Team-Based Learning Exercise: Observational Study Design Worksheet

Question Cross-Sectional Design

1a) Research question Is there an association between the prevalence of periodontal

1b) P: disease and e-cigarette use?
I/E: P: Adults with periodontitis in the United States
C: I/E: E-cigarette use
O: C: Never-smokers
O: Prevalence and severity (risk) of periodontal disease

2) Null hypothesis There is no association between the use of e-cigarettes and

prevalence of periodontal disease.
3a) Target population Target: Adults that are e-cigarette users or never-smokers
3b) Study population Study: Adults with periodontitis that self-identify/report as e-cig-
3c) Recruitment strategies arette users or never-smokers
Can utilize public national self-reported questionnaires from
NHANES/CDC, if adequate funding can formulate more specific
questionnaire and conduct at one time point, population can be
recruited from out-patient population of dental or medical clinic
4a) Inclusion criteria Inclusion: Users and non-users with periodontitis, self-reported
4b) Exclusion criteria status, specified use of tobacco, adults, have had a medical or
dental exam completed within the last 5 years
Exclusion: Never-smokers with second hand smoking exposure,
previous smokers, missing periodontal data
5a) Exposure definition Exposure variable is the use of e-cigarettes. The inclusion is de-
5b) Exposure measurement pendent on the questionnaire to self-identity as a smoker. “Use of
e-cigarette is the last 30 days?” “What is the frequency of e-cig
use?”
6) Outcome questions: individualized for each study design Outcome to be measured is the prevalence of periodontal disease
across e-cig users and never smokers. Periodontal assessment
will be pooled from self-report. If measured in the field then peri-
odontal clinical parameters should be measured (PD, radio-
graphic bone loss, BOP, CAL) and categorized.

7a) Potential confounders Patients that self-report as e-cigarette users may also utilize other
7b) Minimize confounders forms of tobacco or alcohol consumption which may affect risk
of periodontal disease, other common risk factors may become
confounders within the e-cigarette users (stress, SES). Minimize
confounders by more tightly regulated exclusion factors which
are options that population can self-identify with on the question-
naire. We should not assume that the population or individual
does not possess this characteristic that turns into a confounder.

8a) Effect measure (e.g., Odds Ratio, difference of means) Odds ratio (OR) is a measure of association between exposure
8b) Measure equation and an outcome. The OR represents the odds that an outcome
will occur given a particular exposure, compared to the odds of
the outcome occurring in the absence of that exposure.

OR >1 indicates increased occurrence of an event

OR <1 indicates decreased occurrence of an event
9a) Advantages of design
9b) Disadvantages of design
10) Potential biases
11) Why a clinical trial is not appropriate?
Advantages:
• Conducted relatively faster and inexpensive when compared to
cohort studies
• Conducted as a baseline in a cohort study, this study gives us
information about the prevalence of outcomes or exposures,
useful in the design of cohort study
• Cross-sectional useful for public health planning, monitoring
and evaluation
Disadvantages:
• A one-time measurement of exposure and outcome, difficult to
derive causal relationship
• Doesn’t take into account different incidence of periodontal
disease in a particular community, just one snapshot of a larger
population, cumulative analysis that may not be sufficient to
understand disease trends
Hard to derive a causal relationship due to one-time measurement
that introduces the bias that individuals have began to al-
ter habits. There may have been e-cig users that reported lower
than personal average of usage as they are attempting to quit.
In order for a clinical trial to be approved there should be preliminary
studies that demonstrate efficacy and safety of the intervention that
would be put into place. A clinical trial would not answer the question
about the prevalence of a certain disease or the association between
a risk factor and a disease. Instead, clinical trials focus on novel treat-
ments or interventions that may or may not aid or halt the progres-
sion of a disease. These types of studies are also prospective in that a
group of individuals under certain criteria undergo treatment and
their response is recorded. This type of study would not answer our
hypothesis about how the development of periodontitis may or may
not arise from e-cig smoking.