MCQ Quiz: Study Design in Quality Improvement

Quality Improvement (QI) is not just about making changes; it’s about using structured study designs to test if those changes lead to actual, measurable improvements in patient care and safety. Understanding these practical research methods, which draw on principles from the Principles of Evidence-Based Practice course and are applied in medication safety initiatives, is essential for any pharmacist looking to enhance healthcare processes. This quiz will test your knowledge on the specific study designs used in QI, such as the Plan-Do-Study-Act (PDSA) cycle and time series analysis, and how they differ from traditional clinical research.

1. The primary goal of a Quality Improvement study is to:

• a. Generate new, generalizable scientific knowledge.
• b. Implement and evaluate a change within a specific local setting to improve a process.
• c. Publish a paper in a high-impact journal.
• d. Test a new drug for FDA approval.

Answer: b. Implement and evaluate a change within a specific local setting to improve a process.

2. The most fundamental and widely used model for testing changes in Quality Improvement is the:

• a. Randomized Controlled Trial (RCT)
• b. Case-Control Study
• c. Plan-Do-Study-Act (PDSA) Cycle
• d. Cross-Sectional Study

Answer: c. The Plan-Do-Study-Act (PDSA) Cycle

3. In which phase of the PDSA cycle is the change actually implemented on a small scale?

• a. Plan
• b. Do
• c. Study
• d. Act

Answer: b. Do

4. A simple QI study design measures a process before an intervention and then again after the intervention. This is called a:

• a. Randomized Controlled Trial
• b. Pre-post or Before-and-After study
• c. Case Series
• d. Cohort Study

Answer: b. Pre-post or Before-and-After study

5. What is the major limitation of a simple pre-post study design?

• a. It is too expensive.
• b. It cannot determine if the observed improvement was due to the intervention or some other factor that changed over the same time period.
• c. It requires a very large sample size.
• d. It is too complicated to analyze.

Answer: b. It cannot determine if the observed improvement was due to the intervention or some other factor that changed over the same time period.

6. The “Root Cause Analysis,” a retrospective study design for QI, is a topic in the Patient Care 3 curriculum.

• a. True
• b. False

Answer: a. True

7. An Interrupted Time Series (ITS) design is stronger than a simple pre-post design because it:

• a. Is a form of randomized trial.
• b. Does not require any data.
• c. Uses multiple data points before and after the intervention to establish a baseline trend.
• d. Is easier to perform.

Answer: c. Uses multiple data points before and after the intervention to establish a baseline trend.

8. Which QI tool is used to visually display data over time to distinguish between common cause and special cause variation?

• a. A fishbone diagram
• b. A Pareto chart
• c. A run chart or control chart
• d. A flowchart

Answer: c. A run chart or control chart

9. “The percentage of patients on an ACE inhibitor who have had a potassium level checked within the last 6 months” is an example of what type of QI measure?

• a. An outcome measure
• b. A process measure
• c. A balancing measure
• d. A structural measure

Answer: b. A process measure

10. “The hospital’s 30-day readmission rate for heart failure” is an example of what type of QI measure?

• a. An outcome measure
• b. A process measure
• c. A balancing measure
• d. A structural measure

Answer: a. An outcome measure

11. The Principles of Evidence-Based Practice course provides the foundation for understanding all study designs.

• a. True
• b. False

Answer: a. True

12. A Failure Mode and Effects Analysis (FMEA) is a study design used to:

• a. Retrospectively analyze an error that has already occurred.
• b. Proactively analyze a process to identify potential failure points before they result in an error.
• c. Compare two active treatments.
• d. Determine the cost-effectiveness of a new service.

Answer: b. Proactively analyze a process to identify potential failure points before they result in an error.

13. A key difference between a QI study and a traditional research study is that QI studies:

• a. Are generally not subject to the same level of IRB review, although oversight is still needed.
• b. Are always double-blinded.
• c. Aim to produce generalizable knowledge.
• d. Never use statistical analysis.

