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Background. Between 2015 and 2020, 1,578 care homes in the UK closed, displacing nearly 50,000 older and disabled people with very significant care and support needs. It is widely thought that relocation can have a significant impact on the health and well-being of older people. Yet, evidence is limited due to sensitivity and logistical difficulties with data collection. This study aimed to review the published literature in order to (i) identify evidence on the costs, consequences, and wider impacts of care home closures, for older people, family members, care home staff, and local authorities and (ii) understand the causes of and processes surrounding the closure of residential care homes in the UK. Methods. Eight electronic databases (Medline, Embase, Web of Science, Scopus, ASSIA, HMIC, AgeInfo, and SPP) were searched from 1st January 2000 to 9th February 2023; Google and Google Scholar were searched for guidance/policy documents from the grey literature. Data on the objectives, methods, and main results were extracted, and the findings were narratively reported. Results. Eighteen records, comprising guidance documents and academic publications (quantitative, qualitative, and mixed-method approaches), met the inclusion criteria. We found a lack of good quality evidence on costs of closure and no consideration of outcomes for staff. Studies reporting on outcomes for residents suggest there may not be any long-term adverse effects on their health, in contrast to often-expressed views that care home closures result in harm. Conclusion. Future research should consider the stress and anxiety experienced by staff and families as relevant outcomes and show caution with respect to the use of proxy reporting of resident health outcomes. Given that a sizable portion of the costs associated with care home closure falls on local authorities, an evidence-based approach to closures that includes an assessment of cost-effectiveness will help to improve future outcomes and guide the most efficient use of limited public resources. [ABSTRACT FROM AUTHOR]

Introduction: Major trauma centre (MTC) care has been associated with improved outcomes for injured patients. English ambulance services and trauma networks currently use a range of triage tools to select patients for bypass to MTCs. A standardised national triage tool may improve triage accuracy, cost-effectiveness and the reproducibility of decision-making. Methods: We conducted an expert consensus process to derive and develop a major trauma triage tool for use in English trauma networks. A web-based Delphi survey was conducted to identify and confirm candidate triage tool predictors of major trauma. Facilitated roundtable consensus meetings were convened to confirm the proposed triage tool’s purpose, target diagnostic threshold, scope, intended population and structure, as well as the individual triage tool predictors and cut points. Public and patient involvement (PPI) focus groups were held to ensure triage tool acceptability to service users. Results: The Delphi survey reached consensus on nine triage variables in two domains, from 109 candidate variables after three rounds. Following a review of the relevant evidence during the consensus meetings, iterative rounds of discussion achieved consensus on the following aspects of the triage tool: reference standard, scope, target diagnostic accuracy and intended population. A three-step tool comprising physiology, anatomical injury and clinical judgement domains, with triage variables assessed in parallel, was recommended. The triage tool was received favourably by PPI focus groups. Conclusions: This paper presents a new expert consensus derived major trauma triage tool with defined purpose, scope, intended population, structure, constituent variables, variable definitions and thresholds. Prospective evaluation is required to determine clinical and cost-effectiveness, acceptability and usability. [ABSTRACT FROM AUTHOR]

Background: The E-Freeze trial is a multi-centre randomised controlled trial of fresh versus frozen embryo transfer for women undergoing in vitro fertilisation. This paper describes the statistical analysis plan for the E-Freeze trial.Methods and Design: E-Freeze is a two-arm parallel-group, multi-centre, individually randomised controlled trial to determine if a policy of freezing embryos, followed by thawed frozen embryo transfer, results in a higher healthy baby rate when compared with the current policy of transferring fresh embryos. Couples undergoing their first, second or third cycle of in vitro fertilisation at fertility centres in the UK were randomised to either fresh or frozen embryo transfer. The primary outcome is a healthy baby, defined as a live singleton baby born at term with an appropriate weight for gestation. This paper describes the statistical analysis plan for the trial, including the analysis principles, definitions of outcomes, methods for primary analysis, pre-specified subgroup analysis and sensitivity analysis. This plan was finalised prior to completion of recruitment to the trial.Trial Registration: ISRCTN registry: ISRCTN61225414 . Registered on 29 December 2015. [ABSTRACT FROM AUTHOR]

Background: Up to 20% of UK children experience socio-emotional difficulties which can have serious implications for themselves, their families and society. Stark socioeconomic and ethnic inequalities in children's well-being exist. Supporting parents to develop effective parenting skills is an important preventive strategy in reducing inequalities. Parenting interventions have been developed, which aim to reduce the severity and impact of these difficulties. However, most parenting interventions in the UK focus on early childhood (0-10 years) and often fail to engage families from ethnic minority groups and those living in poverty. Strengthening Families, Strengthening Communities (SFSC) is a parenting programme designed by the Race Equality Foundation, which aims to address this gap. Evidence from preliminary studies is encouraging, but no randomised controlled trials have been undertaken so far.Methods/design: The TOGETHER study is a multi-centre, waiting list controlled, randomised trial, which aims to test the effectiveness of SFSC in families with children aged 3-18 across seven urban areas in England with ethnically and socially diverse populations. The primary outcome is parental mental well-being (assessed by the Warwick-Edinburgh Mental Well-Being Scale). Secondary outcomes include child socio-emotional well-being, parenting practices, family relationships, self-efficacy, quality of life, and community engagement. Outcomes are assessed at baseline, post intervention, three- and six-months post intervention. Cost effectiveness will be estimated using a cost-utility analysis and cost-consequences analysis. The study is conducted in two stages. Stage 1 comprised a 6-month internal pilot to determine the feasibility of the trial. A set of progression criteria were developed to determine whether the stage 2 main trial should proceed. An embedded process evaluation will assess the fidelity and acceptability of the intervention.Discussion: In this paper we provide details of the study protocol for this trial. We also describe challenges to implementing the protocol and how these were addressed. Once completed, if beneficial effects on both parental and child outcomes are found, the impact, both immediate and longer term, are potentially significant. As the intervention focuses on supporting families living in poverty and those from minority ethnic communities, the intervention should also ultimately have a beneficial impact on reducing health inequalities.Trial Registration: Prospectively registered Randomised Controlled Trial ISRCTN15194500 . [ABSTRACT FROM AUTHOR]

Introduction: Several forces are contributing to an increase in the number of people living with and surviving colorectal cancer (CRC). However, due to the lack of available data, little is known about the implications of these forces. In recent years, the use of administrative records to inform research has been increasing. The aim of this paper is to investigate the potential contribution that administrative data could have on the health economic research of CRC. Methods: To achieve this aim, we conducted a systematic review of the health economic CRC literature published in the United Kingdom and Europe within the last decade (2009–2019). Results: Thirty‐seven relevant studies were identified and divided into economic evaluations, cost of illness studies and cost consequence analyses. Conclusions: The use of administrative data, including cancer registry, screening and hospital records, within the health economic research of CRC is commonplace. However, we found that this data often come from regional databases, which reduces the generalisability of results. Further, administrative data appear less able to contribute towards understanding the wider and indirect costs associated with the disease. We explore several ways in which various sources of administrative data could enhance future research in this area. [ABSTRACT FROM AUTHOR]

Objective: To examine the impact and cost associated with mental illness. Methods: A rapid review of the literature from Australia, New Zealand, UK and Canada was undertaken. The review included literature pertaining to the cost-of-illness and impact of mental illness as well as any modelling studies. Included studies were categorised according to impact on education, labour force engagement, earlier retirement or welfare dependency. The well-accepted Drummond 10-point economic appraisal checklist was used to assess the quality of the studies. Results: A total of 45 methodologically diverse studies were included. The studies highlight the significant burden mental illness places on all facets of society, including individuals, families, workplaces and the wider economy. Mental illness results in a greater chance of leaving school early, a lower probability of gaining full-time employment and a reduced quality of life. Research from Canada suggests that the total economic costs associated with mental illness will increase six-fold over the next 30 years with costs likely to exceed A$2.8 trillion (based on 2015 Australian dollars). Conclusions: Mental illness is associated with a high economic burden. Further research is required to develop a better understanding of the trajectory and burden of mental illness so that resources can be directed towards cost-effective interventions. What is known about the topic?: Although mental illness continues to be one of the leading contributors to the burden of disease, there is limited information on the economic impact that mental illness imposes on individuals, families, workplaces and the wider economy. What does this paper add?: This review provides a summary of the economic impact and cost of mental illness. The included literature highlights the significant burden mental illness places on individuals, families, workplaces, society and the economy in general. The review identified several areas for improvement. For example, only limited information is available on the impact of attention deficit hyperactivity disorder, anxiety, cognitive function, conduct disorder, eating disorder and psychological distress. There was also a dearth of evidence on the intangible elements of pain and suffering of people and their families with depressive disorders. More research is required to better understand the full extent of the impact of mental illness and strategies that may be implemented to minimise this harm. What are the implications for practitioners?: Knowing the current and future impact of mental illness highlights the imperative to develop an effective policy response. [ABSTRACT FROM AUTHOR]

