Cost-effectiveness of the children and young People's health partnership (CYPHP) model of integrated care versus enhanced usual care: analysis of a pragmatic cluster randomised controlled trial in South London.

Background: Integration of paediatric health services across primary and secondary care holds great promise for the management of chronic conditions, yet limited evidence exists on its cost-effectiveness. This paper reports the results of the economic evaluation of the Children and Young People's Health Partnership (CYPHP) aimed at integrating care for children with common chronic conditions (asthma, eczema, and constipation). Methods: Cost-effectiveness, cost-utility and cost-benefit analyses were conducted alongside a pragmatic cluster randomised controlled trial involving 97,970 children in 70 general practices in South London, including 1,731 participants with asthma, eczema and or constipation with self-reported health-related quality of life measures. Analyses considered the National Health Service (NHS)/Personal Social Service (PSS) and societal perspectives, and time horizons of 6 and 12-months. Costs included intervention delivery, health service use (primary and secondary care), referrals to social services, and time lost from work and school. Health outcomes were measured through the Paediatric Quality of Life Inventory, the Child Health Utility 9-Dimensions, and monetarised benefit combining Quality-Adjusted Life Years (QALYs) for children and parental mental well-being. Results present incremental cost-effectiveness ratios (ICERs), compared to a willingness to pay threshold (WTP) of £20,000-30,000/QALY, and net monetary benefit (NMB), with deterministic sensitivity analyses. Findings: At 6 months, from the NHS/PSS perspective, CYPHP is not cost-effective (ICER = £721,000/QALY), and this result holds at 12 months (ICER = £45,586/QALY). However, under the societal perspective CYPHP falls within WTP thresholds (ICER = £22,966/QALY), with a probability of being cost-effective between 0.4 and 0.6 at £20,000/QALY and £30,000/QALY, respectively. The cost-benefit analysis yields a positive NMB of CYPHP at 12 months £109 under the societal perspective, with similar probabilistic results. Interpretation: CYPHP was not cost-effective at 6 months or under the NHS/PSS perspective. Trends towards cost-effectiveness are observed once a longer time horizon and a more inclusive perspective on effects is considered. Further research beyond 12 months is needed as the model becomes firmly embedded into the paediatric healthcare delivery system. Funding: This research was funded by Guy's and St Thomas' Charity, Lambeth and Southwark Clinical Commissioning Groups. The funders had no role in the writing of the manuscript, decision to submit it for publication, or any other process involved in the research.

Economic Evaluations of Digital Health Interventions for Patients With Heart Failure: Systematic Review.

BACKGROUND: Digital health interventions (DHIs) have shown promising results in enhancing the management of heart failure (HF). Although health care interventions are increasingly being delivered digitally, with growing evidence on the potential cost-effectiveness of adopting them, there has been little effort to collate and synthesize the findings. OBJECTIVE: This study's objective was to systematically review the economic evaluations that assess the adoption of DHIs in the management and treatment of HF. METHODS: A systematic review was conducted using 3 electronic databases: PubMed, EBSCOhost, and Scopus. Articles reporting full economic evaluations of DHIs for patients with HF published up to July 2023 were eligible for inclusion. Study characteristics, design (both trial based and model based), input parameters, and main results were extracted from full-text articles. Data synthesis was conducted based on the technologies used for delivering DHIs in the management of patients with HF, and the findings were analyzed narratively. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed for this systematic review. The reporting quality of the included studies was evaluated using the CHEERS (Consolidated Health Economic Evaluation Reporting Standards) guidelines. RESULTS: Overall, 27 economic evaluations were included in the review. The economic evaluations were based on models (13/27, 48%), trials (13/27, 48%), or a combination approach (1/27, 4%). The devices evaluated included noninvasive remote monitoring devices (eg, home telemonitoring using digital tablets or specific medical devices that enable transmission of physiological data), telephone support, mobile apps and wearables, remote monitoring follow-up in patients with implantable medical devices, and videoconferencing systems. Most of the studies (24/27, 89%) used cost-utility analysis. The majority of the studies (25/27, 93%) were conducted in high-income countries, particularly European countries (16/27, 59%) such as the United Kingdom and the Netherlands. Mobile apps and wearables, remote monitoring follow-up in patients with implantable medical devices, and videoconferencing systems yielded cost-effective results or even emerged as dominant strategies. However, conflicting results were observed, particularly in noninvasive remote monitoring devices and telephone support. In 15% (4/27) of the studies, these DHIs were found to be less costly and more effective than the comparators (ie, dominant), while 33% (9/27) reported them to be more costly but more effective with incremental cost-effectiveness ratios below the respective willingness-to-pay thresholds (ie, cost-effective). Furthermore, in 11% (3/27) of the studies, noninvasive remote monitoring devices and telephone support were either above the willingness-to-pay thresholds or more costly than, yet as effective as, the comparators (ie, not cost-effective). In terms of reporting quality, the studies were classified as good (20/27, 74%), moderate (6/27, 22%), or excellent (1/27, 4%). CONCLUSIONS: Despite the conflicting results, the main findings indicated that, overall, DHIs were more cost-effective than non-DHI alternatives. TRIAL REGISTRATION: PROSPERO CRD42023388241; https://tinyurl.com/2p9axpmc.

