Infliximab versus ciclosporin in steroid resistant acute severe ulcerative colitis: a model-based cost-utility analysis of data from CONSTRUCT pragmatic trial.

BACKGROUND: There is limited evidence in the literature on the long-term effectiveness and cost-effectiveness of treatments for Acute Severe Ulcerative Colitis (ASUC). The study aimed to perform decision analytic model-based long-term cost-utility analysis (CUA) of infliximab versus ciclosporin for steroid-resistant ASUC investigated in CONSTRUCT pragmatic trial. METHODS: A decision tree (DT) model was developed using two-year health effect, resource use and costs data from CONSTRUCT trial to estimate relative cost-effectiveness of two competing drugs from the United Kingdom (UK) National Health Services (NHS) perspective. Using short-term trial data, a Markov model (MM) was then developed and evaluated over further 18 years. Both DT and MM were combined to investigate cost-effectiveness of infliximab versus ciclosporin for ASUC patients over 20-year time horizon, with a rigorous multiple deterministic and probabilistic sensitivity analyses to address uncertainty in results. RESULTS: The decision tree mirrored trial-based results. Beyond 2-year trial follow-up, Markov model predicted a decrease in colectomy rate, but it remained slightly higher for ciclosporin. NHS costs and quality adjusted life years (QALYs) over base-case 20 year time horizon were £26,793 and 9.816 for ciclosporin and £34,185 and 9.106 for infliximab, suggesting ciclosporin dominates infliximab. Ciclosporin had 95% probability of being cost-effective at a willingness-to-pay (WTP) threshold value up to £20,000. CONCLUSION: Using data from a pragmatic RCT, the cost-effectiveness models produced incremental net health benefit in favour of ciclosporin relative to infliximab. Results from long-term modelling indicated that ciclosporin remains dominant compared with infliximab for the treatment of NHS ASUC patients, however, these need to be interpreted cautiously. TRIAL REGISTRATION: CONSTRUCT Trial registration number ISRCTN22663589; EudraCT number: 2008- 001968-36 (Date 27/08/2008).

Overweight/Obesity and Time Preference: Evidence from a Survey among Adults in the UK.

INTRODUCTION: Overweight and obesity is a global problem incurring substantial health and economic implications. This has also been highlighted by the ongoing COVID-19 pandemic which has disproportionately affected overweight and obese individuals. Most of the interventions have concentrated on promotion of physical activities and healthy eating which may involve current sacrifices for future health gains. The purpose of this study was to explore the relationship between bodyweight and how individuals state they would trade-off immediate income for higher amounts in the future (time preference). METHODS: An online survey was conducted targeting adults aged >16 years in the UK (England, Northern Ireland, Scotland, and Wales) from January 1, 2016 to July 31, 2016. Using paid online adverts, as well as personal and professional networks for distribution of links to the online survey, the questionnaire asked respondents to report socio-economic and demographic information, height, and weight and to complete a time preference exercise. Data were analysed using descriptive statistics; associations were explored between BMI and respondents' characteristics and time preference using Spearman rank-order correlation and χ2 tests as appropriate. We adopted STROBE guidelines for the reporting of the study. RESULTS: A total of 561 responses were analysed (female = 293, males = 268). The relationship between time preference and overweight/obesity, using BMI as the measure is highly significant (χ2 = 95.92: p < 0.001). Individuals of normal weight have low time preferences and are more likely to invest in activities in a bid to reap future health benefits. There are also significant relationships between BMI and employment status (χ2 = 37.03; p < 0.001), physical activities (p < 0.0001), income levels (χ2 = 6.68; p < 0.035), family orientation, i.e., with or without children (χ2 = 12.88; p < 0.012), and ethnicity (χ2 = 18.31; p < 0.001). These imply that individuals in employment and with children in their families are less likely to be overweight or obese compared to those who do not. People from black backgrounds are also more likely to be overweight or obese and have higher time preferences compared to people from white backgrounds. DISCUSSIONS/CONCLUSIONS: People's preventive behaviours today can be predicted by their time preference and this understanding could be vital in improving population's uptake and maintenance of overweight and obesity prevention actions. People who have low time preference are more likely to invest time and resources in physical activities and healthy lifestyles to reap future health benefits hence value utilities-in-anticipation. Public health programmes should therefore use the knowledge of the association between time preference and overweight/obesity to inform designs of intervention programmes.

A multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL Trial.

OBJECTIVE: A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the emergency department (ED). The aim of this trial is to assess the feasibility and acceptability of a definitive impact trial investigating the clinical and cost-effectiveness of a new prognostic model for the management of patients with blunt chest wall trauma in the ED. DESIGN: Stepped wedge feasibility trial. SETTING: Four EDs in England and Wales. PARTICIPANTS: Adult blunt chest wall trauma patients presenting to the ED with no concurrent, life-threatening injuries. INTERVENTION: A prognostic model (the STUMBL score) to guide clinical decision-making. OUTCOME MEASURES: Primary: participant recruitment rate and clinicians' use of the STUMBL score. Secondary: composite outcome measure (mortality, pulmonary complications, delayed upgrade in care, unplanned representations to the ED), physical and mental components of quality of life, clinician feedback and health economic data gathering methodology for healthcare resource utilisation. RESULTS: Quantitative data were analysed using the intention-to-treat principle. 176 patients were recruited; recruitment targets were achieved at all sites. Clinicians used the model in 96% of intervention cases. All feasibility criteria were fully or partially met. After adjusting for predefined covariates, there were no statistically significant differences between the control and intervention periods. Qualitative analysis highlighted that STUMBL was well-received and clinicians would support a definitive trial. Collecting data on intervention costs, health-related quality of life and healthcare resource use was feasible. DISCUSSION: We have demonstrated that a fully powered randomised clinical trial of the STUMBL score is feasible and desirable to clinicians. Minor methodological modifications will be made for the full trial. TRIAL REGISTRATION NUMBER: ISRCTN95571506; Post-results.

Home-based pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): a feasibility randomized controlled trial.

OBJECTIVE: To determine the feasibility of conducting a trial of a pre-surgical psychological intervention on pain, function, and mood in people with knee osteoarthritis listed for total knee arthroplasty. DESIGN: Multi-centre, mixed-methods feasibility randomized controlled trial of intervention plus usual care versus usual care. SETTING: Participants' homes or hospital. PARTICIPANTS: Patients with knee osteoarthritis listed for total knee arthroplasty and score >7 on either subscales of Hospital Anxiety and Depression Scale. INTERVENTION: Up-to 10 sessions of psychological intervention (based on cognitive behavioural therapy). MAIN MEASURES: Feasibility outcomes (recruitment and retention rates, acceptability of trial procedures and intervention, completion of outcome measures), and standardized questionnaires assessing pain, function, and mood at baseline, and four and six months post-randomisation. RESULTS: Of 222 people screened, 81 did not meet inclusion criteria, 64 did not wish to participate, 26 were excluded for other reasons, and 51 were randomized. A total of 30 completed 4-month outcomes and 25 completed 6-month outcomes. Modal number of intervention sessions completed was three (range 2-8). At 6-month follow-up, mood, pain, and physical function scores were consistent with clinically important benefits from intervention, with effect sizes ranging from small ( d = 0.005) to moderate ( d = 0.74), and significant differences in physical function between intervention and usual care groups ( d = 1.16). Feedback interviews suggested that participants understood the rationale for the study, found the information provided adequate, the measures comprehensive, and the intervention acceptable. CONCLUSION: A definitive trial is feasible, with a total sample size of 444 people. Pain is a suitable primary outcome, but best assessed 6 and 12 months post-surgery.

Prioritisation of specialist health care services; not NICE, not easy but it can be done.

The challenges of delivering healthcare within budget constraints are ever present. Highly specialised technologies (HSTs) have high costs of provision inevitably contributing to NHS cost pressures. Between 2012-2015 the Welsh Health Specialised Services Committee (WHSSC) developed prioritisation methods to make recommendations for HST funding in Wales. Methods adapted as the process continued but was always evidence based and supported by a prioritisation panel of stakeholders. Methods changed from discreet choice to the Portsmouth Score Card, a simple multi-criteria decision analysis (MCDA) method. A strength of MCDA is that the impact on a decision of relevant criteria and their relative importance is explicit. This was, later, augmented by group decision support techniques. The prioritisation panel workload was on average eight HST condition treatment pairs in each l meeting, covering 133 HSTs over 3 years. Available evidence, information and value judgements were used to make decisions. The WHSSC framework identifies investment, dis-investment and recommendations transparently. The 'real-world' need for timely decisions was met, in the absence of National Institute for Health and Care Excellence (NICE) guidance on HSTs (initiated 2013, covering only drugs). In mid-2015 the prioritisation process was benchmarked against the EVIDEM framework, identifying areas of best practice and improvement: need for greater public and patient engagement. Some implementation issues for decisions based on panel recommendations remain to be resolved.

Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial.

INTRODUCTION: A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the emergency department (ED). A definitive randomised controlled trial (impact trial) is required to assess the clinical and cost effectiveness of the new model before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design. METHODS/ANALYSIS: This feasibility trial is designed to test the methods of a multicentre, cluster-randomised (stepped- wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a 5-month period; in the initial period acting as the controls (normal care), and in the second period acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a 6-week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory). Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed. ETHICS AND DISSEMINATION: Wales Research Ethics Committee 6 granted approval for the trial in September 2016. Patient recruitment will commence in February 2017. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to stakeholders at professional meetings. TRIAL REGISTRATION NUMBER: ISRCTN95571506; Pre-results.

Antibiotic prescribing and associated diarrhoea: a prospective cohort study of care home residents.

BACKGROUND: the risk factors for and frequency of antibiotic prescription and antibiotic-associated diarrhoea (AAD) among care home residents are unknown. AIM: to prospectively study frequency and risks for antibiotic prescribing and AAD for care home residents. DESIGN AND SETTING: a 12-month prospective cohort study in care homes across South Wales. METHOD: antibiotic prescriptions and the development of AAD were recorded on case report forms. We defined AAD as three or more loose stools in a 24-h period occurring within 8 weeks of exposure to an antibiotic. RESULTS: we recruited 279 residents from 10 care homes. The incidence of antibiotic prescriptions was 2.16 prescriptions per resident year (95% CI: 1.90-2.46). Antibiotics were less likely to be prescribed to residents from dual-registered homes (OR compared with nursing homes: 0.38, 95% CI: 0.18-0.79). For those who were prescribed antibiotics, the incidence of AAD was 0.57 episodes per resident year (95% CI: 0.41-0.81 episodes). AAD was more likely in residents who were prescribed co-amoxiclav (hazards ratio, HR = 2.08, 95% confidence interval, CI: 1.18-3.66) or routinely used incontinence pads (HR = 2.54, 95% CI: 1.26-5.13) and less likely in residents from residential homes (HR compared with nursing homes: 0.14, 95% CI: 0.06-0.32). CONCLUSION: residents of care homes, particularly of nursing homes, are frequently prescribed antibiotics and often experience diarrhoea following such prescriptions. Co-amoxiclav is associated with greater risk of AAD.

A national Programme Budgeting and Marginal Analysis (PBMA) of health improvement spending across Wales: disinvestment and reinvestment across the life course.

BACKGROUND: Wales faces serious public health challenges, with relatively low life expectancies and wide inequalities in life expectancy with associated pressures on the National Health Service (NHS) at a time of financial recession. This has led to growing recognition of the need to better understand the range of health improvement and prevention programmes across Welsh Government, NHS, local government and voluntary sector agencies. METHODS: The Minister for Health and Social Care commissioned Public Health Wales, the single national public health organisation, to establish a Health Improvement Advisory Group, to oversee a Programme Budgeting and Marginal Analysis (PBMA) expert panel. The panel drew on evidence from a range of sources to explore potential alternative modes of health improvement initiative delivery across Wales. Electronic voting was used to agree an appropriate time horizon for health improvement programme outcomes, main objective of the health improvement review and criteria for evaluating candidate services for disinvestment and investment. The panel also used electronic voting to state whether they wished to disinvest or invest in a candidate service. RESULTS: The review identified a budget of £15.1 million, spanning 10 Welsh Government priority areas, and 6 life course stages. Due to lack of evidence the panel recommended total disinvestment in 7 out of 25 initiatives releasing £1.5 million of resources, and partial disinvestment in a further 3 interventions releasing £7.3 million of resources. The panel did not recommend increasing investment in any of the 25 initiatives under review. Marginal analyses prioritised child health, mental health and wellbeing and tobacco control as key areas for investment. CONCLUSIONS: Wales is championing a concept of "prudent healthcare". The PBMA exercise undertaken here was a transparent evidence-based tool to reach decisions about potential for disinvestment and reinvestment in health improvement strategies. It also demonstrates the potential wider application at a national level across government public health functions, to ensure resources are most cost-effectively deployed, with due consideration for equity.

