# Contextual Knowledge Core

> **NIH NIH U54** · VIRGINIA COMMONWEALTH UNIVERSITY · 2020 · $270,551

## Abstract

Project Summary. The Center for the Study of Tobacco Products (CSTP) has developed a model for
evaluating novel tobacco products using, as exemplars, electronic cigarettes (ECIGs) that heat a liquid that
often contains nicotine, forming an aerosol that users inhale. Now, CSTP leverages its methodological and
ECIG expertise to pivot from product evaluation to an integrative theme of impact analysis. Specifically, the
CSTP proposes methods with which FDA can generate predictions regarding a potential regulation’s effects,
and then whether or not the predicted effects occur in the population can be tested. The CSTP’s model
assesses how potential regulation might influence product toxicity (Project 1), user behavior (Project 2), and
product addiction/abuse liability (Project 3). Results from Projects 1-3 are used to generate predictions
regarding population-level phenomena, and we test those population-level predictions using a prospective
cohort survey (Project 4). Because all Projects involve manipulating ECIG device/liquid characteristics and/or
collecting data from ECIG users, all would benefit from detailed and up-to-date knowledge of ECIG user
behavior as well as ECIG characteristics, effects, and changing consumer and ECIG manufacturer/distributor
behaviors. Because changes are rapid, this information is often difficult to attain using data from annual
national surveys. In this context, the overarching goal of the Contextual Knowledge Core (CKC) is to support
each project by using a combination of concept mapping and online data sources to inform Projects 1-4 so that
testing conditions and data collection instruments reflect current, real-world conditions.
The team’s prior studies used several methods to understand ECIG effects and user and manufacturer
behavior, using strategies such as a cost- and time-efficient participatory online method known as “concept
mapping”; content analysis of a popular online video sharing site (YouTube); and systematic analyses of online
forums, and manufacturer/distributor retail outlets to understand ECIG use behaviors, consumer engagement,
and industry labeling practices. These studies then informed an ongoing RCT, an acute laboratory study, and
work in Project 1’s aerosol research laboratory. Collectively, these methodological approaches can inform
CSTP study designs, measurement instruments, and hypotheses. The CKC builds on this work and its aims
are to inform Projects 1-4 using: (1) concept mapping, (2) systematic and longitudinal surveillance of online
data sources like YouTube and ECIG forms, and (3) systematic and longitudinal surveillance of ECIG online
retail sites. In sum, the CKC draws on the team’s proven expertise to ensure that Projects 1-4 use detailed, up-
to-date information to guide device/liquid manipulations and assessment instruments. As with prior studies, the
CKC will produce novel, publishable information about real-world ECIG user experience as well as user and
manufacturer/distributor...

## Key facts

- **NIH application ID:** 10113516
- **Project number:** 5U54DA036105-08
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** Pebbles Fagan
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $270,551
- **Award type:** 5
- **Project period:** 2013-09-30 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10113516

## Citation

> US National Institutes of Health, RePORTER application 10113516, Contextual Knowledge Core (5U54DA036105-08). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10113516. Licensed CC0.

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