Surveys and Self-Reported Usage Data

These studies were conducted to explicitly understand electronic cigarette user topography. Table 3.9 (below) shows the studies dependent on either questionnaires or users self-reported data to quantify the puffing topography characteristics.

Table 3.9: Topography studies that use Survey and Self-Reported data for electronic cigarette topography protocols.

Author

55

56

Etter [63] assessed the use patterns, reasons for use and the users’ opinions of electronic cigarettes.

This research group utilized a questionnaire in order to collect the desired data. The survey was posted on a smoking cessation website Stop-Tabac.ch between September and October 2009.

Participants in the study were eligible if they had ever used an electronic cigarette and provided the brand name of the most used electronic cigarette. Participants were asked if they were still using electronic cigarettes, they were asked how many puffs they consumed on a daily basis, the brand they used most often, preferred flavor, nicotine concentration, cost per package and whether the electronic cigarettes helped them quit smoking conventional cigarettes. Demographics of the users, age, sex and country of residence, were also captured in the questionnaire. Eighty one participants, 77 men and 4 women, responded to the questionnaire. The median age of the participants was 37 years old. The participants lived in various countries: 81% in France, 8%

Belgium, 6% Canada and 5% in Switzerland. The majority of the participants, 63%, indicated they quit smoking conventional cigarettes in the past 100 days. Most of the participants had been using the electronic cigarettes for 3 months or longer. The average number of puffs taken daily was 175, identified in Table 3.9 (above). There were 16 brands of electronic cigarettes named in the study

57 the most popular being: Janty, Joye, Sedansa, Econolope, Liberty-cig, Smoke51 and Edsylver.

There was no information provided about the models of the brands. The most popular flavors were:

tobacco, mint, fruit, vanilla, coffee and tea. This study captured valuable data about the participant’s demographics however, the only topography characteristic it was able to gather was number of puffs on a daily basis. This information also presents user bias since the method used to collect data is dependent of the participant’s response. In order to mitigate user bias utilizing an instrument that can quantitatively measure the desired puffing topography characteristics would improve the validity of the data gathered.

Etter and Bullen [64] conducted a research study aimed to assess electronic cigarette user’s profiles, utilization patterns and determine the satisfaction and perceived effects. Data was collected from a questionnaire on the smoking cessation website Stop-Tabac.ch as well as other discussion forums and websites. Data was collected between the months of March to October 2010. Participants were required to be over the age of 18 and either be current, past or never-users of electronic cigarettes. In order to regulate duplicate responses IP addresses and computer numbers were recorded.

The survey used was approved by the ethics committee of the Geneva University Hospitals to collect the following information:

1) Prior or current use of electronic cigarettes and intention to use them.

2) Dosage, puffs/day, brand, flavors, cost and where obtained.

3) Duration of use, delivery of nicotine, ease in staying off cigarettes.

4) Effect on smoking cessation and on tobacco withdrawal symptoms in participants who had used the electronic cigarette during a quit attempt.

5) Respiratory symptoms.

6) Reasons for using and reasons for stopping use.

7) Side effects, acceptability and satisfaction.

8) Use of smoking cessation medications (nicotine therapy, bupropion and varenicline).

9) Smoking status, cigarettes per day and time to first cigarette.

10) Currently trying to quit or reduce smoking, intention to quit, confidence in ability to quit.

11) Age, sex, income, education, country and, from May 2010 onwards, where respondents learned about the survey.

58 After deleting duplicates and removing records that corresponded with users who were less than 18 years old, 3587 records were analyzed. The median age of the users was 41 years old. 61% of the participants were male and 70% were former smokers. The respondents came from various countries: 62% United States, 14% France, 6% United Kingdom, 4% Switzerland, 3% Canada and 11% from other countries. The popularity of brands and flavors varied by country. However, the most used models were 510, the eGo, the KR808, 901, and the Tornado while the most used flavor was tobacco with mint-menthol and fruit flavors closely following behind.

