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临床试验/NCT02928536
NCT02928536已完成不适用

The TackSHS Survey: a Cross-sectional Study on Secondhand Smoke in 12 European Countries

Mario Negri Institute for Pharmacological Research1 个研究点 分布在 1 个国家目标入组 11,902 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11,902
试验地点
1
主要终点
Prevalence of Daily Exposure to Secondhand Smoke (SHS) in Indoor Settings

研究概览

简要总结

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.

详细描述

Study characteristics The TackSHS survey is a face-to-face population-based cross-sectional survey that will be conducted in 12 selected European countries, coordinated by Dr Silvano Gallus, Department of Epidemiology of the "Mario Negri" Institute (Milan, Italy).

Background Exposure to secondhand smoke (SHS) has serious adverse health effects on adults and children, causing more than 600,000 deaths each year worldwide. Estimates of prevalence of non-smokers exposed to SHS range between 20% and 60% in various European countries. The WHO recommend to develop smoke-free policies to protect non-smokers from SHS exposure. E-cigarettes have irrupted in the market over the last 5 years, and their sales and popularity have considerably grown in the European Union (EU). Approximately 7% of Europeans ever used e-cigarettes. TackSHS is a new research project funded by the European Commission (EC) within the Horizon 2020 programme (grant agreement: 681040). Within the TackSHS Project, selected work packages (WP; i.e., WP3, WP9 and WP10) involve the conduction of a survey in 12 EU countries: the TackSHS survey.

Objectives Objectives of this cross-sectional study include: i) to estimate prevalence, and investigate individual-level and country-specific determinants, of smoking, e-cigarette use, and exposure to SHS and to e-cigarette aerosol in selected European countries (WP3); ii) to analyze the attitudes, perceptions and behaviours of the adult European population towards policies to limit SHS exposure (WP3); iii) to compare selected smoking-related data collected through the TackSHS survey with those from a companion pan-European survey conducted in 2010 (WP3); iv) to assess morbidity and mortality from selected respiratory and cardiovascular diseases attributable to SHS exposure among adults and children in the European population (WP9); v) to quantify the economic burden associated to the exposure to SHS and e-cigarette aerosol in Europe (WP10).

Methods The cross-sectional survey will be conducted in 12 European countries (Bulgaria, England, France, Germany, Greece, Ireland, Italy, Latvia, Poland, Portugal, Romania, and Spain), representing geographical, legislative and cultural variations across the EU. In each of the 12 selected countries, approximately 1000 individuals, representative of the general population aged 15 years and over will be enrolled. The final sample will therefore include a total of approximately 12,000 subjects. 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.

Survey participants will have to satisfy the following inclusion criteria: i) 15 years and over of age; ii) residence in one of the 12 selected countries; iii) ability to understand and answer the questions of the questionnaire of the study in the country-specific language; iv) formal acceptance to participate in the study.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • No specific exclusion criteria are considered.

结局指标

主要结局

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

时间窗: Baseline

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).

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

时间窗: Baseline

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).

次要结局

  • Prevalence of Never, Current and Former Smokers(Baseline)
  • Prevalence of Never, Current and Former Electronic Cigarette Users(Baseline)

研究者

发起方
Mario Negri Institute for Pharmacological Research
申办方类型
Other
责任方
Sponsor

研究点 (1)

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