COVID-19NCT05479383
Tobacco Use and Uptake of COVID-19 Vaccinations
An observational study of COVID-19 and Smoking, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
This is an observational study of participants in two general population health surveys (FinSote 2018 and 2020) who are followed up for their COVID-19 vaccinations or end of follow-up. The primary objective is to examine the association between tobacco use and COVID-19 vaccine uptake and between-dose spacing. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Smoking, Tobacco Use
- What is being tested?
- Not applicable, this is an observational study
- How many people
- 42,935 participants
- Where
- 1 siteFinland
- Study dates
- 2 Oct 2017to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Permanent residents in Finland aged 20 and over who participated in the FinSote surveys in 2018 and 2020. These are general population samples representative of the Finnish population. The sampling frame was the Population Register (in 2020 the Digital and Population Data Services Agency, created after the merge between the Population Register of Statistics Finland and local register offices), which includes all individuals residing permanently in Finland, including conscripts and people living in institutions.
Who may be able to join
- Permanent residents of Finland
- Registered in the Population Register at the moment of sampling
- Aged 20 and over
- Participated in the FinSote surveys in 2018 or 2020
- Provided consent for register linkage
Who cannot join
- Temporary residents in Finland or tourists
- Age less than 20 years old
- Did not participate in FinSote surveys in 2018, 2019 and 2020
- Did not provide consent for register linkage
Trial locations and contacts
1 site in 1 country.
Finland1 site
Finnish Institute for Health and Welfare
Helsinki, Uusimaa, 00271
About this study
Official title: Tobacco Use and Uptake of COVID-19 Vaccinations in Finland: a General Population Study
This is an observational study of participants in two general population health surveys (FinSote 2018 and 2020) who are followed up for their COVID-19 vaccinations or end of follow-up. The primary objective is to examine the association between tobacco use and COVID-19 vaccine uptake and between-dose spacing.
Read the detailed description
Most high income countries have rolled out COVID-19 vaccinations, with the promise of reducing incident COVID-19 infections and preventing hospitalizations and deaths. A high vaccination coverage is crucial for several reasons: (i) to reduce the number of new COVID-19 cases, (ii) to diminish selective pressures leading to the emergence of new variants of concern, (iii) to prevent severe COVID-19 outcomes, such as hospitalizations and deaths, and (iv) to potentially reduce the risk of post-acute COVID-19 symptoms.
Smokers are at higher risk of COVID-19 hospitalizations and deaths and might thus benefit greatly from high vaccination coverage. However, evidence suggests that they may be less likely to be vaccinated, as smokers are less likely to adhere to preventive measures in general and have lower adherence to other vaccines. Reports of a protective role of smoking on the risk of COVID-19 infection might have also reduced the perceived risks from being infected.
Evidence regarding tobacco use and COVID-19 vaccine hesitancy is mixed. Some studies have shown greater mistrust in COVID-19 vaccine benefits and greater vaccine hesitancy and lower vaccine acceptance compared to non-smokers, while other studies have reported no differences by smoking status or lower levels of vaccine hesitancy in smokers compared to non-smokers. Few studies have examined the relationship between tobacco use and vaccine uptake, showing that smokers had higher odds of being vaccinated. These studies, however, are not representative of the general population and relied on self-reported vaccination status, resulting in higher risk of selection and information bias.
The investigators will expand current knowledge by examining two forms of tobacco use in Finland -smoking and smokeless tobacco use (snus)- and by analysing the spacing between vaccine doses. The study will use data from nationally representative surveys in Finland linked to vaccination registries, which reduces the risk of selection and information bias.
- Conditions
- COVID-19, Smoking, Tobacco Use, Vaccination Refusal
- Being tested
- Not applicable, this is an observational study
- Keywords
- Tobacco use, Smoking, COVID-19, SARS-CoV-2, Vaccinations, Cohort studies
- Medical subject headings
- COVID-19, Smoking, Tobacco Use, Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable, this is an observational studyOther
Not applicable, this is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Tobacco users | Tobacco users
Never smokers (reference group) will be compared with former smokers, occasional smokers and daily smokers.