The IMPROVE trial: study protocol for a pragmatic cluster randomised controlled trial to assess the effectiveness of using lay health workers to improve uptake and completion of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease.

BACKGROUND: Pulmonary rehabilitation (PR) is a programme of exercise and education and the most effective treatment for the symptoms and disability associated with chronic obstructive pulmonary disease. However, the benefits of PR are limited by poor uptake and completion. This trial will determine whether using trained volunteer lay health workers, called "PR buddies," improves uptake and completion of PR and is cost-effective. This trial protocol outlines the methods for evaluating effectiveness, cost-effectiveness, and acceptability. METHODS: The IMPROVE trial is a pragmatic, open, cluster randomised controlled trial planned in 38 PR services across England and Wales. PR services will be randomised to either intervention arm-offering support from PR buddies to patients with chronic obstructive pulmonary disease-or to usual care as the control arm. PR staff in trial sites randomised to the intervention arm will receive training in recruiting and training PR buddies. They will deliver training to volunteers, recruited from among people who have recently completed PR in their service. The 3-day PR-buddy training programme covers communication skills, confidentiality, boundaries of the PR-buddy role and behaviour change techniques to help patients overcome obstacles to attending PR. An internal pilot will test the implementation of the trial in eight sites (four intervention sites and four in control arm). The primary outcome of the trial is the uptake and completion of PR. A process evaluation will investigate the acceptability of the intervention to patients, PR staff and the volunteer PR buddies, and intervention fidelity. We will also conduct a cost-effectiveness analysis. DISCUSSION: Improving outcomes for chronic obstructive pulmonary disease and access to PR are priorities for the UK National Health Service (NHS) in its long-term plan. The trial hypothesis is that volunteer PR buddies, who are recruited and trained by local PR teams, are an effective and cost-effective way to improve the uptake and completion rates of PR. The trial is pragmatic, since it will test whether the intervention can be incorporated into NHS PR services. Information obtained in this trial may be used to influence policy on the use of PR buddies in PR and other similar services in the NHS. TRIAL REGISTRATION: ISRCTN12658458. Registered on 23/01/2023.

Disease patterns in high-cost individuals with multimorbidity: a retrospective cross-sectional study in primary care.

BACKGROUND: 'High-cost' individuals with multimorbidity account for a disproportionately large share of healthcare costs and are at most risk of poor quality of care and health outcomes. AIM: To compare high-cost with lower-cost individuals with multimorbidity and assess whether these populations can be clustered based on similar disease patterns. DESIGN AND SETTING: A cross-sectional study based on 2019/2020 electronic medical records from adults registered to primary care practices (n = 41) in a London borough. METHOD: Multimorbidity is defined as having ≥2 long-term conditions (LTCs). Primary care costs reflected consultations, which were costed based on provider and consultation types. High cost was defined as the top 20% of individuals in the cost distribution. Descriptive analyses identified combinations of 32 LTCs and their contribution to costs. Latent class analysis explored clustering patterns. RESULTS: Of 386 238 individuals, 101 498 (26%) had multimorbidity. The high-cost group (n = 20 304) incurred 53% of total costs and had 6833 unique disease combinations, about three times the diversity of the lower-cost group (n = 81 194). The trio of anxiety, chronic pain, and depression represented the highest share of costs (5%). High-cost individuals were best grouped into five clusters, but no cluster was dominated by a single LTC combination. In three of five clusters, mental health conditions were the most prevalent. CONCLUSION: High-cost individuals with multimorbidity have extensive heterogeneity in LTCs, with no single LTC combination dominating their primary care costs. The frequent presence of mental health conditions in this population supports the need to enhance coordination of mental and physical health care to improve outcomes and reduce costs.

Genetic-Guided Pharmacotherapy for Coronary Artery Disease: A Systematic and Critical Review of Economic Evaluations.

BACKGROUND: Genetic-guided pharmacotherapy (PGx) is not recommended in clinical guidelines for coronary artery disease (CAD). We aimed to examine the extent and quality of evidence from economic evaluations of PGx in CAD and to identify variables influential in changing conclusions on cost-effectiveness. METHODS AND RESULTS: From systematic searches across 6 databases, 2 independent reviewers screened, included, and rated the methodological quality of economic evaluations of PGx testing to guide pharmacotherapy for patients with CAD. Of 35 economic evaluations included, most were model-based cost-utility analyses alone, or alongside cost-effectiveness analyses of PGx testing to stratify patients into antiplatelets (25/35), statins (2/35), pain killers (1/35), or angiotensin-converting enzyme inhibitors (1/35) to predict CAD risk (8/35) or to determine the coumadin doses (1/35). To stratify patients into antiplatelets (96/151 comparisons with complete findings of PGx versus non-PGx), PGx was more effective and more costly than non-PGx clopidogrel (28/43) but less costly than non-PGx prasugrel (10/15) and less costly and less effective than non-PGx ticagrelor (22/25). To predict CAD risk (51/151 comparisons), PGx using genetic risk scores was more effective and less costly than clinical risk score (13/17) but more costly than no risk score (16/19) or no treatment (9/9). The remaining comparisons were too few to observe any trend. Mortality risk was the most common variable (47/294) changing conclusions. CONCLUSIONS: Economic evaluations to date found PGx to stratify patients with CAD into antiplatelets or to predict CAD risk to be cost-effective, but findings varied based on the non-PGx comparators, underscoring the importance of considering local practice in deciding whether to adopt PGx.

