MCQ Quiz: Pharmacoepidemiology Study Design

Pharmacoepidemiology is the study of the use and effects of drugs in large populations, forming a crucial bridge between clinical pharmacology and public health. Understanding the different study designs is fundamental to interpreting the evidence on a drug’s real-world safety and effectiveness, a core competency taught in the Principles of Evidence-Based Practice course. This quiz will test your ability to differentiate, analyze, and appraise the various observational and experimental study designs used in pharmacoepidemiology.

1. Pharmacoepidemiology is best defined as the study of the:

• a. Chemical structure of drugs.
• b. Use and effects of drugs in large populations.
• c. Economic impact of pharmaceuticals.
• d. Process of drug discovery and development.

Answer: b. Use and effects of drugs in large populations.

2. In which type of study design does the investigator assign the exposure or intervention to the participants?

• a. Experimental study (e.g., RCT)
• b. Cohort study
• c. Case-control study
• d. Cross-sectional study

Answer: a. Experimental study (e.g., RCT)

3. A study identifies a group of patients who take a new cholesterol medication and a group who do not, and follows both groups forward in time to see who develops liver disease. This is an example of a(n):

• a. Case-control study
• b. Cross-sectional study
• c. Prospective cohort study
• d. Case report

Answer: c. Prospective cohort study

4. The primary measure of association calculated in a cohort study is the:

• a. Odds Ratio (OR)
• b. P-value
• c. Relative Risk (RR)
• d. Standard deviation

Answer: c. Relative Risk (RR)

5. A study identifies patients with a rare form of cancer (cases) and a similar group of patients without the cancer (controls), and then looks back in time to assess their history of exposure to a certain medication. This is a(n):

• a. Cohort study
• b. Case-control study
• c. Randomized controlled trial
• d. Ecological study

Answer: b. Case-control study

6. The “Pharmacoepidemiology Study Designs” is a specific learning module in which course?

• a. PHA5244 Principles of Evidence-Based Practice
• b. PHA5104 Sterile Compounding
• c. PHA5703 Pharmacy Law and Ethics
• d. PHA5787C Patient Care 5

Answer: a. PHA5244 Principles of Evidence-Based Practice

7. The primary measure of association calculated in a case-control study is the:

• a. Relative Risk (RR)
• b. Attributable Risk
• c. Prevalence Ratio
• d. Odds Ratio (OR)

Answer: d. Odds Ratio (OR)

8. What is a major advantage of a case-control study design?

• a. It can establish temporality with certainty.
• b. It is efficient for studying rare diseases.
• c. It is not susceptible to bias.
• d. It can directly calculate disease incidence.

Answer: b. It is efficient for studying rare diseases.

9. A study that assesses both exposure (e.g., medication use) and outcome (e.g., high blood pressure) at a single point in time is a(n):

• a. Cohort study
• b. Case-control study
• c. Randomized controlled trial
• d. Cross-sectional study

Answer: d. Cross-sectional study

10. What is a primary limitation of a cross-sectional study?

• a. It is too expensive to conduct.
• b. It cannot establish temporality (i.e., whether the exposure preceded the outcome).
• c. It is the best design for studying rare exposures.
• d. It is a type of experimental study.

Answer: b. It cannot establish temporality (i.e., whether the exposure preceded the outcome).

11. The appraisal of cohort studies is a specific lecture within the Principles of Evidence-Based Practice course.

• a. True
• b. False

Answer: a. True

12. Randomization in a clinical trial is the best way to control for:

• a. Information bias
• b. Recall bias
• c. Confounding variables (both known and unknown)
• d. Selection bias after enrollment

Answer: c. Confounding variables (both known and unknown)

13. A study reports a Relative Risk of 0.6 (95% CI 0.4 – 0.9) for an outcome. This means the exposure is:

• a. A risk factor for the outcome.
• b. Not associated with the outcome.
• c. A statistically significant protective factor for the outcome.
• d. Not statistically significant.

Answer: c. A statistically significant protective factor for the outcome.

14. A study that uses population-level data (e.g., average statin sales per country vs. heart disease rates per country) is a(n):

• a. Case-control study
• b. Ecological study
• c. Cohort study
• d. Randomized controlled trial

Answer: b. Ecological study

15. A major limitation of an ecological study is the “ecological fallacy,” which means:

• a. The study has a high environmental impact.
• b. An association observed at the population level may not be true at the individual level.
• c. The study is too expensive.
• d. The study is free from all bias.

