Mapping functions for the PHQ-9 and GAD-7 to generate EQ-5D-3L for economic evaluation.

PURPOSE: Generic preferenced-based measures, such as EQ-5D-3L, that are used to estimate quality adjusted life years (QALYs) for economic evaluation are not always available in clinical trials. Predicting EQ-5D-3L values from the commonly used Patient Health Questionnaire 9 (PHQ-9) and Generalised Anxiety Disorder-7 (GAD-7) would allow estimation of QALYs from such trials. The aim was to provide mapping functions to estimate EQ-5D-3L from PHQ-9 and GAD-7 to facilitate economic evaluation. METHODS: Data was drawn from four trials of patients with symptoms of depression testing collaborative care or computerised cognitive behavioural therapy. Patients completed PHQ-9, GAD-7, and EQ-5D-3L at different timepoints. Mapping was undertaken using adjusted limited dependent variable mixture models (ALDVMM), ordinary least squares (OLS), and Tobit models based on PHQ-9, GAD-7 scores or questions, and age to predict EQ-5D-3L utilities. Models were selected based on mean error (ME), mean absolute error (MAE), root mean squared error (RMSE), model goodness of fit, and visual inspection of the predictions. RESULTS: There were 5583 and 3942 observations for EQ-5D-3L combined with PHQ-9 and GAD-7 respectively. ALDVMM models had low ME ( ≤|0.0018|) and MAE ranging from 0.189 to 0.192, while RMSE was from 0.251 to 0.254 and had better predictions than OLS and Tobit models. ALDVMM models with four components based on PHQ-9 and GAD-7 scores are recommended for estimating EQ-5D-3L utilities. CONCLUSIONS: Recommended mapping functions provide users with an approach to estimate EQ-5D-3L utilities for economic evaluation using PHQ-9, GAD-7, or both scores where they have been used together.

Is Economic Evaluation and Care Commissioning Focused on Achieving the Same Outcomes? Resource-Allocation Considerations and Challenges Using England as a Case Study.

Commissioning describes the process of contracting appropriate care services to address pre-identified needs through pre-agreed payment structures. Outcomes-based commissioning (i.e., paying services for pre-agreed outcomes) shares a common goal with economic evaluation: achieving value for money for relevant outcomes (e.g., health) achieved from a finite budget. We describe considerations and challenges as to the practical role of relevant outcomes for evaluation and commissioning, seeking to bridge a gap between economic evaluation evidence and care commissioning. We describe conceptual (e.g., what are 'relevant' outcomes) alongside practical considerations (e.g., quantifying and using relevant endpoint or surrogate outcomes) and pertinent issues when linking outcomes to commissioning-based payment mechanisms, using England as a case study. Economic evaluation often focuses on a single endpoint health-focused maximand, e.g., quality-adjusted life-years (QALYs), whereas commissioning often focuses on activity-based surrogate outcomes (e.g., health monitoring), as easier-to-measure key performance indicators that are more acceptable (e.g., by clinicians) and amenable to being linked with payment structures. However, payments linked to endpoint and/or surrogate outcomes can lead to market inefficiencies; for example, when surrogates do not have the intended causal effect on endpoint outcomes or when service activity focuses on only people who can achieve prespecified payment-linked outcomes. Accounting for and explaining direct links from commissioners' payment structures to surrogate and then endpoint economic outcomes is a vital step to bridging a gap between economic evaluation approaches and commissioning. Decision-analytic models could aid this but they must be designed to account for relevant surrogate and endpoint outcomes, the payments assigned to such outcomes, and their interaction with the system commissioners purport to influence.

Appropriate Categorization of Inequality to Inform Policy Decisions: Estimating Distribution of Lifetime Health Using Alternative Approaches to Socioeconomic Stratification.

