Examination of Lifetime Established Use Criteria for Adult Tobacco Product Users

Lai Wei; Mohamadi Sarkar; Thaddaeus Hannel; Edward Largo; Raheema Muhammad-Kah

doi:10.12688/f1000research.130607.1

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Research Article

Examination of Lifetime Established Use Criteria for Adult Tobacco Product Users 

[version 1; peer review: 1 approved]

Lai Wei ¹, Mohamadi Sarkar¹, Thaddaeus Hannel¹, Edward Largo¹, Raheema Muhammad-Kah¹

Lai Wei ¹, Mohamadi Sarkar¹, [...] Thaddaeus Hannel¹, Edward Largo¹, Raheema Muhammad-Kah¹

PUBLISHED 28 Feb 2023

Author details Author details

¹ Center for Research & Technology, Altria Client Services LLC, Richmond, Virginia, 23219, USA

Lai Wei
Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Resources, Software, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Mohamadi Sarkar
Roles: Conceptualization, Methodology, Writing – Review & Editing

Thaddaeus Hannel
Roles: Conceptualization, Methodology, Writing – Review & Editing

Edward Largo
Roles: Conceptualization, Methodology, Writing – Review & Editing

Raheema Muhammad-Kah
Roles: Conceptualization, Methodology, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Addiction and Related Behaviors gateway.

Abstract

Background: Lifetime established use criteria are essential to distinguish tobacco product experimental and established users; however, these criteria are not as well defined for some tobacco product categories. The objective of this analysis is to examine various lifetime use criteria to facilitate an objective characterization of experimental versus established use behaviors.
Methods: Our analyses were conducted using the Population Assessment of Tobacco and Health (PATH) Study Waves 1 to 5 datasets. We first examined the level of agreement between non-numerical (having smoked/used the product fairly regularly) and numerical ( having smoked/used the product 20/50/100 times (e.g., use occasions) or product units) lifetime established use criteria among ever-, current-, and former-tobacco product users of various tobacco products. Logistic regression models were constructed to compare demographics, socioeconomic status, and tobacco product use patterns among current experimental versus current established users. Longitudinal analyses were performed to investigate the association between numerical or non-numerical criteria and discontinuation of past 30-day use at follow-up waves.
Results: For tobacco product categories other than cigarette, we identified the following numerical thresholds as the objective characterization of established use: 50 for cigars and pipe products and 20 times for hookah, electronic nicotine products, smokeless, snus, and dissolvable tobacco products, based on level of agreement with the non-numerical criterion (kappa coefficients ranging from 0.3 to 0.6) and also with consideration of existing consensus. Significant differences were observed in demographics, socioeconomic status, tobacco product use and discontinuation of past 30-day use patterns when comparing current experimental and current established users with either non-numerical or numerical criteria.
Conclusions: This study is the first PATH data analysis to derive quantitative thresholds of lifetime established use criteria to characterize experimental versus established use behaviors. Consistent applications of the lifetime established use criteria in data analysis and reporting would improve harmonization in research findings.

Keywords

Tobacco established use behavior, experimental use behavior, lifetime established use thresholds, numerical lifetime established use criterion, non-numerical lifetime established use criterion.  

Corresponding author: Lai Wei

Competing interests: The authors are employees of Altria Client Services LLC, which provides certain services, including regulatory affairs, research and development, and regulatory sciences to the Altria family of companies. Altria’s operating companies manufacture and market tobacco products, including cigarettes.

Grant information: This research was funded by Altria Client Services LLC.

Copyright: © 2023 Wei L et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Wei L, Sarkar M, Hannel T et al. Examination of Lifetime Established Use Criteria for Adult Tobacco Product Users  [version 1; peer review: 1 approved]. F1000Research 2023, 12:225 (https://doi.org/10.12688/f1000research.130607.1) First published: 28 Feb 2023, 12:225 (https://doi.org/10.12688/f1000research.130607.1) Latest published: 28 Feb 2023, 12:225 (https://doi.org/10.12688/f1000research.130607.1)

Introduction

Distinguishing experimental and established tobacco product users is essential to study product use behavior (e.g., consumption or transition patterns), determine product adoption/cessation versus trial, and compare perceptions and intentions measures. The use of lifetime consumption of 100 cigarettes threshold has been well accepted to define established cigarette smokers.¹^–³ However, the lifetime established use criteria for other combustible or smoke-free product categories are less clear. Sánchez-Romero et al. conducted a comparison of tobacco product prevalence by different frequency of use thresholds and demonstrated lower variability in cigarette smoking prevalence by different current use frequency thresholds, which may be due, in part, to the adoption of the ‘100 cigarette lifetime’ criteria for prevalence estimation.⁴

There have been various efforts made to define established use for tobacco categories other than cigarette. For example, “ever smoked 50 or more cigars” has been adopted as the lifetime established use criterion for cigars from national surveys, such as the National Health Interview Survey (NHIS) and the National Adult Tobacco Survey (NATS).⁵^–⁸ “Ever use of smokeless tobacco greater than or equal to 20 times” has been applied as the established use criterion for smokeless tobacco products from national surveys, such as the NHIS.⁹^–¹¹ However, there is a lack of consensus regarding the numerical criteria of lifetime established use for electronic nicotine delivery system (ENDS) or other tobacco products. As examples, in the 2012–2013 and 2013–2014 NATS, numerical threshold of “1 time” (i.e., ever use) was used as threshold for lifetime use for hookah, e-cigarette, snus, and dissolvable tobacco products while the thresholds for conventional products were 100 for cigarettes, 50 times for cigars and pipe products and 20 times for chew, snuff, or dip.¹²^,¹³ On the other hand, the thresholds were 50 times for a pipe tobacco product in the 2000 NHIS and 2005 NHIS surveys,⁸ and 50 times for e-cigarettes.¹⁴^–¹⁷ Lastly, “fairly regularly” has been used in national surveys as a way to describe a persistent and stable product usage state. There are survey questions such as “smoke cigarettes fairly regularly throughout the day” (National Survey on Drug Use and Health (NSDUH)) (with response options of 1-Not at all true to 5-Extremely true), and “how old (were/was) (you/name) when (you/he/she) first started smoking cigarettes fairly regularly” (Tobacco Use Supplement - Current Population Survey (TUS-CPS)). The lifetime criterion of “having ever used the tobacco product fairly regularly” has been widely used now for tobacco products other than cigarettes (e.g., electronic nicotine products, smokeless tobacco, and snus products) with the inclusion of the questions in the Population Assessment of Tobacco and Health (PATH) Study.²^,⁷^,¹¹^,¹⁸^–²⁵

The PATH study is an on-going nationally representative, longitudinal cohort study of U.S. civilian non-institutionalized youth and adults. The study was launched in 2011 as a collaborative effort by the U.S. Food and Drug Administration (FDA), Center for Tobacco Products (CTP), the National Institutes of Health (NIH), and the National Institute on Drug Abuse (NIDA). The first wave of data from the PATH study was collected in 2013, and seven waves have been implemented or planned through 2022. The study generates longitudinal data on tobacco use behaviors, including patterns of use, attitudes, beliefs, exposures, and health consequences associated with the use of tobacco products. The PATH study interviews adult tobacco users and non-users about the use of multiple tobacco products, including cigarettes, e-cigarettes and electronic nicotine products, cigars (traditional cigars, cigarillos, filtered cigars), smokeless tobacco, snus pouches, pipe tobacco, hookah, and dissolvable tobacco products. There are two types of lifetime established use criteria that can be derived from PATH study questionnaires: (1) non-numerical criterion of having ever smoked/used the product fairly regularly, and (2) numerical criterion of having smoked/used the product X number of product units or used X or more times (e.g., 100 or more cigarettes, 100 or more times). Our secondary analyses provide a comprehensive overview of the response patterns and relationships between these two types of criteria for available tobacco product categories in PATH. To our knowledge, this is the first analysis to examine the differences in characteristics, such as demographics (e.g., age, sex), socioeconomic status (e.g., household income, education), tobacco product use and discontinuation of past 30-day use patterns, between experimental and established users across a wide spectrum of tobacco product categories. Additionally, through our review of the response patterns and relationships, we have provided recommendations of numerical thresholds that are in fair to substantial agreement with the non-numerical thresholds and can be used to facilitate alignment and harmonization in future tobacco research.

Methods

Our analyses were based on adult participants from the PATH study who were 18 years and older at each interview wave. At the time of our analyses, there were five waves of publicly available PATH data sets²⁶ with annual data collections between Wave 1 (September 2013 to December 2014) to Wave 4 (December 2016 to January 2018), and biennial collections after Wave 4 (e.g., Wave 5 data collection: December 2018 to November 2019). We derived the lifetime established use criteria based on two lifetime use questions in PATH¹: the non-numerical criterion from the survey question “have you ever smoked/used the tobacco product fairly regularly?” and² and the numerical criterion based on “how many [units] have you smoked/used in your entire life?” Both questions were asked to ever users of the tobacco product(s) except for the cigarette category. Only ever smokers who had smoked 100 or more cigarettes were asked if they “have ever smoked cigarettes fairly regularly”. PATH defines established tobacco product users as “having smoked 100 or more cigarettes” for cigarette smokers and “having smoked/used the tobacco product fairly regularly” for other tobacco product users. These definitions were used to implement survey conditional branching (i.e., skip logic) in the PATH questionnaires, and to assess tobacco use patterns and use histories in secondary data analysis. We did not stratify our analyses by sex as we do not expect the lifetime established use criteria to differ by sex. Sex was taken into account as one covariate with other demographic variables in logistic regression models to investigate the association with reaching lifetime established use criteria for various tobacco products.

