 eligible studies were identified, covering general practice (n=14), dental health (n=4), child mental health (MN) services (n=3) and immunisation (n=1). Only eight studies (36%) controlled for variables associated with healthcare need (eg, age, birth weight and long-term conditions). In these, evidence of horizontal inequity in primary care use was reported for CYP living in deprived areas in England, with and without complex needs. Horizontal inequity was also identified in primary care MN referrals for CYP in England identifying as mixed-race, Asian or black ethnicity, compared with their white British peers. No evidence of horizontal inequity was observed, however, in primary care use for CYP in England exposed to parental depression, or for CYP children from low-income households in Scotland. Increasing CYP's age was associated with decreasing primary care use across included studies. No studies were found regarding CYP from Gypsy or Traveller communities, children in care, or those with disabilities or special educational needs. CONCLUSIONS: There is evidence that socioeconomic factors impact on CYP's primary care use, in particular age, ethnicity and deprivation. However, better quality evidence is required to evaluate horizontal inequity in use and address knowledge gaps regarding primary care use for vulnerable CYP populations and the impact of policy and practice related 'supply side' of primary care.

Access to primary care for children and young people (CYP) in the UK: a scoping review of CYP's, caregivers' and healthcare professionals' views and experiences of facilitators and barriers.

OBJECTIVES: To examine children and young people's (CYP), caregivers' and healthcare professionals' (HCPs) views or experiences of facilitators and barriers to CYP access to UK primary care services to better understand healthcare inequity. To explore differences across CYP subpopulations with greater health needs from deprived areas, identifying as ethnic minorities, with experiences of state care, special educational needs or disabilities, chronic conditions or mental health problems. DESIGN: Scoping review. ELIGIBILITY CRITERIA: Included studies were in English, published 2012-2022 and reported: the views/experiences of CYP (0-25 years), caregivers or HCPs about accessing UK primary care; using quantitative or qualitative empirical methods. DATA SOURCES: PubMed, CINAHL, Web of Science, PsycINFO and Scopus. RESULTS: We included 47 reports (46 studies). CYP/caregivers' decision to access care was facilitated by CYP/caregivers' or their family/friends' ability to identify a health issue as warranting healthcare attention. Barriers to accessing care included perceived stigma (eg, being seen as a bad parent), embarrassment and discrimination experiences. CYP and caregivers believed longer opening hours could facilitate more timely access to care. Caregivers and HCPs reported that delayed or rejected referrals to secondary or adult care were a barrier to having needs met, especially for CYP with poor mental health. CYP and caregivers in numerous studies emphasised the importance of communication and trust with HCPs, including taking their concerns seriously, being knowledgeable and providing continuity of care for CYP. Common barriers reported across high-need subpopulations were caregivers needing knowledge and confidence to advocate for their child, gaps in HCP's knowledge and a lack of connectedness between primary and secondary care. CONCLUSIONS: Connecting general practices and community health workers/services, improving CYP/caregivers' understanding of common childhood conditions, addressing HCP's knowledge gaps in paediatric care and integrated approaches between primary and secondary care may reduce inequity in access.

Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): protocol for a multicentre phase 3 pragmatic clinical and cost-effectiveness randomised trial in the UK.

INTRODUCTION: Almost all patients receiving mechanical ventilation (MV) in intensive care units (ICUs) require analgesia and sedation. The most widely used sedative drug is propofol, but there is uncertainty whether alpha2-agonists are superior. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial aims to determine whether clonidine or dexmedetomidine (or both) are clinically and cost-effective in MV ICU patients compared with usual care. METHODS AND ANALYSIS: Adult ICU patients within 48 hours of starting MV, expected to require at least 24 hours further MV, are randomised in an open-label three arm trial to receive propofol (usual care) or clonidine or dexmedetomidine as primary sedative, plus analgesia according to local practice. Exclusions include patients with primary brain injury; postcardiac arrest; other neurological conditions; or bradycardia. Unless clinically contraindicated, sedation is titrated using weight-based dosing guidance to achieve a Richmond-Agitation-Sedation score of -2 or greater as early as considered safe by clinicians. The primary outcome is time to successful extubation. Secondary ICU outcomes include delirium and coma incidence/duration, sedation quality, predefined adverse events, mortality and ICU length of stay. Post-ICU outcomes include mortality, anxiety and depression, post-traumatic stress, cognitive function and health-related quality of life at 6-month follow-up. A process evaluation and health economic evaluation are embedded in the trial.The analytic framework uses a hierarchical approach to maximise efficiency and control type I error. Stage 1 tests whether each alpha2-agonist is superior to propofol. If either/both interventions are superior, stages 2 and 3 testing explores which alpha2-agonist is more effective. To detect a mean difference of 2 days in MV duration, we aim to recruit 1437 patients (479 per group) in 40-50 UK ICUs. ETHICS AND DISSEMINATION: The Scotland A REC approved the trial (18/SS/0085). We use a surrogate decision-maker or deferred consent model consistent with UK law. Dissemination will be via publications, presentations and updated guidelines. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT03653832.