OBJECTIVES: Estimation of gradients in lifetime health, notably quality-adjusted life expectancy (QALE), has largely focused on index of multiple deprivation to categorize the population by socioeconomic position. In this article, we estimate QALE using alternate, individual- rather than area-level, indicators of socioeconomic position. METHODS: Building on previous research methods, the distribution of QALE is estimated across education and income groups based on data from the Health Survey for England and the Office for National Statistics. QALE is estimated for each group by combining multivariate mortality rates and health-related quality of life (HRQL) weights using life tables. HRQL weights were estimated using ordinary least squares and missing data were handled using multiple imputation. RESULTS: The estimated lifetime HRQL weights decreased with increased age, lower educational attainment, and lower income. For example, the QALE at birth for males in the lowest educational attainment group was 61.69 quality-adjusted life-years (QALYs), 1.54 QALYs lower than females in the same group. This is in contrast to 76.58 and 75.89 QALYs for males and females in the highest educational attainment group, respectively. A similar trend was observed across income quintiles albeit the gap was less pronounced. CONCLUSIONS: The use of index of multiple deprivation to assess health inequalities may be masking important information about individual-level variation. Decisions makers should consider this alongside the merits of using area-level approaches to categorizing the population if individual-level approaches are preferable.

Effectiveness of a midwife-led continuity of care model on birth outcomes and maternal mental health in vulnerable women: study protocol for a randomised controlled trial with an internal pilot, process evaluation and economic analysis.

INTRODUCTION: Women from social disadvantage are at greater risk of poor birth outcomes. The midwife-led continuity of care (MCC) model, which offers flexible and relational care from a small team of midwives, has demonstrated improved birth outcomes. In the general population, the impact of MCC on socially disadvantaged women and on birth outcomes is still unclear. This protocol describes a pragmatic evaluation of the MCC model in a socially disadvantaged population. METHODS AND ANALYSIS: An open-labelled individual prospective randomised controlled trial with an internal pilot, process evaluation and economic analysis, from 1 April 2022 to 31 March 2024.Women will be randomly allocated to MCC or standard care as part of usual midwifery practice. Participants and midwives will not be blinded, but researchers will be. An internal pilot will test the feasibility of this process.Participants are those randomised into MCC or standard care, who consent to participate in one of two Born in Bradford (BiB) birth cohort studies. Outcomes are taken from routinely linked health data, supplemented by additional data capture. The sample size is fixed by the capacity of MCC teams, commissioning duration and numbers recruited into the cohort. The estimated maximum fixed sample size is 1,410 pregnancies (minimum 734).Intention to treat (ITT) analysis will be undertaken to assess the impact of MCC on two independent primary outcomes. An economic evaluation will explore the impact on health resource use and a process evaluation will explore fidelity to the MCC model, and barriers/facilitators to implementation from midwives' and women's perspectives. ETHICS AND DISSEMINATION: Ethical approval has been obtained for the randomisation in midwifery practice, use of the cohort data for evaluation and for the process evaluation. Findings will be published in peer-reviewed journals, presented at conferences and translated into policy briefings. TRIAL REGISTRATION NUMBER: IsRCTNhttps://doi.org/10.1186/ISRCTN31836167.

A quasi-experimental effectiveness evaluation of the 'Incredible Years Toddler' parenting programme on children's development aged 5: A study protocol.

Child behavioural and mental health problems have become a public health crisis. The consequences of poor mental health in childhood have large economic costs and consequences for the individual, their families, and for society. Early intervention through parenting programmes can reduce the onset of poor mental health in childhood, hence evaluating the effectiveness of parenting programmes is critical. The 'Incredible Years Toddler' parent programme is an education and training intervention designed to enhance the social and emotional wellbeing of children aged 1-3 years. Whilst previous studies show Incredible Years Toddler to provide promising effects on child outcomes in the short term, the research samples have lacked ethnic diversity and representation from socioeconomically deprived families. This quasi-experimental study is registered on ISRCTN (ISRCTN49991769). We will investigate the effectiveness of Incredible Years Toddler being delivered in three neighbourhoods in inner city Bradford, England. These neighbourhoods contain a socially and ethnically diverse population with 84% living in the poorest decile for England and Wales. Parents with a child aged 1-3 years old who are enrolled in Born in Bradford's Better Start interventional family cohort study are eligible for this study. Intervention participants will be matched to a demographically comparable control group using propensity score matching. This study will use retrospective and prospective data from participants who attended Incredible Years groups between September 2018 and April 2024. The required minimum sample is n = 1336 (ratio 1:3) to detect a small effect (odds = 1.5, d = .20) on the Early Years Foundation Stage profile total score at age 5; a measure of early child development that is routinely collected by teachers. We will also establish whether these effects are moderated by child age at entry to intervention, programme delivery mode, socioeconomic status, and ethnicity. We will also estimate the cost of the intervention and conduct a cost-consequence analysis.