Never snus users (reference group) will also compare with never users, former users and current users. Receives: Other: Not applicable, this is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination uptake of at least two doses of a COVID-19 vaccine
Proportion of participants with at least two doses of a COVID-19 vaccine
Measured: Baseline until date of vaccination or May 31, 2022
Secondary outcomes (4)
Vaccination uptake of at least one dose of a COVID-19 vaccine
Proportion of participants with at least one dose of a COVID-19 vaccine
Measured: Baseline until date of vaccination or May 31, 2022
Vaccination uptake of complete COVID-19 vaccination scheme (two doses and a booster dose)
Proportion of participants with two doses and a booster dose of a COVID-19 vaccine
Measured: Baseline until date of vaccination or May 31, 2022
Spacing of first and second COVID-19 dose
Proportion of participants with more than 7 months between the first and second COVID-19 dose
Measured: Baseline until date of vaccination or May 31, 2022
Spacing of second dose and booster dose of the COVID-19 vaccine
Proportion of participants with more than 7 months between the second dose and booster dose of the COVID-19 vaccine
Measured: Baseline until date of vaccination or May 31, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start2 Oct 2017
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42,935 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, Norwegian Institute of Public Health
- Responsible party
- Sponsor
- Investigators
- Sakari Karvonen, PhD, Principal investigator, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479383
- Sponsor's protocol ID
- THL/713/6.00.00/2021.2
- Status last verified
- May 2023
- First submitted
- 28 Jul 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers can access individual data by contacting the Responsible Researcher at the Finnish Institute for Health and Welfare, Suvi Parikka, suvi.parikka \[at\] thl.fi. Information about FinSote surveys, including questionnaires, can be found in https://thl.fi/fi/tutkimus-ja-kehittaminen/tutkimukset-ja-hankkeet/finsote-tutkimus
Publications
Simons D, Shahab L, Brown J, Perski O. The association of smoking status with SARS-CoV-2 infection, hospitalization and mortality from COVID-19: a living rapid evidence review with Bayesian meta-analyses (version 7). Addiction. 2021 Jun;116(6):1319-1368. doi: 10.1111/add.15276. Epub 2020 Nov 17.
PubMed 33007104Jackson SE, Paul E, Brown J, Steptoe A, Fancourt D. Negative Vaccine Attitudes and Intentions to Vaccinate Against Covid-19 in Relation to Smoking Status: A Population Survey of UK Adults. Nicotine Tob Res. 2021 Aug 18;23(9):1623-1628. doi: 10.1093/ntr/ntab039.
PubMed 33751125Krebs NM, D'Souza G, Bordner C, Allen SI, Hobkirk AL, Foulds J, Yingst JM. COVID-19 Vaccination Uptake and Hesitancy Among Current Tobacco Users. Tob Use Insights. 2021 Dec 20;14:1179173X211068027. doi: 10.1177/1179173X211068027. eCollection 2021.
PubMed 34987300Ali M, Ahmed S, Bonna AS, Sarkar AS, Islam MA, Urmi TA, Proma TS. Parental coronavirus disease vaccine hesitancy for children in Bangladesh: a cross-sectional study. F1000Res. 2022 Jan 25;11:90. doi: 10.12688/f1000research.76181.2. eCollection 2022.
PubMed 35211297Oruc MA, Ozturk O. Attitudes of health care professionals towards COVID-19 vaccine - a sequence from Turkey. Hum Vaccin Immunother. 2021 Oct 3;17(10):3377-3383. doi: 10.1080/21645515.2021.1928462. Epub 2021 Jun 18.
PubMed 34142925Wu J, Li Q, Silver Tarimo C, Wang M, Gu J, Wei W, Ma M, Zhao L, Mu Z, Miao Y. COVID-19 Vaccine Hesitancy Among Chinese Population: A Large-Scale National Study. Front Immunol. 2021 Nov 29;12:781161. doi: 10.3389/fimmu.2021.781161. eCollection 2021.
PubMed 34912346Luk TT, Zhao S, Wu Y, Wong JY, Wang MP, Lam TH. Prevalence and determinants of SARS-CoV-2 vaccine hesitancy in Hong Kong: A population-based survey. Vaccine. 2021 Jun 16;39(27):3602-3607. doi: 10.1016/j.vaccine.2021.05.036. Epub 2021 May 18.