Child maltreatment and parental domestic violence and abuse, co-occurrence and the effect on lifetime outcomes in the Avon Longitudinal Study of Parents and Children (ALSPAC).

Exposure to child maltreatment (CM), and parental domestic violence and abuse (DVA), impose considerable adverse life outcomes in both the short and long term, yet, the extent and effects of their co-occurrence on outcomes have not been comprehensively quantified. This study describes the analysis of data from the Avon Longitudinal Study of Parents and Children, quantifying the prevalence of CM, parental DVA, co-occurrence rates, and the impact of different combinations of childhood exposures on life outcomes (health, economic, and likelihood of perpetrating intimate partner violence as a young person). Childhood exposure prevalences were estimated at 41.7% for any form of CM, 19.3% for parental DVA, and 49.0% for exposure to at least one form of CM and/or parental DVA. Co-occurring parental DVA was reported in 21%-42% of CM-exposed households. Sexual abuse was reported in 2% of parental DVA-exposed households, whilst co-occurrence of other forms of CM ranged between 19% and 41%. Co-occurring CM and parental DVA exposures were associated with increased risks of drug use, anxiety, depression, smoking, unemployment, social welfare use, and perpetration of intimate partner violence as a young person - highlighting the intergenerational effects of exposure. Increased risks across a wider range of adverse outcomes were associated with child-reported awareness of parental DVA, compared to parent-reported DVA exposure. The high cumulative prevalence of childhood exposure to CM and/or parental DVA, and the scale of the resulting adverse impacts emphasise the need for policies and family interventions sensitive to the possibility of co-occurring forms of abuse.

Impact of specialist ataxia centres on health service resource utilisation and costs across Europe: cross-sectional survey.

BACKGROUND: Little is known about the costs of treating ataxia and whether treatment at a specialist ataxia centre affects the cost of care. The aim of this study was to investigate whether patients who attended specialist ataxia centres in three European countries reported differences in their health care use and costs compared with patients who did not attend a specialist ataxia centre. We compared mean resource use and health service costs per patient affected by ataxia in the United Kingdom, Italy and Germany over a 12-month period. Data were obtained from a survey distributed to people with ataxia in the three countries. We compared mean resource use for each contact type and costs, stratifying patients by whether they were currently attending a specialist ataxia centre or had never attended one. RESULTS: Responses were received from 181 patients from the United Kingdom, 96 from Italy and 43 from Germany. Differences in the numbers of contacts for most types of health service use between the specialist ataxia centre and non-specialist ataxia centre groups were non-significant. In the United Kingdom the mean total cost per patient was €2209 for non-specialist ataxia centre patients and €1813 for specialist ataxia centre patients (P = 0.59). In Italy these figures were €2126 and €1971, respectively (P = 0.84). In Germany they were €2431 and €4087, respectively (P = 0.19). Inpatient stays made the largest contribution to total costs. CONCLUSIONS: Within each country, resource use and costs were broadly similar for specialist ataxia centre and non-specialist ataxia centre groups. There were differences between countries in terms of health care contacts and costs.

Rapid evaluation of service innovations in health and social care: key considerations.

Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (RSET: 16/138/17; BRACE: 16/138/31).

A rapid mixed-methods evaluation of remote home monitoring models during the COVID-19 pandemic in England.

