The cost-effectiveness of a bimekizumab versus IL-17A inhibitors treatment-pathway in patients with active axial spondyloarthritis in Scotland.

OBJECTIVE: To estimate the cost-effectiveness of a treatment-pathway initiated with bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A, in patients with axial spondyloarthritis (axSpA) compared with IL-17Ai's, ixekizumab, and secukinumab, from the NHS Scotland perspective. METHODS: The axSpA treatment-pathway was modeled using a decision tree followed by a lifetime Markov model. The pathway included first- and second-line biologic disease-modifying antirheumatic drugs (bDMARD), followed by best supportive care (bDMARD, nonbiologic). Bimekizumab followed by any bDMARD ("BKZ") was compared with IL-17Ai's: secukinumab 150 mg followed by a blend ("SEC") of dose up-titration to secukinumab 300 mg and any bDMARD, or ixekizumab followed by any bDMARD ("IXE"). Transition to the next therapy was triggered by Bath Ankylosing Spondylitis Disease Activity Index-50% (BASDAI50) non-response or any-cause discontinuation. A published network meta-analysis provided efficacy data. EuroQoL-5-dimensions utilities were derived by mapping from Ankylosing Spondylitis Disease Activity Score. Costs included disease management (linked to functional limitations), biologics acquisition (list prices), administration and monitoring (NHS 2021/22). Discounting was 3.5%/year. Probabilistic results from patients with non-radiographic axSpA and ankylosing spondylitis were averaged to reflect the axSpA disease spectrum. Scenario and sensitivity analyses were performed. RESULTS: The incremental cost-effectiveness ratio (ICER) of BKZ was £24,801/quality-adjusted life-year (QALY) vs. SEC (95% credible interval £24,163-£25,895). BKZ had similar costs (Δ -£385 [-£15,239-£14,468]) and QALYs (Δ 0.039 [-0.748-0.825]) to IXE, with £1,523 (£862-£2,222) net monetary benefit. Conclusions remained unchanged in most scenarios. Results' drivers included BASDAI50 response rate and disease management cost. LIMITATIONS: Results were based on list prices. Data concerning up-titration to secukinumab 300 mg was scarce. CONCLUSIONS: The bimekizumab treatment-pathway represents a cost-effective option across the axSpA disease spectrum in Scotland. Bimekizumab is cost-effective compared to a secukinumab-pathway that includes dose up-titration, and has similar costs and QALYs to an ixekizumab-pathway.

AI-driven translations for kidney transplant equity in Hispanic populations.

Health equity and accessing Spanish kidney transplant information continues being a substantial challenge facing the Hispanic community. This study evaluated ChatGPT's capabilities in translating 54 English kidney transplant frequently asked questions (FAQs) into Spanish using two versions of the AI model, GPT-3.5 and GPT-4.0. The FAQs included 19 from Organ Procurement and Transplantation Network (OPTN), 15 from National Health Service (NHS), and 20 from National Kidney Foundation (NKF). Two native Spanish-speaking nephrologists, both of whom are of Mexican heritage, scored the translations for linguistic accuracy and cultural sensitivity tailored to Hispanics using a 1-5 rubric. The inter-rater reliability of the evaluators, measured by Cohen's Kappa, was 0.85. Overall linguistic accuracy was 4.89 ± 0.31 for GPT-3.5 versus 4.94 ± 0.23 for GPT-4.0 (non-significant p = 0.23). Both versions scored 4.96 ± 0.19 in cultural sensitivity (p = 1.00). By source, GPT-3.5 linguistic accuracy was 4.84 ± 0.37 (OPTN), 4.93 ± 0.26 (NHS), 4.90 ± 0.31 (NKF). GPT-4.0 scored 4.95 ± 0.23 (OPTN), 4.93 ± 0.26 (NHS), 4.95 ± 0.22 (NKF). For cultural sensitivity, GPT-3.5 scored 4.95 ± 0.23 (OPTN), 4.93 ± 0.26 (NHS), 5.00 ± 0.00 (NKF), while GPT-4.0 scored 5.00 ± 0.00 (OPTN), 5.00 ± 0.00 (NHS), 4.90 ± 0.31 (NKF). These high linguistic and cultural sensitivity scores demonstrate Chat GPT effectively translated the English FAQs into Spanish across systems. The findings suggest Chat GPT's potential to promote health equity by improving Spanish access to essential kidney transplant information. Additional research should evaluate its medical translation capabilities across diverse contexts/languages. These English-to-Spanish translations may increase access to vital transplant information for underserved Spanish-speaking Hispanic patients.