Answer: a. Are generally not subject to the same level of IRB review, although oversight is still needed.

14. What happens during the “Study” phase of a PDSA cycle?

• a. The plan is developed.
• b. The test is carried out.
• c. The data is analyzed and compared to predictions.
• d. The change is implemented on a large scale.

Answer: c. The data is analyzed and compared to predictions.

15. A “balancing measure” is important in a QI project to:

• a. Ensure the project is successful.
• b. Measure the primary outcome.
• c. Monitor for unintended negative consequences of the change being tested.
• d. Track the project budget.

Answer: c. Monitor for unintended negative consequences of the change being tested.

16. A pharmacist wants to improve the rate of annual eye exams for patients with diabetes in their clinic. This is an example of a:

• a. Research project
• b. Quality improvement project
• c. Dispensing function
• d. Financial audit

Answer: b. Quality improvement project

17. The “Medication Safety” module is part of the Patient Care 5 curriculum.

• a. True
• b. False

Answer: a. True

18. What is the purpose of starting with a small-scale test in a PDSA cycle?

• a. To minimize risk and allow for refinement of the intervention before large-scale implementation.
• b. To make the project take as long as possible.
• c. To ensure the results are not statistically significant.
• d. It is not recommended to start small.

Answer: a. To minimize risk and allow for refinement of the intervention before large-scale implementation.

19. A Root Cause Analysis is a study design that primarily uses what kind of data collection methods?

• a. Prospective surveys
• b. Randomized allocation
• c. Retrospective chart review and interviews
• d. Economic modeling

Answer: c. Retrospective chart review and interviews

20. An active learning session on medication safety is part of the Patient Care 5 course.

• a. True
• b. False

Answer: a. True

21. A study that compares a new pharmacist-led service at one hospital to a “control” hospital that does not have the service is using what type of QI design?

• a. A simple pre-post study
• b. An interrupted time series
• c. A controlled before-and-after study
• d. A case report

Answer: c. A controlled before-and-after study

22. The “Act” phase of a PDSA cycle could involve:

• a. Adopting the change and implementing it on a wider scale.
• b. Adapting the change based on the results and re-testing.
• c. Abandoning the change if it was not effective.
• d. All of the above.

Answer: d. All of the above.

23. The principles of pharmacoepidemiology study design are covered in the EBP course.

• a. True
• b. False

Answer: a. True

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’s role in QI study design is often to:

• a. Provide expertise on the medication-use process to be improved.
• b. Help define appropriate process and outcome measures.
• c. Participate in implementing and evaluating the change.
• d. All of the above.

Answer: d. All of the above.

26. A run chart with 8 or more consecutive points above or below the median suggests:

• a. Random variation
• b. A non-random shift in the process (special cause variation).
• c. That the data is inaccurate.
• d. That the process is stable.

Answer: b. A non-random shift in the process (special cause variation).

27. A key part of the “Plan” stage of a PDSA cycle is:

• a. Writing the final report.
• b. Implementing the change.
• c. Making a prediction about what will happen when the change is implemented.
• d. Analyzing the results.

Answer: c. Making a prediction about what will happen when the change is implemented.

28. An active learning session on medication safety is part of which course module?

• a. Module 4: Medication Safety
• b. Module 1: Diabetes Mellitus
• c. Module 3: Women’s Health
• d. Module 8: Men’s Health

Answer: a. Module 4: Medication Safety

29. The main goal of an FMEA is to:

• a. Understand why a past failure occurred.
• b. Identify where a process might fail in the future and how to prevent it.
• c. Compare two different processes.
• d. Measure patient outcomes.

Answer: b. Identify where a process might fail in the future and how to prevent it.

30. The “Root Cause Analysis” transcending concept is part of the Patient Care 3 curriculum.

• a. True
• b. False

Answer: a. True

31. Which of the following is NOT a typical characteristic of a QI study?

• a. It is iterative.
• b. It is designed to be generalized to a large, national population.
• c. It uses data to guide decisions.
• d. It is focused on improving a local process.