Cross-sectional analyses based on PATH Wave 1 data

Due to the longitudinal nature of the PATH study, our cross-sectional analyses relied mainly on Wave 1 data to compare experimental versus established use for available tobacco product categories. During the data collection period of Wave 1 (2013–2014) to Wave 5 (2018–2019), changes were made to the PATH survey questionnaires pertaining to the assessment and description of some tobacco product categories to accommodate for the evolution of the tobacco products. For instance, “e-cigarettes” evaluated in Wave 1 expanded to include “electronic nicotine products” such as e-cigarettes, e-hookahs, e-cigars, e-pipes, personal vaporizers, vape pens, and hookah pens in Waves 2 to 5. Accordingly, there were also changes in the lifetime established use questions for electronic nicotine products and snus, as summarized in Table 1, to increase consistency in survey questions across tobacco product categories. For example, the unit for electronic nicotine product category was “disposable e-cigarettes or e-cigarette cartridges” in Wave 1, “e-cigarettes or total milliliters (if with e-liquid)” in Wave 2 and “times” used in Waves 3 to 5.

Table 1. Lifetime Established Use Questions from PATH Wave 1 to Wave 5 Survey Questionnaire.

	Lifetime Established Use Question
All	Have you ever smoked/used [tobacco product] fairly regularly? (Note: the question in the cigarette category was only asked to those who have ever smoked 100 or more cigarettes in their lifetime)
Cigarette	How many cigarettes have you smoked in your entire life? A pack usually has 20 cigarettes in it.
Cigar	How many traditional cigars/cigarillos/filtered cigars have you smoked in your entire life?
Pipe	How many bowls filled with pipe tobacco have you smoked in your entire life?
Hookah	How many times have you smoked hookah in your entire life? Count each sitting or session where you smoked tobacco in a hookah, whether alone, or with others.
Electronic Nicotine Products*	Wave 1: How many disposable e-cigarettes or e-cigarette cartridges have you used in your entire life? Wave 2: How many e-cigarettes have you used in your entire life? (If you refill your e-cigarette with e-liquid, count up the total milliliters you have used.) Wave 3: How many times have you used a [primary electronic nicotine product]* in your entire life? Wave 4 to Wave 5: How many times have you used an electronic nicotine product in your entire life?
Smokeless	How many times have you used smokeless tobacco in your entire life?
Snus	Wave 1 to Wave 3: How many snus pouches have you used in your entire life? Wave 4 to Wave 5: How many times have you used snus in your entire life?
Dissolvable^†	Wave 1 to Wave 2: How many pieces of dissolvable tobacco have you used in your entire life? (Note: only available in Waves 1 and 2)

* The primary electronic nicotine product could be an e-cigarette, e-cigar, e-pipe, e-hookah, or other electronic nicotine product based on the question “Which electronic nicotine product do you use most often?” in Wave 3.

† Dissolvable tobacco product is described in PATH Wave 1 as “You don’t smoke dissolvable tobacco products – they are made of finely ground flavored tobacco that dissolves in your mouth. Dissolvable tobacco products come in a variety of shapes, including small round pellets, thin sticks, and flat strips. Some common brands are Ariva, Stonewall, and Camel Orbs, Sticks or Strips.”

For each tobacco product category, we first presented demographics, socioeconomic status, and tobacco product use patterns among current users, current experimental users, and current established users based on the PATH definition of established use. Table 2 lists the descriptive statistics generated for sex, age, race/ethnicity, household income, education, current use status (every day, and some days), and concurrent use status (exclusive, and dual/poly use). The definition of exclusive use is reported as current (“every day” or “some days”) use of the tobacco product and no current use of any other tobacco products. The definition of dual/poly use is current use of two or more tobacco products among the tobacco product categories being assessed.

Table 2. Demographics, Socioeconomic Status, and Tobacco Use Patterns Among Current Experimental versus Current Established Tobacco Users.

	Cigarette			Cigar – Traditional			Cigar - Cigarillo			Cigar -Filtered			Pipe			Hookah
	Overall	Exp	Est	Overall	Exp	Est	Overall	Exp	Est	Overall	Exp	Est	Overall	Exp	Est	Overall	Exp	Est
n	13,529	2,076	11,402	2,586	1,691	890	3,051	1,778	1,186	1,301	743	551	709	390	318	3,049	1,989	1,058
	%	%	%	%	%	%	%	%	%	%	%	%	%	%	%	%	%	%
Sex
Male	55.7	57.7	55.3	88.8	88.5	89.5	73.8	75.7	72.7	71.4	73.8	68.6	91.2	90.7	91.8	57.7	55.5	62.1
Female	44.3	42.3	44.7	11.2	11.5	10.5	26.2	24.3	27.3	28.6	26.2	31.4	8.8	9.3	8.2	42.3	44.5	37.9
Age
18-24	15.5	24.1	14.1	17.3	16.2	19.4	32.7	30.4	35.9	23.3	27.3	18.0	25.1	27.7	21.7	56.7	52.6	65.0
25-44	41.9	33.8	43.5	44.8	45.6	43.3	44.4	45.0	44.2	39.6	43.9	34.3	37.5	39.9	34.5	37.9	40.7	32.2
45+	42.5	42.1	42.5	37.9	38.2	37.3	22.9	24.6	19.9	37.0	28.8	47.7	37.4	32.5	43.8	5.4	6.6	2.9
Race/Ethnicity
Non-Hispanic White	65.0	38.2	69.8	71.0	72.8	67.7	53.7	62.0	41.6	64.8	64.2	65.8	75.0	72.9	77.9	50.7	48.2	55.6
Non-Hispanic Black	15.2	26.9	13.1	10.9	8.6	15.3	25.2	18.0	35.8	14.6	13.2	16.2	7.4	9.0	5.5	14.7	16.2	11.7
Non-Hispanic Others	6.3	7.6	6.0	6.9	7.3	6.1	6.7	6.6	6.8	7.3	7.8	6.8	8.3	9.5	6.7	11.7	12.3	10.5
Hispanic	13.5	27.3	11.1	11.1	11.3	10.9	14.4	13.4	15.8	13.3	14.8	11.2	9.3	8.6	9.9	22.9	23.3	22.2
Household Income
<$50K	75.9	85.8	74.2	51.2	47.3	59.0	75.2	70.0	82.0	78.7	73.2	86.1	69.4	68.6	70.3	70.1	68.5	73.4
$50K-100K	17.0	9.6	18.3	24.0	25.9	20.3	15.8	18.5	12.2	14.5	18.7	9.1	18.4	17.8	19.4	17.3	18.2	15.6
>=$100K	7.1	4.6	7.5	24.7	26.8	20.7	9.1	11.5	5.8	6.8	8.0	4.8	12.2	13.7	10.3	12.6	13.3	11.0
Education
Less than College	57.0	68.2	54.9	35.2	32.3	41.2	52.1	50.3	54.0	53.9	49.9	59.2	44.2	45.0	43.2	36.1	36.0	36.3
Some College	32.2	23.5	33.8	34.8	33.9	36.5	36.2	35.3	38.2	34.4	35.4	33.0	35.6	34.7	36.7	43.6	41.7	47.6
College and Higher	10.8	8.3	11.3	29.9	33.7	22.3	11.7	14.4	7.8	11.6	14.7	7.8	20.2	20.3	20.1	20.3	22.3	16.1
Current Use Status
Every Day	74.7	47.2	79.5	6.3	1.4	16.5	10.3	3.0	22.0	18.5	3.7	37.3	8.8	1.6	18.0	2.0	0.6	4.7
Some Day	25.3	52.8	20.5	93.7	98.6	83.5	89.7	97.0	78.0	81.5	96.3	62.7	91.2	98.4	82.0	98.0	99.4	95.3
Concurrent Use Status
Exclusive	58.3	58.2	58.1	25.0	27.4	20.2	10.1	7.9	11.1	4.0	2.2	6.1	10.6	7.2	14.8	28.4	28.4	28.3
Dual/Poly	41.7	41.8	41.9	75.0	72.6	79.8	89.9	92.1	88.9	96.0	97.8	93.9	89.4	92.8	85.2	71.6	71.6	71.7