The data collected in this study was dependent on the participant’s responses in order to collect the desired utilization patterns which introduces user bias. A questionnaire alone is not sufficient enough to rely on these participants profiles. In order to expand on this research utilizing an instrument in conjunction with the questionnaire would help mitigate the user’s bias. It could also show the accuracy of self-reporting. If all the participants’ responses were statistically close to the collected data then it could support a questionnaires validity. However, if it proved to show a great difference then a questionnaire could be problematic. There was no reported data for electronic cigarette topography other than number of puffs collected in a day found in Table 3.9 (above). A questionnaire is unable to capture specific parameters of such as mean puff volume, mean puff flow rate or interpuff.

Vansickel and Eissenberg [50] study was mentioned in the previous referenced topography profile Chapter 3.1.3 (above). After the first study referencing Eissenberg [12] topography characteristics, the subjects were asked to smoke ad lib for 60 minutes and self-report how many puffs were taken throughout the duration identified in Table 3.9 (above). Blood was sampled every 15 minutes to measure plasma nicotine. The results from the ad lib session ranged from 4 to 76 puffs with an average of 46.6 puffs in 60 minutes. This data is dependent on the subjects’ response and therefore, introduces user bias. It should be noted that the range of number of puffs is so broad, which means subjects consuming 76 puffs in 60 minutes consumed 19 times the amount of nicotine users who puffed 4 puffs consumed, assuming the same puff volume, puff flow rate and puff duration. This emphasizes the necessity for a range of puffing topography profiles to understand nicotine consumption. This study could also be improved by using a quantitative measuring device to collect the desired puffing topography characteristics.

59 Dawkins and Corcoran [22] study was mentioned in the no referenced topography profile Chapter 3.1.1 (above). After completing the first study collecting information about how much nicotine was consumed in 10 puffs, the subjects were asked to smoke ad lib for 60 minutes. Throughout this duration the subjects were asked to note how many puffs were consumed under the observation of the researchers. The range of puffs taken in the 60 minutes was 11 to 63 with an average value of 29, found in Table 3.9 (above). Like the previous Vansickel and Eissenberg study mentioned it is necessary to have a range of puffing topographies to understand consumption of nicotine since users puffing 63 puffs consumed 5 times more than the users puffing 11 puffs, assuming the same puffing topography profiles. This study can also improve by using a quantitative instrument to measure the desired puffing topography characteristics. Unlike the previous study the researchers also observed the number of puffs reported from the subjects and therefore supports the validity of the reported data.

Etter and Eissenberg [65] conducted a study to assess the dependence levels of electronic cigarette users compared to nicotine gum users and tobacco cigarette smokers. The study was divided into five phases.

1) Daily electronic cigarette users who were former cigarette smokers compared their current level of dependence on electronic cigarettes with their former level of tobacco cigarette dependence.

2) Dependence ratings were taken for electronic cigarette users versus without nicotine.

3) Former cigarette smokers’ daily electronic cigarette dependence was compared to daily nicotine gum users.

4) The dependence level on electronic cigarettes in former cigarette smokers and in current cigarette smokers was compared.

5) In daily cigarette smokers a comparison between dual users’ electronic cigarette dependence and dependence on tobacco cigarettes was compared.

A questionnaire was utilized in this study to gather participants and their use data. A questionnaire for electronic cigarette users was posted on a smoking cessation website Stop-tabac,ch between October 2012 and October 2013. Participants were eligible if they were over the age of 18 and daily electronic cigarette users. Nicotine gum users data was collected between 2004 and 2007 utilizing the same website. 451 former smokers who used the nicotine gum daily and had stopped

60 smoking in the last 7 days were included. Two samples of daily cigarette smokers were gathered.

2206 daily cigarette smokers were gathered using the same website from 2004 to 2007 while a sample of 1487 completed a mailed questionnaire from a registry of residents in Geneva, Switzerland.

There were different methods established in order to assess the level of dependence for the users.

The only measurements that were not validated were the dependence on electronic cigarettes and the nicotine gum. For tobacco cigarette smokers’ dependence instruments like the 6-item Fagerstrӧm test (FTND), the 19-item nicotine dependence syndrome scale (NDSS) and cigarette dependence scale (CDS) were utilized. The data collected from this study, identified in Table 3.9 (above) showed that former cigarette smokers who now consumed electronic cigarettes daily had more puffs, 217, compared to daily cigarette users who smoke electronic cigarettes daily at 140 puffs per day.

