A research database collecting long-term behavioural data directly from participants, and health data from medical records to create a bank of data pertaining to people who have quit smoking, both with and without switching to e-cigarettes
| ISRCTN | ISRCTN15698754 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15698754 |
| IRAS number | 272523 |
| Secondary identifying numbers | Version 4.0 10 Feb 2022, IRAS 272523, CPMS 53821 |
- Submission date
- 10/08/2022
- Registration date
- 31/08/2022
- Last edited
- 25/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In the UK 3.6 million people use e-cigarettes (ECs). In the short-term ECs have been shown to be much less harmful than tobacco cigarettes, but there is not much data available on the long-term effects. The E-Cigarette Registry has been created to collect data on people who have quit smoking, both with and without switching to ECs, with the aim of collecting a broad range of data over a long period of time to see the long-term effects.
Over recent years ECs have become the most popular tool to help people stop smoking (cessation). Whilst studies suggest ECs are much less toxic than conventional cigarettes, there is no good quality long-term data on their effects. Compared to other nicotine replacement therapies (NRTs) we don’t know very much about them. This is partly because ECs only came on to the market around 15 years ago, but also because EC trials tend to be quite short.
Smokers, healthcare professionals and regulators need more evidence on potential risks associated with long-term EC use.
A Patient and Public Involvement (PPI) Advisory Board of smokers and ex-smokers (including EC users) has been established to inform the recruitment designs, data collection, storage, data sharing and dissemination procedures. The PPI Advisory Board plays an essential role in developing and refining the project with the PMG. A participant in the Registry may be recruited to the PPI Advisory Board to give insight into Registry processes and the participant experience. The researchers will also keep in touch with Registry participants by sending an annual newsletter to keep them informed of progress, engaged, and to thank them for their continued participation. They will also contact participants in order to recruit a participant representative to the PPI board.
Who can participate?
People aged 16 years or over who live in England or Wales, are happy to for their data to be collected, are willing to complete an annual questionnaire and are happy to communicate with the researchers in English
What does the study involve?
Participants will be sent a questionnaire once a year, to see how they are doing and what (if anything) they are smoking. The researchers will also collect information about the participants from organisations like NHS Digital. This can include but is not limited to NHS Digital, UK Health Security Agency (formerly Public Health England), the Office of National Statistics, participants' GPs, and other health data providers and research organisations.
To do this, the researchers will send them some information like participants' names and NHS numbers (so they can find them in their system). They will use the minimum number of identifiers possible to access the data, but this could also include postcodes. When they send this information they will attach a code and the information they send back will be health data and the code only, which means there will be nothing in that data which identifies participants directly, just the code.
Very few people will have access to the code and be able to link data back, this would be people like auditors who are there to make sure the researchers are protecting the data adequately and doing everything they should be to uphold the participants' rights and the integrity of the study. The data will be mixed with the other participants' data to make this resource for researchers. All information about participants will be kept confidential, de-identified (separate from their name with a code), safe and secure.
Over time, this will show if there’s a difference between tobacco and vaping. Researchers may apply to use this data to improve their research. This may include commercial and overseas partners like universities abroad or companies interested in making nicotine replacement products. Participants will be emailed updates and asked if they would like to take part in any more research. If the researchers send a questionnaire and don’t hear back in a few days, they will send a reminder email no more than twice.
What are the possible benefits and risks?
The researchers don’t consider there to be any risk to participants as they are not asking that anyone change their behaviour or try anything new on their account, and there are no appointments to attend. There are some incentives available to participants for completing assessments. There are no other direct benefits to participants other than the knowledge that their involvement could help people in the future, and they may enjoy a sense of altruism from participation.
Where is the study run from?
The Cancer Research UK & King’s College London Cancer Prevention Trials Unit (CPTU) (UK)
When is the study starting and how long is it expected to run?
February 2019 to February 2023
Who is funding the study?
Cancer Research UK
Who is the main contact?