Background: Remote home monitoring services were developed and implemented for patients with COVID-19 during the pandemic. Patients monitored blood oxygen saturation and other readings (e.g. temperature) at home and were escalated as necessary. Objective: To evaluate effectiveness, costs, implementation, and staff and patient experiences (including disparities and mode) of COVID-19 remote home monitoring services in England during the COVID-19 pandemic (waves 1 and 2). Methods: A rapid mixed-methods evaluation, conducted in two phases. Phase 1 (July-August 2020) comprised a rapid systematic review, implementation and economic analysis study (in eight sites). Phase 2 (January-June 2021) comprised a large-scale, multisite, mixed-methods study of effectiveness, costs, implementation and patient/staff experience, using national data sets, surveys (28 sites) and interviews (17 sites). Results: Phase 1 Findings from the review and empirical study indicated that these services have been implemented worldwide and vary substantially. Empirical findings highlighted that communication, appropriate information and multiple modes of monitoring facilitated implementation; barriers included unclear referral processes, workforce availability and lack of administrative support. Phase 2 We received surveys from 292 staff (39% response rate) and 1069 patients/carers (18% response rate). We conducted interviews with 58 staff, 62 patients/carers and 5 national leads. Despite national roll-out, enrolment to services was lower than expected (average enrolment across 37 clinical commissioning groups judged to have completed data was 8.7%). There was large variability in implementation of services, influenced by patient (e.g. local population needs), workforce (e.g. workload), organisational (e.g. collaboration) and resource (e.g. software) factors. We found that for every 10% increase in enrolment to the programme, mortality was reduced by 2% (95% confidence interval: 4% reduction to 1% increase), admissions increased by 3% (-1% to 7%), in-hospital mortality fell by 3% (-8% to 3%) and lengths of stay increased by 1.8% (-1.2% to 4.9%). None of these results are statistically significant. We found slightly longer hospital lengths of stay associated with virtual ward services (adjusted incidence rate ratio 1.05, 95% confidence interval 1.01 to 1.09), and no statistically significant impact on subsequent COVID-19 readmissions (adjusted odds ratio 0.95, 95% confidence interval 0.89 to 1.02). Low patient enrolment rates and incomplete data may have affected chances of detecting possible impact. The mean running cost per patient varied for different types of service and mode; and was driven by the number and grade of staff. Staff, patients and carers generally reported positive experiences of services. Services were easy to deliver but staff needed additional training. Staff knowledge/confidence, NHS resources/workload, dynamics between multidisciplinary team members and patients' engagement with the service (e.g. using the oximeter to record and submit readings) influenced delivery. Patients and carers felt services and human contact received reassured them and were easy to engage with. Engagement was conditional on patient, support, resource and service factors. Many sites designed services to suit the needs of their local population. Despite adaptations, disparities were reported across some patient groups. For example, older adults and patients from ethnic minorities reported more difficulties engaging with the service. Tech-enabled models helped to manage large patient groups but did not completely replace phone calls. Limitations: Limitations included data completeness, inability to link data on service use to outcomes at a patient level, low survey response rates and under-representation of some patient groups. Future work: Further research should consider the long-term impact and cost-effectiveness of these services and the appropriateness of different models for different groups of patients. Conclusions: We were not able to find quantitative evidence that COVID-19 remote home monitoring services have been effective. However, low enrolment rates, incomplete data and varied implementation reduced our chances of detecting any impact that may have existed. While services were viewed positively by staff and patients, barriers to implementation, delivery and engagement should be considered. Study registration: This study is registered with the ISRCTN (14962466). Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (RSET: 16/138/17; BRACE: 16/138/31) and NHSEI and will be published in full in Health and Social Care Delivery Research; Vol. 11, No. 13. See the NIHR Journals Library website for further project information. The views expressed in this publication are those of the authors and not necessarily those of the National Institute for Health and Care Research or the Department of Health and Social Care.

COVID-19 patients can experience very low oxygen levels, without feeling breathless. Patients may not realise there is a problem until they become extremely unwell, risking being admitted to hospital too late. To address this, COVID-19 remote home monitoring services were developed and later rolled out across England. Patients monitored oxygen levels at home using an 'oximeter' (a small device which clips on to your finger) and sent these readings to providers via phone or technology (e.g. an app). Patients could access further care if needed. We did not know whether these services worked, or what people felt about them. • How services were set up and used in England. • Whether services work (e.g. by reducing deaths and length of hospital stay). • How much they cost. • What patients, carers and staff think about these services (including differences between groups and telephone vs. technology). We looked at available existing evidence and collected data from eight services operating in the first wave of the pandemic. During the second wave of the pandemic, we used data available at a national level and conducted surveys (28 sites) and interviews (17 sites) with staff, patients and individuals involved in developing/leading services nationally. These services have been used worldwide, but they vary considerably. We found many things that help these services to be used (e.g. good communication) but also things that get in the way (e.g. unclear referrals). Our findings did not show that services reduce deaths or time in hospital. But these findings are limited by a lack of data. Staff and patients liked these services, but we found some barriers to delivering and using the service. Some groups found services harder to use (e.g. older patients, those with disabilities and ethnic minorities). Using technology helped with large patient groups, but it did not completely replace phone calls. Better information is needed to know whether these services work. Staff and patients liked these services. However, improvements may make them easier to deliver and use (e.g. further staff training and giving additional support to patients who need it).