Regional perspectives on the coordination and delivery of paediatric end-of-life care in the UK: a qualitative study.

BACKGROUND: Provision of and access to paediatric end-of-life care is inequitable, but previous research on this area has focused on perspectives of health professionals in specific settings or children with specific conditions. This qualitative study aimed to explore regional perspectives of the successes, and challenges to the equitable coordination and delivery of end-of-life care for children in the UK. The study provides an overarching perspective on the challenges of delivering and coordinating end-of-life care for children in the UK, and the impact of these on health professionals and organisations. Previous research has not highlighted the successes in the sector, such as the formal and informal coordination of care between different services and sectors. METHODS: Semi-structured interviews with Chairs of the regional Palliative Care Networks across the UK. Chairs or co-Chairs (n = 19) of 15/16 Networks were interviewed between October-December 2021. Data were analysed using thematic analysis. RESULTS: Three main themes were identified: one standalone theme ("Communication during end-of-life care"); and two overarching themes ("Getting end-of-life services and staff in the right place", with two themes: "Access to, and staffing of end-of-life care" and "Inconsistent and insufficient funding for end-of-life care services"; and "Linking up healthcare provision", with three sub-themes: "Coordination successes", "Role of the networks", and "Coordination challenges"). Good end-of-life care was facilitated through collaborative and network approaches to service provision, and effective communication with families. The implementation of 24/7 advice lines and the formalisation of joint-working arrangements were highlighted as a way to address the current challenges in the specialism. CONCLUSIONS: Findings demonstrate how informal and formal relationships between organisations and individuals, enabled early communication with families, and collaborative working with specialist services. Formalising these could increase knowledge and awareness of end of life care, improve staff confidence, and overall improve professionals' experiences of delivering care, and families' experiences of receiving it. There are considerable positives that come from collaborative working between different organisations and sectors, and care could be improved if these approaches are funded and formalised. There needs to be consistent funding for paediatric palliative care and there is a clear need for education and training to improve staff knowledge and confidence.

Consultant-led UK paediatric palliative care services: professional configuration, services, funding.

OBJECTIVES: To systematically gather information on the professional team members, services provided, funding sources and population served for all consultant-led specialised paediatric palliative care (SPPC) teams in the UK. METHODS: Two-part online survey. RESULTS: Survey 1: All 17 medical leads from hospital-based or hospice-based SPPC teams responded to the survey (100% response rate).Only six services met the NICE guidance for minimum SPPC team.All services reported providing symptom management, specialist nursing care, end-of-life planning and care, and supporting discharges and transfers to home or hospice for the child's final days-hours. Most services also provided care coordination (n=14), bereavement support (n=13), clinical psychology (n=10) and social work-welfare support (n=9). Thirteen had one or more posts partially or fully funded by a charity.Survey 2: Nine finance leads provided detailed resource/funding information, finding a range of statutory and charity funding sources. Only one of the National Health Service (NHS)-based services fully funded by the NHS. CONCLUSIONS: One-third of services met the minimum criteria of professional team as defined by NICE. Most services relied on charity funding to fund part or all of one professional post and only one NHS-based service received all its funding directly from the NHS.

A randomised controlled, feasibility study to establish the acceptability of early outpatient review and early cardiac rehabilitation compared to standard practice after cardiac surgery and viability of a future large-scale trial (FARSTER).