	Electronic Nicotine Products			Smokeless			Snus			Dissolvable
	Overall	Exp.	Est.	Overall	Exp.	Est.	Overall.	Exp.	Est.	Overall	Exp.	Est.
n	3,642	2,065	1,575	1,873	273	1,597	482	205	276	67	48^†	19^†
	%	%	%	%	%	%	%	%	%	%	%	%
Sex
Male	53.5	52.9	54.3	94.8	88.6	95.8	91.7	85.3	96.2	62.3	70.8	36.5
Female	46.5	47.1	45.7	5.2	11.4	4.2	8.3	14.7	3.8	37.7	29.2	63.5
Age
18-24	20.9	20.9	20.7	19.3	26.8	18.1	30.4	32.4	29.1	27.2	32.1	12.4
25-44	45.3	43.8	47.2	45.2	42.0	45.7	51.6	48.4	53.8	47.0	50.0	38.0
45+	33.9	35.3	32.1	35.5	31.2	36.2	18.0	19.3	17.1	25.8	17.9	49.6
Race/Ethnicity
Non-Hispanic White	70.8	67.9	74.7	86.5	74.2	88.5	85.5	78.9	90.2	57.0	63.1	38.6
Non-Hispanic Black	9.4	10.2	8.3	4.6	9.9	3.8	2.3	3.6	1.3	20.2	15.6	33.9
Non-Hispanic Others	7.3	7.0	7.7	4.9	5.8	4.8	5.3	7.9	3.5	8.6	11.5	-
Hispanic	12.5	14.9	9.3	3.9	10.1	2.9	6.8	9.6	4.9	14.2	9.8	27.5
Household Income
<$50K	70.3	72.4	67.6	57.9	66.5	56.4	58.2	64.5	54.0	69.1	64.7	82.9
$50K-100K	20.0	18.5	22.0	27.9	17.9	29.6	25.4	22.4	27.3	18.8	24.7	-
>=$100K	9.7	9.0	10.4	14.2	15.6	14.0	16.4	13.1	18.7	12.1	10.5	17.1
Education
Less than College	48.1	51.6	43.4	55.3	61.7	54.2	50.2	52.7	48.3	69.4	67.6	74.6
Some College	39.2	36.9	42.3	31.5	24.2	32.6	36.0	32.7	38.4	20.0	19.5	21.5
College and Higher	12.8	11.5	14.3	13.3	14.1	13.1	13.8	14.5	13.3	10.6	12.9	3.9
Current Use Status
Every Day	21.3	5.3	42.3	53.9	4.1	61.9	16.4	1.7	26.7	14.7	10.3	28.1
Some Day	78.7	94.7	57.7	46.1	95.9	38.1	83.6	98.3	73.3	85.3	89.7	71.9
Concurrent Use Status
Exclusive	13.7	7.7	21.7	45.4	25.3	48.7	10.8	5.7	14.4	7.1	1.6	23.6
Dual/Poly	86.3	92.3	78.3	54.6	74.7	51.3	89.2	94.3	85.6	92.9	98.4	76.4

† Caution: low sample size. The estimates may not be reliable due to low base sample size (n< 50) or coefficient of variation greater than 30.

To evaluate the two sets of lifetime established use definitions, we presented the response patterns among current users in Figure 1. We then examined the level of agreement between the two sets of responses using kappa coefficient among ever, current, and former tobacco product users for all available tobacco categories except for cigarette (Table 3). Ever tobacco use is defined as having ever used the product, even once. Current tobacco use is defined as currently using the tobacco product “every day” or “some days”. Former tobacco use is defined as having ever used the tobacco product and reported using the tobacco product “not at all” now.

Figure 1. Response pattern of lifetime usage based on numerical and non-numerical criterion among current tobacco users.

Cross-sectional analyses were performed based on PATH Wave 1 data to study the response pattern of lifetime usage based on numerical and non-numerical criterion among current tobacco product users for each tobacco category.

Sample sizes of current tobacco user groups: N = 13,470 (cigarette), 2,575 (cigar-traditional), 2,948 (cigar-cigarillo), 1,290 (cigar-filtered), 703 (pipe), 3,040 (hookah), 3,586 (electronic nicotine products), 1,867 (smokeless), 480 (snus), and 63 (dissolvable).

Note: Missing responses of the numerical and non-numerical criteria are excluded from the analysis.

*The fairly regular use question was only assessed among those who had smoked 100 or more cigarettes for current cigarette smokers.

Table 3. Levels of Agreement between Non-Numerical and Numerical Criteria among Ever-, Current-, and Former-Tobacco Users.

	Among Ever Users			Among Current Users			Among Former Users
	20 or more	50 or more	100 or more	20 or more	50 or more	100 or more	20 or more	50 or more	100 or more
Cigarette*	-	-	-	-	-	-	-	-	-
Cigar - Traditional	0.37	0.48	0.48	0.23	0.38	0.39	0.35	0.47	0.48
Cigar - Cigarillo	0.39	0.48	0.46	0.35	0.45	0.42	0.34	0.42	0.42
Cigar - Filtered	0.45	0.50	0.51	0.41	0.46	0.47	0.38	0.44	0.45
Pipe	0.55	0.62	0.57	0.37	0.46	0.45	0.55	0.63	0.57
Hookah	0.55	0.45	0.30	0.48	0.42	0.27	0.49	0.37	0.24
Electronic Nicotine Products	0.34	0.20	0.13	0.25	0.15	0.11	0.31	0.17	0.10
Smokeless	0.75	0.78	0.74	0.57	0.60	0.56	0.69	0.72	0.67
Snus	0.61	0.63	0.59	0.40	0.51	0.49	0.60	0.61	0.57
Dissolvable	0.34	0.24	0.23	0.03	0	0.02	0.44	0.33	0.31

Kappa Agreement

0.01-0.20 Slight

0.21-0.40 Fair

0.41-0.60 Moderate

0.61-0.80 Substantial

0.81-0.99 Almost perfect

Cross-sectional analyses were performed based on PATH Wave 1 data to study the levels of agreement between non-numerical criteria (i.e., having used the product fairly regularly), and numerical criteria (i.e., having used the product 20/50/100 or more units) among ever-, current-, and former tobacco-users.

Wave 1 Tobacco User Group Sample size:

Cigarette: ever users (n=25,183), current users (n=13,478), former users (n=11,571).

Cigar - Traditional: ever users (n=10,220), current users (n=2,581), former users (n=7,624).

Cigar - Cigarillo: ever users (n=13,701), current users (n=2,964), former users (n=10,565).

Cigar – Filtered: ever users (n=6,636), current users (n=1,294), former users (n=5,323).

Pipe: ever users (n=7,178), current users (n=708), former users (n=6,460).

Hookah: ever users (n=10,623), current users (n=3,047), former users (n=7,563).

Electronic nicotine products: ever users (n=11,523), current users (n=3,640), former users (n=7,866).

Smokeless: ever users (n=6,611), current users (n=1,870), former users (n=4,538).

Snus: ever users (n=2,917), current users (n=478), former users (n=2,436).

Dissolvable: ever users (n=347), current users (n=67), former users (n=277).

* The fairly regular use question was only assessed among those who had smoked 100 or more cigarettes for current cigarette smokers, so we are not able to examine the level of agreement.

Suggested numerical thresholds were discussed (Table 4) based on the level of agreement with the non-numerical fairly regular use criterion and review of existing lifetime usage criteria from national surveys or literature. With suggested numerical thresholds, logistic regression models were fitted to evaluate the covariates of reaching non-numerical and numerical lifetime established use criterion (Table 5). The reference group consisted of experimental users in each tobacco product category. Covariates in the logistic regression models included self-report sex, age, race/ethnicity, household income, education, current use, and concurrent use status.

Table 4. Recommendation of Numerical Thresholds to Define Adult Lifetime Established Use for Tobacco Products.

Category	Suggested Unit	Suggested Criterion for Established Use	Reference
Cigarette	Cigarette	Having smoked 100 cigarettes	¹^–³^,¹³
Cigar	Traditional Cigars, Cigarillo, Filtered Cigars	Having smoked 50 traditional cigars/cigarillos/filtered cigars	Addressed in this publication and others⁵^–⁸
Pipe	Bowl	Having smoked 50 bowls filled with pipe tobacco	Novel finding addressed in this publication
Hookah	Time*	Having smoked hookah 20 times	Novel finding addressed in this publication
Electronic Nicotine Products	Time	Having used ENDS products 20 times	Novel finding addressed in this publication
Smokeless	Time	Having used smokeless tobacco 20 times	Addressed in this publication and others⁹^–¹²^,³⁰
Snus	Time	Having used snus 20 times	Addressed in this publication and others³¹
Dissolvable	Time	Having used dissolvable tobacco products 20 times	Novel finding addressed in this publication

* One time refers to a typical session when the participant picks up the product to use it. For example, description in PATH Wave 5 questionnaire is “the time the participant picks up the ENDS product to use it. Multiple puffs can be taken within one session.”

Table 5. Odds Ratio Comparisons between Current Tobacco Users Reaching Non-Numerical or Numerical Criterion.