The Societal and Indirect Economic Burden of Seasonal Influenza in the United Kingdom.

Seasonal influenza is a significant public-health issue. In the UK, the influenza season is associated with an increased demand for and pressure on the NHS. The direct health and economic impacts of seasonal influenza have received much attention. However, less attention has been given to its broader societal burden, including its indirect economic impact. We first conducted a rapid evidence assessment of the literature to understand the societal burden of seasonal influenza in the UK. Secondly, we conducted analyses of publicly available, aggregated data from NHS England and NHS Digital to better understand the impact of seasonal influenza on the provision of NHS services both before and after the COVID-19 pandemic. We also conducted a geographically representative survey of 1,000 working-age adults across the UK, who reported having influenza or caring for a dependent with influenza during at least one of the past four influenza seasons to understand impacts related to absenteeism and presenteeism in the workplace, lost wages and out-of-pocket costs. Fourthly, we conducted interviews with 20 key stakeholders within the NHS from primary care and secondary care across the four UK nations. Lastly, we used an epidemiologic-economic framework to estimate the number of influenza cases and then applied a macro-economic computable general equilibrium model to estimate the indirect economic costs associated with lost economic productivity among working-age adults who become ill with influenza.

Economic evaluations of predictive genetic testing: A scoping review.

Predictive genetic testing can provide information about whether or not someone will develop or is likely to develop a specific condition at a later stage in life. Economic evaluation can assess the value of money for such testing. Studies on the economic evaluation of predictive genetic testing have been carried out in a variety of settings, and this research aims to conduct a scoping review of findings from these studies. We searched the PubMed, Web of Science, Embase, and Cochrane databases with combined search terms, from 2019 to 2022. Relevant studies from 2013 to 2019 in a previous systematic review were also included. The study followed the recommended stages for undertaking a scoping review. A total of 53 studies were included, including 33 studies from the previous review and 20 studies from the search of databases. A significant number of studies focused on the US, UK, and Australia (34%, 23%, and 11%). The most frequently included health conditions were cancer and cardiovascular diseases (68% and 19%). Over half of the studies compared predictive genetic testing with no genetic testing, and the majority of them concluded that at least some type of genetic testing was cost-effective compared to no testing (94%). Some studies stated that predictive genetic testing is becoming more cost-effective with the trend of lowering genetic testing costs. Studies on predictive genetic testing covered various health conditions, particularly cancer and cardiovascular diseases. Most studies indicated that predictive genetic testing is cost-effective compared to no testing.

Proactive breast cancer risk assessment in primary care: a review based on the principles of screening.

In the UK, the National Institute for Health and Care Excellence (NICE) recommends that women at moderate or high risk of breast cancer be offered risk-reducing medication and enhanced breast screening/surveillance. In June 2022, NICE withdrew a statement recommending assessment of risk in primary care only when women present with concerns. This shift to the proactive assessment of risk substantially changes the role of primary care, in effect paving the way for a primary care-based screening programme to identify those at moderate or high risk of breast cancer. In this article, we review the literature surrounding proactive breast cancer risk assessment within primary care against the consolidated framework for screening. We find that risk assessment for women under 50 years currently satisfies many of the standard principles for screening. Most notably, there are large numbers of women at moderate or high risk currently unidentified, risk models exist that can identify those women with reasonable accuracy, and management options offer the opportunity to reduce breast cancer incidence and mortality in that group. However, there remain a number of uncertainties and research gaps, particularly around the programme/system requirements, that need to be addressed before these benefits can be realised.

Variations in the 24 h temporal patterns and time budgets of grazing, rumination, and idling behaviors in grazing dairy cows in a New Zealand system.