OBJECTIVE: To determine the acceptability and feasibility of delivering early outpatient review following cardiac surgery and early cardiac rehabilitation (CR), compared to standard practice to establish if a future large-scale trial is achievable. METHODS: A randomised controlled, feasibility trial with embedded health economic evaluation and qualitative interviews, recruited patients aged 18-80 years from two UK cardiac centres who had undergone elective or urgent cardiac surgery via a median sternotomy. Eligible, consenting participants were randomised 1:1 by a remote, centralised randomisation service to postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control), or postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention). The primary outcome measures related to trial feasibility including recruitment, retention, CR adherence, and acceptability to participants/staff. Secondary outcome measures included health-rated quality of life using EQ-5D-5L, NHS resource-use, Incremental Shuttle Walk Test (ISWT) distance, 30- and 90-day mortality, surgical site complications and hospital readmission rates. RESULTS: Fifty participants were randomised (25 per group) and 92% declared fit for CR. Participant retention at final follow-up was 74%; completion rates for outcome data time points ranged from 28 to 92% for ISWT and 68 to 94% for follow-up questionnaires. At each time point, the mean ISWT distance walked was greater in the intervention group compared to the control. Mean utility scores increased from baseline to final follow-up by 0.202 for the intervention (0.188 control). Total costs were £1519 for the intervention (£2043 control). Fifteen participants and a research nurse were interviewed. Many control participants felt their outpatient review and CR could have happened sooner; intervention participants felt the timing was right. The research nurse found obtaining consent for willing patients challenging due to discharge timings. CONCLUSION: Recruitment and retention rates showed that it would be feasible to undertake a full-scale trial subject to some modifications to maximise recruitment. Lower than expected recruitment and issues with one of the clinical tests were limitations of the study. Most study procedures proved feasible and acceptable to participants, and professionals delivering early CR. TRIAL REGISTRATION: ISRCTN80441309 (prospectively registered on 24/01/2019).

Methods of assessing value for money of UK-based early childhood public health interventions: a systematic literature review.

INTRODUCTION: Economic evaluation has an important role to play in the demonstration of value for money of early childhood public health interventions; however, concerns have been raised regarding their consistent application and relevance to commissioners. This systematic review of the literature therefore aims to collate the breadth of the existing economic evaluation evidence of these interventions and to identify the approaches adopted in the assessment of value. SOURCE OF DATA: Recently published literature in Medline, EMBASE, EconLit, Health Management Information Consortium, Cochrane CENTRAL, Cochrane Database of Systematic Reviews, Health Technology Assessment, NHS EED and Web of Science. AREAS OF AGREEMENT: The importance of the early childhood period on future health and well-being as well as the potential to impact health inequalities making for a strong narrative case for expenditure in early childhood public health. AREAS OF CONTROVERSY: The most appropriate approaches to evaluating value for money of such preventative interventions relevant for UK decision-makers given the evident challenges. GROWING POINTS: The presented review considered inconsistencies across methodological approaches used to demonstrate value for money. The results showed a mixed picture in terms of demonstrating value for money. AREAS TIMELY FOR DEVELOPING RESEARCH: Future resource allocations decisions regarding early childhood public health interventions may benefit from consistency in the evaluative frameworks and health outcomes captured, as well as consistency in approaches to incorporating non-health costs and outcomes, incorporating equity concerns and the use of appropriate time horizons.

Economic Evaluation Evidence for Resource-Allocation Decision Making: Bridging the Gap for Local Decision Makers Using English Case Studies.

Best-practice economic evaluation methods for health-related decision making at a national level in England are well established, and as a first principle generally involve attempting to maximise the amount of health generated from the health system's budget. Such methods are applied in ways that are broadly transparent and accountable, often at arm's length from explicit political pressures. At local levels of decision making, however, decision making is arguably less likely to be applied according to established overarching principles, is less transparent and is more subject to political pressures. This may be owing to a multiplicity of reasons, for example, undesirability/inappropriateness of such methods, or a failure to make the methods clear to local decision makers. We outline principles for economic evaluations and break down these methods into their component parts, considering their relevance in the English local context. These include taxonomies of decision-making frameworks, budgets, costs, outcome, and characterisations of cost effectiveness. We also explore the role of broader factors, including the relevance of assuming a single fixed budget, pressures resulting from political and budgetary cycles and affordability. We consider the data requirements to inform such deliberations. By setting out principles for economic evaluation methods in a clear language aimed at local decision making, a potential role for such methods can be established, which to date has failed to emerge. While the extent to which these methods can and should be applied are a matter for continued debate, the establishment of such a mutual understanding may assist in the improvement of methods for such decision making and the outcomes resulting from their application.