Changing contexts of child health: an assessment of unmet physical, psychological and social needs of children with common chronic childhood illness.

BACKGROUND: We assessed the biopsychosocial needs and key health drivers among children living with a common chronic illness, as baseline for a cluster randomised controlled trial of a child health system strengthening intervention. METHODS: Cross-sectional data were analysed from a large population sample of children from South London with asthma, eczema or constipation, as exemplar tracer conditions of a new integrated care service. Descriptive and regression analyses, accounting for sociodemographic factors, investigated social needs, psychosocial outcomes and quality of life associated with poor symptom control. RESULTS: Among 7779 children, 4371 children (56%) had at least one uncontrolled physical health condition. Across the three domains of physical health, mental health and social needs, 77.5% of children (n=4304 of 5554) aged 4-15 years had at least one unmet need, while 16.3% of children had three unmet needs. Children from the most socioeconomically disadvantaged quintile had a 20% increased risk of at least one poorly controlled physical condition (risk ratio (RR)=1.20, 95% CI: 1.11 to 1.31, p<0.001) compared with those from the least disadvantaged quintile. There was an 85% increased risk of clinically important mental health needs among children with uncontrolled asthma (RR=1.85, 95% CI: 1.65 to 2.07, p<0.001), 57% for active constipation (RR=1.57, 95% CI: 1.12 to 2.20, p<0.01) and 39% for uncontrolled eczema (RR=1.39, 95% CI: 1.24 to 1.56, p<0.001). Health-related quality of life was associated with poor symptom control. CONCLUSIONS: There is a large burden of unmet biopsychosocial needs among children with chronic illness, signalling an urgent need for prevention, early intervention and integrated biopsychosocial care.

Effect of the Children and Young People's Health Partnership model of paediatric integrated care on health service use and child health outcomes: a pragmatic two-arm cluster randomised controlled trial.

BACKGROUND: Paediatric health systems across high-income countries are facing avoidable adverse outcomes and increasing demands and costs. The aim of this study was to compare the effect of an enhanced usual care model with that of an integrated health-care model that offers local health clinics for general paediatric problems and early intervention and care for children and young people with tracer conditions. METHODS: In this pragmatic two-arm cluster randomised controlled trial, we compared the Children and Young People's Health Partnership (CYPHP) model of care versus enhanced usual care (EUC) among children registered at general practices in south London, UK. The CYPHP trial intervention was delivered between April 1, 2018, and June 30, 2021, and children younger than 16 years during the intervention period and registered at study practices on June 30, 2021, were included in the analysis. A restricted randomisation (1:1) following a computer-generated sequence was done by a masked independent statistician at the level of general practice cluster, stratified by borough (Lambeth or Southwark). Cluster allocation and data collection were masked, with unmasking of trial statisticians before analysis. The CYPHP model comprised all elements of EUC (electronic decision support, a primary care hotline, health checks, self-management support and health promotion, and resilience building and mental health first aid) plus local child health clinics delivered by paediatricians and general practitioners, and a nurse-led early intervention service for children with tracer conditions (asthma, eczema, and constipation). Primary outcomes were non-elective admissions (NELA; admissions coded as an emergency) among the whole trial population up to June 30, 2021, and paediatric quality of life (Pediatric Quality of Life Inventory [PedsQL]) among participants with tracer conditions at 6 months after recruitment. Secondary outcomes were primary and secondary care use, child mental health, parental wellbeing, standardised symptom scores for asthma, eczema, and constipation, health-care quality, and child absences from school and parent absences from work. The trial was registered on ClinicalTrials.gov, NCT03461848, and is complete. FINDINGS: The trial was conducted between April 1, 2018, and Dec 31, 2021. In total, 23 general practice clusters, consisting of 70 practices with 97 970 registered children, were randomised to CYPHP (n=11) or EUC (n=12). We found no effect, at the population level, of CYPHP versus EUC on non-elective admissions during the intervention period (adjusted mean incidence rate ratio [IRR] 1·00 [95% CI 0·91 to 1·10], p=0·99). Among children with tracer conditions, we found no difference in paediatric quality of life (PedsQL score) at 6 months (adjusted mean difference -0·033 [95% CI -0·122 to 0·055], p=0·46). As a secondary outcome, among children with tracer conditions and requiring care, NELA rates at 12 months did not differ between the CYPHP and EUC groups (66·1 per 1000 person-years vs 75·3 per 1000 person-years; adjusted mean IRR 0·87 [0·61-1·22], p=0·42). In children requiring care, a statistically significant improvement was observed in eczema symptoms at 6 months from baseline in the CYPHP group versus the EUC group (adjusted mean difference -1·370 [-2·630 to -0·122], p=0·032). Quality of asthma care significantly improved among children in the CYPHP group compared with children in the EUC group. No significant improvement was seen for all other secondary outcomes. INTERPRETATION: Although the CYPHP trial found a null effect for the primary outcomes, we found clinically important improvements in some secondary outcomes including care quality. Previous research has shown that large-scale system change requires time to observe a potential positive effect. FUNDING: Guy's and St Thomas Charity, the Lambeth and Southwark Clinical Commissioning Groups, and Evelina London Children's Hospital.

