Study design of a post market surveillance pilot study on reduced risk tobacco and nicotine products
In recent years there has been a proliferation of alternative tobacco and nicotine products that reduce consumers’ exposure to harmful substances and therefore have the potential to reduce risk to health. Post-market surveillance (PMS) enables the evaluation of newly introduced tobacco and nicotine products (aka reduced risk products (RRPs)) at a population level. An epidemiological cross-sectional pilot study was designed to develop a questionnaire as a PMS tool. The main objectives of the questionnaire are to investigate tobacco and nicotine consumer demographics, use behavioural patterns, and characterise behavioural trends as transitions between RRPs and other nicotine products. These behavioural aspects, in conjunction with the intrinsic risk of the product, are essential for assessing the potential health effects and establishing a population risk assessment.
PMS data was collected using a self-administered study instrument that consists of three modules, each focused on a RRP; e-cigarettes, oral nicotine pouches and heated tobacco products.
A two phase approach was implemented; Development and a Pilot Study in Switzerland and Belgium. The development phase included concept elicitation and cognitive interviewing to identify appropriate questions and establish a robust PMS tool. Once developed, the envisaged approach was piloted. Participants must be regular users of the respective RRP to be enrolled into the study and to complete the appropriate questionnaire module. The targeted sampling size is 300 participants per module. The 3-module style questionnaire will be piloted in Switzerland and Belgium (where only the Oral Nicotine Pouches module will be piloted).
Together with the development phase and the pilot study, results and outcomes from this work ensured the development of a questionnaire that fulfilled the key PMS objectives; description of RRP behaviour, estimation of prevalence data and product-specific risk perception measurement to allow for a comprehensive assessment of the effect of introducing RRPs into a market.