Background: In the UK, tens of millions of working days are lost due to work‐related ill health every year, costing billions of pounds. The role of Occupational Health (OH) services is vital in helping workers to maintain employment when they encounter injury or illness. OH providers traditionally rely on a clinical workforce to deliver these services, particularly doctors and nurses with OH qualifications. However, the increasing demand for OH services is unlikely to be met in the future using this traditional model, due to the declining number of OH‐trained doctors and nurses in the UK. Multi‐disciplinary models of OH delivery, including a more varied range of healthcare and non‐healthcare professionals, could provide a way to meet this new demand for OH services. There is a need to identify collaborative models of OH service delivery and review their effectiveness on return‐to work outcomes. There is an existing pool of systematic review evidence evaluating workplace based, multi‐disciplinary OH interventions, but it is difficult to identify which aspects of the content and/or delivery of these interventions may be associated with improved work‐related outcomes. Objectives: The aim of this evidence and gap map (EGM) was to provide an overview of the systematic review evidence that evaluates the effectiveness and cost‐effectiveness of multi‐disciplinary OH interventions intending to improve work‐related outcomes. Search Methods: In June 2021 we searched a selection of bibliographic databases and other academic literature resources covering a range of relevant disciplines, including health care and business studies, to identify systematic review evidence from a variety of sectors of employment. We also searched Google Search and a selection of topically relevant websites and consulted with stakeholders to identify reports already known to them. Searches were updated in February 2023. Selection Criteria: Systematic reviews needed to be about adults (16 years or over) in employment, who have had absence from work for any medical reason. Interventions needed to be multi‐disciplinary (including professionals from different backgrounds in clinical and non‐clinical professions) and designed to support employees and employers to manage health conditions in the workplace and/or to help employees with health conditions retain and/or return to work following medical absence. Effectiveness needed to be measured in terms of return to work, work retention or measures of absence, or economic evaluation outcomes. These criteria were applied to the title and abstract and full text of each systematic review independently by two reviewers, with disagreements resolved through discussion. We awarded each systematic review a rating of 'High', 'Medium' or 'Low' relevance to indicate the extent to which the populations, interventions and their contexts synthesised within the review were consistent with our research question. We also recorded the number of primary studies included within each of the 'High' and 'Medium' reviews that were relevant to research question using the same screening process applied at review level. Data Collection and Analysis: Summary data for each eligible review was extracted. The quality of the systematic reviews, rated as 'High' or 'Medium' relevance following full text screening, was appraised using the AMSTAR‐2 quality appraisal tool. All data were extracted by one reviewer and checked by a second, with disagreements being settled through discussion. Summary data for all eligible systematic reviews were tabulated and described narratively. The data extracted from reviews of 'High' and 'Medium' relevance was imported into EPPI‐Mapper software to create an EGM. Stakeholder Involvement: We worked alongside commissioners and policy makers from the Department of Health and Social Care (DHSC) and Department of Work and Pensions (DWP), OH personnel, and people with lived experience of accessing OH services themselves and/or supporting employees to access OH services. Individuals contributed to decision making at all stages of the project. This ensured our EGM reflects the needs of individuals who will use it. Main Results: We identified 98 systematic reviews that contained relevant interventions, which involved a variety of professionals and workplaces, and which measured effectiveness in terms of return to work (RTW). Of these, we focused on the 30 reviews where the population and intervention characteristics within the systematic reviews were considered to be of high or medium relevance to our research questions. The 30 reviews were of varying quality, split evenly between High/Moderate quality and Low/Critically‐Low quality ratings. We did not identify any relevant systematic review evidence on any other work‐related outcome of interest. Interventions were heterogenous, both within and across included systematic reviews. The EGM is structured according to the health condition experienced by participants, and the effectiveness of the interventions being evaluated, as reported within the included systematic reviews. It is possible to view (i) the quality and quantity of systematic review evidence for a given health condition, (ii) how review authors assessed the effectiveness or cost‐effectiveness of the interventions evaluated. The EGM also details the primary studies relevant to our research aim included within each review. Authors' Conclusions: This EGM map highlights the array of systematic review evidence that exists in relation to the effectiveness or cost‐effectiveness of multi‐disciplinary, workplace‐based OH interventions in supporting RTW. This evidence will allow policy makers and commissioners of services to determine which OH interventions may be most useful for supporting different population groups in different contexts. OH professionals may find the content of the EGM useful in identifying systematic review evidence to support their practice. The EGM also identifies where systematic review evidence in this area is lacking, or where existing evidence is of poor quality. These may represent areas where it may be particularly useful to conduct further systematic reviews. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the impact of usual care plus a fundamental nursing care guideline compared to usual care only for patients in hospital with COVID‐19 on patient experience, care quality, functional ability, treatment outcomes, nurses' moral distress, patient health‐related quality of life and cost‐effectiveness. Design: Parallel two‐arm, cluster‐level randomized controlled trial. Methods: Between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID‐19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them. We randomly assigned hospitals to use a fundamental nursing care guideline and usual care or usual care only. Our patient‐reported co‐primary outcomes were the Relational Aspects of Care Questionnaire and four scales from the Quality from the Patient Perspective Questionnaire. We undertook intention‐to‐treat analyses. Results: We randomized 15 clusters and recruited 581 patient and 418 nurse participants. Primary outcome data were available for 570–572 (98.1%–98.5%) patient participants in 14 clusters. We found no evidence of between‐group differences on any patient, nurse or economic outcomes. We found between‐group differences over time, in favour of the intervention, for three of our five co‐primary outcomes, and a significant interaction on one primary patient outcome for ethnicity (white British vs. other) and allocated group in favour of the intervention for the 'other' ethnicity subgroup. Conclusion: We did not detect an overall difference in patient experience for a fundamental nursing care guideline compared to usual care. We have indications the guideline may have aided sustaining good practice over time and had a more positive impact on non‐white British patients' experience of care. Implications for the Profession and/or Patient Care: We cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required. Impact: Fundamental nursing care drives patient experience but is severely impacted in pandemics. Our guideline was not superior to usual care, albeit it may sustain good practice and have a positive impact on non‐white British patients' experience of care. Reporting Method: CONSORT and CONSERVE. Patient or Public Contribution: Patients with experience of hospitalization with COVID‐19 were involved in guideline development and writing, trial management and interpretation of findings. [ABSTRACT FROM AUTHOR]

Objectives: It has been estimated that vaccines can accrue a relatively large part of their value from patient and carer productivity. Yet, productivity value is not commonly or consistently considered in health economic evaluations of vaccines in several high-income countries. To contribute to a better understanding of the potential impact of including productivity value on the expected cost-effectiveness of vaccination, we illustrate the extent to which the incremental costs would change with and without productivity value incorporated. Methods: For two vaccines currently under development, one against Cloistridioides difficile (C. difficile) infection and one against respiratory syncytial disease (RSV), we estimated their incremental costs with and without productivity value included and compared the results. Results: In this analysis, reflecting a UK context, a C. difficile vaccination programme would prevent £12.3 in productivity costs for every person vaccinated. An RSV vaccination programme would prevent £49 in productivity costs for every vaccinated person. Conclusions: Considering productivity costs in future cost-effectiveness analyses of vaccines for C. difficile and RSV will contribute to better-informed reimbursement decisions from a societal perspective. [ABSTRACT FROM AUTHOR]

