Title: A nationwide registry of participants in e-cigarette trials to evaluate long-term health outcomes associated with their use
Funder: Cancer Research UK

Abstract: Over recent years, e-cigarettes (ECs) have become the most popular smoking cessation tool. Whilst studies of EC aerosols suggest ECs are much less toxic than conventional cigarettes, the long term effects are inferred as there is an absence of longitudinal data. Tracking long-term health outcomes in EC users is the key research priority in this field. However, collecting follow up health data over extended periods is complex for individual trial teams, expensive and of limited use in trials with modest sample sizes. We will establish a national registry of participants that have been involved in EC trials . Trial participants taking part in EC trials from across the UK would be asked to give written informed consent to be followed up beyond the end of their current trial to capture important health events including cancers and other non-cancerous diseases associated with smoking. We would do this using routine data from health records e.g. Hospital Episode Statistics and cancer registry data facilitating large-scale follow-up in a resource efficient manner. The specifics of the project will be scoped, proposed and refined in close collaboration with EC trialists and participants of the PPI advisory board. Whilst the use of the registry would extend beyond this two year award, key outputs of this period will be to develop the design and infrastructure of the registry. Having obtained all relevant permissions, we will work with investigating teams to facilitate maximal participant recruitment. There will be three clear data sharing routes 1) trials that contribute participants to the registry will be able to access registry data for their participants 2) bona fide researchers will be able to apply to the data access committee to utilise the data on specific groups or the whole cohort and 3) data will be published periodically from the central registry team to provide an ongoing narrative of trends in the data via the project website. This project would provide added value to studies where long term follow up activities were not within initial scope, and generate a ‘first-of-a-kind’ research resource of global importance about the long term impacts of EC use.

Lay abstract: Over recent years, e-cigarettes (ECs) have become the most popular smoking cessation tool. Whilst studies of EC aerosols suggest ECs are much less toxic than conventional cigarettes, the long term effects are inferred as there is an absence of longitudinal data. Tracking long-term health outcomes in EC users is the key research priority in this field. However, collecting follow up health data over extended periods is complex for individual trial teams, expensive and of limited use in trials with modest sample sizes. We will establish a national registry of participants that have been involved in EC trials . Trial participants taking part in EC trials from across the UK would be asked to give written informed consent to be followed up beyond the end of their current trial to capture important health events including cancers and other non-cancerous diseases associated with smoking. We would do this using routine data from health records e.g. Hospital Episode Statistics and cancer registry data facilitating large-scale follow-up in a resource efficient manner. The specifics of the project will be scoped, proposed and refined in close collaboration with EC trialists and participants of the PPI advisory board. Whilst the use of the registry would extend beyond this two year award, key outputs of this period will be to develop the design and infrastructure of the registry. Having obtained all relevant permissions, we will work with investigating teams to facilitate maximal participant recruitment. There will be three clear data sharing routes 1) trials that contribute participants to the registry will be able to access registry data for their participants 2) bona fide researchers will be able to apply to the data access committee to utilise the data on specific groups or the whole cohort and 3) data will be published periodically from the central registry team to provide an ongoing narrative of trends in the data via the project website. This project would provide added value to studies where long term follow up activities were not within initial scope, and generate a ‘first-of-a-kind’ research resource of global importance about the long term impacts of EC use.

Research activity codes: 2.4 SURVEILLANCE AND DISTRIBUTION;3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CANCER AND NEOPLASMS