PubMed 34034950Wisniak A, Baysson H, Pullen N, Nehme M, Pennacchio F, Zaballa ME, Guessous I, Stringhini S; Specchio-COVID19 study group. COVID-19 vaccination acceptance in the canton of Geneva: a cross-sectional population-based study. Swiss Med Wkly. 2021 Dec 14;151:w30080. doi: 10.4414/smw.2021.w30080. eCollection 2021 Dec 6.
PubMed 34908389Ishimaru T, Okawara M, Ando H, Hino A, Nagata T, Tateishi S, Tsuji M, Matsuda S, Fujino Y; CORoNaWork Project. Gender differences in the determinants of willingness to get the COVID-19 vaccine among the working-age population in Japan. Hum Vaccin Immunother. 2021 Nov 2;17(11):3975-3981. doi: 10.1080/21645515.2021.1947098. Epub 2021 Jul 2.
PubMed 34213406Ko T, Dendle C, Woolley I, Morand E, Antony A. SARS-COV-2 vaccine acceptance in patients with rheumatic diseases: a cross-sectional study. Hum Vaccin Immunother. 2021 Nov 2;17(11):4048-4056. doi: 10.1080/21645515.2021.1958611. Epub 2021 Aug 6.
PubMed 34357827Tan LF, Huak CY, Siow I, Tan AJ, Venugopalan PM, Premkumar A, Seetharaman SK, Tan BYQ. The road to achieving herd immunity: factors associated with Singapore residents' uptake and hesitancy of the COVID-19 vaccination. Expert Rev Vaccines. 2022 Apr;21(4):561-567. doi: 10.1080/14760584.2022.2021883. Epub 2022 Jan 11.
PubMed 34937504Tiirinki H, Viita-Aho M, Tynkkynen LK, Sovala M, Jormanainen V, Keskimaki I. COVID-19 in Finland: Vaccination strategy as part of the wider governing of the pandemic. Health Policy Technol. 2022 Jun;11(2):100631. doi: 10.1016/j.hlpt.2022.100631. Epub 2022 Apr 14.
PubMed 35437478Pena S, Zhou Z, Kestila L, Galanti MR, Shaaban AN, Caspersen IH, Magnus P, Geraldo P, Rojas-Saunero P, Parikka S, Nohynek H, Karvonen S. Tobacco Use and Uptake of COVID-19 Vaccinations in Finland: A Population-Based Study. Nicotine Tob Res. 2024 Oct 22;26(11):1553-1562. doi: 10.1093/ntr/ntad234.
PubMed 38196092
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Use and Uptake of COVID-19 Vaccinations in Finland: a General Population Study
- ClinicalTrials.gov ID
- NCT05479383
- Acronym / sponsor ID
- THL/713/6.00.00/2021.2
- Conditions
- COVID-19, Smoking, Tobacco Use, Vaccination Refusal
- Keywords
- Tobacco use, Smoking, COVID-19, SARS-CoV-2, Vaccinations, Cohort studies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42,935 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Karolinska Institutet, Norwegian Institute of Public Health
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study of participants in two general population health surveys (FinSote 2018 and 2020) who are followed up for their COVID-19 vaccinations or end of follow-up. The primary objective is to examine the association between tobacco use and COVID-19 vaccine uptake and between-dose spacing.
Detailed description
Most high income countries have rolled out COVID-19 vaccinations, with the promise of reducing incident COVID-19 infections and preventing hospitalizations and deaths. A high vaccination coverage is crucial for several reasons: (i) to reduce the number of new COVID-19 cases, (ii) to diminish selective pressures leading to the emergence of new variants of concern, (iii) to prevent severe COVID-19 outcomes, such as hospitalizations and deaths, and (iv) to potentially reduce the risk of post-acute COVID-19 symptoms.
Smokers are at higher risk of COVID-19 hospitalizations and deaths and might thus benefit greatly from high vaccination coverage. However, evidence suggests that they may be less likely to be vaccinated, as smokers are less likely to adhere to preventive measures in general and have lower adherence to other vaccines. Reports of a protective role of smoking on the risk of COVID-19 infection might have also reduced the perceived risks from being infected.
