User Definitions & History
This is the minimum number of cigarettes someone must have smoked in their lifetime to be classified as a former or current smoker according to standard definitions.
What is 100 cigarettes?
This behavioral outcome describes when someone uses both cigarettes and the MRTP during the same time period.
What is dual use?
Reviewers evaluate whether these three study elements are appropriate to generate valid and interpretable behavioral estimates.
What are study population, recruitment methods, and measures?
Reviewers examine data integrity by reviewing these three elements to ensure accuracy, reproducibility, and reliability.
What are data management, variable definitions, and analytic transparency?
When interpreting applicant conclusions, reviewers determine whether findings are methodologically sound, internally consistent, and supportive of this.
What is continued population health benefit?
These two national tobacco surveillance studies provide definitions that reviewers should consider aligning with when evaluating user group categories.
What are PATH (Population Assessment of Tobacco and Health) and TUS-CPS (Tobacco Use Supplement to the Current Population Survey)?
These five MRTP use behaviors should be captured in a protocol, if applicable.
What are initiation, frequency, dual use, complete switching, and flavor use?
Protocols should capture tobacco use measures for both of these time windows.
What are past 30-day and past 12-month?
These four types of bias should be evaluated as potential sources of error in PMSS protocols.
What are selection bias, recall bias, misclassification bias, and confounding? (Also accept: attrition bias)
This principle states that no single element is determinative when assessing PMSS protocols.
What is totality of evidence (or totality assessment)?
When assessing smoking history, reviewers should confirm these four elements are clearly defined and consistently applied.
What are lifetime use (≥100 cigarettes), frequency, intensity, and initiation/patterns of use?
This measure determines whether MRTP use came before or after cigarette smoking or use of other tobacco products.
What is temporal sequence?
This type of study design is preferred because it can track individual behavior changes over time.
What is longitudinal (or cohort) design?
When evaluating potential biases, reviewers assess whether analytic methods adequately address these two specific issues.
What are confounding and attrition?
Applicant conclusions should be these three things according to the reviewer checklist.
What are data-supported, transparent, and consistent with expected population-level health benefit?
When reviewing other tobacco and nicotine product history, these four details should be captured for each product type.
What are frequency, duration, product type, and flavor use?
When evaluating complete switching, reviewers assess whether former smokers have done this while currently using the MRTP.
What is stopped smoking cigarettes (or quit smoking/ceased cigarette use)?
When a longitudinal design is not feasible, this study design is an acceptable alternative if it includes adequate recall measures.
What is cross-sectional design?
This type of bias occurs when participants cannot accurately remember past tobacco use behaviors, particularly concerning temporal sequence.
What is recall bias?
In totality assessment, this can occur when strengths in one area compensate for limitations in another.
What is compensatory evidence?
User categories should include clear definitions for these three primary groups, at minimum, to facilitate meaningful comparisons.
What are never users, former users, and current users (or never smokers, former smokers, and current smokers)?
A protocol should capture whether MRTP initiation preceded or followed these three tobacco-related events.
What are initiation (of other products), cessation (of cigarettes), and use of other tobacco or nicotine products?
These five behavioral outcomes should be clearly defined, measured, and appropriately analyzed over time.
What are initiation, dual use, complete switching, cessation, and reduction?
This type of bias occurs when participants are incorrectly categorized into user groups due to ambiguous definitions or measurement error.
What is misclassification bias?
Reviewers must ensure that applicant interpretations demonstrate findings are methodologically sound, internally consistent, and supportive of continued benefit to this.
What is population health (or public health)?