Purpose -- The purpose of this paper is to evaluate the effectiveness and cost-effectiveness of a peer-led self-management intervention for people with severe mental disorders. Design/methodology/approach -- This is a one-arm longitudinal study without control group. In all, 262 adults with (self-reported) severe mental disorders, who have used secondary mental health services and were living in the community were evaluated at three time points (baseline, six and 12 months). Socio-demographic data were collected at baseline. Wellbeing (Warwick-Edinburgh Mental Wellbeing Scale), functional living skills (Health Promoting Lifestyle Profile II) and service use (Client Service Receipt Inventory) data were assessed over time. Findings -- Self-management for people with severe mental disorders improved wellbeing and health-promoting lifestyles. After an increase in the short term, costs appeared to decrease in the longer term, although this change was not statistically significant. Due to the lack of a control group, the authors are unable to attribute those changes to the intervention only. Nevertheless, the self-management intervention appears to warrant further attention on both wellbeing and economic grounds. Originality/value -- Self-management may facilitate recovery, helping to support people with severemental disorders at no additional cost. Given recent emphasis on recovery, peer workers and self-management, this peer-led self-management approach for people with severe mental disorders appears to have potential. [ABSTRACT FROM AUTHOR]

Background This paper presents the results of an evaluation of the Better Health at Work Award—a structured regional workplace health programme which combined changes to the work environment with lifestyle interventions. Methods Baseline and follow-up data on sickness-absence rates and programme costs were collected retrospectively via a web survey of all participating organizations. Changes over time were calculated using 95% confidence intervals of the mean, supplemented by hypothesis testing using a t-test. The indicative cost–benefits of the intervention were also calculated. Results Participation was associated with a mean reduction in sickness absence of 0.26–1.6 days per employee per year depending on the length and level of participation in the programme. The estimated cost for the programme was £3 per sickness-absence day saved. Conclusions These results suggest that the Better Health at Work Award could be a cost-effective way of improving health and reducing sickness absence particularly in the public sector. However, controlled evaluations of future interventions are needed. [ABSTRACT FROM PUBLISHER]

Background: Migraine is the world's second most common disabling disorder, affecting 15% of UK adults and costing the UK over £1.5 billion per year. Several costly new drugs have been approved by National Institute for Health and Care Excellence. Aim: To assess the cost-effectiveness of drugs used to treat adults with chronic migraine. Methods: We did a systematic review of placebo-controlled trials of preventive drugs for chronic migraine. We then assessed the cost-effectiveness of the currently prescribable drugs included in the review: Onabotulinum toxin A (BTA), Eptinezumab (100mg or 300mg), Fremanezumab (monthly or quarterly dose), Galcanezumab or Topiramate, each compared to placebo, and we evaluated them jointly. We developed a Markov (state-transition) model with a three-month cycle length to estimate the costs and quality-adjusted life years (QALYs) for the different medications from a UK NHS and Personal Social Services perspective. We used a two-year time horizon with a starting age of 30 years for the patient cohort. We estimated transition probabilities based on monthly headache days using a network meta-analysis (NMA) developed by us, and from published literature. We obtained costs from published sources and applied discount rates of 3.5% to both costs and outcomes. Results: Deterministic results suggest Topiramate was the least costly option and generated slightly more QALYs than the placebo, whereas Eptinezumab 300mg was the more costly option and generated the most QALYs. After excluding dominated options, the incremental cost-effectiveness ratio (ICER) between BTA and Topiramate was £68,000 per QALY gained and the ICER between Eptinezumab 300mg and BTA was not within plausible cost-effectiveness thresholds. The cost-effectiveness acceptability frontier showed that Topiramate is the most cost-effective medication for any amount the decision maker is willing-to-pay per QALY. Conclusions: Among the various prophylactic medications for managing chronic migraine, only Topiramate was within typical cost-effectiveness threshold ranges. Further research is needed, ideally an economic evaluation alongside a randomised trial, to compare these newer, expensive CGRP MAbs with the cheaper oral medications. [ABSTRACT FROM AUTHOR]

Background: This article presents evaluation findings of the India English Language Programme, an innovative programme aimed at providing Indian nurses with an opportunity to participate in an ethical and mutually beneficial learning programme aimed at supporting migration into the United Kingdom's National Health Service (NHS). The programme provided 249 Indian nurses wishing to migrate to the NHS on an 'earn, learn, and return' basis with funding to support English language learning and accreditation sufficient to apply for Nursing and Midwifery Council (NMC) registration. The Programme provided English language training and pastoral support to candidates, in addition to the availability of remedial training and examination entry for those not meeting NMC proficiency requirements on their first attempt. Methods: Descriptive statistical analysis of programme examination results and cost-effectiveness analysis is presented to demonstrate programme outputs and outcomes. Descriptive economic analysis of programme costings is presented alongside programme results to investigate the value-for-money provided by this programme. Results: A total of 89 nurses were successful in meeting NMC proficiency requirements, representing a pass rate of 40%. Those undertaking OET training and examination(s) were more successful, compared to those undertaking British Council provision, with over half of candidates passing at the required level. This equates to an overall programme cost-per-pass of £4139 and represents a model to support health worker migration, in line with WHO guidelines, delivering individual learning and development, mutual health system gain, and value-for-money. Conclusions: Taking place during the coronavirus pandemic, the programme evidences the effective delivery of online English language training to support health worker migration during a highly disruptive period for global health. This programme demonstrates an ethical and mutually beneficial pathway for English language improvement amongst internationally educated nurses to facilitate migration to and global health learning in the NHS. It provides a template through which healthcare leaders and nurse educators, working in policy and practice environments in the NHS and other English-speaking countries, can design future ethical health worker migration and training programmes to strengthen the global healthcare workforce. [ABSTRACT FROM AUTHOR]

Aims: Assess effectiveness of a hybrid intervention targeting physical activity in women with prior gestational diabetes. Methods: Randomised controlled trial with parallel arms. 293 women (35.1 ± 5.1 years; 40% ethnic minority) recruited from two hospitals and randomised to routine care or hybrid lifestyle intervention comprising two group sessions and access to a mobile web app. Primary outcome was a change in objectively measured physical activity at 12 months. Secondary outcomes included self‐efficacy for exercise, quality of life and anxiety and depression. Linear regression compared outcome measures between groups. Results: 83% of intervention participants attended at least one group session, of who 66% registered to use the app. There was a non‐significant increase in physical activity at 12 months (between‐group difference of 0.95 mg [95% CI: −0.46 to 2.37]), equivalent to approximately 500 steps per day. Intervention participants reported higher self‐efficacy for exercise (0.54, 95% CI: 0.05 to 1.102; p = 0.029), lower anxiety (−0.91, 95% CI: −1.74 to −0.09; p = 0.031), and higher quality of life (0.05, 95% CI: 0.004 to 0.09; p = 0.032), compared to controls. Conclusions: The intervention improved confidence in exercise and quality of life. Further research is needed to improve participant engagement with physical activity interventions in multi‐ethnic populations with a history of gestational diabetes. [ABSTRACT FROM AUTHOR]

Aim: To measure the cost‐effectiveness of adding text message (TMB), exercise (EB) and abstinent‐contingent financial incentive‐based (CFIB) stop smoking interventions to standard smoking cessation support for pregnant women in England. Design: Modelling cost‐effectiveness outcomes by separately adding three cessation interventions to standard cessation care offered to pregnant women in England. English National Health Service Stop Smoking Services (NHS SSS) statistics from 2019 to 2020 were used for estimating the base quit rate. Intervention effectiveness and cost data for interventions were taken from trial reports. Cost‐effectiveness was derived using the economics of smoking in pregnancy (ESIP) model from a health service and personal social services perspective. Interventions were compared with each other as well as against standard cessation care. Setting English NHS SSS. Participants/cases: A total of 13 799 pregnant women who accessed NHS SSS. Interventions and comparator; comparator: standard stop smoking support comprising behavioural intervention and an offer of nicotine replacement therapy (NRT). Three additive interventions were TMB, EB and CFIB. Measurements Incremental cost‐effectiveness ratios per quality‐adjusted life‐years gained for both mothers and offspring over their life‐times; return on investment (ROI); and cost‐effectiveness acceptability curves (CEACs). Findings The addition of any of the interventions compared with standard care alone was preferred, but only significant for the addition of CFIB, with the CEAC suggesting an at least 90% chance of being favoured to standard care alone. When compared against each other CFIB appeared to yield the largest returns, but this was not significant. The estimated ROI for CFIB was £2 [95% confidence interval (CI) = £1–3] in health‐care savings for every £1 spent by the NHS on the cessation intervention. Conclusions: For a health system which currently provides behavioural support and an offer of nicotine replacement therapy as standard stop smoking support for pregnant women, the greatest economic gains would be provided by operating an abstinent‐contingent financial incentives scheme alongside this. [ABSTRACT FROM AUTHOR]