Evidence regarding tobacco use and COVID-19 vaccine hesitancy is mixed. Some studies have shown greater mistrust in COVID-19 vaccine benefits and greater vaccine hesitancy and lower vaccine acceptance compared to non-smokers, while other studies have reported no differences by smoking status or lower levels of vaccine hesitancy in smokers compared to non-smokers. Few studies have examined the relationship between tobacco use and vaccine uptake, showing that smokers had higher odds of being vaccinated. These studies, however, are not representative of the general population and relied on self-reported vaccination status, resulting in higher risk of selection and information bias.
The investigators will expand current knowledge by examining two forms of tobacco use in Finland -smoking and smokeless tobacco use (snus)- and by analysing the spacing between vaccine doses. The study will use data from nationally representative surveys in Finland linked to vaccination registries, which reduces the risk of selection and information bias.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tobacco users | – | Other: Not applicable, this is an observational studyTobacco users Never smokers (reference group) will be compared with former smokers, occasional smokers and daily smokers. Never snus users (reference group) will also compare with never users, former users and current users. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Permanent residents in Finland aged 20 and over who participated in the FinSote surveys in 2018 and 2020. These are general population samples representative of the Finnish population. The sampling frame was the Population Register (in 2020 the Digital and Population Data Services Agency, created after the merge between the Population Register of Statistics Finland and local register offices), which includes all individuals residing permanently in Finland, including conscripts and people living in institutions.
Key inclusion criteria (5 listed)
- Permanent residents of Finland
- Registered in the Population Register at the moment of sampling
- Aged 20 and over
- Participated in the FinSote surveys in 2018 or 2020
- Provided consent for register linkage
Key exclusion criteria (4 listed)
- Temporary residents in Finland or tourists
- Age less than 20 years old
- Did not participate in FinSote surveys in 2018, 2019 and 2020
- Did not provide consent for register linkage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable, this is an observational studyNot applicable, this is an observational study | Other | Tobacco users |
Primary outcome
Vaccination uptake of at least two doses of a COVID-19 vaccine
Time frame: Baseline until date of vaccination or May 31, 2022
Proportion of participants with at least two doses of a COVID-19 vaccine
4 secondary outcomes
Vaccination uptake of at least one dose of a COVID-19 vaccine
Time frame: Baseline until date of vaccination or May 31, 2022
Vaccination uptake of complete COVID-19 vaccination scheme (two doses and a booster dose)
Time frame: Baseline until date of vaccination or May 31, 2022
Spacing of first and second COVID-19 dose
Time frame: Baseline until date of vaccination or May 31, 2022
Spacing of second dose and booster dose of the COVID-19 vaccine
Time frame: Baseline until date of vaccination or May 31, 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 33007104Simons D, Shahab L, Brown J, Perski O. The association of smoking status with SARS-CoV-2 infection, hospitalization and mortality from COVID-19: a living rapid evidence review with Bayesian meta-analyses (version 7). Addiction. 2021 Jun;116(6):1319-1368. doi: 10.1111/add.15276. Epub 2020 Nov 17.
- Background: PubMed 33751125Jackson SE, Paul E, Brown J, Steptoe A, Fancourt D. Negative Vaccine Attitudes and Intentions to Vaccinate Against Covid-19 in Relation to Smoking Status: A Population Survey of UK Adults. Nicotine Tob Res. 2021 Aug 18;23(9):1623-1628. doi: 10.1093/ntr/ntab039.
- Background: PubMed 34987300Krebs NM, D'Souza G, Bordner C, Allen SI, Hobkirk AL, Foulds J, Yingst JM. COVID-19 Vaccination Uptake and Hesitancy Among Current Tobacco Users. Tob Use Insights. 2021 Dec 20;14:1179173X211068027. doi: 10.1177/1179173X211068027. eCollection 2021.