End of life care for infants, children and young people (ENHANCE): Protocol for a mixed methods evaluation of current practice in the United Kingdom [version 1; peer review: 2 approved].

Background: Although child mortality has decreased over the last few decades, around 4,500 infants and children die in the UK every year, many of whom require palliative care. There is, however, little evidence on paediatric end-of-life care services. The current National Institute for Health and Care Excellence (NICE) guidance provides recommendations about what should be offered, but these are based on low quality evidence. The ENHANCE study aims to identify and investigate the different models of existing end-of-life care provision for infants, children, and young people in the UK, including an assessment of the outcomes and experiences for children and parents, and the cost implications to families and healthcare providers. Methods: This mixed methods study will use three linked workstreams and a cross-cutting health economics theme to examine end-of-life care models in three exemplar clinical settings: infant, children and young adult cancer services (PTCs), paediatric intensive care units (PICUs), and neonatal units (NNUs).Workstream 1 (WS1) will survey current practice in each setting and will result in an outline of the different models of care used. WS2 is a qualitative comparison of the experiences of staff, parents and patients across the different models identified. WS3 is a quantitative assessment of the outcomes, resource use and costs across the different models identified. Discussion: Results from this study will contribute to an understanding of how end-of-life care can provide the greatest benefit for children at the end of their lives. It will also allow us to understand the likely benefits of additional funding in end-of-life care in terms of patient outcomes.

Health Inequalities: To What Extent are Decision-Makers and Economic Evaluations on the Same Page? An English Case Study.

Economic evaluations have increasingly sought to understand how funding decisions within care sectors impact health inequalities. However, there is a disconnect between the methods used by researchers (e.g., within universities) and analysts (e.g., within publicly funded commissioning agencies), compared to evidence needs of decision makers in regard to how health inequalities are accounted for and presented. Our objective is to explore how health inequality is defined and quantified in different contexts. We focus on how specific approaches have developed, what similarities and differences have emerged, and consider how disconnects can be bridged. We explore existing methodological research regarding the incorporation of inequality considerations into economic evaluation in order to understand current best practice. In parallel, we explore how localised decision makers incorporate inequality considerations into their commissioning processes. We use the English care setting as a case study, from which we make inference as how local commissioning has evolved internationally. We summarise the recent development of distributional cost-effectiveness analysis in the economic evaluation literature: a method that makes explicit the trade-off between efficiency and equity. In the parallel decision-making setting, while the alleviation of health inequality is regularly the focus of remits, few details have been formalised regarding its definition or quantification. While data development has facilitated the reporting and comparison of metrics of inequality to inform commissioning decisions, these tend to focus on measures of care utilisation and behaviour rather than measures of health. While both researchers and publicly funded commissioning agencies are increasingly putting the identification of health inequalities at the core of their actions, little consideration has been given to ensuring that they are approaching the problem in a consistent way. The extent to which researchers and commissioning agencies can collaborate on best practice has important implications for how successful policy is in addressing health inequalities.

What Does Economic Evaluation Mean in the Context of Children at the End of Their Life?

The 'conventional framework' of economic evaluation, the comparative public sector healthcare costs and quality adjusted life year (QALY) of two or more interventions, has become synonymous with commissioning decisions in many countries. However, while useful as a framework in guiding value-based decisions, it has limited relevance in areas such as end of life care in children and young people, where the costs fall across multiple stakeholders and QALY gains are not the primary outcome. This paper makes the case that the restricted relevance of the 'conventional framework' has contributed to the inconsistent and varied provision of care in this setting, and to the knock-on detrimental impact on children nearing the end of their lives as well as their families. We explore the challenges faced by those seeking to conduct economic evaluations in this setting alongside some potential solutions. We conclude that there is no magic bullet approach that will amalgamate the 'conventional framework' with the requirements of a meaningful economic evaluation in this setting. However, this does not imply a lack of need for the summation of the costs and outcomes of care able to inform decision makers, and that methods such as impact inventory analysis may facilitate increased flexibility in economic evaluations.