This study investigated the variations in the temporal distributions and the lengths of times utilized for grazing, ruminating, and idling behaviors by grazing dairy cows over 24 h. Spring-calved lactating dairy cows (N = 54) from three breeds, Holstein-Friesian (HFR), Jersey (JE), and KiwiCross (KC) in different lactations (1st, 2nd, 3rd) and with different breeding worth index values (103 < BW > 151) were selected. The cows were managed through a rotational grazing scheme and milked once a day at 0500 hours. The cows grazed mainly pasture and consumed additional feeds (maize silage and turnips) in the summer and autumn seasons. AfiCollar was used to record grazing and rumination behaviors (min/h) in the individual cows throughout the lactation period (~270 d). The time neither utilized for grazing nor rumination was counted as idling behavior (min/h). A repeat measure design with PROC MIXED was performed in SAS considering the effects of breed, lactation, individual cow, the hour of the day, season, day within the season, and supplementary feed within the season to evaluate the difference in grazing, rumination, and idling behaviors. Hour of the day, season, day within season, and supplementary feed had significant effects on grazing, rumination, and idling behaviors. Regardless of the season and supplementary feed, cows spent most of the daytime grazing and most of the nighttime ruminating. Grazing activity remained consistently high throughout the day with two peaks around dawn and dusk and a short peak around midnight. Rumination activity remained high from the late evening until early morning. Grazing and ruminating patterns were similar between different breeds and lactations, however, JE cows grazed slightly longer than HFR and KC, and first-lactation cows grazed slightly longer than those in higher lactations. The onset and cessation of grazing activity by the cows were adjusted according to varying day lengths by season. Cows finished grazing earlier when they consumed additional supplements or silage along with pasture. Cows from different breed groups and lactations spent most of their 24 h grazing followed by ruminating and idling. Season and supplementary feed potentially affected the variations in behavior time budgets. These findings should support improving measures for grazing management to address pasture allocation and additional feed demands, and animal welfare in varying environmental and/or managemental conditions.

This study explored how grazing dairy cows pattern their essential such as including grazing, rumination, and idling, and how they distribute their time for those behaviors over 24 h. We used a group of spring-calved grazing dairy cows affiliated with different breeds, milking ages, and genetic merits and recorded their grazing and rumination behaviors for the whole milking period. An automated device, AfiCollar was used to continuously record minutes within an hour (min/h) utilized for grazing, rumination, and idling. The cows were mainly offered grass with some additional supplementary feeds on various days in summer and autumn and milked once a day at 0500 hours. Regardless of the breed, milking age, season, and supplementary feeds, grazing cows spent most of the daytime (from dawn to dusk) grazing and most of the nighttime ruminating, with a short grazing period around midnight. Cows adopted their grazing patterns according to varying day lengths during different seasons and finished grazing earlier when received supplementary feeds. Grazing cows allocated most of their time over 24 h for grazing followed by ruminating and idling. These findings could have implications to improve the measures for pasture management efficiency and additional feed demand, and animal welfare in varying environmental and/or managemental conditions.

The Burden of Respiratory Syncytial Virus: Understanding Impacts on the NHS, Society and Economy.

Respiratory syncytial virus (RSV) is a common respiratory virus that affects large numbers, mainly of children younger than five. The burden of RSV includes not only ill health for the children with the virus, which in severe cases results in hospitalisation, intensive care and even death; but also the emotional and practical burden on the affected families and carers; and the impact that has on productivity in the economy; alongside the costs of providing healthcare. We reviewed recent literature and published data relevant to the UK and used this information to model the costs to the healthcare system and to the wider UK economy in terms of productivity losses of parents/carers. We found healthcare costs and productivity losses in the UK resulting from RSV in children younger than five total approximately £80 million annually. These costs are the consequence, in part, of an estimated 467,000 GP visits per year in the UK for children aged under five with RSV and 34,000 hospitalisations. Our study also presents additional material, identified in the literature review, on the health impacts on affected children and the nature of the burden on parents and families of caring for a young child with RSV. The consequences of RSV are short-term for the majority of cases, but for some there are long term sequelae including poorer respiratory health in later life. RSV is also responsible for the deaths each year in the UK of an estimated 33 children under five.

Effectiveness and cost-effectiveness of referral to a commercial open group behavioural weight management programme in adults with overweight and obesity: 5-year follow-up of the WRAP randomised controlled trial.

