E-Cigarette Registry: Long-term health data
Research type
Research Database
IRAS ID
272523
Contact name
Peter Sasieni
Contact email
Research summary
A long-term health data repository of people who have quit smoking with and without using e-cigarettes
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
21/YH/0186
Date of REC Opinion
31 Aug 2021
REC opinion
Further Information Favourable Opinion
Data collection arrangements
The ECigarette Registry will recruit participants who are currently or have previously consented into studies involving electronic cigarette (ECs). We will recruit from existing studies aiming for a balance between EC users and non-users, and will only collect data from people who give their consent.
Participants consent to their health data and personal identifiable data (PID) being transferred securely to King’s College London (KCL), and for it to be used for research and to access their health records from data registries including (but not limited to) the registries and services below.
Participants will be emailed a baseline questionnaire, as well as an annual low-burden questionnaire to collect data which is difficult to obtain through medical records, such as current smoking status and products being used (brands, nicotine content etc.) If these are not completed participants will be prompted three times and then not again until the following year.
Health data will be collected through national data registries. This is the core function of the Registry, collecting the follow-up data with no burden on sites or participants. These data (eg. Mortality, cancer incidence, cardiovascular disease) will be collected from three main registries NHS Digital, Public Health England, and the MHRA.
Research programme
Over recent years ECs have become the most popular smoking cessation tool. Whilst studies suggest ECs are much less toxic than conventional cigarettes, the long-term effects are inferred as there is an absence of longitudinal data. Their safety profile compared to other nicotine replacement therapies (NRTs) is poorly reported. These gaps in knowledge are partly due to the relative novelty of ECs, having come on to the market less than 15 years ago but also because EC trials published to date typically have a short follow-up time (6 or 12 months) and the overall quality of the evidence is low. Smokers, healthcare professionals and regulators need more evidence on potential risks associated with long-term EC use. Tracking long-term health outcomes in EC users is thus the primary research priority in this field. However, collecting follow-up health data over extended periods is complex and expensive to individual trialists and of limited use in trials with modest sample sizes. Project-specific funding also rarely extends to resource such activities and if it does, it concerns patient reported rather than objective outcomes. Participant follow-up utilising electronic health records enables long-term tracking of objective health outcomes.
Research database title
A long-term health data repository of people who have quit smoking with and without using e-cigarettes
Establishment organisation
King’s College London
Establishment organisation address
Strand
London
WC2R 2LS