Sample Analysis Plans

Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Attachment 19
PATH Study
Sample Analysis Plans

Sample Data Analysis Plan For Packaging And Health Warning Labels Domain
Key outcomes: Uptake; Quitting; Relapse
Key variables: Health warning labels; Light/mild/low ban; Menthol; Other Flavors; Other
packaging and labeling changes
Covariates: Age; Sex; Race/Ethnicity; Education; Current Employment Status; Income; other
intermediate factors from model
Analysis: Frequencies; could also look at changes across time using logistic regression (odds
ratios, confidence intervals)
EXAMPLE: Awareness of health warning labels on cigarette packages among
current smokers
Characteristic
Wave 1
Wave 2
Wave 3
%
%
%
Age (years)
12-17
18-24
25-44
45-64
65 and older
25 and older
Sex
Female
Male
Ethnicity
Not of Hispanic or Latino/ Spanish origin
Hispanic or Latino/ Spanish origin
Race
White
Black or African American
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific
Islander
Education
Less than high school
Some high school
High school graduate/GED
Some college
Associate degree
(occupational/vocational)
Associate degree (academic program)
Bachelor’s degree
Graduate degree
Current employment status

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Don’t currently work for pay
Work part-time (<15 hours/week)
Work part-time (15-34 hours/week)
Work full-time (>=35 hours/week)
Annual Household Income
Under $10,000
$10,000-$29,999
$30,000-$44,999
$45,000-$59,999
$60,000-$74,999
$75,000-$99,999
$100,000-$149,999
$150,000 and over
Source: Population Assessment of Tobacco and Health Survey
*p-value<0.05; **p-value<0.01

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Sample of Analysis Plan of Larger Pictorial Warning Labels on Cigarettes.
The accompanying conceptual model in Figure 1 guides the analysis plan with respect to this
regulatory action. Regulatory action is hypothesized to cause changes in a variety of proximal
and distal measures that will ultimately result in changes in smoking cessation, uptake and
relapse. The enumerated list below are specific analyses that will be undertaken to examine
these various pathways. The parenthetical number in each bullet refers to the numbered box in
Figure 1. All potential analyses would include above outlined demographic factors, as well as
additional covariates outlined within each outcome
• Awareness of health warning labels among nonusers and former users of tobacco
products(1a)
• Knowledge of health warnings among nonusers, former users, and current users (1b)
• Depth of Processing of Message on label among nonusers, former users, and current
users (1d)
• Uptake and Positive Beliefs/Product Appeal among nonusers (2)
• Quitting and Positive Beliefs/Product Appeal among current users (2)
• Relapse and Positive Beliefs/Product Appeal among former users (2)
• Uptake and Social norms among nonusers (3)
• Quitting and Social norms among current users (3)
• Relapse and Social norms among former users (3)
• Uptake and Affective reactions among nonusers (4)
• Quitting and Affective reactions among current users (4)
• Relapse and Affective reactions among former users (4)
• Uptake and Cognitive reactions (beliefs about health effects) among nonusers (5a)
• Uptake and Cognitive reactions (thinking/worry about health risks) among nonusers (5b)
• Quitting and Cognitive reactions (beliefs about health effects) among current users (5a)
• Quitting and Cognitive reactions (thinking/worry about health risks) among current users
(5b)
• Relapse and Cognitive reactions (beliefs about health effects) among former users (5a)
• Relapse and Cognitive reactions (thinking/worry about health risks) among former users
(5b)
• Uptake and Cessation beliefs among nonusers (6)
• Quitting and Cessation beliefs among current users (6)
• Relapse and Cessation beliefs among former users (6)
• Perceived Risk among nonusers, taking into account Salience and Processing (1) and
Affective (4) and Cognitive (5) reactions
• Uptake among nonusers taking into account Salience and Processing, Positive
Beliefs/Product Appeal (2), Social Norms (3), Perceived Risk (7), and Cessation beliefs
(6)
• Perceived Risk from tobacco use (7) among current users, taking into account Salience
and Processing (1), Affective Reactions (4), and Cognitive Reactions (5)
• Avoidance of the health warning labels among current users, taking into account Salience
and Processing (1), Affective Reactions (4), and Cognitive Reactions (5)

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•
•
•
•
•
•
•
•

Quit intentions among current users taking into account Salience and Processing (1),
Positive beliefs and product appeal (2), Social Norms (3), Perceived Risk (7), Affective
(4) and Cognitive (5) Reactions, and Cessation beliefs (6)
Use of Cessation Assistance (10) among current users, accounting for quit intentions (9),
and Cessation Beliefs (6)
Smoking behavior changes (11) among current users, including changes in consumption
(11a), quit attempts (11b), or abstinence (11c), taking into account quit intentions (9) and
use of cessation assistance (10)
Perceived risk (7) among former users, accounting for salience and processing (1) and
affective (4) and cognitive (5) reactions
Motivation to remain abstinent (9) among former tobacco users, taking into account
positive beliefs/product appeal (2), social norms (3), perceived risk (7), and Cessation
beliefs (6)
Use of cessation assistance (10) among former tobacco users, taking into account
cessation beliefs (6) and motivation to remain abstinent (9)
Continued abstinence as smoking behavior (11) among former users, taking into account
motivation to remain abstinent (9) and use of cessation assistance (10)
Relapse among former tobacco users, taking into account motivation to remain abstinent
(9)

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FIGURE 1. CONCEPTUAL MODEL FOR PACKAGING AND HEALTH
WARNING LABELS
Health Warnings

1. Salience & Processing
1a. Awareness of warnings
1b. Knowledge of warnings
1c. Noticing of warnings
1d. Depth of processing

2. Positive Beliefs
/ Product Appeal
2a. Attractiveness

3. Social
Norms

4. Affective
reactions
4a. Fear
4b. Disgust

5. Cognitive
Reactions
5a. Beliefs about
health effects
5b.
Thinking/worry
about health risks

7. Perceived
Risk

8. Avoidance
8a. Covering
warnings
8b. Requesting
Packs

9. Quit
Intentions/Motivation to
remain abstinent

6. Cessation
Beliefs
6a. Selfefficacy
6b. Quit-line
information
6c. Website
information

10. Use of
Cessation
Assistance

11. Smoking Behavior
11a. Changes in
consumption
11b. Quit Attempt
11c. Abstinence
11d. Relapse

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