	Cigarette	Cigar - Traditional		Cigar - Cigarillo		Cigar -Filtered		Pipe
Established Use Criterion Reached	100+	FR	50+	FR	50+	FR	50+	FR	50+
n	13,529	2,586		3,051		1,301		709
% Reached Lifetime Criterion	85.1%	32.8%	40.0%	37.8%	43.0%	43.8%	44.7%	44.2%	41.2%
Sex (Ref: Male)
Female	1.0 (0.9,1.1)	0.7* (0.5,0.9)	0.3* (0.2,0.5)	0.9 (0.8,1.1)	0.5* (0.4,0.6)	1.1 (0.8,1.5)	0.6* (0.4,0.8)	1.0 (0.5,1.9)	0.7 (0.3,1.5)
Age (Ref: 18-24)
25-44	1.8* (1.5,2.2)	0.8 (0.7,1.0)	1.5* (1.1,1.9)	0.8* (0.7,1.0)	1.4* (1.1,1.7)	1.0 (0.7,1.4)	1.8* (1.2,2.6)	1.1 (0.7,1.7)	1.3 (0.7,2.5)
45+	1.2* (1.0,1.4)	0.8 (0.6,1.0)	3.4* (2.7,4.3)	0.6* (0.5,0.8)	1.6* (1.2,2.0)	1.2 (0.8,1.8)	2.8* (1.9,4.2)	1.5 (0.9,2.3)	4.6* (2.6,8.3)
Race/Ethnicity (Ref: NHB)
Non-Hispanic White	3.2* (2.7,3.7)	0.6* (0.4,0.8)	0.9 (0.6,1.3)	0.4* (0.3,0.6)	0.8* (0.6,0.9)	0.9 (0.6,1.4)	2.8* (1.9,4.2)	1.8 (0.9,3.7)	5.0* (1.4,17.4)
Non-Hispanic Others	1.6* (1.2,2.1)	0.6 (0.3,1.0)	0.6 (0.3,1.0)	0.6* (0.4,0.9)	0.7 (0.5,1.1)	1.1 (0.6,2.0)	1.5 (0.8,2.7)	1.2 (0.5,2.7)	3.6* (0.9,15.3)
Hispanic	1.1 (0.9,1.4)	0.6* (0.4,0.9)	0.7 (0.5,1.1)	0.7* (0.5,0.9)	0.7* (0.5,0.9)	0.7 (0.4,1.3)	1.5 (0.8,2.8)	2.4* (1.0,5.5)	1.4 (0.4,5.8)
Household Income (Ref: Less than $50K)
$50K-100K	1.7* (1.4,2.0)	0.8 (0.7,1.0)	1.2 (0.9,1.5)	0.7* (0.5,0.9)	0.9 (0.7,1.1)	0.5* (0.3,0.7)	0.6* (0.4,1.0)	1.1 (0.6,2.0)	1.0 (0.5,1.7)
$100K or More	1.5* (1.1,1.9)	0.9 (0.7,1.2)	1.3 (0.9,1.7)	0.6* (0.4,0.9)	0.5* (0.4,0.8)	0.6 (0.3,1.1)	1.0 (0.5,1.9)	0.7 (0.4,1.3)	1.1 (0.6,2.0)
Education (Ref: Less than College)
Some College	1.7* (1.5,2.0)	1.0 (0.8,1.2)	1.0 (0.8,1.3)	1.1 (0.9,1.3)	1.3* (1.1,1.5)	0.9 (0.7,1.2)	1.5* (1.1,2.0)	1.0 (0.7,1.7)	1.1 (0.7,1.8)
College and Higher	1.7* (1.3,2.1)	0.7* (0.5,1.0)	1.0 (0.7,1.3)	0.8 (0.5,1.2)	0.8 (0.6,1.2)	0.7 (0.4,1.2)	1.0 (0.6,1.7)	0.9 (0.5,1.7)	1.4 (0.7,2.6)
Current Use Status (Ref: Some Day)
Every Day	4.2* (3.6,4.8)	11.6* (6.1,22.2)	3.3* (2.1,5.3)	7.6* (5.1,11.4)	5.1* (3.6,7.2)	13.2* (7.8,22.4)	7.3* (4.6,11.6)	11.4* (4.1,31.8)	5.7* (2.4,13.3)
Concurrent Use Status (Ref: Exclusive)
Dual/Poly	1.0 (0.9,1.1)	1.2 (0.9,1.6)	1.3* (1.0,1.6)	0.9 (0.6,1.4)	0.8 (0.6,1.1)	0.6 (0.3,1.2)	1.0 (0.4,2.3)	0.8 (0.3,1.9)	0.7 (0.3,1.5)

	Hookah		Electronic Nicotine Products		Smokeless		Snus
Established Criterion Reached	FR	20+	FR	20+	FR	20+	FR	20+
n	3,049		3,642		1,873		482
% Reached Lifetime Criterion	33.1%	42.4%	43.2%	17.9%	86.1%	90.2%	58.6%	74.9%
Sex (Ref: Male)
Female	0.7* (0.6,0.9)	0.5* (0.5,0.6)	1.0 (0.9,1.2)	0.7* (0.6,0.9)	0.4* (0.2,0.8)	0.2* (0.1,0.5)	0.2* (0.1,0.7)	0.4* (0.2,0.8)
Age (Ref: 18-24)
25-44	0.7* (0.6,0.8)	0.8 (0.6,0.9)	0.9 (0.8,1.1)	1.3 (1.0,1.8)	1.5* (1.0,2.2)	1.3 (0.9,2.0)	1.3 (0.8,2.1)	1.7* (1.0,3.0)
45+	0.4* (0.2,0.6)	0.7 (0.5,1.1)	0.6* (0.5,0.8)	1.8* (1.3,2.5)	0.8 (0.5,1.3)	1.6 (0.8,3.2)	0.5* (0.3,1.0)	1.1 (0.6,2.0)
Race/Ethnicity (Ref: NHB)
Non-Hispanic White	1.7* (1.3,2.3)	2.9* (2.1,4.0)	1.2 (0.9,1.6)	1.9* (1.2,3.0)	2.2* (1.0,4.8)	3.1* (1.3,7.5)	1.4 (0.2,7.7)	2.2 (0.5,9.5)
Non-Hispanic Others	1.3 (0.8,2.0)	2.9* (2.1,4.1)	1.2 (0.8,1.7)	2.5* (1.4,4.7)	2.2 (0.8,6.0)	3.2* (1.1,9.3)	0.5 (0.1,3.4)	1.7 (0.3,8.3)
Hispanic	1.3 (0.9,1.9)	2.2* (1.6,3.1)	0.7* (0.5,1.0)	1.4 (0.8,2.6)	0.8 (0.3,2.3)	0.8 (0.3,2.2)	0.7 (0.1,4.7)	1.2 (0.2,6.3)
Household Income (Ref: Less than $50K)
$50K-100K	0.8 (0.6,1.1)	0.9 (0.7,1.1)	1.1 (0.9,1.3)	0.9 (0.7,1.3)	1.5 (0.9,2.4)	1.9* (1.1,3.2)	0.9 (0.5,1.7)	2.0 (0.9,4.2)
$100K or More	0.7* (0.5,1.0)	0.8 (0.6,1.1)	1.0 (0.7,1.4)	1.2 (0.8,1.7)	0.8 (0.5,1.4)	0.9 (0.5,1.8)	1.4 (0.7,2.9)	1.4 (0.5,3.7)
Education (Ref: Less than College)
Some College	1.2 (1.0,1.5)	1.4* (1.2,1.7)	1.3* (1.1,1.6)	1.0 (0.8,1.3)	1.6* (1.2,2.2)	1.5 (1.0,2.4)	1.3 (0.8,2.2)	2.0* (1.1,3.6)
College and Higher	0.9 (0.7,1.2)	1.2 (0.9,1.7)	1.6* (1.2,2.2)	1.4 (1.0,1.9)	1.1 (0.6,1.9)	2.0 (1.0,4.0)	0.7 (0.3,1.4)	1.1 (0.4,2.8)
Current Use Status (Ref: Some Day)
Every Day	9.2* (4.3,19.5)	5.7* (2.9,11.1)	13.4* (10.3,17.6)	4.6* (3.5,6.0)	38.6* (16.5,90.3)	6.2* (3.2,11.9)	23.8* (4.4,127.4)	6.0* (1.2,29.6)
Concurrent Use Status (Ref: Exclusive)
Dual/Poly	0.9 (0.7,1.1)	1.3* (1.1,1.6)	0.7* (0.5,1.0)	0.7* (0.5,1.0)	0.7 (0.4,1.3)	0.5* (0.3,0.9)	0.6 (0.2,1.6)	0.8 (0.3,2.4)

* p-value < 0.05

Longitudinal analyses based on Waves 1 to 4 data

Prior research has demonstrated that established tobacco product users are less likely to discontinue past 30-day use.¹⁶^,²⁷ In this article, we examined the predictive validity of the suggested numerical thresholds by constructing generalized estimating equation (GEE) logistic regression models among current tobacco product users at baseline wave (Table 6). These models allow an understanding of the association between established use and discontinuation of past-30 day use at follow-up waves (i.e., in a one-year interval) based on Wave 1 to Wave 4 data. Follow-up wave means the wave after the baseline wave. Baseline waves include Wave 1, 2 and 3. Our analyses only included the first four waves because there was a one-year interval between Wave 1 to Wave 2, Wave 2 to Wave 3, and Wave 3 to Wave 4. There was a two-year interval between Wave 4 and Wave 5. Therefore, Wave 5 data was not included in the GEE logistic regression models.

Table 6. Odds Ratio of Discontinuing Past-30 Day Use at Follow-Up Wave among Current Tobacco Users.

