Trial Outcomes & Findings for The TackSHS Survey: a Pan-European Study on SHS (NCT NCT02928536)

NCT ID: NCT02928536

Last Updated: 2019-11-20

Results Overview

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).

• Recruitment status: COMPLETED
• Target enrollment: 11902 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2019-11-20

Participant Flow

A pilot study was conducted in Italy in November 2016. The fieldwork in other countries was conducted between June 2017 (in Romania) and October 2018 (in Latvia). The questionnaire was administered with computer-assisted personal interviewing (CAPI) through face-to-face interviews at participants' homes.

Participant milestones

Measure	Overall Sample Population aged 15 years or more from 12 European countries
Overall Study STARTED	11902
Overall Study COMPLETED	11902
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Sample n=11902 Participants Population aged 15 years or more from 12 European countries
Age, Categorical <=18 years	572 Participants n=11902 Participants
Age, Categorical Between 18 and 65 years	9283 Participants n=11902 Participants
Age, Categorical >=65 years	2047 Participants n=11902 Participants
Age, Continuous	46.4 years STANDARD_DEVIATION 17.1 • n=11902 Participants
Age, Customized	46 years n=11902 Participants
Sex: Female, Male Female	6270 Participants n=11902 Participants
Sex: Female, Male Male	5632 Participants n=11902 Participants
Region of Enrollment Bulgaria	1050 participants n=11902 Participants
Region of Enrollment United Kingdom	1013 participants n=11902 Participants
Region of Enrollment France	1018 participants n=11902 Participants
Region of Enrollment Germany	1031 participants n=11902 Participants
Region of Enrollment Greece	1000 participants n=11902 Participants
Region of Enrollment Ireland	941 participants n=11902 Participants
Region of Enrollment Italy	1059 participants n=11902 Participants
Region of Enrollment Latvia	1022 participants n=11902 Participants
Region of Enrollment Poland	724 participants n=11902 Participants
Region of Enrollment Portugal	1000 participants n=11902 Participants
Region of Enrollment Romania	1018 participants n=11902 Participants
Region of Enrollment Spain	1026 participants n=11902 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Non-smokers (i.e., never and former smokers) aged 15 years or more from 12 European countries

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).

Outcome measures

Measure	Overall Sample n=8562 Participants Population aged 15 years or more from 12 European countries
Prevalence of Daily Exposure to Secondhand Smoke (SHS) in Indoor Settings	2888 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Electronic cigarette non-users (i.e., never or former users) aged 15 years or more from 12 European countries

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).

Outcome measures

Measure	Overall Sample n=11604 Participants Population aged 15 years or more from 12 European countries
Prevalence of Exposure to Secondhand Aerosol (SHA) From Electronic Cigarettes	1858 Participants

SECONDARY outcome

Timeframe: Baseline

Cigarette consumption is assessed at baseline (thus representing current use at interview) through self-reported questions on lifetime use. Never smokers were defined as participants who had never smoked or had smoked less than 100 cigarettes in their lifetime. Smokers were defined as participants who reported smoking at least 100 cigarettes (including hand-rolled cigarettes) during their lifetime. Current smokers were smokers who reported smoking at the time they participated in this survey, while former smokers were smokers who stopped smoking by the time they participated in this survey.

Outcome measures

Measure	Overall Sample n=11902 Participants Population aged 15 years or more from 12 European countries
Prevalence of Never, Current and Former Smokers Never smokers	6513 Participants
Prevalence of Never, Current and Former Smokers Former smokers	2049 Participants
Prevalence of Never, Current and Former Smokers Current smokers	3340 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Participants with available information on electronic cigarette use

Electronic cigarette use is assessed at baseline (thus representing current use at interview) through self-reported questions on lifetime use. Current electronic cigarette users were defined as those who reported using the electronic cigarette occasionally (5 days or less) or regularly (more than 5 days) in the last 30 days. Former users of electronic cigarette were those who reported using it in the part but not over the last 30 days.

Outcome measures

Measure	Overall Sample n=11876 Participants Population aged 15 years or more from 12 European countries
Prevalence of Never, Current and Former Electronic Cigarette Users Never users	11299 Participants
Prevalence of Never, Current and Former Electronic Cigarette Users Former users	305 Participants
Prevalence of Never, Current and Former Electronic Cigarette Users Current users	272 Participants

Adverse Events

Overall Sample

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Silvano Gallus, head of the Laboratory of Lifestyle Epidemiology

Istituto di Ricerche Farmacologiche Mario Negri

Phone: 0039023901

Email: silvano.gallus@marionegri.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place