Answer: b. It is designed to be generalized to a large, national population.

32. A pharmacist wants to reduce the time it takes to verify STAT orders. After implementing a new workflow, they measure the average verification time. This is what type of study?

• a. A pre-post study
• b. A case-control study
• c. A case report
• d. A randomized controlled trial

Answer: a. A pre-post study

33. The principles of study design are foundational to EBP.

• a. True
• b. False

Answer: a. True

34. A “balancing measure” for a project aimed at faster discharge times could be:

• a. The average time from discharge order to patient leaving.
• b. The 30-day hospital readmission rate.
• c. The number of patients discharged per day.
• d. The number of discharge orders written.

Answer: b. The 30-day hospital readmission rate.

35. A pharmacist is part of a team using PDSA cycles to improve medication reconciliation. This is an example of:

• a. A research study requiring full IRB approval.
• b. A quality improvement initiative.
• c. A dispensing function.
• d. A financial audit.

Answer: b. A quality improvement initiative.

36. A key difference between QI and research is the primary audience. The audience for a QI project is typically:

• a. A high-impact medical journal.
• b. The local stakeholders and managers of the process being studied.
• c. The national news media.
• d. The FDA.

Answer: b. The local stakeholders and managers of the process being studied.

37. Which of the following is a “process” measure?

• a. Patient mortality rate
• b. Percentage of patients with diabetes receiving an annual A1c test.
• c. Patient satisfaction score
• d. Hospital-acquired infection rate

Answer: b. Percentage of patients with diabetes receiving an annual A1c test.

38. The “Introduction to Medication Errors” module provides a basis for QI.

• a. True
• b. False

Answer: a. True

39. A QI project is not considered research if its primary purpose is to:

• a. Generate new, generalizable knowledge.
• b. Improve internal operations and patient care within a specific setting.
• c. Be published.
• d. Test a new, unapproved drug.

Answer: b. Improve internal operations and patient care within a specific setting.

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 strength of evidence from an Interrupted Time Series study is generally considered:

• a. Weaker than a pre-post study.
• b. Stronger than a pre-post study but weaker than an RCT.
• c. Stronger than an RCT.
• d. Equal to a case report.

Answer: b. Stronger than a pre-post study but weaker than an RCT.

42. A pharmacist participating on a committee to develop policies that enhance quality patient care is an objective in the HIPPE course.

• a. True
• b. False

Answer: a. True

43. A successful QI study design requires:

• a. A clear aim.
• b. A defined set of measures.
• c. A plan for testing a change.
• d. All of the above.

Answer: d. All of the above.

44. What is the role of a pharmacist in a study to improve adherence?

• a. Designing the intervention (e.g., a new counseling technique).
• b. Measuring the outcome (e.g., using pharmacy refill data).
• c. Implementing the intervention.
• d. All of the above.

Answer: d. All of the above.

45. “Benchmarking” in quality improvement refers to:

• a. The final report of a project.
• b. Comparing your own process or outcomes to an external standard or best practice.
• c. A type of statistical test.
• d. The first step in a PDSA cycle.

Answer: b. Comparing your own process or outcomes to an external standard or best practice.

46. A QI study is an example of applying the scientific method to process improvement.

• a. True
• b. False

Answer: a. True

47. The “D” in the PDSA cycle stands for:

• a. Data
• b. Design
• c. Do
• d. Document

Answer: c. Do

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 management of a QI project requires:

• a. A systematic and iterative approach.
• b. A single, large change implemented all at once.
• c. No data analysis.
• d. The work of only one person.

Answer: a. A systematic and iterative approach.

50. The ultimate goal of learning about QI study designs is to:

• a. Be able to use a structured, evidence-based approach to improve patient care and safety in one’s own practice setting.
• b. Pass the EBP exam.
• c. Become a statistician.
• d. Make all healthcare processes more complex.

Answer: a. Be able to use a structured, evidence-based approach to improve patient care and safety in one’s own practice setting.