Dataset Information

Protocol for the evaluation of cost-effectiveness and health equity impact of a school-based tobacco prevention programme in a cluster randomised controlled trial (the TOPAS study).

ABSTRACT:

Introduction

Despite a long-term downward trend in smoking prevalence, tobacco remains the number one risk factor for death and disability in Sweden. Globally, tobacco use generates a substantial economic burden for health systems and is also a major driver of socioeconomic inequalities in health. This article describes the planned cost-effectiveness and health equity impact evaluation of a multicomponent school-based programme to prevent the onset of tobacco use in adolescents.

Methods and analysis

Cost-effectiveness of the multicomponent Tobacco-Free Duo programme will be evaluated against the educational component of the same programme only. An incremental cost-effectiveness ratio (ICER) will be calculated in terms of the cost per case prevented using the trial primary outcome and within-trial payer costs. If the ICER is negative, an incremental net benefit ratio will be calculated. Robustness of the results will be assessed through one-way sensitivity analyses. The slope index of inequality will be computed to assess the potential impact of the Tobacco-free Duo programme on education-related inequalities in the onset of smoking and in adult smoking cessation, comparing the two trial arms.

Ethics and dissemination

Ethical approval was obtained from the Regional Ethics Review Board, Umeå (registration number 2017/255-31). The Public Health Agency of Sweden commissioned the study. The findings will be disseminated internationally within academia and to national and local policy-makers.

Trial registration number

ISRCTN52858080; Pre-results.

SUBMITTER: Pulkki-Brannstrom AM

PROVIDER: S-EPMC8362718 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:OBJECTIVES:To assess the effectiveness of a combined classroom curriculum and parental intervention (the Steps Towards Alcohol Misuse Prevention Programme (STAMPP)), compared with alcohol education as normal (EAN), in reducing self-reported heavy episodic drinking (HED) and alcohol-related harms (ARHs) in adolescents. SETTING:105 high schools in Northern Ireland (NI) and in Scotland. PARTICIPANTS:Schools were stratified by free school meal provision. Schools in NI were also stratified by school type (male/female/coeducational). Eligible students were in school year 8/S1 (aged 11-12 years) at baseline (June 2012). INTERVENTION:A classroom-based alcohol education intervention, coupled with a brief alcohol intervention for parents/carers. PRIMARY OUTCOMES: (1) The prevalence of self-reported HED in the previous 30 days and (2) the number of self-reported ARHs in the previous 6?months. Outcomes were assessed using two-level random intercepts models (logistic regression for HED and negative binomial for number of ARHs). RESULTS:At 33 months, data were available for 5160 intervention and 5073 control students (HED outcome), and 5234 and 5146 students (ARH outcome), respectively. Of those who completed a questionnaire at either baseline or 12 months (n=12?738), 10?405 also completed the questionnaire at 33 months (81.7%). Fewer students in the intervention group reported HED compared with EAN (17%vs26%; OR=0.60, 95%?CI 0.49 to 0.73), with no significant difference in the number of self-reported ARHs (incident rate ratio=0.92, 95% CI 0.78 to 1.05). Although the classroom component was largely delivered as intended, there was low uptake of the parental component. There were no reported adverse effects. CONCLUSIONS:Results suggest that STAMPP could be an effective programme to reduce HED prevalence. While there was no significant reduction in ARH, it is plausible that effects on harms would manifest later. TRIAL REGISTRATION NUMBER:ISRCTN47028486; Post-results.

Project description:Bullying refers to verbal, physical or psychological aggression repeated over time that is intended to cause harm or distress to the victims who are unable to defend themselves. It is a key public health priority owing to its widespread prevalence in schools and harmful short- and long-term effects on victims' well-being. There is a need to strengthen the evidence base by testing innovative approaches to preventing bullying. KiVa is a school-based bullying prevention programme with universal and indicated elements and an emphasis on changing bystander behaviour. It achieved promising results in a large trial in Finland, and now requires testing in other countries. This paper describes the protocol for a cluster randomised controlled trial (RCT) of KiVa in Wales.The study uses a two-arm waitlist control pragmatic definitive parallel group cluster RCT design with an embedded process evaluation and calculation of unit cost. Participating schools will be randomised a using a 1:1 ratio to KiVa plus usual provision (intervention group) or usual provision only (control group). The trial has one primary outcome, child self-reported victimisation from bullying, dichotomised as 'victimised' (bullied at least twice a month in the last couple of months) versus 'not victimised'. Secondary outcomes are: bullying perpetration; aspects of child social and emotional well-being (including emotional problems, conduct, peer relations, prosocial behaviour); and school attendance. Follow-up is at 12 months post-baseline. Implementation fidelity is measured through teacher-completed lesson records and independent school-wide observation. A micro-costing analysis will determine the costs of implementing KiVa, including recurrent and non-recurrent unit costs. Factors related to the scalability of the programme will be examined in interviews with head teachers and focus groups with key stakeholders in the implementation of school-based bullying interventions.The results from this trial will provide evidence on whether the KiVa programme is transportable from Finland to Wales in terms of effectiveness and implementation. It will provide information about the costs of delivery and generate insights into factors related to the scalability of the programme.Current Controlled Trials ISRCTN23999021 Date 10-6-13.

