Study sample and methodology for data collection

The current study is part of a European Commission Horizon-2020 funded study entitled European Regulatory Science on Tobacco: Policy implementation to reduce lung diseases (EUREST-PLUSHCO-06-2015). The EUREST-PLUS Project aims to monitor and evaluate the impact of the implementing Acts of the TPD within the context of the FCTC and its implementation within Europe¹³. Using the methodology of The International Tobacco Control Policy Evaluation (ITC) Project, a cross-sectional survey was conducted among six European countries (Wave 1 6E)¹⁴. A nationally representative sample of 6011 cigarette smokers of age 18 years or older was collected from Germany (n=1003), Greece (n=1000), Hungary (n=1000), Poland (n=1006), Romania (n=1001), and Spain (n=1001). Ethics approval for data collection was provided for each national cohort by the corresponding local ethics committees and informed consent was received from all participants.

Data collection occurred between June 2016 and September 2016. According to Nomenclature of Territorial Units for Statistics (NUTS), the geographic strata were NUTS2 regions (NUTS1 in Germany) crossed with degree of urbanization (urban, semi-urban, rural). Approximately 100 area clusters were sampled in each country, with the aim of obtaining 10 adult smokers per cluster. Clusters were allocated to strata proportionally to the population size for adults 18 years and older. Within each cluster, household addresses were sampled using a random walk design. One randomly selected male smoker and one randomly selected female smoker were chosen for interview from a sampled household where possible. Screening of households continued until the required number of smokers from the cluster had been interviewed. All interviews were conducted face-to-face by interviewers using tablets. Further details on the methodology of the 6E Survey can be found elsewhere¹³.

During the data collection period (June–Sept. 2016), Greece had text warnings on tobacco packages, while Germany and Poland had just moved from text warnings to large pictorial warnings covering ≥50% of the front and back of the package in May 2016. Romania, Hungary and Spain had medium-size pictorial warning (<50% of the front and back of package) which had been in place since 2008 (Romania) or 2011 (Hungary and Spain); in Hungary since 20 August 2016, there may have been tobacco products with large pictorial warnings, but compared to all, probably only to a negligible extent (Table 1).

Measures

Statistical analyses

Data were analyzed with SPSS 20.0 using the Complex Samples package to account for the complex sampling design. We analyzed data for each country separately and calculated percentages and standard errors. All statistical estimates presented are weighted for sex, age and degree of urbanization to make the data more representative of the population of smokers in each country. Participants who did not offer information regarding sociodemographic characteristics or the variables assessing the knowledge about health risks of smoking or the warning label impact were excluded from the analyses. Linear regression analyses were conducted to examine predictors of KHR and LII, the independent variables being age, gender, degree of urbanization, income, and education level, as well as the number of cigarettes smoked per day; these approaches were used based on previous relationships tested in other ITC studies^4,8,15.

In order to assess if the label impact index influences knowledge regarding the health risks of smoking, two approaches were used. First, linear regressions were performed with the KHR index as the dependent variable and the LII index as the independent variable, controlling for sociodemographic variables, as well as the number of cigarettes smoked per day. Second, logistic regression was performed using as dependent variables the measures that assess the knowledge of the risk of smoking for several diseases, and using the LII index as the independent variable, controlling for age, gender, degree of urbanization, income, education level (sociodemographic variables) as well as the number of cigarettes smoked per day.

Characteristics of the study sample

The study sample consisted of 6011 persons (47.2% women and 52.8% men; 35.4% were from urban areas, 37.5% from semi-urban and 27.1% from rural areas). The mean age was 45.1 years (8.4%, 18–24 years; 29.5%, 25–39; 33.3%, 40–54; 28.7% older than 54 years). The education level was: 36.8% low, 51.6% medium, 11% high, 0.6% did not declare. With regard to the income, 22.2% had low income, 37.4% medium, 17.4% high income, while 23% did not declare.

Knowledge of health risks (KHR) of smoking

With the exception of Hungary, more than 80% of the smokers in each country knew that active smoking causes heart diseases, lung cancer, and throat cancer (Table 3). More than two-thirds of smokers from all countries were aware of the risk of active smoking for pulmonary diseases (emphysema, bronchitis) and mouth cancer. In Spain and Hungary less than 60% of the smokers were aware of the risk of active smoking for stroke. The effect of smoking on impotence was recognized by approximately half of smokers and on blindness by one-third or less, the only exception being Romania where almost two-thirds knew the risk of smoking for impotence and more than half knew that smoking can cause blindness. Knowledge regarding the health risks of passive smoking was moderate in most countries, with lower levels of knowledge documented in Germany and Hungary. The risks of passive smoking were best known by smokers in Romania (Table 3). Smokers from Hungary and Germany also reported the lowest KHR index score, while the highest scores were documented in Greece and Romania.