BACKGROUND: There is evidence that commercially available behavioural weight management programmes can lead to short-term weight loss and reductions in glycaemia. Here, we aimed to provide the 5-year impact and cost-effectiveness of these interventions compared with a brief intervention. METHODS: WRAP was a non-blinded, parallel-group randomised controlled trial (RCT). We recruited from primary care practices in England and randomly assigned participants to one of three interventions (brief intervention, 12-week open-group behavioural programme [WW, formerly Weight Watchers], or a 52-week open-group WW behavioural programme) in an uneven (2:5:5) allocation. Participants were followed up 5 years after randomisation using data from measurement visits at primary care practices or a research centre, review of primary care electronic medical notes, and self-report questionnaires. The primary outcome was change in weight at 5 years follow-up, assessed using analysis of covariance. We also estimated cost-effectiveness of the intervention. This study is registered at Current Controlled Trials, ISRCTN64986150. FINDINGS: Between Oct 18, 2012, and Feb 10, 2014, we recruited 1269 eligible participants (two participants were randomly assigned but not eligible and therefore excluded) and 1040 (82%) consented to be approached about additional follow-up and to have their medical notes reviewed at 5 years. The primary outcome (weight) was ascertained for 871 (69%) of 1267 eligible participants. Mean duration of follow-up was 5·1 (SD 0·3) years. Mean weight change from baseline to 5 years was -0·46 (SD 8·31) kg in the brief intervention group, -1·95 (9·55) kg in the 12-week programme group, and -2·67 (9·81) kg in the 52-week programme. The adjusted difference in weight change was -1·76 (95% CI -3·68 to 0·17) kg between the 52-week programme and the brief intervention; -0·80 (-2·13 to 0·54) kg between the 52-week and the 12-week programme; and -0·96 (-2·90 to 0·97) kg between the 12-week programme and the brief intervention. During the trial, the 12-week programme incurred the lowest cost and produced the highest quality-adjusted life-years (QALY). Simulations beyond 5 years suggested that the 52-week programme would deliver the highest QALYs at the lowest cost and would be the most cost-effective. No participants reported adverse events related to the intervention. INTERPRETATION: Although the difference in weight change between groups was not statistically significant, some weight loss was maintained at 5 years after an open-group behavioural weight management programme. Health economic modelling suggests that this could have important implications to reduce the incidence of weight-related disease and these interventions might be cost-saving. FUNDING: The UK National Institute for Health and Care Research Programme Grants for Applied Research and the Medical Research Council.

Validation of the FINE-CKD model for future health technology assessments for finerenone in patients with chronic kidney disease and type 2 diabetes.

BACKGROUND: The FINE-CKD model was developed to estimate the cost-effectiveness of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). OBJECTIVE: To perform internal and external validation by comparing the model estimates with trial results and outcomes from other models. METHODS: Incidence rates from trials were compared with the model predictions. Statistical tests were then performed to assess whether modeled event rates aligned with trial observations. A cross-validation was also performed using the online version of the SHARP CKD-Cardiovascular Disease (SHARP CKD-CVD) model, with population characteristics from the finerenone trials analyzed. Where no finerenone data were available, the default SHARP CKD-CVD values were used. Comparison of the results considered the ranges from both models. RESULTS: The outcomes of the FINE-CKD model reflect the event rates observed in the trials. Based on the results of the statistical tests, the hypothesis of no difference between observed and modeled events cannot be rejected for any of the outcomes. The results of the FINE-CKD model are within the ranges from the SHARP CKD-CVD model. Disease progressions align across the models; however, incident kidney failure events in the SHARP CKD-CVD model were higher. This can be explained by simulation of more severely affected patients in the SHARP CKD-CVD model. CONCLUSIONS: This study demonstrates that the FINE-CKD model adequately reflects the clinical data and provides reliable extrapolation relative to the existing predictive tools while also being conservative in its approach.

Cost-Utility Analysis of Major System Change in Specialist Cancer Surgery in London, England, Using Linked Patient-Level Electronic Health Records and Difference-in-Differences Analysis.

BACKGROUND: Studies have shown that centralising surgical treatment for some cancers can improve patient outcomes, but there is limited evidence of the impact on costs or health-related quality of life. OBJECTIVES: We report the results of a cost-utility analysis of the RESPECT-21 study using difference-in-differences, which investigated the reconfiguration of specialist surgery services for four cancers in an area of London, compared to the Rest of England (ROE). METHODS: Electronic health records data were obtained from the National Cancer Registration and Analysis Service for patients diagnosed with one of the four cancers of interest between 2012 and 2017. The analysis for each tumour type used a short-term decision tree followed by a 10-year Markov model with 6-monthly cycles. Costs were calculated by applying National Health Service (NHS) Reference Costs to patient-level hospital resource use and supplemented with published data. Cancer-specific preference-based health-related quality-of-life values were obtained from the literature to calculate quality-adjusted life-years (QALYs). Total costs and QALYs were calculated before and after the reconfiguration, in the London Cancer (LC) area and in ROE, and probabilistic sensitivity analysis was performed to illustrate the uncertainty in the results. RESULTS: At a threshold of £30,000/QALY gained, LC reconfiguration of prostate cancer surgery services had a 79% probability of having been cost-effective compared to non-reconfigured services using difference-in-differences. The oesophago-gastric, bladder and renal reconfigurations had probabilities of 62%, 49% and 12%, respectively, of being cost-effective at the same threshold. Costs and QALYs per surgical patient increased over time for all cancers across both regions to varying degrees. Bladder cancer surgery had the smallest patient numbers and changes in costs, and QALYs were not significant. The largest improvement in outcomes was in renal cancer surgery in ROE, making the relative renal improvements in LC appear modest, and the probability of the LC reconfiguration having been cost-effective low. CONCLUSIONS: Prostate cancer reconfigurations had the highest probability of being cost-effective. It is not clear, however, whether the prostate results can be considered in isolation, given the reconfigurations occurred simultaneously with other system changes, and healthcare delivery in the NHS is highly networked and collaborative. Routine collection of quality-of-life measures such as the EQ-5D-5L would have improved the analysis.