Background It is unclear whether seven interventions recommended by Public Health England for preventing and managing common musculoskeletal conditions reduce or widen health inequalities in adults with musculoskeletal conditions. Methods We used citation searches of Web of Science (date of 'parent publication' for each intervention to April 2021) to identify original research articles reporting subgroup or moderator analyses of intervention effects by social stratifiers defined using the PROGRESS-Plus frameworks. Randomized controlled trials, controlled before-after studies, interrupted time series, systematic reviews presenting subgroup/stratified analyses or meta-regressions, individual participant data meta-analyses and modelling studies were eligible. Two reviewers independently assessed the credibility of effect moderation claims using Instrument to assess the Credibility of Effect Moderation Analyses. A narrative approach to synthesis was used (PROSPERO registration number: CRD42019140018). Results Of 1480 potentially relevant studies, seven eligible analyses of single trials and five meta-analyses were included. Among these, we found eight claims of potential differential effectiveness according to social characteristics, but none that were judged to have high credibility. Conclusions In the absence of highly credible evidence of differential effectiveness in different social groups, and given ongoing national implementation, equity concerns may be best served by investing in monitoring and action aimed at ensuring fair access to these interventions. [ABSTRACT FROM AUTHOR]

We examined the costs and cost‐effectiveness of the Meeting Centre Support Programme (MCSP) implemented and piloted in the UK, Poland and Italy, replicating the Dutch Meeting Centre model. Dutch Meeting Centres combine day services for people with dementia with carer support. Data were collected over 2015–2016 from MCSP and usual care (UC) participants (people with dementia‐carer dyads) at baseline and 6 months. We examined participants' health and social care (HSC), and societal costs, including Meeting Centre (MC) attendances. Costs and outcomes in MCSP and UC groups were compared. Primary outcomes: Persons with dementia: quality‐adjusted life years (EQ‐5D‐5L‐derived); QOL‐AD. DQoL was examined as a secondary outcome. Carers: Short Sense of Competence Questionnaire (SSCQ). Incremental cost‐effectiveness ratios (ICER) and cost‐effectiveness acceptability curves were obtained by bootstrapping outcome and cost regression estimates. Eighty‐three MCSP and 69 UC dyads were analysed. The 6‐month cost of providing MCSP was €4,703; participants with dementia attended MC a mean of 45 times and carers 15 times. Including intervention costs, adjusted 6‐month HSC costs were €5,941higher in MCSP than in UC. From the HSC perspective: in terms of QALY, the probability of cost‐effectiveness was zero over willingness‐to‐pay (WTP) ranging from €0 to €350,000. On QOL‐AD, the probability of cost‐effectiveness of MCSP was 50% at WTP of €5,000 for a one‐point increase. A one‐point gain in the DQoL positive affect subscale had a probability of cost‐effectiveness of 99% at WTP over €8,000. On SSCQ, no significant difference was found between MCSP and UC. Evidence for cost‐effectiveness of MCSP was mixed but suggests that it may be cost‐effective in relation to gains in dementia‐specific quality of life measures. MCs offer effective tailored post‐diagnostic support services to both people with dementia and carers in a context where few evidence‐based alternatives to formal home‐based social services may be available. [ABSTRACT FROM AUTHOR]

Background: Arthritis (or compression) gloves are widely prescribed to people with rheumatoid arthritis and other forms of hand arthritis. They are prescribed for daytime wear to reduce hand pain and improve hand function, and/or night-time wear to reduce pain, improve sleep and reduce morning stiffness. However, evidence for their effectiveness is limited. The aims of this study were to investigate the clinical and cost effectiveness of arthritis gloves compared to placebo gloves on hand pain, stiffness and function in people with rheumatoid arthritis and persistent hand pain.Methods: A parallel randomised controlled trial, in adults (≥ 18 years) with rheumatoid or undifferentiated inflammatory arthritis at 16 National Health Service sites in the UK. Patients with persistent hand pain affecting function and/or sleep were eligible. Randomisation (1:1) was stratified by recent change (or not) in medication, using permuted blocks of random sizes. Three-quarter-finger length arthritis gloves (Isotoner®: applying 23-32 mmHg pressure) (intervention) were compared to loose-fitting placebo gloves (Jobskin® classic: providing no/minimal pressure) (control). Both gloves (considered to have similar thermal qualities) were provided by occupational therapists. Patients and outcome assessors were blinded; clinicians were not. The primary outcome was dominant hand pain on activity (0-10) at 12 weeks, analysed using linear regression and intention to treat principles.Results: Two hundred six participants were randomly assigned (103 per arm) and 163 (84 intervention: 79 control) completed 12-week follow-up. Hand pain improved by 1.0 (intervention) and 1.2 (control), an adjusted mean difference of 0.10 (95% CI: - 0.47 to 0.67; p = 0.72). Adverse events were reported by 51% of intervention and 36% of control group participants; with 6 and 7% respectively, discontinuing glove wear. Provision of arthritis gloves cost £129, with no additional benefit.Conclusion: The trial provides evidence of no clinically important effect of arthritis gloves on any of the trial outcomes (hand pain, function and stiffness) and arthritis gloves are not cost-effective. The clinical and cost-effectiveness results support ceasing provision of arthritis gloves in routine clinical practice.Funding: National Institute for Health Research.Trial Registration: ISRCTN, ISRCTN25892131 ; Registered 05/09/2016: retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Advance Care Planning is recommended for people with end-stage kidney disease but evidence is limited. Robust clinical trials are needed to investigate the impact of advance care planning in this population. There is little available data on cost-effectiveness to guide decision makers in allocating resources for advance care planning. Therefore we sought to determine the feasibility of a randomised controlled trial and to test methods for assessing cost-effectiveness.Methods: A deferred entry, randomised controlled feasibility trial, incorporating economic and process evaluations, with people with end-stage kidney disease, aged 65 years or older, receiving haemodialysis, in two renal haemodialysis units in Northern Ireland, UK. A nurse facilitator helped the patient make an advance care plan identifying: a surrogate decision-maker; what the participant would like to happen in the future; any advance decision to refuse treatment; preferred place of care at end-of-life.Results: Recruitment lasted 189 days; intervention and data collection 443 days. Of the 67 patients invited to participate 30 (45%) declined and 36 were randomised to immediate or deferred advance care plan groups. Twenty-two (61%) made an advance care plan and completed data collection at 12 weeks; 17 (47.2%) were able to identify a surrogate willing to be named in the advance care plan document. The intervention was well-received and encouraged end-of-life conversations, but did not succeed in helping patients to fully clarify their values or consider specific treatment choices. There was no significant difference in health system costs between the immediate and deferred groups.Conclusions: A trial of advance care planning with participants receiving haemodialysis is feasible and acceptable to patients, but challenging. A full trial would require a pool of potential participants five times larger than the number required to complete data collection at 3 months. Widening eligibility criteria to include younger (under 65 years of age) and less frail patients, together with special efforts to engage and retain surrogates may improve recruitment and retention. Traditional advance care planning outcomes may need to be supplemented with those that are defined by patients, helping them to participate with clinicians in making medical decisions.Trial Registration: Registered December 16, 2015. ClinicalTrials.gov Identifier: NCT02631200 . [ABSTRACT FROM AUTHOR]

This article provides an educational review covering the consideration of conducting 'value for money' analyses as part of non-randomised study designs including service evaluations. These evaluations represent a vehicle for producing evidence such as value for money of a care intervention or service delivery model. Decision makers including charities and local and national governing bodies often rely on evidence from non-randomised data and service evaluations to inform their resource allocation decision-making. However, as randomised data obtained from randomised controlled trials are considered the 'gold standard' for assessing causation, the use of this alternative vehicle for producing an evidence base requires careful consideration. We refer to value for money analyses, but reflect on methods associated with economic evaluations as a form of analysis used to inform resource allocation decision-making alongside a finite budget. Not all forms of value for money analysis are considered a full economic evaluation with implications for the information provided to decision makers. The type of value for money analysis to be conducted requires considerations such as the outcome(s) of interest, study design, statistical methods to control for confounding and bias, and how to quantify and describe uncertainty and opportunity costs to decision makers in any resulting value for money estimates. Service evaluations as vehicles for producing evidence present different challenges to analysts than what is commonly associated with research, randomised controlled trials and health technology appraisals, requiring specific study design and analytic considerations. This educational review describes and discusses these considerations, as overlooking them could affect the information provided to decision makers who may make an 'ill-informed' decision based on 'poor' or 'inaccurate' information with long-term implications. We make direct comparisons between randomised controlled trials relative to non-randomised data as vehicles for assessing causation; given 'gold standard' randomised controlled trials have limitations. Although we use UK-based decision makers as examples, we reflect on the needs of decision makers internationally for evidence-based decision-making specific to resource allocation. We make recommendations based on the experiences of the authors in the UK, reflecting on the wide variety of methods available, used as documented in the empirical literature. These methods may not have been fully considered relevant to non-randomised study designs and/or service evaluations, but could improve and aid the analysis conducted to inform the relevant value for money decision problem. [ABSTRACT FROM AUTHOR]