Project description:Background: Aiming to contribute to prevention of cardiovascular disease (CVD), the National Health Service (NHS) Health Check programme has been implemented across England since 2009. The programme involves cardiovascular risk stratification-at 5-year intervals-of all adults between the ages of 40 and 74 years, excluding any with preexisting vascular conditions (including CVD, diabetes mellitus, and hypertension, among others), and offers treatment to those at high risk. However, the cost-effectiveness and equity of population CVD screening is contested. This study aimed to determine whether the NHS Health Check programme is cost-effective and equitable in a city with high levels of deprivation and CVD.Methods and findings: IMPACTNCD is a dynamic stochastic microsimulation policy model, calibrated to Liverpool demographics, risk factor exposure, and CVD epidemiology. Using local and national data, as well as drawing on health and social care disease costs and health-state utilities, we modelled 5 scenarios from 2017 to 2040: Scenario (A): continuing current implementation of NHS Health Check;Scenario (B): implementation 'targeted' toward areas in the most deprived quintile with increased coverage and uptake;Scenario (C): 'optimal' implementation assuming optimal coverage, uptake, treatment, and lifestyle change;Scenario (D): scenario A combined with structural population-wide interventions targeting unhealthy diet and smoking;Scenario (E): scenario B combined with the structural interventions as above. We compared all scenarios with a counterfactual of no-NHS Health Check. Compared with no-NHS Health Check, the model estimated cumulative incremental cost-effectiveness ratio (ICER) (discounted £/quality-adjusted life year [QALY]) to be 11,000 (95% uncertainty interval [UI] -270,000 to 320,000) for scenario A, 1,500 (-91,000 to 100,000) for scenario B, -2,400 (-6,500 to 5,700) for scenario C, -5,100 (-7,400 to -3,200) for scenario D, and -5,000 (-7,400 to -3,100) for scenario E. Overall, scenario A is unlikely to become cost-effective or equitable, and scenario B is likely to become cost-effective by 2040 and equitable by 2039. Scenario C is likely to become cost-effective by 2030 and cost-saving by 2040. Scenarios D and E are likely to be cost-saving by 2021 and 2023, respectively, and equitable by 2025. The main limitation of the analysis is that we explicitly modelled CVD and diabetes mellitus only.Conclusions: According to our analysis of the situation in Liverpool, current NHS Health Check implementation appears neither equitable nor cost-effective. Optimal implementation is likely to be cost-saving but not equitable, while targeted implementation is likely to be both. Adding structural policies targeting cardiovascular risk factors could substantially improve equity and generate cost savings.

Project description:OBJECTIVES:This study aimed to assess the cost-effectiveness of the Steps Towards Alcohol Misuse Prevention Programme (STAMPP) compared with education as normal (EAN) in reducing self-reported heavy episodic drinking (HED) in adolescents. DESIGN:This is a cost-effectiveness analysis from a public sector perspective conducted as part of a cluster randomised trial. SETTING:This study was conducted in 105 high schools in Northern Ireland and in Scotland. PARTICIPANTS:Students in school year 8/S1 (aged 11-12) at baseline were included in the study. INTERVENTIONS:This is a classroom-based alcohol education curricula, combined with a brief alcohol intervention for parents/carers. OUTCOME MEASURES:The outcome of this study is the cost per young person experiencing HED avoided due to STAMPP at 33 months from baseline. RESULTS:The total cost of STAMPP was £85 900, equivalent to £818 per school and £15 per pupil. Due to very low uptake of the parental component, we calculated costs of £692 per school and £13 per pupil without this element. Costs per pupil were reduced further to £426 per school and £8 per pupil when it was assumed there were no additional costs of classroom delivery if STAMPP was delivered as part of activities such as personal, social, health and economic education. STAMPP was associated with a significantly greater proportion of pupils experiencing a heavy drinking episode avoided (0.08/8%) and slightly lower public sector costs (mean difference -£17.19). At a notional willingness-to-pay threshold of £15 (reflecting the cost of STAMPP), the probability of STAMPP being cost-effective was 56%. This level of uncertainty reflected the substantial variability in the cost differences between groups. CONCLUSIONS:STAMPP was relatively low cost and reduced HED. STAMPP was not associated with any clear public sector cost savings, but neither did it increase them or lead to any cost-shifting within the public sector categories. Further research is required to establish if the cost-effectiveness of STAMPP is sustained in the long term. TRIAL REGISTRATION NUMBER:ISRCTN47028486; Results.

