Statistics Related to InterventionalCardiology Procedures

Question 1

What is the primary endpoint in clinical trials?

Answer 1

The primary endpoint is the main question that the trial is designed and powered to answer.

Question 2

How should subgroups of patients be viewed in clinical trials?

Answer 2

Subgroups should be viewed for consistency based on patient and disease characteristics.

Question 3

What is likely to be seen in treatment effects among subgroups?

Answer 3

Quantitative differences in treatment effect may favor certain subgroups, but qualitative differences are unlikely.

Question 4

Why are randomized clinical trials (RCTs) preferred over observational studies?

Answer 4

RCTs are preferred because they are designed to minimize bias and provide stronger evidence for treatment effectiveness.

Question 5

What is a potential limitation when applying RCT results to different populations?

Answer 5

The results may not generalize if the trial was conducted in a different population than the patient of interest.

Question 6

What is the significance of blinding in clinical trials?

Answer 6

Blinding reduces bias in treatment effect assessments by preventing investigators and patients from knowing the treatment assignments.

Question 7

What does Type II error (β) represent in clinical trials?

Answer 7

Type II error occurs when no effect is seen when, in fact, a treatment effect truly exists.

Question 8

What is the relationship between Type II error and trial power?

Answer 8

One minus the Type II error (1 - β) is known as the trial’s power.

Question 9

What is the primary benefit of randomizing patients into treatment groups?

Answer 9

Randomization balances covariate information across groups, ensuring observed associations are due to treatment.

Question 10

What are competing risks in statistical analysis?

Answer 10

Competing risks modify the chances of occurrence of an event of interest or hinder its occurrence.

Question 11

What is Absolute Risk Reduction (ARR)?

Answer 11

ARR is the difference in event risk between the treatment and placebo groups.

Question 12

How is the Number Needed to Treat (NNT) calculated?

Answer 12

NNT is calculated as 1 divided by the risk difference (ARR).

Question 13

What are the key components of diagnostic test evaluation?

Answer 13

Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy.

Question 14

What does high sensitivity in a diagnostic test indicate?

Answer 14

High sensitivity indicates a low chance of missing a disease.

Question 15

What is the potential issue with using box plots for correlated data?

Answer 15

Box plots cannot adequately represent data with a correlation structure due to non-independence of data points.

Question 16

What is the main drawback of observational studies?

Answer 16

Observational studies do not randomize patients, making it difficult to establish causality.

Question 17

What is the significance of the equivalence margin in clinical trials?

Answer 17

The equivalence margin defines the maximum allowable difference between treatments to consider them equivalent.

Question 18

What is the role of case-control studies in clinical research?

Answer 18

Case-control studies provide preliminary information using previously collected data to identify associations.

Question 19

What is the implication of underpowered studies?

Answer 19

Underpowered studies result in wide confidence intervals, making it difficult to detect treatment effects.

Question 20

Fill in the blank: The _______ method uses first and subsequent events as long as the subject is still being observed.

Answer 20

Andersen–Gill