Objectives: Transvenous lead extraction (TLE) poses a significant economic and resource burden on healthcare systems; however, limited data exist on its true cost. We therefore estimate real-world healthcare reimbursement costs of TLE to the UK healthcare system at a single extraction centre.Methods: Consecutive admissions entailing TLE at a high-volume UK centre between April 2013 and March 2018 were prospectively recorded in a computer registry. In the hospital's National Health Service (NHS) clinical coding/reimbursement database, 447 cases were identified. Mean reimbursement cost (n=445) and length of stay (n=447) were calculated. Ordinary least squares regressions estimated the relationship between cost (bed days) and clinical factors.Results: Mean reimbursement cost per admission was £17 399.09±£13 966.49. Total reimbursement for all TLE admissions was £7 777 393.51. Mean length of stay was 16.3±15.16 days with a total of 7199 bed days. Implantable cardioverter-defibrillator and cardiac resynchronisation therapy defibrillator devices incurred higher reimbursement costs (70.5% and 68.7% higher, respectively, both p<0.001). Heart failure and prior valve surgery also incurred significantly higher reimbursement costs. Prior valve surgery and heart failure were associated with 8.3 (p=0.017) and 5.5 (p=0.021) additional days in hospital, respectively.Conclusions: Financial costs to the NHS from TLE are substantial. Consideration should therefore be given to cost/resource-sparing potential of leadless/extravascular cardiac devices that negate the need for TLE particularly in patients with prior valve surgery and/or heart failure. Additionally, use of antibiotic envelopes and other interventions that reduce infection risk in patients receiving transvenous leads should be considered. [ABSTRACT FROM AUTHOR]

Background: Chronic kidney disease with metabolic acidosis is common in older people, but the effectiveness of oral sodium bicarbonate therapy in this group is unclear. We tested whether oral sodium bicarbonate provides net health benefit for older people with advanced chronic kidney disease and serum bicarbonate concentrations < 22 mmol/L.Methods: Pragmatic multicentre, parallel group, double-blind, placebo-controlled randomised trial. We recruited adults aged ≥ 60 years with estimated glomerular filtration rate of < 30 mL/min/1.73 m2, not receiving dialysis, with serum bicarbonate concentration < 22 mmol/L, from 27 nephrology and geriatric medicine departments in the UK. Participants received oral sodium bicarbonate (up to 3 g/day) or matching placebo given for up to 2 years, randomised in a 1:1 ratio. The primary outcome was between-group difference in the Short Physical Performance Battery (SPPB) at 12 months, adjusted for baseline values, analysed by intention to treat. Secondary outcomes included generic and disease-specific quality of life (EQ-5D and KDQoL tools), anthropometry, renal function, walk distance, blood pressure, bone and vascular health markers, and incremental cost per quality-adjusted life year gained.Results: We randomised 300 participants between May 2013 and February 2017, mean age 74 years, 86 (29%) female. At 12 months, 116/152 (76%) participants allocated to bicarbonate and 104/148 (70%) allocated to placebo were assessed; primary outcome data were available for 187 participants. We found no significant treatment effect for the SPPB: bicarbonate arm 8.3 (SD 2.5) points, placebo arm 8.8 (SD 2.2) and adjusted treatment effect - 0.4 (95% CI - 0.9 to 0.1, p = 0.15). We found no significant treatment effect for glomerular filtration rate (0.6 mL/min/1.73 m2, 95% CI - 0.8 to 2.0, p = 0.39). The bicarbonate arm showed higher costs and lower quality of life as measured by the EQ-5D-3L tool over 1 year (£564 [95% CI £88 to £1154]); placebo dominated bicarbonate under all sensitivity analyses. Adverse events were more frequent in those randomised to bicarbonate (457 versus 400).Conclusions: Oral sodium bicarbonate did not improve physical function or renal function, increased adverse events and is unlikely to be cost-effective for use by the UK NHS for this patient group.Trial Registration: European Clinical Trials Database (2011-005271-16) and ISRCTN09486651; registered 17 February 2012. [ABSTRACT FROM AUTHOR]

Background: Young women's attendance at cervical screening in the UK is continuing to fall, and the incidence of invasive cervical cancer is rising. Objectives: We assessed the preferences of non‐attending young women for alternative ways of delivering cervical screening. Design: Postal discrete choice experiment (DCE) conducted during the STRATEGIC study of interventions for increasing cervical screening uptake. Attributes included action required to arrange a test, location of the test, availability of a nurse navigator and cost to the National Health Service. Setting and participants: Non‐attending young women in two UK regions. Main outcome measures: Responses were analysed using a mixed multinomial logit model. A predictive analysis identified the most preferable strategy compared to current screening. Preferences from the DCE were compared with observed behaviours during the STRATEGIC trial. Results: The DCE response rate was 5.5% (222/4000), and 94% of respondents agreed screening is important. Preference heterogeneity existed around attributes with strong evidence for test location. Relative to current screening, unsolicited self‐sampling kits for home use appeared most preferable. The STRATEGIC trial showed this same intervention to be most effective although many women who received it and were screened, attended for conventional cytology instead. Conclusions: The DCE and trial identified the unsolicited self‐sampling kit as the most preferred/effective intervention. The DCE suggested that the decision of some women receiving the kit in the trial to attend for conventional cytology may be due to anxieties around home testing coupled with a knowledge that ignoring the kit could potentially have life‐changing consequences. [ABSTRACT FROM AUTHOR]

Background: An increasing number of technologies are obtaining marketing authorisation based on sparse evidence, which causes growing uncertainty and risk within health technology reimbursement decision making. To ensure that uncertainty is considered and addressed within health technology assessment (HTA) recommendations, uncertainties need to be identified, included in health economic models, and reported.Objective: Our objective was to develop the TRansparent Uncertainty ASsessmenT (TRUST) tool for systematically identifying, assessing, and reporting uncertainties in decision models, with the aim of making uncertainties and their impact on cost effectiveness more explicit and transparent.Methods: TRUST was developed by drawing on the uncertainty and risk assessment literature. To develop and validate this tool, we conducted HTA stakeholder discussion meetings and interviews and applied it in six real-world HTA case studies in the Netherlands and the UK.Results: The TRUST tool enables the identification and categorisation of uncertainty according to its source (transparency issues, methodology issues, and issues with evidence: imprecision, bias and indirectness, and unavailability) in each model aspect. The source of uncertainty determines the appropriate analysis. The impact of uncertainties on cost effectiveness is also assessed. Stakeholders found using the tool to be feasible and of value for transparent uncertainty assessment. TRUST can be used during model development and/or model review.Conclusion: The TRUST tool enables systematic identification, assessment, and reporting of uncertainties in health economic models and may contribute to more informed and transparent decision making in the face of uncertainty. [ABSTRACT FROM AUTHOR]