Problems with NICE's severity weights.

This essay examines the implications, plausibility, and justification of the severity weighting that NICE (The National Institute for Health and Care Excellence) has endorsed for technology assessments in the U.K. It argues that the assignment by NICE of additional weights to health conditions which involve a large absolute or proportional shortfall of future expected QALYs (Quality-Adjusted Life Years) as compared to those who do not have these health conditions is not well supported and has troubling implications. The literature concerned with attitudes toward prioritizing severity has found a variety of notions of severity, and it is questionable to what extent those studies bear on whether to assign greater weights to health states involving large absolute or proportional shortfalls. In addition, the severity weighting is not well supported by either egalitarian or prioritarian political philosophy, because it is concerned only with the future and focuses only on health rather than well-being in general.

Solving poverty or tackling healthcare inequalities? Qualitative study exploring local interpretations of national policy on health inequalities under new NHS reforms in England.

OBJECTIVES: Major reforms to the organisation of the National Health Service (NHS) in England established 42 integrated care systems (ICSs) to plan and coordinate local services. The changes are based on the idea that cross-sector collaboration is needed to improve health and reduce health inequalities-and similar policy changes are happening elsewhere in the UK and internationally. We explored local interpretations of national policy objectives on reducing health inequalities among senior leaders working in three ICSs. DESIGN: We carried out qualitative research based on semistructured interviews with NHS, public health, social care and other leaders in three ICSs in England. SETTING AND PARTICIPANTS: We selected three ICSs with varied characteristics all experiencing high levels of socioeconomic deprivation. We conducted 32 in-depth interviews with senior leaders of NHS, local government and other organisations involved in the ICS's work on health inequalities. Our interviewees comprised 17 leaders from NHS organisations and 15 leaders from other sectors. RESULTS: Local interpretations of national policy objectives on health inequalities varied, and local leaders had contrasting-sometimes conflicting-perceptions of the boundaries of ICS action on reducing health inequalities. Translating national objectives into local priorities was often a challenge, and clarity from national policy-makers was frequently perceived as limited or lacking. Across the three ICSs, local leaders worried that objectives on tackling health inequalities were being crowded out by other short-term policy priorities, such as reducing pressures on NHS hospitals. The behaviour of national policy-makers appeared to undermine their stated priorities to reduce health inequalities. CONCLUSIONS: Varied and vague interpretations of NHS policy on health inequalities are not new, but lack of clarity among local health leaders brings major risks-including interventions being poorly targeted or inadvertently widening inequalities. Greater conceptual clarity is likely needed to guide ICS action in future.

An exploration of service use pattern changes and cost analysis following implementation of community perinatal mental health teams in pregnant women with a history of specialist mental healthcare in England: a national population-based cohort study.