A Longitudinal Evaluation of the Preferences of Patients With Advanced Cancer for Quality of Life and Survival in Malaysia: A Discrete Choice Experiment.

OBJECTIVES: This study aims to quantify the preferences of patients with advanced cancer for quality of life (QoL) outcomes versus survival extension in Malaysia. The secondary aim of this study is to explore the change in preferences over time. METHODS: A discrete choice experiment was developed to include 7 attributes valued in cancer management: physical, psychological and social functioning, pain control, survival, place of death, and cost. Patients were recruited via convenience sampling from 2 Malaysian public hospitals. The survey questionnaire was administered to patients within 6 months of their cancer diagnosis with a follow-up 3 months later. Conditional logit regression was used to estimate the preference weight, relative attribute importance, and willingness to pay. RESULTS: One hundred valid responses were collected at baseline and 45 at follow-up. Respondents placed higher values on QoL improvements from severe to moderate or mild levels and to achieve home death over survival extension from 6 to 18 months. However, additional improvements (from moderate to mild) in some of the QoL outcomes were not valued as highly as life extension from 12 to 18 months, showing that it was vital for patients to avoid being in "severe" health dysfunction. Improving physical dysfunction from severe to mild yielded 3 times as much value as additional 1-year survival. After 3 months, the respondents' preferences changed significantly, with increased relative attribute importance of physical functioning, pain control, and cost. CONCLUSIONS: As QoL outcomes are valued more than survival, palliative care should be introduced as early as possible to alleviate suffering related to advanced cancer.

Continuous Positive Airway Pressure plus Mandibular Advancement Therapy (PAPMAT): study protocol for an adaptive randomised crossover trial comparing the benefits and costs of combining two established treatments for obstructive sleep apnoea.

BACKGROUND: Obstructive sleep apnoea (OSA) involves repeated breathing pauses during sleep due to upper airway obstruction. It causes excessive daytime sleepiness and has other health impacts. Continuous positive airway pressure (CPAP) therapy is effective first line treatment for moderate to severe OSA. Unfortunately, many patients have difficulty tolerating CPAP and pressure intolerance is probably an important contributing factor. Mandibular advancement devices (MAD) are an alternative to CPAP. They are worn in the mouth during sleep to reduce airway obstruction. There is some evidence that, when used in combination with CPAP, MADs improve airway anatomy enough to reduce the CPAP pressure required to treat OSA and that this combination therapy could improve CPAP adherence. METHODS: Consecutive patients starting on CPAP for moderate to severe OSA will be recruited at a regional NHS sleep service. Patients with high CPAP pressure requirements after initial titration, who satisfy all entry criteria and consent to participate, will undertake a 2-arm randomised crossover trial. The arms will be (i) standalone CPAP and (ii) CPAP + MAD therapy. Each arm will last 12 weeks, including 2 weeks acclimatisation. CPAP machines will be auto-titrating and with facility for data download, so the impact of MAD on CPAP pressure requirements and CPAP adherence can be easily measured. The primary outcome will be CPAP adherence. Secondary outcomes will include measures of OSA severity, patient-reported outcome measures including subjective daytime sleepiness, quality of life, and treatment preference at the trial exit and health service use. Cost-effectiveness analyses will be undertaken. DISCUSSION: If the intervention is shown to be effective and cost-effective in improving adherence in this standard CPAP-eligible OSA patient population it would be relatively straightforward to introduce into existing OSA treatment pathways, within the wider NHS and more widely. Both MAD and CPAP are already used by sleep services so their combination would require only minor adjustments to existing clinical pathways. It would be straightforward to disseminate the results of the study through regional, national, and international respiratory meetings. The health economics analysis would provide cost-effectiveness data to inform service planning and clinical guidelines through policy briefing papers, including those by NICE and SIGN. TRIAL REGISTRATION: PAPMAT was registered with ISRCTN prior to recruitment beginning (ISRCTN Registry 2021): https://www.isrctn.com/ISRCTN33966032 . Registered on 17th November 2021.

Stroke in Sierra Leone: Case fatality rate and functional outcome after stroke in Freetown.