The Cost Effectiveness of Ecotherapy as a Healthcare Intervention, Separating the Wood from the Trees.

Internationally, shifts to more urbanised populations, and resultant reductions in engagements with nature, have been a contributing factor to the mental health crisis facing many developed and developing countries. While the COVID-19 pandemic reinforced recent trends in many countries to give access to green spaces more weight in political decision making, nature-based activities as a form of intervention for those with mental health problems constitute a very small part of patient pathways of care. Nature-based interventions, such as ecotherapy, are increasingly used as therapeutic solutions for people with common mental health problems. However, there is little data about the potential costs and benefits of ecotherapy, making it difficult to offer robust assessments of its cost-effectiveness. This paper explores the capacity for ecotherapy to be cost-effective as a healthcare intervention. Using a pragmatic scoping review of the literature to understand where the potential costs and health benefit lie, we applied value of information methodology to identify what research is needed to inform future cost-effectiveness assessments. We show that there is the potential for ecotherapy for people with mild to moderate common mental health problems to be cost-effective but significant further research is required. Furthermore, nature-based interventions such as ecotherapy also confer potential social and wider returns on investment, strengthening the case for further research to better inform robust commissioning.

Cost-effectiveness of surgery versus cast immobilization for adults with a bicortical fracture of the scaphoid waist : an economic evaluation of the SWIFFT trial.

AIMS: The aim of the Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) was to determine the optimal treatment for adults with a bicortical undisplaced or minimally displaced fracture of the waist of the scaphoid, comparing early surgical fixation with initial cast immobilization, with immediate fixation being offered to patients with nonunion. METHODS: A cost-effectiveness analysis was conducted to assess the relative merits of these forms of treatment. The differences in costs to the healthcare system and quality-adjusted life years (QALYs) of the patients over the one-year follow-up of the trial in the two treatment arms were estimated using regression analysis. RESULTS: Our base case analysis found that patients randomized to early surgical fixation had statistically significantly higher mean costs to the NHS of £1,295 more than for the cast immobilization arm (p < 0.001), primarily due to the cost of surgery. They also had a marginally better quality of life, over the period, of 0.0158 QALYs; however, this was not statistically significant (p = 0.379). The mean combined cost per additional QALY was £81,962, well above the accepted threshold for cost-effectiveness used in the UK and internationally. The probability of early surgery being cost-effective in this setting was only 5.6%. CONCLUSION: Consistent with the clinical findings of SWIFFT, these results indicate that initial cast immobilization of minimally displaced scaphoid fractures, with immediate fixation only offered to patients with nonunion, is the optimal form of treatment, resulting in comparable outcomes with less cost to the healthcare system. Cite this article: Bone Joint J 2021;103-B(7):1277-1283.

Delayed transfers of care for older people: a wider perspective.

Delayed transfers of care (DTOC), often unhelpfully referred to as 'bed blocking', has become a byword for waste and inefficiency in healthcare systems throughout the world. An estimated 2.7 million bed days are occupied each year in England by older people no longer in need of acute treatment, estimated to cost £820 million (2014/15) in inpatient care. Policy and media attention have often been drawn to this narrative of financial waste, resulting in policy setting that directly targets the level of DTOC, but has done little to put patient health first. These figures and policies portray a misleading image of the delays as primarily of concern in terms of their financial burden on acute hospital care, with little consideration given to the quantification on patient health or wider societal impacts. In spite of the multi-factorial decision-making process that occurs for each patient discharge, current evaluation frameworks and national policy setting fail to reflect the complexity of the process. In this commentary, we interrogate the current approach to the quantification of the DTOC impact and explore how policies and evaluation methods can do more to reflect the true impact of the delays.

Surgical fixation compared with cast immobilisation for adults with a bicortical fracture of the scaphoid waist: the SWIFFT RCT.