BACKGROUND: The National Health Service in England pledged >£365 million to improve access to mental healthcare services via Community Perinatal Mental Health Teams (CPMHTs) and reduce the rate of perinatal relapse in women with severe mental illness. This study aimed to explore changes in service use patterns following the implementation of CPMHTs in pregnant women with a history of specialist mental healthcare in England, and conduct a cost-analysis on these changes. METHODS: This study used a longitudinal cohort design based on existing routine administrative data. The study population was all women residing in England with an onset of pregnancy on or after 1st April 2016 and who gave birth on or before 31st March 2018 with pre-existing mental illness (N = 70,323). Resource use and costs were compared before and after the implementation of CPMHTs. The economic perspective was limited to secondary mental health services, and the time horizon was the perinatal period (from the start of pregnancy to 1-year post-birth, ~ 21 months). RESULTS: The percentage of women using community mental healthcare services over the perinatal period was higher for areas with CPMHTs (30.96%, n=9,653) compared to areas without CPMHTs (24.72%, n=9,615). The overall percentage of women using acute care services (inpatient and crisis resolution teams) over the perinatal period was lower for areas with CPMHTs (4.94%, n=1,540 vs. 5.58%, n=2,171), comprising reduced crisis resolution team contacts (4.41%, n=1,375 vs. 5.23%, n=2,035) but increased psychiatric admissions (1.43%, n=445 vs. 1.13%, n=441). Total mental healthcare costs over the perinatal period were significantly higher for areas with CPMHTs (fully adjusted incremental cost £111, 95% CI £29 to £192, p-value 0.008). CONCLUSIONS: Following implementation of CPMHTs, the percentage of women using acute care decreased while the percentage of women using community care increased. However, the greater use of inpatient admissions alongside greater use of community care resulted in a significantly higher mean cost of secondary mental health service use for women in the CPMHT group compared with no CPMHT. Increased costs must be considered with caution as no data was available on relevant outcomes such as quality of life or satisfaction with services.

Does shortage of GPs matter? A cross-sectional study of practice population life expectancy.

BACKGROUND: There are not enough GPs in England. Access to general practice and continuity of care are declining. AIM: To investigate whether practice characteristics are associated with life expectancy of practice populations. DESIGN AND SETTING: A cross-sectional ecological study of patient life expectancy from 2015-2019. METHOD: Selection of independent variables was based on conceptual frameworks describing general practice's influence on outcomes. Sixteen non-correlated variables were entered into multivariable weighted regression models: population characteristics (Index of Multiple Deprivation, region, % White ethnicity, and % on diabetes register); practice organisation (total NHS payments to practices expressed as payment per registered patient, full-time equivalent fully qualified GPs, GP registrars, advanced nurse practitioners, other nurses, and receptionists per 1000 patients); access (% seen on the same day); clinical performance (% aged ≥45 years with blood pressure checked, % with chronic obstructive pulmonary disease vaccinated against flu, % with diabetes in glycaemic control, and % with coronary heart disease on antiplatelet therapy); and the therapeutic relationship (% continuity). RESULTS: Deprivation was strongly negatively associated with life expectancy. Regions outside London and White ethnicity were associated with lower life expectancy. Higher payment per patient, full-time equivalent fully qualified GPs per 1000 patients, continuity, % with chronic obstructive pulmonary disease having the flu vaccination, and % with diabetes with glycaemic control were associated with higher life expectancy; the % being seen on the same day was associated with higher life expectancy in males only. The variable aged ≥45 years with blood pressure checked was a negative predictor in females. CONCLUSION: The number of GPs, continuity of care, and access in England are declining, and it is worrying that these features of general practice were positively associated with life expectancy.

Practices of falls risk assessment and prevention in acute hospital settings: a realist investigation.