	Cigarette	Cigar - Traditional	Cigar - Cigarillo	Electronic Nicotine Products	Smokeless
n	25,398	4,104	4,266	6,993	3,219
Sex (Ref: Male)
Female	1.0 (0.8,1.1)	1.2 (0.9,1.5)	0.9 (0.8,1.1)	1.0 (0.8,1.1)	1.1 (0.7,1.8)
Age (Ref: 18-24)
25-44	0.8* (0.7,0.9)	1.3 (1.0,1.7)	1.1 (0.9,1.3)	1.1 (0.9,1.3)	1.1 (0.8,1.4)
45+	0.8* (0.7,0.9)	0.9 (0.7,1.2)	1.2 (0.9,1.5)	1.1 (0.9,1.3)	0.9 (0.6,1.2)
Race/Ethnicity (Ref: NHB)
Non-Hispanic White	1.2* (1.0,1.5)	1.9* (1.4,2.7)	2.5* (2.0,3.0)	1.0 (0.7,1.2)	0.9 (0.5,1.7)
Non-Hispanic Others	1.3 (0.9,1.8)	2.2* (1.3,3.5)	2.1* (1.5,3.1)	0.9 (0.7,1.3)	1.1 (0.5,2.2)
Hispanic	1.4* (1.1,1.7)	1.3 (0.9,2.0)	1.7* (1.3,2.3)	0.9 (0.7,1.2)	1.1 (0.5,2.4)
Household Income (Ref: Less than $50K)
$50K-100K	1.2* (1.1,1.5)	0.9 (0.7,1.1)	1.0 (0.8,1.3)	1.0 (0.9,1.2)	0.8 (0.6,1.1)
$100K or More	1.4* (1.2,1.7)	0.9 (0.7,1.2)	1.1 (0.8,1.5)	0.8* (0.6,1.0)	0.7 (0.5,1.1)
Education (Ref: Less than College)
Some College	1.3* (1.1,1.5)	1.0 (0.8,1.2)	1.2* (1.0,1.4)	1.0 (0.8,1.1)	1.0 (0.8,1.4)
College and Higher	1.5* (1.3,1.8)	0.9 (0.7,1.2)	1.7* (1.2,2.4)	1.0 (0.8,1.3)	1.4 (1.0,2.0)
Current Use (Ref: Some Day)
Every Day	0.2* (0.2,0.3)	0.6* (0.4,0.9)	0.6* (0.5,0.8)	0.4* (0.3,0.4)	0.2* (0.2,0.3)
Concurrent Use Status (Ref: Exclusive)
Dual/Poly	1.0 (0.9,1.2)	1.1 (0.8,1.4)	0.9 (0.7,1.3)	1.6* (1.3,2.0)	1.8* (1.4,2.4)
Non-Numerical Criterion (Ref: Not Reached)
Reached		0.5* (0.4,0.6)	0.6* (0.5,0.8)	0.6* (0.5,0.7)	0.3* (0.2,0.4)
Numerical Criterion (Ref: Not Reached)
Reached	0.4* (0.4,0.5)	0.6* (0.5,0.8)	0.7* (0.5,0.8)	0.7* (0.6,0.9)	0.8 (0.5,1.2)

* p-value < 0.05.

Covariates in GEE logistic regression models include self-report sex, age, race/ethnicity, household income, education, current use status, concurrent use status, non-numerical lifetime established use criterion, and numerical lifetime established use criterion. Due to sample size constraints, models were only constructed for cigarette, traditional cigar, cigarillo, electronic nicotine product, and smokeless tobacco product categories.

All statistical analyses were conducted in SAS 9.4. The appropriate cross-sectional and longitudinal weights and replicate weights were used with balanced repeated replication (BRR) using a Fay’s adjustment value of 0.3 for variance estimation as required in the PATH user guide.²⁶ For proportions, confidence intervals were computed using the modified Wilson score option. The GEE logistic regression models were constructed using longitudinal weights and replicate weights²¹ to account for the complex survey design.

Additional Cross-Sectional Analysis based on Waves 1 to 5 Data

To account for survey questionnaire changes between waves, additional cross-sectional analyses were conducted based on Waves 1 to 5 data sets for the electronic nicotine product and snus product categories. We presented demographics, socioeconomic status, and tobacco product use patterns for current, current experimental, and current established e-vapor users based on Waves 1 to 5 data (Table 7). We showed the lifetime established use response patterns (Figure 2) and level of agreement coefficients for electronic nicotine products (Table 8) to investigate the dynamic landscape of this emerging tobacco category. Level of agreement coefficients were also generated for snus products (Table 9) using five waves of data as the unit of the numerical threshold changed from number of pouches in Waves 1–3, to number of times in Waves 4 and 5 (see Table 1 for details).

Table 7. Comparison of Current Experimental versus Current Established ENDS Users based on Five Waves of Data^┼.

	Wave 1			Wave 2			Wave 3			Wave 4			Wave 5
	Overall	Exp.	Est.	Overall	Exp.	Est.	Overall	Exp.	Est.	Overall	Exp.	Est.	Overall	Exp.	Est.
n	3,642	2,065	1,575	3,074	1,288	1,783	2,671	894	1,771	2,958	966	1,988	4,184	1,223	2,957
	%	%	%	%	%	%	%	%	%	%	%	%	%	%	%
Sex
Male	53.5	52.9	54.3	54.9	53.8	55.6	55.2	52.2	56.7	57.6	54.3	59.0	56.2	51.5	57.9
Female	46.5	47.1	45.7	45.1	46.2	44.4	44.8	47.8	43.3	42.4	45.7	41.0	43.8	48.5	42.1
Age
18-24	20.9	20.9	20.7	21.9	22.4	21.6	26.4	30.1	24.8	27.6	33.2	25.2	34.8	36.3	34.4
25-44	45.3	43.8	47.2	45.9	42.1	48.5	43.8	40.9	45.1	44.8	43.2	45.4	43.1	41.2	43.9
45+	33.9	35.3	32.1	32.2	35.5	29.8	29.7	29.1	30.1	27.6	23.6	29.3	22.1	22.5	21.8
Race/Ethnicity
Non-Hispanic White	70.8	67.9	74.7	72.6	66.8	76.6	71.1	62.9	75.2	70.5	59.2	75.3	69.3	56.7	73.9
Non-Hispanic Black	9.4	10.2	8.3	8.3	11.5	6.0	9.4	13.5	7.4	9.2	13.6	7.4	9.5	14.9	7.6
Non-Hispanic Others	7.3	7.0	7.7	7.7	7.8	7.6	6.8	7.1	6.7	7.2	7.4	7.1	7.6	7.5	7.7
Hispanic	12.5	14.9	9.3	11.4	13.9	9.7	12.7	16.6	10.7	13.1	19.9	10.2	13.6	21.0	10.8
Household Income
<$50K	70.3	72.4	67.6	68.2	72.1	65.5	67.7	71.6	65.6	64.9	71.1	62.3	60.1	63.4	58.8
$50K-100K	20.0	18.5	22.0	21.7	19.4	23.3	20.8	16.5	23.0	22.0	18.6	23.5	23.9	22.2	24.6
>=$100K	9.7	9.0	10.4	10.1	8.5	11.2	11.6	11.9	11.4	13.0	10.3	14.2	16.0	14.4	16.6
Education
Less than College	48.1	51.6	43.4	47.5	51.3	44.8	46.3	50.2	44.4	48.2	51.3	46.8	45.7	46.7	45.4
Some College	39.2	36.9	42.3	39.8	35.2	43.0	40.3	37.8	41.5	40.1	36.8	41.6	40.3	37.1	41.5
College and Higher	12.8	11.5	14.3	12.7	13.4	12.2	13.4	12.0	14.1	11.7	11.8	11.6	14.0	16.2	13.2
Current Use
Every Day	21.3	5.3	42.3	27.1	4.5	42.9	36.6	8.0	48.5	37.4	5.9	50.7	40.1	5.8	53.3
Some Day	78.7	94.7	57.7	72.9	95.5	57.1	63.4	92.0	51.5	62.6	94.1	49.3	59.9	94.2	46.7
Concurrent Use
Exclusive	13.7	7.7	21.7	21.2	12.1	27.5	26.6	16.9	31.4	29.0	19.2	33.3	39.6	31.3	42.7
Dual/Poly	86.3	92.3	78.3	78.8	87.9	72.5	73.4	83.1	68.6	71.0	80.8	66.7	60.4	68.7	57.3

┼ PATH data collection period: September 2013 to December 2014 (Wave 1), October 2014 to October 2015 (Wave 2), October 2015 to October 2016 (Wave 3), December 2016 to January 2018 (Wave 4), and December 2018 to November 2019 (Wave 5).

Figure 2. Response pattern of lifetime usage based on numerical and non-numerical criterion among current ENDS users.

Cross-sectional analyses of PATH Wave 1 to Wave 5 data sets were performed.

PATH data collection period: September 2013 to December 2014 (Wave 1), October 2014 to October 2015 (Wave 2), October 2015 to October 2016 (Wave 3), December 2016 to January 2018 (Wave 4), and December 2018 to November 2019 (Wave 5).