Delivering Positive Newborn Screening Results: Cost Analysis of Existing Practice versus Innovative, Co-Designed Strategies from the ReSPoND Study.

Although the communication pathways of Newborn Bloodspot Screening (NBS) are a delicate task, these pathways vary across different conditions and are often not evidence-based. The ReSPoND interventions were co-designed by healthcare professionals alongside parents who had received a positive NBS result for their child. To calculate the cost of these co-designed strategies and the existing communication pathways, we interviewed 71 members of the clinical and laboratory staff of the 13 English NBS laboratories in the English National Health Service. Therefore, a scenario analysis was used to compare the cost of the existing communication pathways to the co-designed strategies delivered by (i) home-visits and (ii) telecommunications. On average, the existing communication pathway cost £447.08 per infant (range: £237.12 to £628.51) or £234,872.75 (£3635.99 to £1,932,986.23) nationally. Implementing the new interventions relying on home-visits exclusively would cost on average £521.62 (£312.84 to £646.39) per infant and £297,816.03 (£4506.37 to £2,550,284.64) nationally, or £447.19 (£235.79 to £552.03) and £231,342.40 (£3923.7 to £1,922,192.22) if implemented via teleconsultations, respectively. The new strategies delivered are not likely to require additional resources compared with current practice. Further research is needed to investigate whether this investment represents good value for money for the NHS budget.

Cost-utility analysis of community occupational therapy in dementia (COTiD-UK) versus usual care: Results from VALID, a multi-site randomised controlled trial in the UK.

BACKGROUND: A community-based occupational therapy intervention for people with mild to moderate dementia and their family carers: the Community Occupational Therapy in Dementia-UK version (COTiD-UK); and Treatment as usual (TAU) were randomly assigned to 468 pairs (each comprising a person with dementia and a family carer) in the Valuing Active Life in Dementia (VALID) randomised controlled trial (RCT). OBJECTIVES: To compare the cost-utility of the COTiD-UK intervention compared to TAU, using data from the VALID RCT. METHODS: We performed a cost-utility analysis estimating mean costs and quality adjusted life years (QALYs) per person with dementia and carer for both treatments over a 26 weeks' time horizon based on resource use data and utility values collected in the trial. RESULTS: Taking the National Health Service and Personal Social Services perspective, including costs and benefits to the person with dementia only, measuring Health Related Quality of Life based on Dementia Quality of Life scale (DEMQOL), accounting for missing data and adjusting for baseline values, there was a significant difference in costs between COTiD-UK and TAU (mean incremental cost for COTiD-UK £784 (95% CI £233 to £1334)), but no significant difference in outcomes (mean QALYs gained 0.00664 (95% CI -0.00404, 0.01732)). The Incremental Net Monetary Benefit (INMB) for COTiD-UK versus TAU was negative at a maximum willingness to pay for a QALY of £20000 (mean -£651, 95% CI -£878 to -£424) or £30000 (mean -£585, 95% CI -£824 to -£345). Extensive sensitivity analyses confirmed the results. CONCLUSIONS: This community-based occupational therapy intervention has a very low probability of being cost-effective.

Observational retrospective study calculating health service costs of patients receiving surgery for chronic rhinosinusitis in England, using linked patient-level primary and secondary care electronic data.