Answer: b. An association observed at the population level may not be true at the individual level.

16. Which of the following study designs sits at the top of the traditional evidence hierarchy for treatment efficacy?

• a. Cohort study
• b. Case-control study
• c. Randomized controlled trial
• d. Case series

Answer: c. Randomized controlled trial

17. The review and appraisal of cohort studies is a “Transcending Concept” in the Patient Care 5 curriculum.

• a. True
• b. False

Answer: a. True

18. A systematic error in the design or conduct of a study that leads to a distorted result is known as:

• a. Confounding
• b. Bias
• c. Random error
• d. A p-value

Answer: b. Bias

19. In a case-control study, asking participants to remember their medication use from 20 years ago can lead to which type of bias?

• a. Selection bias
• b. Attrition bias
• c. Recall bias
• d. Performance bias

Answer: c. Recall bias

20. A “Journal Club” is an activity where students practice appraising primary literature like pharmacoepidemiology studies.

• a. True
• b. False

Answer: a. True

21. A cohort study is generally better than a case-control study for studying:

• a. Rare diseases
• b. Rare exposures
• c. Diseases with a long latency period
• d. It is never better.

Answer: b. Rare exposures

22. An Odds Ratio of 3.0 means:

• a. The odds of exposure among the cases are three times the odds of exposure among the controls.
• b. The risk of the disease is three times higher in the exposed group.
• c. The treatment is three times as effective.
• d. The odds of developing the disease are 3%.

Answer: a. The odds of exposure among the cases are three times the odds of exposure among the controls.

23. When the disease being studied is rare, the Odds Ratio from a case-control study can be a good approximation of the:

• a. P-value
• b. Standard deviation
• c. Prevalence
• d. Relative Risk

Answer: d. Relative Risk

24. An active learning session on EBP is part of which course?

• a. PHA5244 Principles of Evidence-Based Practice
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5787C Patient Care 5

Answer: a. PHA5244 Principles of Evidence-Based Practice

25. A pharmacist making a formulary decision about a drug’s long-term safety would likely rely on evidence from:

• a. Pre-clinical animal studies.
• b. Phase I clinical trials.
• c. Large, observational pharmacoepidemiology studies.
• d. A single case report.

Answer: c. Large, observational pharmacoepidemiology studies.

26. A key difference between an RCT and a cohort study is that the RCT:

• a. Is observational.
• b. Lacks a comparison group.
• c. Involves random assignment to the exposure group.
• d. Cannot determine causality.

Answer: c. Involves random assignment to the exposure group.

27. What is the primary purpose of a “washout period” in a crossover study design?

• a. To allow patients to clean the medication vials.
• b. To minimize the carryover effects of the first treatment into the second treatment period.
• c. To increase the sample size.
• d. To ensure adequate blinding.

Answer: b. To minimize the carryover effects of the first treatment into the second treatment period.

28. An active learning session on appraising cohort studies is part of which course module?

• a. Module 5: Urological Disorders
• b. Module 1: Diabetes Mellitus
• c. Module 4: Medication Safety
• d. Module 8: Men’s Health

Answer: a. Module 5: Urological Disorders

29. The main goal of pharmacoepidemiology is to:

• a. Study the spread of infectious diseases.
• b. Describe the distribution and determinants of drug-related events in populations and apply this study to the control of health problems.
• c. Regulate the price of medications.
• d. Develop new drug molecules.

Answer: b. Describe the distribution and determinants of drug-related events in populations and apply this study to the control of health problems.

30. The “Observational Studies” module is part of the EBP course.

• a. True
• b. False

Answer: a. True

31. “Selection bias” occurs when:

• a. The way study participants are chosen is systematically different and related to the exposure and outcome.
• b. Participants are lost to follow-up.
• c. The measurement of information is different between groups.
• d. The researchers choose which results to publish.

Answer: a. The way study participants are chosen is systematically different and related to the exposure and outcome.

32. A pharmacoepidemiology study using a large insurance claims database is an example of what kind of study?

• a. A prospective cohort study
• b. A randomized controlled trial
• c. A retrospective cohort study
• d. A clinical trial phase 1

Answer: c. A retrospective cohort study

33. What is a strength of using a large administrative database for a pharmacoepidemiology study?

• a. It has a large sample size and reflects real-world medication use.
• b. The data is always perfectly accurate and complete.
• c. It is free from all confounding.
• d. The exact reasons for prescribing are always clear.