BACKGROUND: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. Immediate surgical fixation of this fracture has increased. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of surgical fixation with cast treatment and early fixation in adults with scaphoid waist fractures that fail to unite. DESIGN: Multicentre, pragmatic, open-label, parallel two-arm randomised controlled trial with an economic evaluation and a nested qualitative study. SETTING: Orthopaedic departments of 31 hospitals in England and Wales recruited from July 2013, with final follow-up in September 2017. PARTICIPANTS: Adults (aged ≥ 16 years) presenting within 2 weeks of injury with a clear, bicortical fracture of the scaphoid waist on plain radiographs. INTERVENTIONS: Early surgical fixation using Conformité Européenne-marked headless compression screws. Below-elbow cast immobilisation for 6-10 weeks and urgent fixation of confirmed non-union. MAIN OUTCOME MEASURES: The primary outcome and end point was the Patient-Rated Wrist Evaluation total score at 52 weeks, with a clinically relevant difference of 6 points. Secondary outcomes included Patient-Rated Wrist Evaluation pain and function subscales, Short Form questionnaire 12-items, bone union, range of movement, grip strength, complications and return to work. RESULTS: The mean age of 439 participants was 33 years; 363 participants were male (83%) and 269 participants had an undisplaced fracture (61%). The primary analysis was on 408 participants with valid Patient-Rated Wrist Evaluation outcome data for at least one post-randomisation time point (surgery, n = 203 of 219; cast, n = 205 of 220). There was no clinically relevant difference in the Patient-Rated Wrist Evaluation total score at 52 weeks: the mean score in the cast group was 14.0 (95% confidence interval 11.3 to 16.6) and in the surgery group was 11.9 (95% confidence interval 9.2 to 14.5), with an adjusted mean difference of -2.1 in favour of surgery (95% confidence interval -5.8 to 1.6; p = 0.27). The non-union rate was low (surgery group, n = 1; cast group, n = 4). Eight participants in the surgery group had a total of 11 reoperations and one participant in the cast group required a reoperation for non-union. The base-case economic analysis at 52 weeks found that surgery cost £1295 per patient more (95% confidence interval £1084 to £1504) than cast treatment. The base-case analysis of a lifetime-extrapolated model confirmed that the cast treatment pathway was more cost-effective. The nested qualitative study identified patients' desire to have a 'sense of recovering', which surgeons should address at the outset. LIMITATION: There were 17 participants who had initial cast treatment and surgery for confirmed non-union, which in 14 cases was within 6 months from randomisation and in three cases was after 6 months. Three of the four participants in the cast group who had a non-union at 52 weeks were not offered surgery. CONCLUSIONS: Adult patients with an undisplaced or minimally displaced scaphoid waist fracture should have cast immobilisation and suspected non-unions immediately confirmed and urgently fixed. Patients should be followed up at 5 years to investigate the effect of partial union, degenerative arthritis, malunion and screw problems on their quality of life. TRIAL REGISTRATION: Current Controlled Trials ISRCTN67901257. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 52. See the NIHR Journals Library website for further project information.

Fracture of the scaphoid bone (one of eight small bones in the wrist) is common in young active people. It is caused by a fall on the hand or the hand being suddenly forced backwards. The usual treatment is to rest the wrist in a plaster cast for 6­10 weeks and allow the broken bone to heal. In 1 in 10 cases in which the fracture is treated in a plaster cast, the bone does not heal and an operation is needed. In the operation, the broken bone is held still with a screw. In the last few years, it has become more common to fix the broken bone with a screw in the first few days after injury, instead of resting the wrist in a plaster cast. It is not clear if fixing the bone early with a screw, compared with resting the wrist in a cast, gives better outcomes for patients and if one treatment is better value for money for the NHS. In this study, 439 adult patients agreed either to have surgery to hold the broken scaphoid with a special screw or to have the wrist held still in a plaster cast (with surgery offered after 6 weeks to those who were still not healed). The decision about which treatment to use was made using randomisation, which is similar to tossing a coin. Patients reported their own wrist pain and function at 6, 12, 26 and 52 weeks. Information was also collected on general health, bone healing, grip strength and range of movement, complications from treatment and costs. No important differences were found in patients' wrist pain and function at 52 weeks. The bone did not heal properly in four patients in the surgery group or in nine patients in the plaster cast group at 52 weeks. For one of these patients in the surgery group and four of these patients in the plaster cast group, the bone did not join at all. Eight patients in the surgery group had further surgery following their initial operation to fix their wrist, and one patient in the cast group required repeated surgery because the bone did not join at all. The overall cost of treating with a plaster cast was lower than that of early surgery. Therefore, the findings of the study suggest that a plaster cast should be used initially and that the bone should be immediately fixed with a screw if it does not heal.