BACKGROUND: There is limited information on long-term outcomes after stroke in sub-Saharan Africa (SSA). Current estimates of case fatality rate (CFR) in SSA are based on small sample sizes with varying study design and report heterogeneous results. AIMS: We report CFR and functional outcomes from a large, prospective, longitudinal cohort of stroke patients in Sierra Leone and describe factors associated with mortality and functional outcome. METHODS: A prospective longitudinal stroke register was established at both adult tertiary government hospitals in Freetown, Sierra Leone. It recruited all patients ⩾ 18 years with stroke, using the World Health Organization definition, from May 2019 until October 2021. To reduce selection bias onto the register, all investigations were paid by the funder and outreach conducted to raise awareness of the study. Sociodemographic data, National Institute of Health Stroke Scale (NIHSS), and Barthel Index (BI) were collected on all patients on admission, at 7 days, 90 days, 1 year, and 2 years post stroke. Cox proportional hazards models were constructed to identify factors associated with all-cause mortality. A binomial logistic regression model reports odds ratio (OR) for functional independence at 1 year. RESULTS: A total of 986 patients with stroke were included, of which 857 (87%) received neuroimaging. Follow-up rate was 82% at 1 year, missing item data were <1% for most variables. Stroke cases were equally split by sex and mean age was 58.9 (SD: 14.0) years. About 625 (63%) were ischemic, 206 (21%) primary intracerebral hemorrhage, 25 (3%) subarachnoid hemorrhage, and 130 (13%) were of undetermined stroke type. Median NIHSS was 16 (9-24). CFR at 30 days, 90 days, 1 year, and 2 years was 37%, 44%, 49%, and 53%, respectively. Factors associated with increased fatality at any timepoint were male sex (hazard ratio (HR): 1.28 (1.05-1.56)), previous stroke (HR: 1.34 (1.04-1.71)), atrial fibrillation (HR: 1.58(1.06-2.34)), subarachnoid hemorrhage (HR: 2.31 (1.40-3.81)), undetermined stroke type (HR: 3.18 (2.44-4.14)), and in-hospital complications (HR: 1.65 (1.36-1.98)). About 93% of patients were completely independent prior to their stroke, declining to 19% at 1 year after stroke. Functional improvement was most likely to occur between 7 and 90 days post stroke with 35% patients improving, and 13% improving between 90 days to 1 year. Increasing age (OR: 0.97 (0.95-0.99)), previous stroke (OR: 0.50 (0.26-0.98)), NIHSS (OR: 0.89 (0.86-0.91)), undetermined stroke type (OR: 0.18 (0.05-0.62)), and ⩾1 in-hospital complication (OR: 0.52 (0.34-0.80)) were associated with lower OR of functional independence at 1 year. Hypertension (OR: 1.98 (1.14-3.44)) and being the primary breadwinner of the household (OR: 1.59 (1.01-2.49)) were associated with functional independence at 1 year. CONCLUSION: Stroke affected younger people and resulted in high rates of fatality and functional impairment relative to global averages. Key clinical priorities for reducing fatality include preventing stroke-related complications through evidence-based stroke care, improved detection and management of atrial fibrillation, and increasing coverage of secondary prevention. Further research into care pathways and interventions to encourage care seeking for less severe strokes should be prioritized, including reducing the cost barrier for stroke investigations and care.

Mapping PedsQL™ scores to CHU9D utility weights for children with chronic conditions in a multi-ethnic and deprived metropolitan population.

PURPOSE: The Child Health Utility-9 Dimensions (CHU9D) is a patient-reported outcome measure to generate Quality-Adjusted Life Years (QALYs), recommended for economic evaluations of interventions to inform funding decisions. When the CHU9D is not available, mapping algorithms offer an opportunity to convert other paediatric instruments, such as the Paediatric Quality of Life Inventory™ (PedsQL), onto the CHU9D scores. This study aims to validate current PedsQL to CHU9D mappings in a sample of children and young people of a wide age range (0 to 16 years of age) and with chronic conditions. New algorithms with improved predictive accuracy are also developed. METHODS: Data from the Children and Young People's Health Partnership (CYPHP) were used (N = 1735). Four regression models were estimated: ordinal least squared, generalized linear model, beta-binomial and censored least absolute deviations. Standard goodness of fit measures were used for validation and to assess new algorithms. RESULTS: While previous algorithms perform well, performance can be enhanced. OLS was the best estimation method for the final equations at the total, dimension and item PedsQL scores levels. The CYPHP mapping algorithms include age as an important predictor and more non-linear terms compared with previous work. CONCLUSION: The new CYPHP mappings are particularly relevant for samples with children and young people with chronic conditions living in deprived and urban settings. Further validation in an external sample is required. Trial registration number NCT03461848; pre-results.

Ethnic inequalities in the impact of COVID-19 on primary care consultations: a time series analysis of 460,084 individuals with multimorbidity in South London.