Project description:BackgroundMelioidosis, an often-fatal infectious disease caused by the environmental Gram-negative bacillus Burkholderia pseudomallei, is endemic in tropical countries. Diabetes mellitus and environmental exposure are important risk factors for melioidosis acquisition. We aim to evaluate the effectiveness of a multifaceted prevention programme for melioidosis in diabetics in northeast Thailand.Methodology/principal findingsFrom April 2014 to December 2018, we conducted a stepped-wedge cluster-randomized controlled behaviour change trial in 116 primary care units (PCUs) in Ubon Ratchathani province, northeast Thailand. The intervention was a behavioural support group session to help diabetic patients adopt recommended behaviours, including wearing rubber boots and drinking boiled water. We randomly allocated the PCUs to receive the intervention starting in March 2016, 2017 and 2018. All diabetic patients were contacted by phone yearly, and the final follow-up was December 2018. Two primary outcomes were hospital admissions involving infectious diseases and culture-confirmed melioidosis. Of 9,056 diabetics enrolled, 6,544 (72%) received a behavioural support group session. During 38,457 person-years of follow-up, we observed 2,195 (24%) patients having 3,335 hospital admissions involved infectious diseases, 80 (0.8%) melioidosis, and 485 (5%) deaths. In the intention-to-treat analysis, implementation of the intervention was not associated with primary outcomes. In the per-protocol analysis, patients who received a behavioural support group session had lower incidence rates of hospital admissions involving infectious diseases (incidence rate ratio [IRR] 0.89; 95%CI 0.80-0.99, p = 0.03) and of all-cause mortality (IRR 0.54; 95%CI 0.43-0.68, p<0.001). However, the incidence rate of culture-confirmed melioidosis was not significantly lower (IRR 0.96, 95%CI 0.46-1.99, p = 0.66).Conclusions/significanceClear benefits of this multifaceted prevention programme for melioidosis were not observed. More compelling invitations for the intervention, modification of or addition to the behaviour change techniques used, and more frequent intervention may be needed.Trial registrationThis trial is registered with ClinicalTrials.gov, number NCT02089152.

Project description:BackgroundAlthough childhood overweight and obesity prevalence has increased substantially worldwide in the past three decades, scarce evidence exists for effective preventive strategies. We aimed to establish whether a school-based intervention for children aged 9-10 years would prevent excessive weight gain after 24 months.MethodsThis pragmatic cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a school-based obesity prevention intervention, was done in 32 schools in southwest England. All state-run primary and junior schools in Devon and Plymouth (UK) with enough pupils for at least one year-5 class were eligible. Schools were assigned (1:1) using a computer-generated sequence to either intervention or control, stratified by the number of year-5 classes (one vs more than one) and the proportion of children eligible for free school meals (<19% [the national average] vs ≥19%). HeLP was delivered to year-5 children (ages 9-10 years) over 1 year, and included dynamic and interactive activities such as physical activity workshops, education sessions delivered by teachers with short homework tasks, drama sessions, and setting goals to modify behaviour (with parental support and one-to-one discussions with HeLP coordinators). The primary outcome was change in body-mass index (BMI) standard deviation score (SDS) between baseline and 24 months, analysed in children with BMI data available for both timepoints. This study is registered with the International Standard Randomised Controlled Trial register, number ISRCTN15811706, and the trial status is complete.FindingsBetween March 21, 2012, and Sept 30, 2013, 32 eligible schools with 1324 children were recruited, of which 16 schools (676 children) were randomly assigned to the HeLP intervention and 16 schools (648 children) to control. All schools that began the trial completed the intervention, and 1244 children (628 in intervention group and 616 in control group) had BMI data at both baseline and 24 months for the primary outcome analysis. Mean BMI SDS was 0·32 (SD 1·16) at baseline and 0·35 (1·25) at 24 months in the intervention group, and 0·18 (1·14) at baseline and 0·22 (1·22) at 24 months in the control group. With adjustment for school-level clustering, baseline BMI scores, sex, cohort, and number of year-5 classes and socioeconomic status of each school, the mean difference in BMI SDS score (intervention-control) at 24 months was -0·02 (95% CI -0·09 to 0·05), p=0·57. One parent reported an adverse event related to their child's eating and activity behaviours, but agreed for the child to continue trial participation after discussion with the chief investigator.InterpretationDespite a theoretically informed and extensively piloted intervention that achieved high levels of engagement, follow-up, and fidelity of delivery, we found no effect of the intervention on preventing overweight or obesity. Although schools are an ideal setting in which to deliver population-based interventions, school-based interventions might not be sufficiently intense to affect both the school and the family environment, and hence the weight status of children. Future research should focus on more upstream determinants of obesity and use whole-systems approaches.FundingUK National Institute for Health Research, Public Health Research Programme.