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Social and Behavioral Sciences Commons

Open Access. Powered by Scholars. Published by Universities.®

Medicine and Health Sciences

Virginia Commonwealth University

Theses and Dissertations

Clinical trial

Publication Year

Articles 1 - 2 of 2

Full-Text Articles in Social and Behavioral Sciences

The Influence Of Flavor On The Abuse Liability Of A Heated Tobacco Product And Its Feasibility As A Menthol Cigarette Substitute, Augustus White Jan 2024

The Influence Of Flavor On The Abuse Liability Of A Heated Tobacco Product And Its Feasibility As A Menthol Cigarette Substitute, Augustus White

Theses and Dissertations

Heated Tobacco Products (HTPs) purport to expose people that use cigarettes to fewer of the harmful or potentially harmful constituents of tobacco while still delivering reinforcing amounts of nicotine (Auer, Concha-Lozano et al., 2017). An exemplar of the HTP class, IQOS, and its three varieties of “HeatSticks” have been authorized by the Food and Drug Administration (FDA) as “Modified Risk Tobacco Products” (MRTP). However, as the FDA is planning to ban menthol as a characterizing flavor in cigarettes, questions remain regarding whether characterizing flavors should be permitted in HTPs (FDA, 2022e). New evidence regarding HTP abuse liability (i.e., the likelihood …


Evaluating And Reducing The Effects Of Misclassification In A Sequential Multiple Assignment Randomized Trial (Smart), Jun He Jan 2018

Evaluating And Reducing The Effects Of Misclassification In A Sequential Multiple Assignment Randomized Trial (Smart), Jun He

Theses and Dissertations

SMART designs tailor individual treatment by re-randomizing patients to subsequent therapies based on their response to initial treatment. However, the classification of patients being responders/non-responders could be inaccurate and thus lead to inappropriate treatment assignment. In a two-step SMART design, by assuming equal randomization, and equal variances of misclassified patients and correctly classified patients, we evaluated misclassification effects on mean, variance, and type I error/ power of single sequential treatment outcome (SST), dynamic treatment outcome (DTRs), and overall outcome. The results showed that misclassification could introduce bias to estimates of treatment effect in all types of outcome. Though the magnitude …