The results of the regression analysis examining predictors or KHR are reported in Table 4. KHR index scores were lower among men than women in Germany, Hungary and Poland. In Romania and Greece, significantly lower KHR index scores were documented for smokers of age 18–24 years, compared to older age groups. In Poland, smokers who smoke less cigarettes/day had a better score. No other significant associations were documented for income or education at the country-level.

Effects of warning labels

The proportion of smokers who reported noticing warning labels ‘often or very often’ varied across countries (Table 5). Specifically, rates were lowest in Greece and Hungary, and highest in Romania and Poland where more than half of respondents reported they noticed the warnings. Less than one in five smokers declared that they read the warning labels often or very often, except in Romania where one-third of the smokers declared this.

The percentage of smokers who recalled seeing a helpline number on cigarette packs was around 30% in Germany, Romania and Poland, but was lower than 22% in Hungary and Spain, while in Greece it was around 7%. Information regarding quitting websites was noticed on cigarette packs by about 15% of smokers in all countries, ranging from the highest in Germany (20.9%) to the lowest in Greece (5.4%).

The percentage of smokers who declared that the warning labels made them think ‘a lot’ about health risks or made them more likely to quit was less than 6% for all countries, except in Romania, where more than 10% declared this. In Germany, Greece, Spain and Romania, 15% or less of smokers declared that in the last 30 days warning labels made them refrain from smoking at least once, while the percentage in Hungary and Poland was around 20%.

LII scores were lowest in Germany and Hungary, followed by Greece and Spain, and highest in Poland and Romania (Table 5). In all countries, except for Spain, the LII was higher among respondents who reported lower daily cigarette consumption (Table 6). In Poland, the LII was lower among people with lower educational level, while in Romania it was higher among those with low income. In Poland and Romania, it was lower among younger age groups, while in Greece a reverse situation was found. In Germany, urban residence was positively associated with a higher LII, while in Poland, the LII was lower among men.

Around two-thirds of smokers reported they wanted the same amount of health information to appear on cigarette packages, with the exception of Germany where more than 40% of smokers reported wanting less information on warning labels.

Relationship between the level of knowledge and labels impact index

Table 7 shows that in all countries, except for Poland, a higher LII score was positively associated with a higher KHR index score, even after controlling for sociodemographic variables and number of cigarettes smoked per day. Higher LII scores were also associated with greater knowledge of specific smoking-related diseases and conditions.

Principal findings

The findings of this study indicate that there are significant gaps in smokers’ understanding of the health risks of smoking across the six EU MS of the EUREST-PLUS ITC Survey. The vast majority of smokers were aware that smoking causes illnesses such as heart disease, lung and throat cancers. However, more than 20% of the smokers did not know that tobacco use causes mouth cancer, pulmonary diseases, and stroke. Smokers’ knowledge of the causal relationship between smoking and impotence and blindness was significantly lower. Importantly, with the exception of Romania, modest levels of knowledge of the health harms caused by exposure to secondhand smoke were observed across all six EU MS. These findings are similar to that of previous ITC reports for other countries^4,19-21. All countries in the present study included health warning labels that address risk of heart attack, stroke, lung cancer, and impotence, and to a lesser extent messages regarding blindness, throat, or mouth cancers. Warning labels included non-specific or general messages in terms of lung disease but did not include specific messages related to emphysema or bronchitis. For the most part, warning labels did not include specific messages about health effects of secondhand smoke on heart disease and lung cancer or asthma in children. In general, levels of knowledge observed in countries for specific diseases and conditions corresponded to the specific warning labels’ messages in circulation.

There were several country-level differences documented, with Romania and Greece having a greater percentage of smokers who recognized the smoking health harms for most of the diseases/ conditions assessed and higher scores on the KHR index. The lowest KHR index scores were documented in Germany and Hungary. These trends did not necessarily correspond to strong health warning labels in these countries in 2016. Given that there are other sources of information on the health risks of smoking, including educational programs in schools, mass media, and medical advice, the higher rates of KHR scores documented in some countries are potentially the consequence of several activities, in addition to warning labels, however this requires further validation^22-24. For instance, EUREST-PLUS Project findings show that there is an association between high exposure to mass media anti-smoking campaigns and increased knowledge of smoking health harms²⁵. Moreover, in Hungary, despite the fact that pictorial warnings were used on tobacco packages, many smokers were using roll-your-own (RYO) tobacco, and packaging of RYO rolling papers and filters, which had no health warning information prior to August 2016²⁶.