Answer: a. It has a large sample size and reflects real-world medication use.

34. A case-crossover study is a design where:

• a. Cases and controls are different people.
• b. Each case serves as their own control.
• c. The exposure is randomized.
• d. There is no control group.

Answer: b. Each case serves as their own control.

35. The “Introduction to study designs in pharmacoepidemiology” is a required reading in the EBP course.

• a. True
• b. False

Answer: a. True

36. A pharmacist’s ability to critically appraise a study is essential for:

• a. Evidence-based practice.
• b. Answering drug information questions.
• c. Making formulary decisions.
• d. All of the above.

Answer: d. All of the above.

37. Which of the following is NOT a type of observational study?

• a. Cohort
• b. Case-control
• c. Randomized controlled trial
• d. Cross-sectional

Answer: c. Randomized controlled trial

38. The “Experimental Studies” module is part of the EBP course.

• a. True
• b. False

Answer: a. True

39. A key question when appraising a cohort study is:

• a. Were the exposed and unexposed groups comparable at the start of the study?
• b. Was the follow-up sufficiently long and complete?
• c. Were the outcomes measured in the same way for both groups?
• d. All of the above.

Answer: d. All of the above.

40. An active learning session covering EBP is part of which course?

• a. PHA5244 Principles of Evidence-Based Practice
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5787C Patient Care 5

Answer: a. PHA5244 Principles of Evidence-Based Practice

41. The term “temporality” refers to:

• a. The length of the study.
• b. The time of day the study was conducted.
• c. The requirement that the exposure must occur before the outcome.
• d. The temporary nature of the study’s findings.

Answer: c. The requirement that the exposure must occur before the outcome.

42. Which observational study design is best for establishing temporality?

• a. Case-control study
• b. Cross-sectional study
• c. Prospective cohort study
• d. Ecological study

Answer: c. Prospective cohort study

43. A pharmacist is asked if a new statin causes a rare side effect. The best type of study to answer this question would be:

• a. A large, well-designed observational study (cohort or case-control).
• b. A small phase II RCT.
• c. A case report.
• d. An animal study.

Answer: a. A large, well-designed observational study (cohort or case-control).

44. A major focus of pharmacoepidemiology is:

• a. Drug discovery.
• b. Post-marketing drug safety and surveillance.
• c. Pre-clinical testing.
• d. Compounding techniques.

Answer: b. Post-marketing drug safety and surveillance.

45. Which of the following is a limitation of a retrospective cohort study?

• a. The researcher has no control over which data was collected and it may be incomplete or inaccurate.
• b. It takes a very long time to complete.
• c. It is very expensive.
• d. It is not good for studying rare outcomes.

Answer: a. The researcher has no control over which data was collected and it may be incomplete or inaccurate.

46. Confounding by indication is a common problem in pharmacoepidemiology, meaning:

• a. The drug was used for the wrong indication.
• b. Patients who receive a drug are often systematically different (e.g., sicker) than those who do not, and this underlying difference is the true cause of the outcome.
• c. The indication for the drug changes over time.
• d. The drug has multiple indications.

Answer: b. Patients who receive a drug are often systematically different (e.g., sicker) than those who do not, and this underlying difference is the true cause of the outcome.

47. A journal club is a practical application of the skills learned in the EBP course.

• a. True
• b. False

Answer: a. True

48. An active learning session on study design is part of which course module?

• a. Module 2: Pharmacoepidemiology Study Designs
• b. Module 1: Formulating a Clinical Question
• c. Module 6: Summarizing the Evidence
• d. Module 3: Applying Biostatistics

Answer: a. Module 2: Pharmacoepidemiology Study Designs

49. The overall goal of understanding pharmacoepidemiology is to:

• a. Be able to conduct your own large-scale studies.
• b. Critically evaluate and apply evidence from population-based studies to make informed clinical and policy decisions.
• c. Discredit all observational research.
• d. Only trust randomized controlled trials.

Answer: b. Critically evaluate and apply evidence from population-based studies to make informed clinical and policy decisions.

50. The ultimate reason for a pharmacist to learn about study design is to:

• a. Be a better consumer of medical literature to provide the best evidence-based patient care.
• b. Pass the EBP final exam.
• c. Be able to talk with researchers.
• d. Fulfill a curriculum requirement.

Answer: a. Be a better consumer of medical literature to provide the best evidence-based patient care.