OBJECTIVES: Chronic rhinosinusitis (CRS) symptoms are experienced by an estimated 11% of UK adults, and symptoms have major impacts on quality of life. Data from UK and elsewhere suggest high economic burden of CRS, but detailed cost information and economic analyses regarding surgical pathway are lacking. This paper estimates healthcare costs for patients receiving surgery for CRS in England. DESIGN: Observational retrospective study examining cost of healthcare of patients receiving CRS surgery. SETTING: Linked electronic health records from the Clinical Practice Research Datalink, Hospital Episode Statistics and Office for National Statistics databases in England. PARTICIPANTS: A phenotyping algorithm using medical ontology terms identified 'definite' CRS cases who received CRS surgery. Patients were registered with a general practice in England. Data covered the period 1997-2016. A cohort of 13 462 patients had received surgery for CRS, with 9056 (67%) having confirmed nasal polyps. OUTCOME MEASURES: Information was extracted on numbers and types of primary care prescriptions and consultations, and inpatient and outpatient hospital investigations and procedures. Resource use was costed using published sources. RESULTS: Total National Health Service costs in CRS surgery patients were £2173 over 1 year including surgery. Total costs per person-quarter were £1983 in the quarter containing surgery, mostly comprising surgical inpatient care costs (£1902), and around £60 per person-quarter in the 2 years before and after surgery, of which half were outpatient costs. Outpatient and primary care costs were low compared with the peak in inpatient costs at surgery. The highest outpatient expenditure was on CT scans, peaking in the quarter preceding surgery. CONCLUSIONS: We present the first study of costs to the English healthcare system for patients receiving surgery for CRS. The total aggregate costs provide a further impetus for trials to evaluate the relative benefit of surgical intervention.

Cluster randomised controlled trial of screening for atrial fibrillation in people aged 70 years and over to reduce stroke: protocol for the pilot study for the SAFER trial.

INTRODUCTION: Atrial fibrillation (AF) is a common arrhythmia associated with 30% of strokes, as well as other cardiovascular disease, dementia and death. AF meets many criteria for screening, but there is limited evidence that AF screening reduces stroke. Consequently, no countries recommend national screening programmes for AF. The Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) trial aims to determine whether screening for AF is effective at reducing risk of stroke. The aim of the pilot study is to assess feasibility of the main trial and inform implementation of screening and trial procedures. METHODS AND ANALYSIS: SAFER is planned to be a pragmatic randomised controlled trial (RCT) of over 100 000 participants aged 70 years and over, not on long-term anticoagulation therapy at baseline, with an average follow-up of 5 years. Participants are asked to record four traces every day for 3 weeks on a hand-held single-lead ECG device. Cardiologists remotely confirm episodes of AF identified by the device algorithm, and general practitioners follow-up with anticoagulation as appropriate. The pilot study is a cluster RCT in 36 UK general practices, randomised 2:1 control to intervention, recruiting approximately 12 600 participants. Pilot study outcomes include AF detection rate, anticoagulation uptake and other parameters to incorporate into sample size calculations for the main trial. Questionnaires sent to a sample of participants will assess impact of screening on psychological health. Process evaluation and qualitative studies will underpin implementation of screening during the main trial. An economic evaluation using the pilot data will confirm whether it is plausible that screening might be cost-effective. ETHICS AND DISSEMINATION: The London-Central Research Ethics Committee (19/LO/1597) and Confidentiality Advisory Group (19/CAG/0226) provided ethical approval. Dissemination will be via publications, patient-friendly summaries, reports and engagement with the UK National Screening Committee. TRIAL REGISTRATION NUMBER: ISRCTN72104369.

FINE-CKD model to evaluate economic value of finerenone in patients with chronic kidney disease and type 2 diabetes.

BACKGROUND: Chronic kidney disease (CKD) is a progressive and irreversible disease often associated with type 2 diabetes (T2D). CKD is associated with an elevated risk of cardiovascular (CV) events, increased mortality, and diminished quality of life. Finerenone is a new treatment for patients with CKD and T2D that delays CKD progression and reduces CV complications. OBJECTIVE: To describe the approach and structure of a costeffectiveness model for finerenone for patients with CKD and T2D and compare it with existing economic models in CKD. METHODS: A de novo cost-effectiveness model (FINE-CKD model), reflective of FIDELIO-DKD results, was developed for finerenone. The FINE-CKD model was designed and implemented in accordance with published guidance on modeling and was developed with input from economic and clinical experts. The final model approach was evaluated against existing modeling structures in CKD identified through a systematic literature review. RESULTS AND CONCLUSIONS: The FINE-CKD model structure follows recommended modeling guidelines and has been designed in accordance with the best practices of modeling in CKD, while also incorporating important features of the FIDELIO-DKD design and results. The approach is consistent with the published literature, ensuring transparency and minimizing uncertainty that can arise from unnecessary complexity. The FINE-CKD model allows for reliable assessment of benefits and costs related to the use of finerenone in patients with CKD and T2D, and it is a reliable assessment of cost-effectiveness.