Background: Falls are the most common safety incident reported by acute hospitals. The National Institute of Health and Care Excellence recommends multifactorial falls risk assessment and tailored interventions, but implementation is variable. Aim: To determine how and in what contexts multifactorial falls risk assessment and tailored interventions are used in acute National Health Service hospitals in England. Design: Realist review and multisite case study. (1) Systematic searches to identify stakeholders' theories, tested using empirical data from primary studies. Review of falls prevention policies of acute Trusts. (2) Theory testing and refinement through observation, staff interviews (n = 50), patient and carer interviews (n = 31) and record review (n = 60). Setting: Three Trusts, one orthopaedic and one older person ward in each. Results: Seventy-eight studies were used for theory construction and 50 for theory testing. Four theories were explored. (1) Leadership: wards had falls link practitioners but authority to allocate resources for falls prevention resided with senior nurses. (2) Shared responsibility: a key falls prevention strategy was patient supervision. This fell to nursing staff, constraining the extent to which responsibility for falls prevention could be shared. (3) Facilitation: assessments were consistently documented but workload pressures could reduce this to a tick-box exercise. Assessment items varied. While individual patient risk factors were identified, patients were categorised as high or low risk to determine who should receive supervision. (4) Patient participation: nursing staff lacked time to explain to patients their falls risks or how to prevent themselves from falling, although other staff could do so. Sensitive communication could prevent patients taking actions that increase their risk of falling. Limitations: Within the realist review, we completed synthesis for only two theories. We could not access patient records before observations, preventing assessment of whether care plans were enacted. Conclusions: (1) Leadership: There should be a clear distinction between senior nurses' roles and falls link practitioners in relation to falls prevention; (2) shared responsibility: Trusts should consider how processes and systems, including the electronic health record, can be revised to better support a multidisciplinary approach, and alternatives to patient supervision should be considered; (3) facilitation: Trusts should consider how to reduce documentation burden and avoid tick-box responses, and ensure items included in the falls risk assessment tools align with guidance. Falls risk assessment tools and falls care plans should be presented as tools to support practice, rather than something to be audited; (4) patient participation: Trusts should consider how they can ensure patients receive individualised information about risks and preventing falls and provide staff with guidance on brief but sensitive ways to talk with patients to reduce the likelihood of actions that increase their risk of falling. Future work: (1) Development and evaluation of interventions to support multidisciplinary teams to undertake, and involve patients in, multifactorial falls risk assessment and selection and delivery of tailored interventions; (2) mixed method and economic evaluations of patient supervision; (3) evaluation of engagement support workers, volunteers and/or carers to support falls prevention. Research should include those with cognitive impairment and patients who do not speak English. Study registration: This study is registered as PROSPERO CRD42020184458. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR129488) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 5. See the NIHR Funding and Awards website for further award information.

Many accidental falls by older people in hospitals could be avoided. There are guidelines to prevent falls, but some hospitals are better at following them than others. This study aimed to find out why. First, we looked at research and hospitals' falls policies for ideas about what stops falls. With advice from service users, we tested these ideas in four hospitals in England, watching how falls were prevented on wards for older people and people who need bone care, and talking to 50 staff, 28 patients and 3 carers. We found the following: Falls leadership: wards had staff called falls link practitioners who supported falls prevention, but senior nurses, not link practitioners, made the most important decisions. Sharing responsibility: patients with falls risks were monitored to try to stop falls. Because only nursing teams were always present to monitor patients, they had most responsibility for preventing falls. This limited sharing responsibility with other staff. Computer tools: nurses used computers to record prevention work, but high workloads could make this a 'tick-box' exercise. Computer tools reminded them to do this, although tools varied. Patients had individual falls plans, but they were also ranked more generally as high or low risk of falling, with 'high-risk' patients being monitored. Patient involvement: nursing staff did not have time to explain to patients how to prevent falls, but other staff could have such conversations. Many patients had problems like dementia and found it difficult to follow safety advice, although some could take steps to keep safe, with sensitive staff support. We need to involve patients, carers and different staff in falls prevention. Hospitals could develop computer systems to support this, think how to involve more ward staff, and provide guidance on helpful ways to talk with patients about falls.

Talking in primary care (TIP): protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients' musculoskeletal pain and enablement.

INTRODUCTION: Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain. METHODS AND ANALYSIS: A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews. ETHICS APPROVAL AND DISSEMINATION: Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country. TRIAL REGISTRATION NUMBER: ISRCTN18010240.