Sample sizes of current electronic nicotine product user group: n = 3,586 (Wave 1), 3,041 (Wave 2), 2,618 (Wave 3), 2,888 (Wave 4), and 3,947 (Wave 5).

Note: Missing responses of the numerical and non-numerical criteria are excluded from the analysis.

Respondents were only asked the numerical lifetime usage question if they had not smoked/used the tobacco product 100 or more units at prior wave. Therefore, the status of having smoked/used 100 or more units was imputed based on responses at current wave and prior waves.

Table 8. Levels of Agreement between Non-Numerical and Numerical Criteria among Ever-, Current-, Former-Users of ENDS Products^┼.

	Among Ever Users			Among Current Users			Among Former Users
	20 or more	50 or more	100 or more	20 or more	50 or more	100 or more	20 or more	50 or more	100 or more
Wave 1	0.34	0.20	0.13	0.25	0.15	0.11	0.31	0.17	0.10
Wave 2	0.47	0.36	0.29	0.41	0.31	0.25	0.37	0.25	0.19
Wave 3	0.58	0.56	0.48	0.48	0.52	0.48	0.52	0.46	0.36
Wave 4	0.60	0.59	0.55	0.47	0.54	0.51	0.55	0.51	0.46
Wave 5	0.62	0.63	0.59	0.46	0.54	0.52	0.57	0.55	0.51

Kappa Agreement

0.01-0.20 Slight

0.21-0.40 Fair

0.41-0.60 Moderate

0.61-0.80 Substantial

0.81-0.99 Almost Perfect

Cross-sectional analyses were performed based on PATH Waves 1 to 5 data sets. Non-numerical criteria is defined as “Having Used the Product Fairly Regularly”. Numerical Criteria is defined as “Having Used the Product 20/50/100 Or More Units”.

Sample sizes:

Wave 1: electronic nicotine products ever users (n=11,523), current users (n=3,640), former users (n=7,866).

Wave 2: electronic nicotine products ever users (n=11,275), current users (n=3,648), former users (n=6,671).

Wave 3: electronic nicotine products ever users (n=13,335), current users (n=2,671), former users (n=7,351).

Wave 4: electronic nicotine products ever users (n=15,969), current users (n=2,958), former users (n=10,382).

Wave 5: electronic nicotine products ever users (n=16,478), current users (n=4,184), former users (n=10,260).

┼ PATH data collection period: September 2013 to December 2014 (Wave 1), October 2014 to October 2015 (Wave 2), October 2015 to October 2016 (Wave 3), December 2016 to January 2018 (Wave 4), and December 2018 to November 2019 (Wave 5).

Table 9. Levels of Agreement between Non-Numerical and Numerical Criteria among Ever-, Current-, Former-Users of Snus Products^┼.

	Among Ever Users			Among Current Users			Among Former Users
	20 or more	50 or more	100 or more	20 or more	50 or more	100 or more	20 or more	50 or more	100 or more
Wave 1	0.61	0.63	0.59	0.40	0.51	0.49	0.60	0.61	0.57
Wave 2	0.47	0.39	0.28	0.30	0.39	0.31	0.44	0.34	0.22
Wave 3	0.48	0.41	0.28	0.40	0.39	0.39	0.46	0.37	0.20
Wave 4	0.52	0.44	0.37	0.54	0.56	0.55	0.48	0.36	0.27
Wave 5	0.47	0.37	0.26	0.40	0.37	0.27	0.45	0.32	0.21

Kappa Agreement

0.01-0.20 Slight

0.21-0.40 Fair

0.41-0.60 Moderate

0.61-0.80 Substantial

0.81-0.99 Almost Perfect

Sample sizes:

Wave 1: snus ever users (n=2,917), current users (n=478), former users (n=2,436).

Wave 2: snus ever users (n=2,798), current users (n=299), former users (n=2,364).

Wave 3: snus ever users (n=2,857), current users (n=288), former users (n=1,968).

Wave 4: snus ever users (n=3,641), current users (n=453), former users (n=2,715).

Wave 5: snus ever users (n=3,465), current users (n=355), former users (n=2,692).

┼ PATH data collection period: September 2013 to December 2014 (Wave 1), October 2014 to October 2015 (Wave 2), October 2015 to October 2016 (Wave 3), December 2016 to January 2018 (Wave 4), and December 2018 to November 2019 (Wave 5).

Results

Demographics, socioeconomic status and tobacco use patterns

Table 2 shows the distinct differences between experimental and established users in terms of demographics, socioeconomic status, and tobacco use patterns among current-, current experimental-, and current established-users based on the PATH definition of established use (i.e., 100+ for cigarettes, and fairly regular use for all other tobacco product categories). Firstly, we did not observe differences in sex distributions between experimental versus established users in most of the tobacco categories. The proportions of male users were relatively higher in established users compared to experimental users for smokeless and snus products, and lower for dissolvable tobacco products. Secondly, there seemed to be notable differences in the age distributions of experimental versus established users. The proportion of young adults (i.e., 18–24 years of age) was higher among experimental cigarette smokers compared to established smokers (24.1% versus 14.1%). Similar differences were observed in filtered cigars, pipe, hookah, smokeless, and dissolvable tobacco products. The impact of the lifetime use criterion on age distribution of experimental versus established tobacco product users was investigated further using logistic regression models and described in the ensuing sections of this manuscript.

In general, the proportions of everyday use were higher among established users when compared to experimental users. We observed predominant proportions of dual/poly use among various tobacco product user groups except for current cigarette smokers. Compared to established users, the proportions of dual/poly use were higher among experimental users for the majority of tobacco product groups including cigarillos, filter cigars, pipe, electronic nicotine products, smokeless, snus, and dissolvable tobacco products. Table 7 depicts the changes in demographics, socioeconomic status, and tobacco use patterns among Wave 1 to Wave 5 current electronic nicotine product users. We observed an increasing proportion of young adults (i.e., 18–24 years of age) (20.9% in Wave 1 to 34.8% in Wave 5) among current electronic nicotine product users. Furthermore, every day electronic nicotine product use increased from 21.3% in Wave 1 to 40.1% in Wave 5, and exclusive electronic nicotine product use increased from 13.7% in Wave 1 to 39.6% in Wave 5.

Response patterns and levels of agreement between numerical and non-numerical lifetime established use criteria

Response patterns of lifetime usage vary greatly among current users of each tobacco product category (Figure 1). The five levels of numerical lifetime use range were color coded for depiction as follows: 1–10 units (orange), 11–20 units (green), 21–50 units (blue), 51–99 units (yellow) and 100+ units (red). Using the same color schemes, but differing degrees of color intensity helped distinguish between reported “not fairly regular use” (lighter colors) and “fairly regular use” (darker colors). We observed that over 80% of current cigarette smokers have smoked 100 or more cigarettes and among those, a majority reported having smoked fairly regularly. For other categories, while the proportions of “fairly regular use” (darker color) tended to be higher in the range of 51–99 units or 100+ units, the reported “fairly regular use” occupied a notable proportion in all five levels of the numerical lifetime usage ranges. When looking at electronic nicotine product lifetime use patterns in Wave 1, more than 60% of current electronic nicotine product users only used the products 1-10 times and about one third of them reported that they had used “fairly regularly”. The proportion that reported fairly regular use within each numerical lifetime usage level for electronic nicotine products seemed relatively higher when compared to other tobacco product categories. Given the continuous evolution of electronic nicotine products, the proportions of having used 20 or more units increased from about 18% in Wave 1 (i.e., 20 or more disposable e-cigarettes or e-cigarette cartridges) to about 78% in Wave 5 (20 or more times) (Figure 2).

Table 3 captures the level of agreement between the non-numerical (i.e., fairly regular use) criterion and numerical criteria with three different thresholds (i.e., 20 units, 50 units, and 100 units) among ever, current, and former users of respective tobacco products. We summarized our observations as follows:

- Cigarette: The level of agreement could not be assessed for cigarette category as only cigarette smokers who have smoked 100 or more cigarettes were asked the fairly regular use question.
- Cigar: In general, observations pointed to moderate agreements (with kappa ranges from 0.38 to 0.50) among ever, current, and former cigar smokers when the threshold reached 50 or more traditional cigars/cigarillos/filtered cigars.
- Pipe: Moderate to substantial agreements (kappa ranges from 0.46 to 0.63) were evident from the 50 or more bowls threshold with ever, current, and former users.
- Hookah: Moderate agreements (kappa ranges from 0.48 to 0.55) were seen with the 20 or more times for ever, current, and former users. The level of agreement became lower with the threshold raised to 50/100 or more times.
- Electronic Nicotine Products: In Wave 1, observations exhibited only fair agreement when the threshold was 20 or more e-cigarettes. However, as shown in Table 8, in later waves, the level of agreement with fairly regular use became higher with different thresholds. A trend began to emerge of moderate agreement with the threshold of 20 or more e-cigarettes/times among ever and current users from Wave 2. Since Wave 3, moderate agreements were displayed with almost all three thresholds pertaining to ever, current, and former electronic nicotine product users. By Wave 5, moderate to substantial agreement (kappa ranges from 0.46 to 0.62) with fairly regular use was shown with the threshold from 20 or more times among ever, current, and former users of electronic nicotine products. We also observed that increasing the lifetime established use threshold to 50 or 100 or more times was not associated with increased level of agreement for electronic nicotine products.
- Smokeless Tobacco Product: Substantial agreements were observed starting from the threshold of 20 or more times among ever and former smokeless tobacco users (kappa=0.75 and 0.69, respectively). Among current smokeless tobacco users, moderate agreement was displayed with three different thresholds (kappa ranges from 0.56 to 0.60).
- Snus: Similar to the smokeless tobacco products, Wave 1 data suggested moderate to substantial agreement with a threshold of 20 or more among ever and former snus users (kappa=0.61 and 0.60, respectively). Among Wave 1 current snus users, moderate agreement corresponded to thresholds of 50 or 100 or more snus pouches (kappa=0.51 and 0.49, respectively). Additionally, assessment of Wave 1 through Wave 5 data showed (Table 9) moderate agreement was reached with a threshold of 20 or more among snus ever and former users in all five waves. Among snus current users, fair to moderate agreement was observed with all three thresholds.
- Dissolvable: As a novel tobacco product category, fair to moderate agreement was seen with the threshold of 20 or more pieces of dissolvable tobacco products among ever and former users (kappa=0.34 and 0.44, respectively). Among current users, only slight agreement with the thresholds was shown with all three thresholds (kappa ranges from 0 to 0.03). The lifetime established use questions for the dissolvable tobacco product category were only available in Waves 1 and 2 so we were not able to examine the established use behavior further for this category.