- Background: PubMed 35211297Ali M, Ahmed S, Bonna AS, Sarkar AS, Islam MA, Urmi TA, Proma TS. Parental coronavirus disease vaccine hesitancy for children in Bangladesh: a cross-sectional study. F1000Res. 2022 Jan 25;11:90. doi: 10.12688/f1000research.76181.2. eCollection 2022.
- Background: PubMed 34142925Oruc MA, Ozturk O. Attitudes of health care professionals towards COVID-19 vaccine - a sequence from Turkey. Hum Vaccin Immunother. 2021 Oct 3;17(10):3377-3383. doi: 10.1080/21645515.2021.1928462. Epub 2021 Jun 18.
- Background: PubMed 34912346Wu J, Li Q, Silver Tarimo C, Wang M, Gu J, Wei W, Ma M, Zhao L, Mu Z, Miao Y. COVID-19 Vaccine Hesitancy Among Chinese Population: A Large-Scale National Study. Front Immunol. 2021 Nov 29;12:781161. doi: 10.3389/fimmu.2021.781161. eCollection 2021.
- Background: PubMed 34034950Luk TT, Zhao S, Wu Y, Wong JY, Wang MP, Lam TH. Prevalence and determinants of SARS-CoV-2 vaccine hesitancy in Hong Kong: A population-based survey. Vaccine. 2021 Jun 16;39(27):3602-3607. doi: 10.1016/j.vaccine.2021.05.036. Epub 2021 May 18.
- Background: PubMed 34908389Wisniak A, Baysson H, Pullen N, Nehme M, Pennacchio F, Zaballa ME, Guessous I, Stringhini S; Specchio-COVID19 study group. COVID-19 vaccination acceptance in the canton of Geneva: a cross-sectional population-based study. Swiss Med Wkly. 2021 Dec 14;151:w30080. doi: 10.4414/smw.2021.w30080. eCollection 2021 Dec 6.
- Background: PubMed 34213406Ishimaru T, Okawara M, Ando H, Hino A, Nagata T, Tateishi S, Tsuji M, Matsuda S, Fujino Y; CORoNaWork Project. Gender differences in the determinants of willingness to get the COVID-19 vaccine among the working-age population in Japan. Hum Vaccin Immunother. 2021 Nov 2;17(11):3975-3981. doi: 10.1080/21645515.2021.1947098. Epub 2021 Jul 2.
- Background: PubMed 34357827Ko T, Dendle C, Woolley I, Morand E, Antony A. SARS-COV-2 vaccine acceptance in patients with rheumatic diseases: a cross-sectional study. Hum Vaccin Immunother. 2021 Nov 2;17(11):4048-4056. doi: 10.1080/21645515.2021.1958611. Epub 2021 Aug 6.
- Background: PubMed 34937504Tan LF, Huak CY, Siow I, Tan AJ, Venugopalan PM, Premkumar A, Seetharaman SK, Tan BYQ. The road to achieving herd immunity: factors associated with Singapore residents' uptake and hesitancy of the COVID-19 vaccination. Expert Rev Vaccines. 2022 Apr;21(4):561-567. doi: 10.1080/14760584.2022.2021883. Epub 2022 Jan 11.
- Background: PubMed 35437478Tiirinki H, Viita-Aho M, Tynkkynen LK, Sovala M, Jormanainen V, Keskimaki I. COVID-19 in Finland: Vaccination strategy as part of the wider governing of the pandemic. Health Policy Technol. 2022 Jun;11(2):100631. doi: 10.1016/j.hlpt.2022.100631. Epub 2022 Apr 14.
- Description of the Tobrisk-CoV projectLink provided by the sponsor.
- Individual participant dataSharing planned: No. Researchers can access individual data by contacting the Responsible Researcher at the Finnish Institute for Health and Welfare, Suvi Parikka, suvi.parikka [at] thl.fi. Information about FinSote surveys, including questionnaires, can be found in https://thl.fi/fi/tutkimus-ja-kehittaminen/tutkimukset-ja-hankkeet/finsote-tutkimus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sakari Karvonen, PhD principal investigator
Finnish Institute for Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Smoking, run by Finnish Institute for Health and Welfare at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination uptake of at least two doses of a COVID-19 vaccine (time frame: Baseline until date of vaccination or May 31, 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05479383, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.