A cluster-randomized study to evaluate the effectiveness and cost-effectiveness of the Assessment of Burden of Chronic Conditions (ABCC) tool in South Tyrolean primary care for patients with COPD, asthma, type 2 diabetes, and heart failure: the ABCC South Tyrol study.

BACKGROUND: Chronic diseases, such as chronic obstructive pulmonary disease (COPD), asthma, type 2 diabetes, and heart failure, often coexist and contribute to a significant burden on individuals and health systems. The Assessment of Burden of Chronic Conditions (ABCC) tool, already in routine clinical use in the Netherlands, aims to comprehensively assess and visualize disease burden, stimulate self-management, and encourage shared decision-making. This study aims to validate the German and Italian versions of the ABCC tool and evaluate its effectiveness and cost-effectiveness in the South Tyrolean Primary Care setting. METHODS: This is a cluster-randomized study involving approximately 400 patients with COPD, asthma, type 2 diabetes, and heart failure who received care from the South Tyrolean General Practices. Initially, the ABCC tool will be translated into German and Italian and validated. Subsequently, half of the participants will use the validated ABCC tool for patient-reported outcome measurement assessments, while the other half will receive usual care. The primary outcome measure is the change in the patients' perception of the quality of care after 18 months. The secondary outcomes included changes in quality of life, self-management behavior, and healthcare utilization. The missing data will be managed using multiple imputations. Additionally, a cost-effectiveness analysis that considers the direct medical costs reimbursed by the National Health Service will be conducted. DISCUSSION: This study provides insights into the application, validation, and efficacy of the ABCC tool in the South Tyrolean healthcare context. The tool's potential to enhance person-centered care, improve the quality of life, and possibly reduce healthcare costs could greatly contribute to sustainable healthcare. The challenges of implementation, such as software integration and the use of an EU data platform, will provide lessons for future international patient care data management. TRIAL REGISTRATION: ISRCTN registry, ISRCTN13531607. Registered on August 23, 2023.

Effectiveness and cost-effectiveness of a web-based cardiac rehabilitation programme for people with chronic stable angina: protocol for the ACTIVATE (Angina Controlled Trial Investigating the Value of the 'Activate your heart' Therapeutic E-intervention) randomised controlled trial.

INTRODUCTION: Chronic stable angina is common and disabling. Cardiac rehabilitation is routinely offered to people following myocardial infarction or revascularisation procedures and has the potential to help people with chronic stable angina. However, there is insufficient evidence of effectiveness and cost-effectiveness for its routine use in this patient group. The objectives of this study are to compare the effectiveness and cost-effectiveness of the 'Activate Your Heart' cardiac rehabilitation programme for people with chronic stable angina compared with usual care. METHODS AND ANALYSIS: ACTIVATE is a multicentre, parallel-group, two-arm, superiority, pragmatic randomised controlled trial, with recruitment from primary and secondary care centres in England and Wales and a target sample size of 518 (1:1 allocation; allocation sequence by minimisation programme with built-in random element). The study uses secure web-based allocation concealment. The two treatments will be optimal usual care (control) and optimal usual care plus the 'Activate Your Heart' web-based cardiac rehabilitation programme (intervention). Outcome assessment and statistical analysis will be performed blinded; participants will be unblinded. Outcomes will be measured at baseline and at 6 and 12 months' follow-up. Primary outcome will be the UK version of Seattle Angina Questionnaire (SAQ-UK), physical limitations domain at 12 months' follow-up. Secondary outcomes will be the remaining two domains of SAQ-UK, dyspnoea, anxiety and depression, health utility, self-efficacy, physical activity and the incremental shuttle walk test. All safety events will be recorded, and serious adverse events assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be cost-utility analysis from health service perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the cardiac rehabilitation programme. ETHICS AND DISSEMINATION: North of Scotland National Health Service Research Ethics Committee approval, reference 21/NS/0115. Participants will provide written informed consent. Results will be disseminated by peer-reviewed publication. TRIAL REGISTRATION NUMBER: ISRCTN10054455.

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.