Objective: To establish feasibility of initiating electrical stimulation treatment of wrist extensors and flexors in patients early after stroke to prevent muscle contractures and pain. Design: Feasibility randomized controlled trial with economic evaluation. Setting: A specialist stroke unit in Nottinghamshire. Subjects: A total of 40 patients recruited within 72 hours post-stroke with arm hemiparesis. Interventions: Participants were randomized to receive usual care or usual care and electrical stimulation to wrist flexors and extensors for 30 minutes, twice a day, five days a week for three months. Initial treatment was delivered by an occupational therapist or physiotherapist who trained participants to self-manage subsequent treatments. Measures: Measures of feasibility included recruitment and attrition rates, completion of treatment, and successful data collection. Outcome data on wrist range of motion, pain, arm function, independence, quality of life, and resource use were measured at 3-, 6-, and 12-months post-randomization. Results: A total of 40 participants (of 215 potentially eligible) were recruited in 15 months (20 men; mean age: 72 (SD: 13.0)). Half the participants lacked mental capacity and were recruited by consultee consent. Attrition at three-month follow-up was 12.5% (death (n = 2), end-of-life care (n = 2), and unable to contact (n = 1)). Compliance varied (mean: 65 (SD: 53)) and ranged from 10 to 166 treatments per patient (target dosage was 120). Data for a valid economic analysis can be adequately collected. Conclusion: Early initiation of electrical stimulation was acceptable and feasible. Data collection methods used were feasible and acceptable to participants. A large definitive study is needed to determine if electrical stimulation is efficacious and cost effective. [ABSTRACT FROM AUTHOR]

Objective: To assess the costs, effects, and cost-utility of an accelerated physiotherapy programme versus a standard physiotherapy programme following resurfacing hip arthroplasty. Design: A cost-utility analysis alongside a randomized controlled trial. Setting: A UK National Health Service hospital and patients' homes. Subjects: A total of 80 male resurfacing hip arthroplasty patients randomized post procedure to one of the two programmes. Interventions: The accelerated physiotherapy programme commenced in hospital with patients being fully weight bearing, without hip precautions, and following a range of exercises facilitating gait re-education, balance, and lower limb strength. Standard physiotherapy commenced in hospital, but hip precautions were used and exercises were only partially weight bearing. In both groups, patients continued with their exercises at home for an eight-week period. Main measures: Data on healthcare contacts were collected from patients to 12 months and costed using unit costs from national sources. Information was also collected on patients' costs. Health-related quality of life was measured using the EuroQol EQ-5D questionnaire and used to estimate quality-adjusted life years (QALYs) to 12 months. Mean costs and QALYs for each trial arm were compared. Results: On average, the accelerated physiotherapy programme was less expensive (mean cost difference −£200; 95% confidence interval: −£656 to £255) and more effective (mean QALY difference 0.13; 95% confidence interval: 0.05 to 0.21) than standard physiotherapy and had a high probability of being cost-effective. Conclusion: From the National Health Service perspective, an accelerated physiotherapy programme for male patients undergoing revision of total hip arthroplasty (RHA) is very likely to be cost-effective when compared to a standard physiotherapy programme. [ABSTRACT FROM AUTHOR]

Objective: To examine the feasibility of a trial to evaluate web-based physiotherapy compared to a standard home exercise programme in people with multiple sclerosis. Design: Multi-centre, randomized controlled, feasibility study. Setting: Three multiple sclerosis out-patient centres. Participants: A total of 90 people with multiple sclerosis (Expanded Disability Status Scale 4–6.5). Interventions: Participants were randomized to a six-month individualized, home exercise programme delivered via web-based physiotherapy (n = 45; intervention) or a sheet of exercises (n = 45; active comparator). Outcome measures: Outcome measures (0, three, six and nine months) included adherence, two-minute walk test, 25 foot walk, Berg Balance Scale, physical activity and healthcare resource use. Interviews were undertaken with 24 participants and 3 physiotherapists. Results: Almost 25% of people approached agreed to take part. No intervention-related adverse events were recorded. Adherence was 40%–63% and 53%–71% in the intervention and comparator groups. There was no difference in the two-minute walk test between groups at baseline (Intervention-80.4(33.91)m, Comparator-70.6(31.20)m) and no change over time (at six-month Intervention-81.6(32.75)m, Comparator-74.8(36.16)m. There were no significant changes over time in other outcome measures except the EuroQol-5 Dimension at six months which decreased in the active comparator group. For a difference of 8(17.4)m in two-minute walk test between groups, 76 participants/group would be required (80% power, P > 0.05) for a future randomized controlled trial. Conclusion: No changes were found in the majority of outcome measures over time. This study was acceptable and feasible by participants and physiotherapists. An adequately powered study needs 160 participants. [ABSTRACT FROM AUTHOR]

Background: In January 2016, clinical TB guidance in the UK changed to no longer recommend screening contacts of non-pulmonary, non-laryngeal (ETB) index cases. However, no new evidence was cited for this change, and there is evidence that screening these contacts may be worthwhile. The objective of this study was to estimate the cost-effectiveness of screening contacts of adult ETB cases and adult pulmonary or laryngeal TB (PTB) cases in London, UK.Methods: We carried out a cross-sectional analysis of data collected on TB index cases and contacts in the London TB register and an economic evaluation using a static model describing contact tracing outcomes. Incremental cost-effectiveness ratios (ICERs) were calculated using no screening as the baseline comparator. All adult TB cases (≥15 years old) in London from 2012 to 2015, and their contacts, were eligible (2465/5084 PTB and 2559/6090 ETB index cases were included).Results: Assuming each contact with PTB infects one person/month, the ICER of screening contacts of ETB cases was £78 000/quality-adjusted life-years (QALY) (95% CI 39 000 to 140 000), and screening contacts of PTB cases was £30 000/QALY (95% CI 18 000 to 50 000). The ICER of screening contacts of ETB cases was £30 000/QALY if each contact with PTB infects 3.4 people/month. Limitations of this study include the use of self-reported symptomatic periods and lack of knowledge about onward transmission from PTB contacts.Conclusions: Screening contacts of ETB cases in London was almost certainly not cost-effective at any conventional willingness-to-pay threshold in England, supporting recent changes to National Institute for Health and Care Excellence national guidelines. [ABSTRACT FROM AUTHOR]

Introduction Coronary heart disease (CHD) remains a leading cause of UK mortality. Dietary trans fats (TFA) represent a powerful CHD risk factor. However, UK efforts to reduce intake have been less successful than other nations. We modelled the potential health and economic effects of eliminating industrial and all TFA up to 2020. Methods We extended the previously validated IMPACTsec model, to estimate the potential effects on health and economic outcomes of mandatory reformulation or a complete ban on dietary TFA in England and Wales from 2011 to 2020. We modelled two policy scenarios: 1) Elimination of industrial TFA consumption, from 0.8% to 0.4% daily energy 2) Elimination of all TFA consumption, from 0.8% to 0% Results Elimination of industrial TFA across the England and Wales population could result in approximately 1600 fewer deaths per year, with some 4000 fewer hospital admissions; gaining approximately 14 000 additional life years. Health inequalities would be substantially reduced in both scenarios. Elimination of industrial TFA would be cost saving. This would include approximately £100m saved in direct healthcare costs. Elimination of all TFA would double the health and economic gains. Conclusions Eliminating industrial or all UK dietary intake of TFA could substantially reduce CHD mortality and inequalities, while resulting in substantial annual savings. [ABSTRACT FROM AUTHOR]

Background There is growing interest in real-time feedback ( RTF), which involves collecting and summarizing information about patient experience at the point of care with the aim of informing service improvement. Objective To investigate the feasibility and acceptability of RTF in UK general practice. Design Exploratory randomized trial. Setting/Participants Ten general practices in south-west England and Cambridgeshire. All patients attending surgeries were eligible to provide RTF. Intervention Touch screens were installed in waiting areas for 12 weeks with practice staff responsible for encouraging patients to provide RTF. All practices received fortnightly feedback summaries. Four teams attended a facilitated reflection session. Outcomes RTF 'response rates' among consulting patients were estimated, and the representativeness of touch screen users were assessed. The frequency of staff-patient interactions about RTF (direct observation) and patient views of RTF (exit survey) were summarized. Associated costs were collated. Results About 2.5% consulting patients provided RTF (range 0.7-8.0% across practices), representing a mean of 194 responses per practice. Patients aged above 65 were under-represented among touch screen users. Receptionists rarely encouraged RTF but, when this did occur, 60% patients participated. Patients were largely positive about RTF but identified some barriers. Costs per practice for the twelve-week period ranged from £1125 (unfacilitated team-level feedback) to £1887 (facilitated team ± practitioner-level feedback). The main cost was the provision of touch screens. Conclusions Response rates for RTF were lower than those of other survey modes, although the numbers of patients providing feedback to each practice were comparable to those achieved in the English national GP patient survey. More patients might engage with RTF if the opportunity were consistently highlighted to them. [ABSTRACT FROM AUTHOR]

