Werkcollege Farmaco-Epidemiology

Computer assignment: case-control study

Prof. Dr. Eelko Hak

Confounding triangle:

VACCINE DEATH

Table 1: Table 2:
association with CONFOUNDER association with
Vaccine Death
Age?
Gender?
N med?
 Exercise 1. Examination vaccinated and non-vaccinated

1. To analyze data per subgroup, please use data -> data split file, compare
groups, click on variable domain and move to box “groups based on”, click
OK.

2. Examine each of the variables in the dataset (analyze -> descriptives). Use
frequencies for the categorical variables and descriptives or explore for the
continues variables.

Question: which variables are categorical, which are continuous?

Variable Categorical/continuous
Age
Gender
N_med
Vaccine
Death

3. Fill out table 1. This gives the association between vaccine (the determinant)
and the covariates that are potential confounders.

4. Use t-tests for continues variables to compare means (and SD) between
vaccinated and non-vaccinated. Go to analyse, compare means, independent
sample t-test. Define vaccine as grouping variable and define the levels (0, 1).
Put in all continuous variables in the test variable.
If Levene’s test > 0.05  first line; If Levene’s test =< 0.0.5  second line

5. Use cross-tables to calculate N and proportions. Use chi-squared tests for

nominal (categorical) variables to compare proportions between groups. Go
to analyse, descriptives, crosstabs, put vaccine in the column and the
covariates in the row. Click on statistics for the chi-square test, and on cells
for row and column percentage.
Table 1.

Variable Vaccinees Non-vaccinees p-value

18-64 years N = 1637 N = 715
Mean age (SD) 48.9 (11.9) 43.4 (13.3) < 0.001
Male gender, N (%) 755 (46.1) 360 (50.3) 0.059
Mean N medications (SD) 0.91 (1.37) 0.72 (1.25) 0.001
High-risk 65+ N = 4133 N = 643
Mean age (SD) 75.8 (7.0) 75.9 (7.4) 0.850
Male gender, N (%) 1840 (44.5) 270 (42.0) 0.230
Mean N medications (SD) 1.79 (2.06) 1.45 (1.83) < 0.001

2. Do you think there might be a potential for confounding bias? For which variables
and why? How is the mean risk of vaccinated as compare with non-vaccinated
groups?

3. Is the potential for confounding less likely or more likely among the 18-64 year
group as compared to the 65+ high-risk elderly?

Exercise 2. Examination cases and controls

Confounders are variables that are related to the exposure status and the outcome
(case status). Variables that are not associated with the exposure status will never be
a confounder and therefore do not need to be examined for an association with the
outcome.

Question 1. For each sub-cohort, please encircle the potential confounders in table 1.

Question 2. Present distribution of potential confounders (erase variables that are not
potential confounders) for those who died during the epidemic (case) and controls.
Table 2.

Variable Death Non death p-value

18-64 years N = 47 N = 2305
Mean age (SD) 54.0 (9.7) 47.1 (12.6) < 0.001
Mean N medications (SD) 2.45 (2.46) 0.82 (1.29) < 0.001

High-risk 65+ N = 191 N = 4585

Mean N medications (SD) 3.15 (2.40) 1.68 (2.00) < 0.001

Question 3. For each sub-cohort, please encircle the confounders (both associated
with exposure and outcome status) in table 2.

Exercise 3. Vaccine effectiveness and logistic regression analysis

Question 1. Please give the unadjusted vaccine effectiveness in percentage (1-odds

ratio*100%) in preventing deaths per sub-cohort. Use regression, binary logistic
regression analysis to calculate odds ratios (exp(B) and corresponding 95% CI (in
options).

Table 3.

Variable Univariate OR Unadjusted Multivariate OR Adjusted

(95% CI) effectiveness (95% CI) effectiveness
(95% CI) (95% CI)
18-64 years
DEATH 0.38 (0.21 – 0.67) 62% (33 – 79) 0.25 (0.14 – 0.46) 75% (54 – 86)

High-risk 65+
DEATH 0.61 (0.43 – 0.88) 40% (12 – 57) 0.56 (0.38 – 0.82) 44% (18 – 62)

Question 2. What is the vaccine effectiveness adjusted for confounding?

Use binary logistic regression analysis with vaccine and add other potential
confounders to the model to calculate adjusted odds ratios and corresponding
95%CI. Adjust for the confounders found in exercise 2. Fill out in table 3.

Question 3. Would you, based on the adjusted and unadjusted estimates, conclude
that there is confounding present in the data? How does confounding affect the
outcome in this dataset?

Question 5. Do you think there is effect modification, and why?