The TackSHS Survey: a Pan-European Study on SHS

NCT02928536 | Completed Results

• 1 other identifier: 6895
• Study Type: observational
• Target: 11,902
• Locations: 1 country
• Sites: 1

Brief Summary

Within the TackSHS project (H2020 project grant agreement No 681040), we will conduct a European cross-sectional study, aiming at i) estimating prevalence and investigating determinants of smoking, e-cigarette use and exposure to SHS and to e-cigarette aerosol; ii) analyzing the attitudes, perceptions and behaviours of the adult European population towards policies to limit SHS exposure; iii) comparing selected smoking-related data between TackSHS and a previously conducted pan-European survey; iv) assessing mortality and morbidity from selected respiratory and cardiovascular diseases attributable to SHS exposure among adults and children in Europe; v) quantifying the economic burden associated to the exposure to SHS and e-cigarette aerosol in Europe. Overall, approximately 12,000 individuals aged 15 years or over will be enrolled in 12 different European countries (BG, DE, ES, FR, GR, IE, IT, LV, PL, PT, RO, UK). Surveys will be representative of the country-specific population in terms of sex, age, and socio-economic characteristics.

Conditions

Second Hand Tobacco Smoke

Outcome Measures

Primary Outcomes (2)

• Prevalence of Daily Exposure to Secondhand Smoke (SHS) in Indoor Settings

  Exposure to secondhand smoke (SHS) is assessed among non-smokers and indicates the general daily exposure (during a working day and during a non-working day) to SHS in indoor settings (i.e., at home, at workplace, in public and private transports and in other indoor settings). SHS exposure is self-reported and is assessed through a face-to-face interview at baseline (thus representing current exposure at interview).

  Baseline

• Prevalence of Exposure to Secondhand Aerosol (SHA) From Electronic Cigarettes

  Exposure to secondhand aerosol (SHA) is assessed among electronic cigarette non-users and indicates the general daily exposure (during a working day and during a non-working day) to SHA in indoor settings (i.e., at home, at workplace, in public and private transports and in other indoor settings). SHA exposure is self-reported and is assessed through a face-to-face interview at baseline (thus representing current exposure at interview).

  Baseline

Secondary Outcomes (2)

• Prevalence of Never, Current and Former Smokers

  Baseline

• Prevalence of Never, Current and Former Electronic Cigarette Users

  Baseline

Interventions

no intervention OTHER

This is an observational study. No intervention is considered

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In each of the 12 selected European countries, approximately 1000 individuals, representative of the general population aged 15 years and over in terms of age, sex, geographic area, and socio-economic characteristics, will be enrolled in this cross-sectional study. The final sample will therefore include a total of approximately 12,000 subjects. Sample size computation The sample size in each specific country will allow us to obtain prevalence estimates with a maximum standard error (SE) lower than ± 1.6%. Therefore, with such a sample size we will be able to provide stable prevalence estimates (with a relatively small 95% confidence interval), overall but also in each specific country.

You may qualify if:

• individuals aged 15 years and over;
• individuals resident of the 12 selected countries;
• individuals able to understand and answer the questions of the questionnaire of the study in the country-specific language;
• individuals who formally accept to participate in the study.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead
• Institut Català d'Oncologia: collaborator
• European Commission: collaborator

Study Sites (1)

DOXA Institute

Milan, 20144, Italy

Location

Related Publications (2)

• Fernandez E, Lopez MJ, Gallus S, Semple S, Clancy L, Behrakis P, Ruprecht A, Gorini G, Lopez-Nicolas A, Radu-Loghin C, Soriano JB; TackSHS Project Investigators; TackSHS Project Investigators. Tackling second-hand exposure to tobacco smoke and aerosols of electronic cigarettes: the TackSHS project protocol. Gac Sanit. 2020 Jan-Feb;34(1):77-82. doi: 10.1016/j.gaceta.2019.07.002. Epub 2019 Sep 23.

  PMID: 31558386 BACKGROUND

• Amalia B, Liu X, Lugo A, Fu M, Odone A, van den Brandt PA, Semple S, Clancy L, Soriano JB, Fernandez E, Gallus S; TackSHS Project Investigators. Exposure to secondhand aerosol of electronic cigarettes in indoor settings in 12 European countries: data from the TackSHS survey. Tob Control. 2021 Jan;30(1):49-56. doi: 10.1136/tobaccocontrol-2019-055376. Epub 2020 Mar 2.

  PMID: 32123139 DERIVED

Limitations and Caveats

* limitations inherent to the cross-sectional study design * there are some differences of sampling in the study countries * there was relatively small sample size in each country

Results Point of Contact

• Title: Silvano Gallus, head of the Laboratory of Lifestyle Epidemiology
• Organization: Istituto di Ricerche Farmacologiche Mario Negri

silvano.gallus@marionegri.it

0039023901

Study Officials

• Silvano Gallus, Sc.D

  Istituto Di Ricerche Farmacologiche Mario Negri

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 10, 2016
• Study Start: December 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 20, 2019
• Results First Posted: November 20, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)