We aim to collect appropriate and up-to-date information to inform the adaptation of the UK ROI model for use in European countries beyond the UK. This data collection includes a review of the relevant literature, collection of current datasets and collection of stakeholder views via interview.
A desk review of published and grey literature as well as government statistics and reports relating to the four included sample European countries (Germany, Hungary, Netherlands and Spain) plus the UK will be carried out. Further literature will be sought by consulting key contacts and by using snowballing techniques on key literature. Additional methods will be used to identify any missing data sources from each of the included countries as necessary. Reviews of qualitative data sources will follow a narrative approach and reviews of quantitative data sources will follow a matrix method.
Our experience from the development of the UK ROI tool suggests that we will have to rely, at least in part, on the analysis of existing databases to collect data on some key model parameters (e.g. smoking prevalence). Key contacts will be consulted to identify relevant datasets. All data collected will be analysed using standard statistical methods (e.g. regression analysis) to control for any confounders.
We will engage stakeholders involved in decision-making on which smoking cessation treatments and wider tobacco control measures are used in different countries. We will use their views, collected via interview, to create an inventory of the perceived advantages and disadvantages of using economic evidence when making such decisions and we will develop a needs-assessment for the inclusion of economic evidence in decision-making. We will follow social marketing approaches that clearly stress the importance of establishing the needs of future users of an innovation. We will target two groups of stakeholders. Stakeholder group 1, to obtain an optimum assessment of preconditions for usability of the final ROI tool, we will target national and European stakeholders consisting of policymakers, academics, health authorities, insurance companies, advocacy groups, ministry of finance, national committees, clinicians and health technology assessment (HTA) professionals. Stakeholder group 2, to obtain an optimum assessment of the parameters to be included in the final ROI tool taking into account the variability of smoking cessation/prevention methods used between different countries, we will target experts on smoking cessation and HTA. This means that two sets of ethically approved interviews will need to be conducted consistently and comparably in each of the five sample countries. This bottom-up approach in the development of decision tools was found to be critical in our earlier UK experience.
Two workshops will be held in each of the five participating countries (one meeting for each stakeholder group) followed by a consensus workshop for each stakeholder group across all five countries. The aim of these workshops will be to assess the need for any further amendments to the final ROI tool or to the guidance and instruction provided for using the final ROI tool. In the consensus workshop for Stakeholder Group 2, we will also discuss whether all relevant parameters have been included.