Seminar 3 Questions

EPIDEMIOLOGY AND BIOSTATISTICS 1 (HSH205)

SEMINAR 3: MEASURES OF ASSOCIATION & EXPERIMENTAL STUDIES

1. You have been asked to construct a 2 by 2 table and to calculate the risk ratio for a (fictitious)
non-randomised trial that investigated the association between using a mindfulness app and
anxiety. You were provided with only partial information. Fill in the 2 by 2 table based on the
following: a = 10; b = 80; c = 10; d = 40

Based on the information provide:

a. What is the total sample in the study?

b. What is risk in the exposed group? What measure of frequency is this?

c. What is the risk in the unexposed group? What measure of frequency is this?

d. What is the risk ratio for this study?

e. What is your interpretation?

f. What is the problem with this trial being non-randomised?

2. The following table shows data from a sub-analysis from a randomised controlled trial testing the
efficacy of the Pfizer vaccine (see reference). The data here show the results for the vaccinated

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group versus the placebo group after 2 doses in those without prior infection and 7 days after the
second dose. The follow-up period was a median of two months. It is worth noting here that
even though each group has approximately 18,000 people the researchers have converted this to
person-years (assuming by adding up weeks).

Results of the analysis are provided in the table below:

Intervention Control Rate

Group Group Ratio

Cases 8 162
?

Person-years of 2214 2222

observation

a. Please calculate the risk in the exposed (vaccinated) group per 1000 person-years.

b. Please calculate the risk in the unexposed (placebo) group per 1000 person-years.

c. Please calculate the rate ratio.

d. What is your interpretation of the rate ratio?

e. What is the change in risk from the vaccination?

3. Please watch the following video: https://www.youtube.com/watch?v=Wy7qpJeozec

4. Please evaluate the following study to identify potential concerns in its design, conduct, and
analysis and suggest how these could be corrected.

In a randomised controlled trial of the effect of a new drug on episodes of anxiety in those
with recurrent anxiety, 1,000 people were randomised to receive the new active drug, while
another 1,000 were randomised to receive a placebo. The active drug was administered by

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weekly injection, and the placebo was a tablet taken daily. By the end of the trial, 100 people
initially randomised to the active drug had stopped using it because they didn’t want to have
a weekly injection. A further 50 from the placebo group also dropped out of the study. The
results are shown below:

Anxiety episodes No anxiety episodes

Received active drug 250 650

Received placebo 350 600