Yorkshire Lung Screening Trial (YLST): protocol for a randomised controlled trial to evaluate invitation to community-based low-dose CT screening for lung cancer versus usual care in a targeted population at risk.

INTRODUCTION: Lung cancer is the world's leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial. Here, we present the Yorkshire Lung Screening Trial (YLST), which will address key questions of relevance for screening implementation. METHODS AND ANALYSIS: Using a single-consent Zelen's design, ever-smokers aged 55-80 years registered with a general practice in Leeds will be randomised (1:1) to invitation to a telephone-based risk-assessment for a Lung Health Check or to usual care. The anticipated number randomised by household is 62 980 individuals. Responders at high risk will be invited for LDCT scanning for lung cancer on a mobile van in the community. There will be two rounds of screening at an interval of 2 years. Primary objectives are (1) measure participation rates, (2) compare the performance of PLCOM2012 (threshold ≥1.51%), Liverpool Lung Project (V.2) (threshold ≥5%) and US Preventive Services Task Force eligibility criteria for screening population selection and (3) assess lung cancer outcomes in the intervention and usual care arms. Secondary evaluations include health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies. ETHICS AND DISSEMINATION: The study has been approved by the Greater Manchester West research ethics committee (18-NW-0012) and the Health Research Authority following review by the Confidentiality Advisory Group. The results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and on the YLST website. TRIAL REGISTRATION NUMBERS: ISRCTN42704678 and NCT03750110.

Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial.

BACKGROUND: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. The use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non-surgical management. The SWIFFT trial compared the clinical effectiveness of surgical fixation with cast immobilisation and early fixation of fractures that fail to unite in adults with scaphoid waist fractures displaced by 2 mm or less. METHODS: This pragmatic, parallel-group, multicentre, open-label, two-arm, randomised superiority trial included adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs. An independent remote randomisation service used a computer-generated allocation sequence with randomly varying block sizes to randomly assign participants (1:1) to receive either early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group). Randomisation was stratified by whether or not there was displacement of either a step or a gap of 1-2 mm inclusive on any radiographic view. The primary outcome was the total patient-rated wrist evaluation (PRWE) score at 52 weeks after randomisation, and it was analysed on an available case intention-to-treat basis. This trial is registered with the ISRCTN registry, ISRCTN67901257, and is no longer recruiting, but long-term follow-up is ongoing. FINDINGS: Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men) were randomly assigned to the surgery group (n=219) or to the cast immobilisation group (n=220). Of these, 408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group). 16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks. There was no significant difference in mean PRWE scores at 52 weeks between the surgery group (adjusted mean 11·9 [95% CI 9·2-14·5]) and the cast immobilisation group (14·0 [11·3 to 16·6]; adjusted mean difference -2·1 [95% CI -5·8 to 1·6], p=0·27). More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]). The number of participants who had a medical complication was similar between the two groups (four [2%] in the surgery group and five [2%] in the cast immobilisation group). INTERPRETATION: Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery. This treatment strategy will help to avoid the risks of surgery and mostly limit the use of surgery to fixing fractures that fail to unite. FUNDING: National Institute for Health Research Health Technology Assessment Programme.

Complex programme evaluation of a 'new care model' vanguard: a shared commitment to quality improvement in an integrated health and care context.

NHS vanguards, under-pressure to perform, required better contracting and data management arrangements with evaluation teams, to ensure that integrated service outcomes could be reported effectively. This communication reflects the experience of evaluating an NHS vanguard and suggests how academic teams can improve capacity for complex programme evaluation of rapid improvements in integrated services. This should be based on a shared commitment to data collection and management. Also, robust knowledge exchange processes can enable systems change and sustainability. The identifying features of the particular site have been withheld.