BACKGROUND: The COVID-19 pandemic caused rapid changes in primary care delivery in the UK, with concerns that certain groups of the population may have faced increased barriers to access. This study assesses the impact of the response to the COVID-19 pandemic on primary care consultations for individuals with multimorbidity and identifies ethnic inequalities. METHODS: A longitudinal study based on monthly data from primary care health records of 460,084 patients aged ≥18 years from 41 GP practices in South London, from February 2018 to March 2021. Descriptive analysis and interrupted time series (ITS) models were used to analyse the effect of the pandemic on primary care consultations for people with multimorbidity and to identify if the effect varied by ethnic groups and consultation type. RESULTS: Individuals with multimorbidity experienced a smaller initial fall in trend at the start of the pandemic. Their primary care consultation rates remained stable (879 (95% CI 869-890) per 1000 patients in February to 882 (870-894) March 2020), compared with a 7% decline among people without multimorbidity (223 consultations (95% CI 221-226) to 208 (205-210)). The gap in consultations between the two groups reduced after July 2020. The effect among individuals with multimorbidity varied by ethnic group. Ethnic minority groups experienced a slightly larger fall at the start of the pandemic. Individuals of Black, Asian, and Other ethnic backgrounds also switched from face-to-face to telephone at a higher rate than other ethnic groups. The largest fall in face-to-face consultations was observed among people from Asian backgrounds (their consultation rates declined from 676 (659-693) in February to 348 (338-359) in April 2020), which may have disproportionately affected their quality of care. CONCLUSIONS: The COVID-19 pandemic significantly affected primary care utilisation in patients with multimorbidity. While there is evidence of a successful needs-based prioritisation of multimorbidity patients within primary care at the start of the pandemic, inequalities among ethnic minority groups were found. Strengthening disease management for these groups may be necessary to control widening inequalities in future health outcomes.

A Comparison of the Content and Consistency of Methodological Quality and Transferability Checklists for Reviewing Model-Based Economic Evaluations.

OBJECTIVES: The aim of this study was to examine whether and how the content of six checklists (Caro, Consensus on Health Economic Criteria [CHEC]-Extended, European Network of Health Economic Databases [EURONHEED], National Institute for Health and Care Excellence [NICE], Philips, Welte) affect the consistency in findings on methodological quality and transferability, using 10 model-based economic evaluations of genetic-guided pharmacotherapy for venous thromboembolism. METHODS: Each checklist was categorised by domain (structure, data, consistency, etc.) and type of assessment (presence vs. appropriateness) and was applied to each study by two independent reviewers who agreed on ratings via consensus, and discussion with a third reviewer when necessary. Methodological quality scores and rankings were examined using Spearman correlation tests, with subgroup analyses for domains and types of assessment. We compared overall ratings of transferability qualitatively, including how content may affect what is considered 'transferable'. RESULTS: The checklists had similar proportions of items judging presence and appropriateness, but varying proportions of items across domains. For methodological quality, ranking consistencies were the highest between CHEC-Extended-Philips, Philips-NICE and NICE-Caro, with similar consistencies for domains and type of assessment. For transferability, NICE and Caro identified the same study, which scored high on EURONHEED, as transferable to the UK, while Welte, which considered methodological quality, identified none as transferable. CONCLUSIONS: We found that the choice of checklist can affect findings on study quality and decisions about whether study results are transferable, indicating that different checklists may shortlist different sets of studies in formulating policy recommendations, leading to different policy decisions. Our systematic approach for evaluating the content of methodological quality and transferability checklists of economic evaluations can be extended to other checklists.

Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: a study protocol for a multicentre adaptive randomised controlled trial.

BACKGROUND: High-flow nasal therapy is a non-invasive form of respiratory support that delivers low-level, flow dependent positive airway pressure. The device can be better tolerated by patients than alternatives such as continuous positive airway pressure. The primary objective is to determine if prophylactic high-flow nasal therapy after tracheal extubation can result in an increase in the number of days alive and at home within the first 90 days after surgery, when compared with standard oxygen therapy. The co-primary objective is to estimate the incremental cost-effectiveness and cost-utility of high-flow nasal therapy vs standard oxygen therapy at 90 days, from the view-point of the public sector, the health service and patients. METHODS: This is an adaptive, multicentre, international parallel-group, randomised controlled trial with embedded cost-effectiveness analysis comparing the use of high-flow nasal therapy with control in patients at high risk of respiratory complications following cardiac surgery. Participants will be randomised before tracheal extubation and allocated either high-flow nasal therapy or standard oxygen therapy for a minimum of 16 h immediately post extubation. Participants will be followed up until 90 days after surgery. The total sample size needed to detect a 2-day increase in DAH90 with 90% power with an intention to treat analysis is 850 patients. The adaptive design includes an interim sample size re-estimation which will provide protection against deviations from the original sample size assumptions made from the single-centre pilot study and will allow for a maximum sample size increase to 1152 patients. DISCUSSION: Evidence to support routine use of high-flow nasal therapy will inform the development of effective enhanced recovery care bundles. Reducing complications should reduce length of stay and re-admission to hospital and provide an important focus for cost reduction. However; high-quality studies evaluating the clinical and cost effectiveness of high-flow nasal therapy after cardiothoracic surgery are lacking. TRIAL REGISTRATION: The study has been registered with ISRCTN ( ISRCTN14092678 , 13/05/2020) Clinicaltrials.gov Registration Pending.