Background: Economic evaluation of palliative care has been slow to develop and the evidence base remains small. Aim: This article estimates formal and informal care costs in the last year of life for a sample of patients who received specialist palliative care in three different areas in Ireland. Design: Formal care costs are calculated for community, specialist palliative care, acute hospital and other services. Where possible, a bottom-up approach is used, multiplying service utilisation by unit cost. Informal care is valued at the replacement cost of care. Setting/participants: Data on utilisation were collected during 215 'after death' telephone interviews with a person centrally involved in the care in the last year of life of decedents who received specialist palliative care in three areas in Ireland with varying levels of specialist palliative care. Results: Mean total formal and informal costs in the last year of life do not vary significantly across the three areas. The components of formal costs, however, do vary across areas, particularly for hospital and specialist palliative care in the last 3 months of life. Conclusion: Costs in the last year of life for patients in receipt of specialist palliative care are considerable. Where inpatient hospice care is available, there are potential savings in hospital costs to offset specialist palliative care inpatient costs. Informal care accounts for a high proportion of costs during the last year of life in each area, underlining the important role of informal caregivers in palliative care. [ABSTRACT FROM AUTHOR]

Objectives To design and evaluate the effectiveness of a pre-notification leaflet about research to increase recruitment to a randomized controlled trial (RCT). Methods A methodological, two-arm, RCT was conducted, embedded within an existing cohort RCT (REFORM). Participants were randomized for the embedded trial, using a 1:2 ratio (intervention : control) before being randomized for REFORM. Controls received a trial recruitment pack. The intervention group received an additional pre-notification leaflet 2-3 weeks before the recruitment pack. Primary and secondary analyses were conducted using relative risk, the Cox proportional hazards model and incremental cost-effectiveness ratios. Results Of the 1436 intervention group participants, 73 (5.1%) were randomized into the REFORM trial compared with 126 (4.4%) of the 2878 control group participants. The associated relative risk (1.16) was not statistically significant [95% confidence interval (CI) 0.88-1.56]. Return rate was not significantly increased (relative risk 1.10, 95% CI 0.92-1.28) nor time to return decreased (hazard ratio: 1.11, 95% CI 0.93-1.33). Incremental cost-effectiveness ratios indicated the intervention may be cost-effective if the true estimate of effect was close to the upper bound of the associated 95% CI. Conclusion Pre-notification for potential trial participants demonstrated a small difference to randomization (0.7% difference) and return rates (1.1% difference) in favour of the intervention. Results should however be interpreted with caution as CIs for these estimates cross the point of no effect. Nevertheless, this research enhances existing evidence for pre-notification to increase recruitment rates, with further development and assessment of this potentially cost-effective intervention being recommended. [ABSTRACT FROM AUTHOR]

Aims To determine whether the provision of contingencymanagement using financial incentives to improve hepatitis B vaccine completion in people who inject drugs entering community treatment represents a cost-effective use of healthcare resources. Design A probabilistic cost-effectiveness analysis was conducted, using a decision-tree to estimate the short-term clinical and health-care cost impact of the vaccination strategies, followed by a Markov process to evaluate the long-term clinical consequences and costs associated with hepatitis B infection. Settings and participants Data on attendance to vaccination from a UK cluster randomized trial. Intervention Two contingency management options were examined in the trial: fixed versus escalating schedule financial incentives. Measurement Life-time health-care costs and quality-adjusted life years discounted at 3.5% annually; incremental cost-effectiveness ratios. Findings The resulting estimate for the incremental life-time health-care cost of the contingency management strategy versus usual care was £21.86 [95% confidence interval (CI) = -£12.20 to 39.86] per person offered the incentive. For 1000 people offered the incentive, the incremental reduction in numbers of hepatitis B infections avoided over their lifetime was estimated at 19 (95% CI = 8-30). The probabilistic incremental cost per quality adjusted life-year gained of the contingency management programmewas estimated to be £6738 (95% CI = £6297-7172),with an 89% probability of being considered cost-effective at a threshold of £20 000 per quality-adjusted life years gained (97.60% at £30 000). Conclusions Using financial incentives to increase hepatitis B vaccination completion in people who inject drugs could be a cost-effective use of health-care resources in the UK as long as the incidence remains above 1.2%. [ABSTRACT FROM AUTHOR]

Background: The role of injections of therapeutic substances into the back as treatment for low back pain is unclear. Facet joint injections are widely used despite the absence of evidence of sustained benefit. We hypothesise that facet joint injections might facilitate engagement with physiotherapist-led, best usual care (a combined physical and psychological programme) and is a clinically and cost-effective treatment for people with suspected low back pain of facet joint origin.Methods/design: We present here the protocol for a randomised controlled feasibility trial for a main trial to test the above hypotheses. Patients referred to secondary care with persistent non-specific low back pain will be screened and invited to take part in the study. Those who meet the eligibility criteria will be invited for a physiotherapy assessment to confirm trial eligibility and for baseline data collection. All participants (n = 150) will be offered the best usual care package with physical and psychological components. Those randomised into the intervention arm (n = 75) will, in addition, receive intra-articular facet joint injections with local anaesthetic and steroids. Primary outcome data will be collected using daily and then weekly text messaging service for a pain score on a 0-10 scale. Questionnaire follow-up will be at 3, 6, and 12 months. Evaluation of trial processes and health economic analyses, including a value of information analysis, will be undertaken. The process evaluation will be mixed methods and will include the views of all stakeholders.Discussion: Whilst this trial is a feasibility study it is currently one of the largest trials in this area. The outcomes will provide some evidence on the use of facet joint injections for patients with clinically diagnosed facet joint pain.Trial Registration: EudraCT identifier 2014-000682-50, (registered on 12 February 14). ISRCTN registry number: ISRCTN93184143 DOI 10.1186/ISRCTN93184143 (registered on 27 February 2014). [ABSTRACT FROM AUTHOR]

Aims. To assess the cost effectiveness of two repositioning strategies and inform the 2014 National Institute for Health and Care Excellence clinical guideline recommendations on pressure ulcer prevention. Background. Pressure ulcers are distressing events, caused when skin and underlying tissues are placed under pressure sufficient to impair blood supply. They can have a substantial impact on quality of life and have significant resource implications. Repositioning is a key prevention strategy, but can be resource intensive, leading to variation in practice. This economic analysis was conducted to identify the most cost-effective repositioning strategy for the prevention of pressure ulcers. Design. The economic analysis took the form of a cost-utility model. Methods. The clinical inputs to the model were taken from a systematic review of clinical data. The population in the model was older people in a nursing home. The economic model was developed with members of the guideline development group and included costs borne by the UK National Health Service. Outcomes were expressed as costs and quality adjusted life years. Conclusion. Despite being marginally more clinically effective, alternating 2 and 4 hourly repositioning is not a cost-effective use of UK National Health Service resources (compared with 4 hourly repositioning) for this high risk group of patients at a cost-effectiveness threshold of £20,000 per quality adjusted life years. These results were used to inform the clinical guideline recommendations for those who are at high risk of developing pressure ulcers. [ABSTRACT FROM AUTHOR]

Objectives: To determine health and equity benefits and cost effectiveness of policies to reduce or eliminate trans fatty acids from processed foods, compared with consumption remaining at most recent levels in England.Design: Epidemiological modelling study.Setting: Data from National Diet and Nutrition Survey, Low Income Diet and Nutrition Survey, Office of National Statistics, and health economic data from other published studiesParticipants: Adults aged ≥25, stratified by fifths of socioeconomic circumstance.Interventions: Total ban on trans fatty acids in processed foods; improved labelling of trans fatty acids; bans on trans fatty acids in restaurants and takeaways.Main Outcome Measures: Deaths from coronary heart disease prevented or postponed; life years gained; quality adjusted life years gained. Policy costs to government and industry; policy savings from reductions in direct healthcare, informal care, and productivity loss.Results: A total ban on trans fatty acids in processed foods might prevent or postpone about 7200 deaths (2.6%) from coronary heart disease from 2015-20 and reduce inequality in mortality from coronary heart disease by about 3000 deaths (15%). Policies to improve labelling or simply remove trans fatty acids from restaurants/fast food could save between 1800 (0.7%) and 3500 (1.3%) deaths from coronary heart disease and reduce inequalities by 600 (3%) to 1500 (7%) deaths, thus making them at best half as effective. A total ban would have the greatest net cost savings of about £265m (€361m, $415m) excluding reformulation costs, or £64m if substantial reformulation costs are incurred outside the normal cycle.Conclusions: A regulatory policy to eliminate trans fatty acids from processed foods in England would be the most effective and equitable policy option. Intermediate policies would also be beneficial. Simply continuing to rely on industry to voluntary reformulate products, however, could have negative health and economic outcomes. [ABSTRACT FROM AUTHOR]

