Epidemiology

Question 1

ITT meaning

Answer 1

Treating all enrolled participants the same (whether they follow protocol, die, etc or not)

Question 2

Type 1 error

Answer 2

Finding an association when there is none.
Probability = alpha

Question 3

Type 2 error

Answer 3

Not finding an association when there is one.
Probability = beta

Question 4

T or F? ITT can introduce misclassification of exposure

Answer 4

True

Question 5

What is sufficient power?

Answer 5

1-beta.
Usually arbitrarily set at 80%.
Needs to take into account losses to follow up.

Question 6

How to calculate NNT

Answer 6

NNT = number needed to treat to prevent one additional bad outcome

NNT = 1/absolute risk reduction

Question 7

Phase 1 trials

Answer 7

Healthy human subjects to assess pharmacokinetics and pharmacological effects.

Question 8

Phase 2 trials

Answer 8

Subjects having disease of interest to determine drug effectiveness and side effects (short term)

Question 9

Phase 3 trials

Answer 9

Larger number of subjects with disease to evaluate efficacy. Drug used as it would be marketed

Question 10

Phase 4 trials

Answer 10

Post-marketing, done to obtain additional info than what was studied in phase 3 trials (dosages, durations, diseases, sub-populations)

Question 11

CONSORT guidelines

Answer 11

Consolidated Standard of Reporting Trials
= standard to which conduct of trials must be adhered