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

IntroductionDespite 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 analysisCost-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 disseminationEthical 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 numberISRCTN52858080; Pre-results.