Background: Iron deficiency anaemia is a common problem in pregnancy despite national recommendations and guidelines for treatment. The aim of this study was to appraise the evidence against the UK National Screening Committee (UKNSC) criteria as to whether a national screening programme could reduce the prevalence of iron deficiency anaemia and/or iron deficiency in pregnancy and improve maternal and fetal outcomes.Methods: Search strategies were developed for the Cochrane library, Medline and Embase to identify evidence relevant to UK National Screening Committee (UKNSC) appraisal criteria which cover the natural history of iron deficiency and iron deficiency anaemia, the tests for screening, clinical management and evidence of cost effectiveness.Results: Many studies evaluated haematological outcomes of anaemia, but few analysed clinical consequences. Haemoglobin and ferritin appeared the most suitable screening tests, although future options may follow recent advances in understanding iron homeostasis. The clinical consequences of iron deficiency without anaemia are unknown. Oral and intravenous iron are effective in improving haemoglobin and iron parameters. There have been no trials or economic evaluations of a national screening programme for iron deficiency anaemia in pregnancy.Conclusions: Iron deficiency in pregnancy remains an important problem although effective tests and treatment exist. A national screening programme could be of value for early detection and intervention. However, high quality studies are required to confirm whether this would reduce maternal and infant morbidity and be cost effective. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to examine the effectiveness and cost of an after-school dance intervention at increasing the physical activity levels of Year 7 girls (age 11-12). Methods: A cluster randomised controlled trial was conducted in 18 secondary schools. Participants were Year 7 girls attending a study school. The Bristol Girls Dance Project (BGDP) intervention consisted of up to forty, 75-minute dance sessions delivered in the period immediately after school by experienced dance instructors over 20-weeks. The pre-specified primary outcome was accelerometer assessed mean minutes of weekday moderate to vigorous physical activity (MVPA) at time 2 (52 weeks are T0 baseline assessments). Secondary outcomes included accelerometer assessed mean minutes of weekday MVPA at time 1 (while the intervention was still running) and psychosocial outcomes. Intervention costs were assessed. Results: 571 girls participated. Valid accelerometer data were collected from 549 girls at baseline with 508 girls providing valid accelerometer data at baseline and time 2. There were no differences between the intervention and control group for accelerometer assessed physical activity at either time 1 or time 2. Only one third of the girls in the intervention arm met the pre-set adherence criteria of attending two thirds of the dance sessions that were available to them. Instrumental variable regression analyses using complier average causal effects provided no evidence of a difference between girls who attended the sessions and the control group. The average cost of the intervention was £73 per girl, which was reduced to £63 when dance instructor travel expenses were excluded. Conclusion: This trial showed no evidence that an after-school dance programme can increase the physical activity of Year 7 girls. The trial highlighted the difficulty encountered in maintaining attendance in physical activity programmes delivered in secondary schools. There is a need to find new ways to help adolescent girls to be physically active via identifying ways to support and encourage sustained engagement in physical activity over the life course. Trial registration: ISRCTN52882523 [ABSTRACT FROM AUTHOR]

Objectives. Evidence regarding the cost-effectiveness of joint protection and hand exercises for the management of hand OA is not well established. The primary aim of this study is to assess the cost-effectiveness (cost-utility) of these management options. In addition, given the absence of consensus regarding the conduct of economic evaluation alongside factorial trials, we compare different analytical methodologies. Methods. A trial-based economic evaluation to assess the cost-utility of joint protection only, hand exercises only and joint protection plus hand exercises compared with leaflet and advice was undertaken over a 12 month period from a UK National Health Service perspective. Patient-level mean costs and mean quality-adjusted life years (QALYs) were calculated for each trial arm. Incremental cost-effectiveness ratios (ICERs) were estimated and cost-effectiveness acceptability curves were constructed. The base case analysis used a within-the-table analysis methodology. Two further methods were explored: the at-the-margins approach and a regression-based approach with or without an interaction term. Results. Mean costs (QALYs) were £58.46 (S.D. 0.662) for leaflet and advice, £92.12 (S.D. 0.659) for joint protection, £64.51 (S.D. 0.681) for hand exercises and £112.38 (S.D. 0.658) for joint protection plus hand exercises. In the base case, hand exercises were the cost-effective option, with an ICER of £318 per QALY gained. Hand exercises remained the most cost-effective management strategy when adopting alternative methodological approaches. Conclusion. This is the first trial evaluating the cost-effectiveness of occupational therapy-supported approaches to self-management for hand OA. Our findings showed that hand exercises were the most cost-effective option. [ABSTRACT FROM AUTHOR]

Background A substantial minority of adolescents suffer from depression and it is associated with increased risk of suicide, social and educational impairment, and mental health problems in adulthood. A recently conducted randomized controlled trial in England evaluated the effectiveness of a manualized universally delivered age-appropriate CBT programme in school classrooms. The cost-effectiveness of the programme for preventing low mood and depression for all participants from a health and social care sector perspective needs to be determined. Methods A trial-based cost-effectiveness analysis based on a cluster-randomized controlled trial (trial registration - ISRCTN 19083628) comparing classroom-based CBT with usual school provision of Personal Social and Health Education. Per-student cost of intervention was estimated from programme records. The study was undertaken in eight mixed-sex UK secondary schools, and included 3,357 school children aged 12 to 16 years (in the two trial arms evaluated in the cost-effectiveness analysis). The main outcome measures were individual self-reported data on care costs, Quality-Adjusted Life-Years ( QALYs, based on the EQ-5D health-related quality-of-life instrument) and symptoms of depression (Short Mood and Feelings Questionnaire) at baseline, 6 and 12 months. Results Although there was lower quality-adjusted life-years over 12 months (−.05 QALYs per person, 95% confidence interval −.09 to −.005, p = .03) with CBT, this is a 'clinically' negligible difference, which was not found in the complete case analyses. There was little evidence of any between-arm differences in SMFQ scores (0.19, 95% CI −0.57 to 0.95, p = .62), or costs (£142, 95% CI −£132 to £415, p = .31) per person for CBT versus usual school provision. Conclusions Our analysis suggests that the universal provision of classroom-based CBT is unlikely to be either more effective or less costly than usual school provision. [ABSTRACT FROM AUTHOR]

Background: Many men with elevated prostate-specific antigen (PSA) levels in serum do not have aggressive prostate cancer and undergo unnecessary biopsy. Retrospective studies using cryopreserved serum suggest that four kallikrein markers can predict biopsy outcome.Methods: Free, intact and total PSA, and kallikrein-related peptidase 2 were measured in cryopreserved blood from 6129 men with elevated PSA (≥3.0ng/mL) participating in the prospective, randomized trial Prostate Testing for Cancer and Treatment. Marker levels from 4765 men providing anticoagulated plasma were incorporated into statistical models to predict any-grade and high-grade (Gleason score ≥7) prostate cancer at 10-core biopsy. The models were corrected for optimism by 10-fold cross validation and independently validated using markers measured in serum from 1364 men. All statistical tests were two-sided.Results: The four kallikreins enhanced prostate cancer detection compared with PSA and age alone. Area under the curve (AUC) for the four kallikreins was 0.719 (95% confidence interval [CI] = 0.704 to 0.734) vs 0.634 (95% CI = 0.617 to 0.651, P < .001) for PSA and age alone for any-grade cancer, and 0.820 (95% CI = 0.802 to 0.838) vs 0.738 (95% CI = 0.716 to 0.761) for high-grade cancer. Using a 6% risk of high-grade cancer as an illustrative cutoff, for 1000 biopsied men with PSA levels of 3.0ng/mL or higher, the model would reduce the need for biopsy in 428 men, detect 119 high-grade cancers, and delay diagnosis of 14 of 133 high-grade cancers. Models exhibited excellent discrimination on independent validation among men with only serum samples available for analysis.Conclusions: A statistical model based on kallikrein markers was validated in a large prospective study and reduces unnecessary biopsies while delaying diagnosis of high-grade cancers in few men. [ABSTRACT FROM AUTHOR]