We summarized the suggested numerical lifetime established use criteria in Table 4, by synthesizing our findings with existing survey measures, and definitions that had been previously adopted in publications. These thresholds for suggested numerical lifetime established use were used to compare with the fairly regular use criteria when conducting the logistic regression models in later sections.

Correlates of reaching (non-numerical and numerical) lifetime established use criterion among current tobacco product users based on logistic regression models

As distinct differences in descriptive statistics were uncovered for demographics, socioeconomic status, and tobacco product use patterns (Table 2), we further examined the correlates of reaching lifetime established use criterion in Wave 1 using logistic regression models (Table 5). In general, we observed female respondents have lower odds of reaching the respective lifetime established use criterion compared to male respondents for most of the tobacco product categories except for cigarettes and pipe tobacco products. Age was a significant covariate for reaching the respective lifetime established use criterion, while in some cases, there were greater associations between age and being established users with the numerical criterion than with non-numerical criterion. For example, among current traditional cigar smokers, compared to the 18–24 age group, older adults were more likely to report having smoked 50 or more cigars in their entire life (25–44 age group, adjusted odds ratio (aOR)=1.5, 95%CI 1.1–1.9; 45+ age group, aOR=3.4, 95%CI 2.7–4.3). On the contrary, no significant differences were found when comparing the odds ratio (OR) of reaching the fairly regular use criterion between younger and older age groups among traditional cigar smokers (25–44 age group, aOR=0.8, 95%CI 0.7–1.0; 45+ age group, aOR=0.8, 95%CI (0.6–1.0).

For other demographic and socioeconomic variables, the patterns varied across different tobacco product user groups when comparing the numerical versus the non-numerical lifetime established use criterion. For instance, among current electronic nicotine product users, education was a significant covariate of reporting having used fairly regularly but was not a significant covariate of reporting having ever used 20 or more e-cigarettes. Across all tobacco product user groups, consistent results showed that “every day” tobacco product users were much more likely to report reaching either non-numerical or numerical lifetime established use criterion in comparison with “some day” use.

Lastly, in regard to dual/poly use, there were some distinct patterns. While the odds of reaching lifetime established use criterion given dual/poly use compared to exclusive use were not significant for most of the combustible tobacco products, there were higher odds of being established users among traditional cigar users (aOR=1.3, 95%CI 1.0–1.6 with lifetime use criterion of 50 or more traditional cigars), and hookah users (aOR=1.3, 95%CI 1.1–1.6 with lifetime use criterion of 20 or more times). For smoke-free tobacco products, there were lower odds of being established users given dual/poly use compared to exclusive use among electronic nicotine product users (aOR=0.7, 95%CI 0.5–1.0 with the fairly regular use criterion, and aOR=0.7, 95%CI 0.5–1.0 with lifetime use criterion of 20 or more disposable e-cigarettes or e-cigarette cartridges (from Wave 1 measure, see Table 1 for reference) and smokeless tobacco product users (aOR=0.5, 95%CI 0.3–0.9 with lifetime use criterion of 20 or more times).

Correlates of discontinuation of past 30-day use at follow-up Wave based on GEE logistic regression models

In general, after adjusting for sex, age, race/ethnicity, household income, education, current and concurrent use status, established tobacco product users (defined using either the numerical or non-numerical lifetime use criterion) were less likely to discontinue past-30 day use at follow-up wave (i.e., in one-year intervals) (Table 6). Similar aORs were displayed with numerical or non-numerical criteria for most tobacco product categories. For example, for electronic nicotine product users, the aOR of discontinuing past 30-day use was aOR=0.6, 95%CI 0.5–0.7 with non-numerical criterion reached, and aOR=0.7, 95%CI 0.6–0.9 with numerical criterion reached. Compared to “some day” users, “every day” users were much less likely to discontinue past 30-day use (cigarette: aOR = 0.2, 95%CI 0.2–0.3; traditional cigar: aOR=0.6, 95%CI 0.4–0.9; cigarillo: aOR=0.6 95%CI 0.5–0.8; electronic nicotine product: aOR=0.4 95%CI 0.3–0.4; and smokeless tobacco: aOR=0.2 95%CI 0.2–0.3). Dual/poly use was not statistically associated with discontinuation of past-30 day use for cigarette, traditional cigar, and cigarillo categories. However, significant associations were shown among electronic nicotine and smokeless tobacco product users. Compared to exclusive users, dual/poly users were more likely to discontinue past 30-day use of the respective products (electronic nicotine product: aOR=1.6 95%1.3–2.0; smokeless tobacco: aOR=1.8 95%CI 1.4–2.4).

Discussion

Although the origin and use of 100 or more cigarettes as lifetime established use criterion may be somewhat arbitrary, it has become an important screener for “never regular” cigarette smoking among adults. In our analyses, we demonstrate the importance of distinguishing between experimental and established use for available tobacco product categories in PATH. For example, adult tobacco users classified as experimental users are more likely to be younger, use on “some days” (versus “every day”), and are less likely to have continued tobacco use at follow-up compared to those classified as established users. Our analyses also reveal that the criterion of “fairly regularly” can be broadly interpreted by adult tobacco users, and thus, suggest that numerical criteria may provide a more objective characterization of established users. That said, subjective criteria may still be warranted to characterize users of new products until more is known about the use behavior with these products. Additionally, it is important to adopt the phrase “established use” when a predefined established use criterion has been applied. For example, for cigarette smokers, we could differentiate “ever established use” with “ever use” based on “having smoked 100 or more cigarettes”. Some national surveys (e.g., NHIS, the Behavioral Risk Factor Surveillance System (BRFSS)) only ask cigarette smoking related questions if the respondent reported having ever smoked 100 or more cigarettes. With this conditional branching, it is not possible to evaluate the true “ever smoker” population from these national surveys.

One key limitation of this study is that our findings are based on analysis of existing PATH survey questions with self-reported data. For cigarette smokers, the concept of “fairly regular” was only asked of those whose threshold reached 100+ cigarettes, which does not allow us to further investigate the “fairly regular” use among experimental smokers. Additionally, dissolvable tobacco products might have been on the U.S. market during early waves of PATH data collection (i.e., 2013–2015), but a majority of the products were no longer sold in the U.S. Moreover, when studying use behavior and discontinuation of past 30-day use patterns, the evolution of new tobacco product categories necessitating changes implemented in survey questionnaires makes comparison across waves challenging. Given the longitudinal nature of the PATH study, some cross-sectional analysis comparisons with five waves of data should be interpreted with caution as the responses may come from the same individuals when they were followed up at later waves. Lastly, we were not able to assess certain emerging tobacco product categories such as heated tobacco products or tobacco-free oral nicotine products, as these products were not included in the PATH surveys. It is worth noting that some existing research has utilized a threshold of “100 or more heatsticks” to identify established IQOS users.²⁸ Additionally, due to the similarity between tobacco-free oral nicotine products and snus, a lifetime use of “20 or more times” may be a relevant threshold for established oral nicotine product use.

In addition to lifetime ever use criteria discussed in this article, there have been other lifetime established use measures/definitions used in national surveys or recent publications. For example, some surveys ask questions such as “has there ever been a period in your life when you smoked cigarettes every day for at least 30 days?” (NSDUH), and “for how long have you smoked every day?” (TUS-CPS). Current use frequency (e.g., used 1+, 5+, 10+, 20+, and 30 days in the past 30 days) has also been adopted by other studies to define established use.⁴^,²⁴^,²⁷^,²⁹ As the key objective of our research is to study numerical lifetime established use criterion, we did not look into other questions in PATH to study established use definitions based on current use frequency or other use patterns.