Genetic-Guided Pharmacotherapy for Atrial Fibrillation: A Systematic and Critical Review of Economic Evaluations.

OBJECTIVES: This study aimed to examine the extent and quality of evidence from economic evaluations (EEs) of genetic-guided pharmacotherapy (PGx) for atrial fibrillation (AF) and to identify variables influential in changing base-case conclusions. METHODS: From systematic searches, we included EEs of existing PGx testing to guide pharmacotherapy for AF, without restrictions on population characteristics or language. Articles excluded were genetic tests used to guide device-based therapy or focused on animals. RESULTS: We found 18 EEs (46 comparisons), all model-based cost-utility analysis with or without cost-effectiveness analysis mostly from health system's perspectives, of PGx testing to determine coumadin/direct-acting anticoagulant (DOAC) dosing (14 of 18), to stratify patients into coumadin/DOACs (3 of 18), or to increase patients' adherence to coumadin (1 of 18) versus non-PGx. Most PGx to determine coumadin dosing found PGx more costly and more effective than standard or clinical coumadin dosing (19 of 24 comparisons) but less costly and less effective than standard DOAC dosing (14 of 14 comparisons). The remaining comparisons were too few to observe any trend. Of 61 variables influential in changing base-case conclusions, effectiveness of PGx testing was the most common (37%), accounted for in the models using time-based or medication-based approaches or relative risk. The cost of PGx testing has decreased and plateaued over time. CONCLUSIONS: EEs to date only partially inform decisions on selecting optimal PGx testing for AF, because most evidence focuses on PGx testing to determine coumadin dosing, but less on other purposes. Future EE may refer to the list of influential variables and the approaches used to account for the effect of PGx testing to inform data collection and study design.

Identifying multimorbidity clusters with the highest primary care use: 15 years of evidence from a multi-ethnic metropolitan population.

BACKGROUND: People with multimorbidity have complex healthcare needs. Some co-occurring diseases interact with each other to a larger extent than others and may have a different impact on primary care use. AIM: To assess the association between multimorbidity clusters and primary care consultations over time. DESIGN AND SETTING: A retrospective longitudinal (panel) study design was used. Data comprised electronic primary care health records of 826 166 patients registered at GP practices in an ethnically diverse, urban setting in London between 2005 and 2020. METHOD: Primary care consultation rates were modelled using generalised estimating equations. Key controls included the total number of long-term conditions, five multimorbidity clusters, and their interaction effects, ethnic group, and polypharmacy (proxy for disease severity). Models were also calibrated by consultation type and ethnic group. RESULTS: Individuals with multimorbidity used two to three times more primary care services than those without multimorbidity (incidence rate ratio 2.30, 95% confidence interval = 2.29 to 2.32). Patients in the alcohol dependence, substance dependence, and HIV cluster (Dependence+) had the highest rate of increase in primary care consultations as additional long-term conditions accumulated, followed by the mental health cluster (anxiety and depression). Differences by ethnic group were observed, with the largest impact in the chronic liver disease and viral hepatitis cluster for individuals of Black or Asian ethnicity. CONCLUSION: This study identified multimorbidity clusters with the highest primary care demand over time as additional long-term conditions developed, differentiating by consultation type and ethnicity. Targeting clinical practice to prevent multimorbidity progression for these groups may lessen future pressures on primary care demand by improving health outcomes.

Inequalities in developing multimorbidity over time: A population-based cohort study from an urban, multi-ethnic borough in the United Kingdom.

BACKGROUND: Social and material deprivation accelerate the development of multimorbidity, yet the mechanisms which drive multimorbidity pathways and trajectories remain unclear. We aimed to examine the association between health inequality, risk factors and accumulation or resolution of LTCs, taking disease sequences into consideration. METHODS: We conducted a retrospective cohort of adults aged 18 years and over, registered between April 2005 and May 2020 in general practices in one inner London borough (n = 826,936). Thirty-two long term conditions (LTCs) were selected using a consensus process, based on a definition adapted to the demographic characteristics of the local population. sThe development and resolution of these LTCs were examined according to sociodemographic and clinical risk factors (hypertension; moderate obesity (BMI 30·0-39·9 kg/m2), high cholesterol (total cholesterol > 5 mmol/L), smoking, high alcohol consumption (>14 units per week), and psychoactive substance use), through the application of multistate Markov chain models. FINDINGS: Participants were followed up for a median of 4.2 years (IQR = 1·8 - 8·4); 631,760 (76%) entered the study with no LTCs, 121,424 (15%) with 1 LTC, 41,720 (5%) with 2 LTCs, and 31,966 (4%) with three or more LTCs. At the end of follow-up, 194,777 (24%) gained one or more LTCs, while 45,017 (5%) had resolved LTCs and 27,021 (3%) died. In multistate models, deprivation (hazard ratio [HR] between 1·30 to 1·64), female sex (HR 1·13 to 1·20), and Black ethnicity (HR 1·20 to 1·30; vs White) were independently associated with increased risk of transition from one to two LTCs, and shorter time spent in a healthy state. Substance use was the strongest risk factor for multimorbidity with an 85% probability of gaining LTCs over the next year. First order Markov chains identified consistent disease sequences including: chronic pain or osteoarthritis followed by anxiety and depression; alcohol and substance dependency followed by HIV, viral hepatitis, and liver disease; and morbid obesity followed by diabetes, hypertension, and chronic pain. INTERPRETATION: We examined the relations among 32 LTCs, taking the order of disease occurrence into consideration. Distinctive patterns for the development and accumulation of multimorbidity have emerged, with increased risk of transitioning from no conditions to multimorbidity and mortality related to ethnicity, deprivation and gender. Musculoskeletal disorders, morbid obesity and substance abuse represent common entry points to multimorbidity trajectories.