Georgia Mannion-Krase, ecregistry@kcl.ac.uk
Contact information
Scientific, Principal Investigator
Centre for Cancer Screening, Prevention & Early Diagnosis, Wolfson Institute of Population Health, Queen Mary University of London
London
EC1M 6BQ
United Kingdom
 ORCID ID |
0000-0003-1509-8744 |
|---|---|
| p.sasieni@qmul.ac.uk |
Public
King's College London
Strand
London
WC2R 2LS
United Kingdom
| Phone | +44 (0)20 7836 5454 |
|---|---|
| georgia.mannion-krase@kcl.ac.uk |
Study information
| Study design | Open-ended prospective observational research study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Research database |
| Study setting(s) | Internet/virtual |
| Study type | Other |
| Study type | Participant information sheet |
| Scientific title | A long-term health data repository of people who have quit smoking with and without using e-cigarettes |
| Study objectives | The aim of the Registry is to collect prospective information on health outcomes in participants who quit smoking with and without using e-cigarettes (ECs). As the study has no pre-specified hypothesis, no formal sample size is required. Instead, the aim is to recruit as many participants as possible during the active recruitment period. The researchers will regularly produce descriptive statistics describing changes in EC use (ex, current and never), dual use, health conditions, missing data, sample characteristics and quality control. The longitudinal design of the Registry will allow the researchers to explore trends over time to assess changes in health conditions between EC users and non-EC users. In an interventional study, a formal sample size calculation may be required which will be dependent on the outcome, the expected effect size and prevalence of disease. This is not the case for the Registry as the results will be used to inform policy and current practice and will also be used to assess the robustness of previous studies conducted on smaller samples. The primary objective of the pilot phase is to establish and test infrastructure. |
| Ethics approval(s) | Favourable opinion received 31/08/2021, Yorkshire & The Humber - Leeds East Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)2071048103; leedseast.rec@hra.nhs.uk), ref: 21/YH/0186 |
| Health condition(s) or problem(s) studied | E-cigarette use |
| Intervention | The Registry is an open-ended, prospective observational research study (with no experimental procedure) to capture the long-term health effects of EC use. The design of the study is data linkage of individuals via national and local healthcare data repositories, with annual active data collection to ascertain relapse to tobacco or continuing use, among other self-reported data items. Data collection until pilot study end (28/02/2023). |
| Intervention type | Other |
| Primary outcome measure | 1. Demand for Registry service measured using targeted surveys during scoping phase (pre-recruitment) 2. The availability and challenges of completing linkage for non-cancers/death particularly in primary care, assessed using quantitative and qualitative analysis at 6 monthly intervals until study end 3. Mortality and cancer incidence data collected from NHS Digital for all participants recruited at the time of application 4. Smoking/vaping status collected using automated participant surveys annually for 1 year |
| Secondary outcome measures | 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study at month 17 (recruitment end) 2. Retention rate assessed using the number of participants who consent to participate who remain in the study until the end of follow-up at month 17 (recruitment end) |
| Overall study start date | 26/02/2019 |
| Completion date | 28/02/2023 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 138 |
| Key inclusion criteria | 1. Is 16+ years of age 2. Has a previous tobacco quit attempt 3. Consents to data linkage 4. Willing to provide annual follow-up data through direct methods (questionnaires) and indirect methods (through their health records) 5. Resides in England or Wales |
| Key exclusion criteria | 1. Unwilling or unable to give consent 2. Cannot communicate (written and spoken) in English |
| Date of first enrolment | 01/09/2021 |
| Date of final enrolment | 28/02/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centre
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Sponsor information
University/education
Strand
London
WC2R 2LS
England
United Kingdom
| Phone | +44 (0)20 7836 5454 |
|---|---|
| R&D@gstt.nhs.uk | |
| Website | https://www.kcl.ac.uk/ |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 28/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The researchers will submit a periodic progress report to the project funder Cancer Research UK (CRUK) and the research ethics committee (REC). An annual progress report will be submitted to the REC within 30 days of the anniversary date on which the favourable opinion was given, and annually until the Registry is declared ended. Once a mailing list has been established there will be a monthly newsletter for collaborators detailing progress and updates, particularly on uptake and closed vs active trials. Long-term health outcomes will be published periodically on behalf of the Registry team. There will be regular outputs on the project website to create an ongoing narrative of the long-term health impacts of the Registry participants in a similar fashion to the Cystic Fibrosis Registry through the posting of regular content on the project website. The data collected in the Registry will be owned by both King's College London (KCL) and Queen Mary University of London (QMUL), who are the joint data controllers and will have equal rights to access the data. On completion of the pilot, the data will be analysed and tabulated, and a Final Study Report released. The report will be available from the Registry website. The grant holders will have rights to publish analysis of the data at this stage. CRUK and CPTU are to be acknowledged in any publications arising from the data. Participants will be contacted by email for their yearly follow-up, and with periodic updates on the progress of the Registry through a newsletter. The newsletter, protocol and report will be made available on the Registry website. The Registry will adhere to the recommendations of the International Committee of Medical Journal Editors that authorship is based on the following four criteria: 1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND 2. Drafting the work or revising it critically for important intellectual content; AND 3. Final approval of the version to be published; AND 4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 31/08/2021 | 26/08/2022 | No | Yes | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/03/2025: The study contacts were updated.
27/08/2024: Internal review.
28/02/2023: Total final enrolment added.
05/09/2022: Internal review.
26/08/2022: Trial's existence confirmed by the Yorkshire & The Humber - Leeds East Research Ethics Committee.