This data set, like some previously mentioned, can improve since a questionnaire was utilized to gather the users’ data. Collecting the data quantitatively in conjunction with the self-reported data would help mitigate the bias introduced to the study. Another area that needs to be improved upon for this study was the dependence of electronic cigarettes and nicotine gum. There was no way to measure dependence at data collection and therefore, any information that was presented had bias introduced from the researchers. Proper validation methods should be establish in order to mitigate these issues.

Nides et al. [27] study was mentioned in the no referenced topography profile Chapter 3.1.1 (above). On Visit 2 the subjects were given a diary to record the number of puffs they took when using the ENDS devices. Subjects recorded the puffs consumed for 7 days which is identified in Table 3.9 (above). The mean puff usage varied widely, 1.7 – 400 puffs per day. The median value reported was 59 puffs per day. There were only 2 subjects who averaged more than 160 puffs per day. Like the previous studies this wide range presents issues. For the subjects consuming 400 puffs a day, they consumed 235 times the amount a subject puffing only 1.7 puffs per day, assuming the same puffing topography profiles. This study could be improved upon if it did not solely rely on self-reported data which introduced user bias. A quantitative measuring instrument would improve the validity of the desired topography characteristics data.

61 Yan and D’Ruiz [31] study was mentioned in the no referenced topography profile Chapter 3.1.1 (above). After subjects completed the controlled session they were asked to puff ad lib for one hour. The subjects were asked to maintain their own puffs. The reported data is identified in Table 3.9 (above). This study relied on self-reported data to measure the number of puffs taken in a one hour session. This introduces user bias and therefore, can be improved by utilizing a measuring device to capture the desire puffing topography characteristics. The range of puffs taken in the one hour session for this study was also very broad. Product A had a range of 5 – 128, Product B = 4 – 136, Product C = 8 – 140, Product D = 8 – 112 and Product E = 3 – 118. Not only does this show a wide range it also shows variability between brands. Therefore, understanding how brand impacts electronic cigarette use is also important.

D’Ruiz et al. [43] study was mentioned in the standard topography profile protocol in Chapter 3.1.2 (above). After the first controlled dose study a one hour ad lib puffing session was tested.

The research group was interested investigating the plasma nicotine levels under uncontrolled, natural use conditions. The subjects were asked to keep track of the number of puffs consumed during the ad lib period. The data collected in this session is identified in Table 3.9 (above) and has the same range of data for each product as the Yan and D’Ruiz [31] study. The same issues presented in the Yan and D’Ruiz study as well as the recommendations for improvement are applicable to this study.

Manzoli et al. [66] evaluated the safety and efficacy of electronic cigarettes. They were interested comparing the results of subjects using only electronic cigarettes, conventional cigarettes or both.

The subjects were recruited from June to November 2013 through direct contact at general practitioners, electronic cigarette stores, internet advertisements and social networks. All subjects that were recruited for the electronic cigarette categories were required to have at least 6 months of electronic cigarette use. This study was only interested in users between 30 and 75 years old.

The mean age was 44.5 ± 11.6 years. All the subjects in this study previously used conventional cigarettes for more than 20 years. The instrument used to collect the desired data was a questionnaire administer either on a phone interview or on the www.ipazienti.it/fumo website. The questionnaire was available for 12 months. Table 3.9 (above) identifies all the data collected. For the electronic cigarette use group, N = 236, the mean value for number of puffs consumed on a daily basis was 162 (SD=276) and the dual smoking group, N = 232, was 96 (SD=146). This study

62 has user bias in the reported data because it solely relies on the response of its subjects. To mitigate this bias and improve the validity of the reported data a quantitative measuring device could be used in conjunction to support the results.

Oncken et al. [62] study was mentioned in the measured topography profile Chapter 3.1.4 (above).

The recruitment, devices tested, procedures and results presented in that section are the same for this section. The reported values are identified in Table 3.9 (above). This study relied on the subjects reporting the number of puffs consumed and therefore can improve by implementing a quantitative measuring device to improve the validity of the results.