IT Evaluation of Foundation Healthcare Group NHS Vanguard programme: IT simultaneously an enabler and a rate limiting factor.

The goal of the Foundation Healthcare Group (FHG) Vanguard model was to develop a sustainable local hospital model between two National Health Service (NHS) Trusts (a London Teaching Hospital Trust and a District General Hospital Trust) that makes best use of scarce resources and can be replicated across the NHS, UK. The aim of this study was to evaluate the provision, use, and implementation of the IT infrastructure based on qualitative interviews focused mainly on the perspectives of the IT staff and the clinicians' perspectives. METHODS: In total, 24 interview transcripts, along with 'Acute Care Collaboration' questionnaire responses, were analyzed using a thematic framework for IT infrastructure, sharing themes across the vascular, pediatric, and cardiovascular strands of the FHG programme. RESULTS: Findings indicated that Skype for Business had been an innovative and helpful development widely available to be used between the two Trusts. Clinicians initially reported lack of IT support and infrastructure expected at the outset for a national Vanguard project but later appreciated that remote access to most clinical applications including scans between the two Trusts became operational. The Local Care Record (LCR), an IT project was perceived to have been delivered successfully in South London. Shared technology reduced patient traveling time by providing locally based shared care. CONCLUSION: Lesson learnt is that ensuring patient benefit and priorities is a strong driver to implementation and one needs to identify IT rate-limiting steps at an early stage and on a regular basis and then focus on rapid implementation of solutions. In fact, future work may also assess how the IT infrastructure developed by FHG vanguard project might have helped/boosted the 'digital health' practice during the COVID-19 times. Spreading and scaling-up innovations from the Vanguard sites was the aspiration and challenge for system leaders. After COVID-19, the use of IT is scaled up and now, the challenges in the use of IT are much less compared to the pre-COVID-19 time when this project was evaluated.

Children and Young People's Health Partnership Evelina London Model of Care: economic evaluation protocol of a complex system change.

INTRODUCTION: The Children and Young People's Health Partnership (CYPHP) Evelina London Model of Care is a new approach to integrated care delivery for children and young people (CYP) with common health complaints and chronic conditions. CYPHP includes population health management (services shaped by data-driven understanding of population and individual needs, applied in this case to enable proactive case finding and tailored biopsychosocial care), specialist clinics with multidisciplinary health teams and training resources for professionals working with CYP. This complex health system strengthening programme has been implemented in South London since April 2018 and will be evaluated using a cluster randomised controlled trial with an embedded process evaluation. This protocol describes the within-trial and beyond-trial economic evaluation of CYPHP. METHODS AND ANALYSIS: The economic evaluation will identify, measure and value resources and health outcome impacts of CYPHP compared with enhanced usual care from a National Health Service/Personal Social Service and a broader societal perspective. The study population includes 90 000 CYP under 16 years of age in 23 clusters (groups of general practitioner (GP) practices) to assess health service use and costs, with more detailed cost-effectiveness analysis of a targeted sample of 2138 CYP with asthma, eczema or constipation (tracer conditions). For the cost-effectiveness analysis, health outcomes will be measured using the Paediatric Quality of Life Inventory and quality-adjusted life years (QALYs) using the Child Health Utility 9 Dimensions (CHU-9D) measure. To account for changes in parental well-being, the Warwick-Edinburg Mental Well-being Scale will be integrated with QALYs in a cost-benefit analysis. The within-trial economic evaluation will be complemented by a novel long-term model that expands the analytical horizon to 10 years. Analyses will adhere to good practice guidelines and National Institute for Health and Care Excellence public health reference case. ETHICS AND DISSEMINATION: The study has received ethical approval from South West-Cornwall and Plymouth Research Ethics Committee (REC Reference: 17/SW/0275). Results will be submitted for publication in peer-reviewed journals, made available in briefing papers for local decision-makers, and provided to the local community through website and public events. Findings will be generalisable to community-based models of care, especially in urban settings. TRIAL REGISTRATION NUMBER: NCT03461848.