Our analysis is the first PATH secondary data analysis to derive quantitative thresholds of lifetime established use criteria to better characterize experimental versus established use behaviors. We provided recommendations of numerical lifetime established use criteria (Table 4) by synthesizing our findings with existing survey measures, and definitions that had been previously adopted in publications. Our analyses showed that, when studying emerging tobacco product categories (e.g., electronic nicotine products), the proportion of established use may be higher with the non-numerical fairly regular use criterion compared to numerical criterion in the early stages (i.e., Waves 1 and 2). But as the product becomes more prevalent, the numerical criterion serves as a more objective alternative to differentiate experimental users from established users. While the selection of the numerical thresholds may be somewhat arbitrary as the original of 100 or more cigarettes, the selection of “20 times” as the numerical lifetime established use threshold for smoke-free tobacco products, including electronic nicotine, smokeless, snus, and dissolvable tobacco products, may improve the consistency in survey design and data analysis. While we did observe some significant differences in demographics (e.g., sex and age) in terms of reaching lifetime established use criteria for some tobacco categories, it may not be desirable to have the lifetime established use criteria differ by demographics. In practice, applying the same criteria is key to facilitating comparisons across sub-populations. As the tobacco landscape rapidly evolves, it becomes increasingly important to develop established use criteria for newer products and re-examine criteria for existing products to characterize product use behavior (e.g., consumption or transition patterns), determine product adoption/cessation versus trial, and compare perceptions and intentions measures.

Conclusion

The adoption of lifetime use criteria would facilitate the study of experimental and established tobacco product users as distinct differences have been demonstrated in terms of demographics, socioeconomic status, use, and discontinuation of past 30-day use patterns. As new tobacco products emerge in the market, non-numerical criterion may be a good approach to identify regular users at an early stage. In comparison, the numerical lifetime use criterion provides a more objective characterization of lifetime established use when the new tobacco product becomes more widely used. The suggested numerical lifetime use thresholds should be evaluated further as the tobacco landscape evolves through qualitative and quantitative studies to ensure the thresholds are appropriate to distinguish between experimental and established users. Finally, consistent applications of the lifetime established use criteria in data analysis and reporting would improve harmonization in research findings.

Ethical Considerations

Not applicable. This secondary analysis only used publicly available PATH data sets.

Author Contributions

Lai Wei conceptualized the research design, developed the study group, performed data analysis, and drafted the manuscript. Thaddaeus Hannel and Raheema S. Muhammad-Kah contributed to the research conceptualization, reviewed, and revised the manuscript. Mohamadi Sarkar and Edward Largo reviewed and revised the manuscript. All authors read and approved the final manuscript.

Data Availability

The data analyzed are publicly available (https://doi.org/10.3886/ICPSR36498.v13) and can be downloaded from https://www.icpsr.umich.edu/icpsrweb/NAHDAP/studies/36498

Reporting Guidelines

Not applicable.

Acknowledgments

The authors acknowledge Krushna Agulla for analytical support; Sucharitha Iyer and Andrea Vansickel for reviewing and providing insightful comments on this publication.

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Author details Author details

¹ Center for Research & Technology, Altria Client Services LLC, Richmond, Virginia, 23219, USA

Lai Wei
Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Resources, Software, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Mohamadi Sarkar
Roles: Conceptualization, Methodology, Writing – Review & Editing

Thaddaeus Hannel
Roles: Conceptualization, Methodology, Writing – Review & Editing

Edward Largo
Roles: Conceptualization, Methodology, Writing – Review & Editing

Raheema Muhammad-Kah
Roles: Conceptualization, Methodology, Writing – Review & Editing

Competing interests

The authors are employees of Altria Client Services LLC, which provides certain services, including regulatory affairs, research and development, and regulatory sciences to the Altria family of companies. Altria’s operating companies manufacture and market tobacco products, including cigarettes.

Grant information

This research was funded by Altria Client Services LLC.

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Wei L, Sarkar M, Hannel T et al. Examination of Lifetime Established Use Criteria for Adult Tobacco Product Users  [version 1; peer review: 1 approved]. F1000Research 2023, 12:225 (https://doi.org/10.12688/f1000research.130607.1)

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Bontle Mbongwe, School of Public Health, University of Botswana, Gaborone, South-East District, Botswana

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The study is the first to assess lifetime tobacco product use criteria to facilitate a realistic characterization of experimental versus established tobacco product use behaviours. The study proposes new numerical life-time use thresh-holds for various tobacco product use. The researchers emphasize ... Continue reading

The study is the first to assess lifetime tobacco product use criteria to facilitate a realistic characterization of experimental versus established tobacco product use behaviours. The study proposes new numerical life-time use thresh-holds for various tobacco product use. The researchers emphasize the importance of this research in light of the changing tobacco control landscape with emerging new tobacco product categories such as electronic nicotine products and the existing non-numerical and numerical lifetime use criteria. Of note is that the proposed thresholds for tobacco product categories (whilst subject to validation through further research) could assist in improving the harmonisation of research findings.

The purpose of the publication is well articulated in the abstract and background information of the article. Whilst the results of this work are well written and explained generally in the results section, the abstract may need some minor improvements to represent and summarize the article's major points.

Abstract
Specify the significant differences observed.
Specify the take-home message in the conclusion.

Results:
Be consistent in reporting clear aOR and confidence intervals in all relevant sections. Some sections report significant/non significance covariates yet not specified.

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

I cannot comment. A qualified statistician is required.
Are all the source data underlying the results available to ensure full reproducibility?

Yes
Are the conclusions drawn adequately supported by the results?

Yes

Competing Interests: No competing interests were disclosed.

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Bontle Mbongwe, School of Public Health, University of Botswana, Gaborone, South-East District, Botswana

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The study is the first to assess lifetime tobacco product use criteria to facilitate a realistic characterization of experimental versus established tobacco product use behaviours. The study proposes new numerical life-time use thresh-holds for various tobacco product use. The researchers emphasize the importance of this research in light of the changing tobacco control landscape with emerging new tobacco product categories such as electronic nicotine products and the existing non-numerical and numerical lifetime use criteria. Of note is that the proposed thresholds for tobacco product categories (whilst subject to validation through further research) could assist in improving the harmonisation of research findings.

The purpose of the publication is well articulated in the abstract and background information of the article. Whilst the results of this work are well written and explained generally in the results section, the abstract may need some minor improvements to represent and summarize the article's major points.

Abstract
Specify the significant differences observed.
Specify the take-home message in the conclusion.

Results:
Be consistent in reporting clear aOR and confidence intervals in all relevant sections. Some sections report significant/non significance covariates yet not specified.

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

I cannot comment. A qualified statistician is required.
Are all the source data underlying the results available to ensure full reproducibility?

Yes
Are the conclusions drawn adequately supported by the results?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Public Health, toxicology

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Examination of Lifetime Established Use Criteria for Adult Tobacco Product Users

Abstract

Keywords

Introduction

Methods

Cross-sectional analyses based on PATH Wave 1 data

Table 1. Lifetime Established Use Questions from PATH Wave 1 to Wave 5 Survey Questionnaire.

Table 2. Demographics, Socioeconomic Status, and Tobacco Use Patterns Among Current Experimental versus Current Established Tobacco Users.

Figure 1. Response pattern of lifetime usage based on numerical and non-numerical criterion among current tobacco users.

Table 3. Levels of Agreement between Non-Numerical and Numerical Criteria among Ever-, Current-, and Former-Tobacco Users.

Table 4. Recommendation of Numerical Thresholds to Define Adult Lifetime Established Use for Tobacco Products.

Table 5. Odds Ratio Comparisons between Current Tobacco Users Reaching Non-Numerical or Numerical Criterion.

Longitudinal analyses based on Waves 1 to 4 data

Table 6. Odds Ratio of Discontinuing Past-30 Day Use at Follow-Up Wave among Current Tobacco Users.

Additional Cross-Sectional Analysis based on Waves 1 to 5 Data

Table 7. Comparison of Current Experimental versus Current Established ENDS Users based on Five Waves of Data┼.

Figure 2. Response pattern of lifetime usage based on numerical and non-numerical criterion among current ENDS users.

Table 8. Levels of Agreement between Non-Numerical and Numerical Criteria among Ever-, Current-, Former-Users of ENDS Products┼.

Table 9. Levels of Agreement between Non-Numerical and Numerical Criteria among Ever-, Current-, Former-Users of Snus Products┼.

Results

Demographics, socioeconomic status and tobacco use patterns

Response patterns and levels of agreement between numerical and non-numerical lifetime established use criteria

Correlates of reaching (non-numerical and numerical) lifetime established use criterion among current tobacco product users based on logistic regression models

Correlates of discontinuation of past 30-day use at follow-up Wave based on GEE logistic regression models

Discussion

Conclusion

Ethical Considerations

Author Contributions

Data Availability

Reporting Guidelines

Acknowledgments

References

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Examination of Lifetime Established Use Criteria for Adult Tobacco Product Users 

Table 7. Comparison of Current Experimental versus Current Established ENDS Users based on Five Waves of Data^┼.

Table 8. Levels of Agreement between Non-Numerical and Numerical Criteria among Ever-, Current-, Former-Users of ENDS Products^┼.

Table 9. Levels of Agreement between Non-Numerical and Numerical Criteria among Ever-, Current-, Former-Users of Snus Products^┼.