Several sociodemographic factors were associated with KHR index scores although trends varied between countries sampled. In three countries (Germany, Hungary, Poland) women had higher KHR scores, while in Romania and Greece, older age was associated with better KHR scores.

Our study found that only about one-third of smokers noticed warning labels often or very often, and only 20% read them often or very often. Approximately 5% of smokers declared that the warning labels made them think ‘a lot’ about health risks, or made them more likely to quit, and 15% reported warning labels made them refrain from smoking at least once. Seeing quitline and website information was reported at significantly lower rates in Greece, which is expected given this information did not appear on the warning labels in Greece in 2016 due to the non-existence of a National quitline.

Additionally, there was variability between countries with regard to health warnings’ impact on perceptions and actions of the smokers. For instance, Romania and Poland were the countries with the highest LII scores, while Germany and Hungary had the lowest scores. One potential explanation of the low LII score observed in Hungary could be that almost half of smokers in Hungary reported using roll-your-own (RYO) tobacco, while packaging of RYO rolling papers and filters had no health warning information prior to August 2016²⁶. At the same time, the impact might vary between countries also as a consequence of type (only text or text and pictorials) and dimension of the health warning, and the type of messages^2-9.

There was a correlation between higher daily cigarette consumption and lower LII scores. Other socioeconomic characteristics also influenced the LII at the country level. In Poland and Romania, the LII was higher among older age groups, while in Greece a reverse situation was observed. In Germany, urban residence was positively associated with a higher LII, while in Poland, the LII was higher among smokers with higher educational level. Other country-level factors, including the prevalence of tobacco use, characteristics of tobacco users and the extent to which comprehensive tobacco policies have been implemented are also expected to play a role in warning label effectiveness. As has been reported by others, it is possible that cultural factors, including receptivity to regulation, may play a role in explaining part of the differences observed between countries^27,28.

In almost all countries, a significant positive relationship was documented between a KHR and LII scores. Romania and Germany being the countries where this relationship was evident for 10 or 11 of the 12 investigated health risks, while in the other countries the LII scores were associated with the level of knowledge for at least three health risks.

Implications to practice

These data provide evidence to support the need for stronger education and policies that can enhance the effectiveness of health warnings among EU MS. Previous ITC studies showed that health warnings on cigarette packages are an important source of information regarding health effects of smoking^8,10. A recent systematic review showed that stronger warnings increased attention to warnings, recall of warnings, and thinking about the health risks of smoking, as well as perceptions that warnings reduce smoking and motivate quitting²⁷. There is substantial evidence to suggest that strengthening health warnings, such as those outlined in the EU TPD, will increase the effectiveness of warning labels and address some of the gaps in knowledge and salience, as well as promote quitting-related behaviors^2,3,5,27. The documented gaps in knowledge regarding the health effects of secondhand smoke may also be an important target for public awareness in countries that are still struggling with implementation of comprehensive smoke-free public spaces, cars, and homes.

Importantly, this study serves as a baseline for examining the impact of the TPD, which began its implementation in most countries examined in the EUREST-PLUS ITC Wave 1 Survey in 2016. Future longitudinal studies should investigate changes in knowledge regarding health risks of smoking and the effectiveness of warning labels over time and as a consequence of implementing the TPD in the EU, which will be done within the context of this Horizon 2020 project.

Limitations and strengths

While this study has many strengths with a large sample size of smokers across six nationally representative EU MS, findings should be interpreted in light of study limitations. First, the study used a cross-sectional design, which allows for the exploration of association rather than causality. The study included only current smokers and as such does not reflect individuals who recently quit smoking. The results are also based on participant self-report that may be subject to respondent and measurement bias. The present study examined variables prior to the implementation of the EU TPD and in some countries large pictorial warnings had been introduced just prior to our assessment and may not be sufficient to measure the effects of warning label changes in these countries. Likewise, KHR may have been influenced by other sources of education including mass media, which were not examined as part of this study. Given that the above warnings differed across countries including the size and health effects featured, some country level differences would be expected that were not controlled for in the analysis. In addition, there are other individual-level factors (e.g. nicotine addiction, presence of smoking-related illness or mental health illness) that might influence outcomes of interest that were not examined as part of this study.

Nevertheless, this study is the only one of its kind to provide a comprehensive baseline of the impact of health warning labels on smokers’ knowledge and smoking behaviors across multiple EU MS prior to the full implementation of the EU TPD, which will then be used to evaluate the impact of health warning provisions in a post-TPD assessment.