Continuity of care in the transition from child to adult diabetes services: a realistic evaluation study.

OBJECTIVES: To identify the continuity mechanisms central to a smooth transition from child to adult diabetes care, the service components through which these can be achieved and their inter-relations in different contexts. METHODS: A realistic evaluation study of five models of transition in England comprising: organizational analysis (semi-structured interviews with 38 health care professionals and selected observations); case studies of 46 young people under-going transition and 39 carers (three qualitative interviews over a 12-18 month period, medical record review and clinical interviews); surveys of 82 (32% response rate at least once and 11% response rate at two time points) young people in the population approaching, undergoing or less than 12 months post-transition, and their carers (questionnaires included psychosocial outcome measures); and a costs and consequences analysis. RESULTS: Seven continuities contribute to smooth transition: relational, longitudinal, management, informational, flexible, developmental and cultural. Relational, longitudinal, flexible and cultural continuity are the most important. Models with high levels of relational, longitudinal, flexible and cultural continuity achieve smooth transition with relatively informal, low-cost informational and management continuity mechanisms. Models with low levels of relational and longitudinal continuity need to invest in more formal interventions to facilitate management, flexible and informational continuity so that smooth transition is not compromised. CONCLUSIONS: Focusing on continuity mechanisms, their inter-relations and the effectiveness of different constellations of service components in achieving smooth transition has furnished evidence to inform the development of innovative models which build on the logic of these findings but are sensitive to local context. Further studies are needed to confirm the quantitative findings from a broader range of services and patients.

Feasibility of using routinely collected inpatient data to monitor quality and inform choice: a case study using the UK inflammatory bowel disease audit.

OBJECTIVE: To assess the utility and cost of using routinely collected inpatient data for large-scale audit. DESIGN: Comparison of audit data items collected nationally in a designed audit of inflammatory bowel disease (UK IBD audit) with routinely collected inpatient data; surveys of audit sites to compare costs. SETTING: National Health Service hospitals across England, Wales and Northern Ireland that participated in the UK IBD audit. PATIENTS: Patients in the UK IBD audit. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Percentage agreement between designed audit data items collected for the UK IBD audit and routine inpatient data items; costs of conducting the designed UK IBD audit and the routine data audit. RESULTS: There were very high matching rates between the designed audit data and routine data for a small subset of basic important information collected in the UK IBD audit, including mortality; major surgery; dates of admission, surgery, discharge and death; principal diagnoses; and sociodemographic patient characteristics. There were lower matching rates for other items, including source of admission, primary reason for admission, most comorbidities, colonoscopy and sigmoidoscopy. Routine data did not cover most detailed information collected in the UK IBD audit. Using routine data was much less costly than collecting designed audit data. CONCLUSION: Although valuable for large population-based studies, and less costly than designed data, routine inpatient data are not suitable for the evaluation of individual patient care within a designed audit.

Abolition of prescription charges in Wales: the impact on medicines use in those who used to pay.

OBJECTIVES: patient co-payments for prescription medicines in Wales were abolished in April 2007 and there has been much speculation on the possible effects. We analysed patient-reported use of medicines before and after abolition of the prescription charge, noting changes in the number of items prescribed, number of non-prescription medicines purchased and participants not collecting all prescribed items (primary non-adherence). METHODS: a sample of community pharmacists across Wales (n = 249) issued questionnaires to customers at the point of dispensing who were not exempt from the prescription charge. A second questionnaire was delivered by post to those who returned the first questionnaire (n = 1027) and expressed a willingness to participate further. Paired t-tests were applied to responses from those completing both questionnaires (n = 593). Further analyses were carried out according to gender, age and reported levels of household income. KEY FINDINGS: there was a statistically significant (P = 0.03) rise in the number of items prescribed, and a statistically significant fall (P = 0.02) in the number of non-prescription medicines purchased. Primary non-adherence was also found to fall between pre- and post-abolition periods. Those most affected in terms of increase in number of prescribed items prescribed were the older age group (45-59 years), and those with household income of between £15600 and £36400. The most affected in the fall in number of medicines purchased were males, those in the lower age group (25-34 years) and those with a higher household income (>£36400). CONCLUSIONS: although the rise in number of items prescribed and fall in number of medicines purchased was generally anticipated, there appeared to be little or no effect for those on the lowest incomes.