MCQ Quiz: Real-World Data

Real-World Data (RWD) is the raw material for generating Real-World Evidence, consisting of health information collected outside of traditional clinical trials. Understanding the various sources, specific strengths, and inherent limitations of RWD is a fundamental skill for evidence-based practice, as highlighted in the Principles of Evidence-Based Practice course. This quiz will focus specifically on the types of Real-World Data, the challenges of data quality, and the pharmacist’s role as both a user and generator of this crucial information.

1. Real-World Data (RWD) is best defined as:

• a. The conclusions drawn from a clinical study.
• b. Data relating to patient health status and/or the delivery of health care collected from sources outside of traditional clinical trials.
• c. Only data from randomized controlled trials.
• d. The statistical analysis plan for a research project.

Answer: b. Data relating to patient health status and/or the delivery of health care collected from sources outside of traditional clinical trials.

2. Which of the following is considered a primary source of Real-World Data?

• a. A published meta-analysis
• b. A clinical practice guideline
• c. Electronic Health Records (EHRs)
• d. A review article in a journal

Answer: c. Electronic Health Records (EHRs)

3. A major strength of using EHR data for research is that it:

• a. Is always perfectly clean and structured for analysis.
• b. Contains detailed, longitudinal clinical information like lab values and progress notes.
• c. Is free from any missing information.
• d. Captures patient experiences outside the healthcare system.

Answer: b. Contains detailed, longitudinal clinical information like lab values and progress notes.

4. What is a primary limitation of using medical claims and billing data as a source of RWD?

• a. The sample sizes are too small.
• b. It lacks detailed clinical information (e.g., severity of illness, lab results) because it is collected for billing purposes.
• c. It has no information on which drugs were dispensed.
• d. The data is not anonymous.

Answer: b. It lacks detailed clinical information (e.g., severity of illness, lab results) because it is collected for billing purposes.

5. Data collected from a patient’s smartphone app or fitness tracker is known as:

• a. Claims Data
• b. Registry Data
• c. Patient-Generated Health Data (PGHD)
• d. Electronic Health Record Data

Answer: c. Patient-Generated Health Data (PGHD)

6. The “Pharmacoepidemiology Study Designs” module, which forms the basis for using RWD, is part of 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. “Data reliability” in RWD refers to:

• a. The volume of the data available.
• b. The speed at which the data can be accessed.
• c. The accuracy and consistency of the data over time.
• d. The cost of acquiring the data.

Answer: c. The accuracy and consistency of the data over time.

8. When a pharmacist accurately documents a patient’s medication history during reconciliation, they are directly contributing to:

• a. The quality of their institution’s Real-World Data.
• b. A decrease in pharmacy profits.
• c. An increase in alert fatigue.
• d. The development of a new drug.

Answer: a. The quality of their institution’s Real-World Data.

9. A disease registry is a valuable source of RWD because it:

• a. Collects data on all patients in a hospital.
• b. Collects specific, uniform data on a population of patients with a particular condition.
• c. Is primarily used for billing.
• d. Contains no clinical information.

Answer: b. Collects specific, uniform data on a population of patients with a particular condition.

10. Real-World Evidence (RWE) is derived from the analysis of Real-World Data (RWD).

• a. True
• b. False

Answer: a. True

11. The appraisal of cohort studies, which often use RWD, is a “Transcending Concept” in the Patient Care 5 curriculum.

• a. True
• b. False

Answer: a. True

12. A researcher is using an EHR database. They find that patient weights are often missing or are not updated regularly. This is an example of what RWD challenge?

• a. Lack of generalizability
• b. Data completeness and quality issues
• c. Small sample size
• d. High cost

Answer: b. Data completeness and quality issues

13. “Structured data” (e.g., from dropdown menus, specific fields) is generally easier to analyze than “unstructured data” (e.g., free text in a progress note).

• a. True
• b. False

Answer: a. True

14. A pharmacist using the EHR to review a patient’s past lab trends to inform a dosing decision is an example of using RWD for:

• a. A population-level study.
• b. Individual patient care.
• c. A clinical trial.
• d. Billing purposes.

Answer: b. Individual patient care.

15. Evaluating relevant primary literature to answer drug information questions is a key objective for student pharmacists.

• a. True
• b. False

Answer: a. True

16. Which source of RWD would be best for determining the total cost of care for a specific disease?

• a. A patient registry
• b. An Electronic Health Record
• c. A patient’s fitness tracker
• d. An insurance claims database

Answer: d. An insurance claims database

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

• a. True
• b. False

Answer: a. True

18. What is a key limitation of using EHR data to study medication adherence?

• a. The EHR shows what was prescribed and dispensed, but not what the patient actually took.
• b. The EHR does not contain any medication information.
• c. The sample sizes are too small.
• d. The EHR is not electronic.

Answer: a. The EHR shows what was prescribed and dispensed, but not what the patient actually took.

19. “Data curation” is the process of:

• a. Deleting all old data.
• b. Organizing, cleaning, and validating data to make it suitable for analysis.
• c. Collecting new data only.
• d. Publishing the raw data.

Answer: b. Organizing, cleaning, and validating data to make it suitable for analysis.

20. 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

21. A major challenge in linking different sources of RWD (e.g., a patient’s EHR and their insurance claims) is:

• a. Data interoperability and patient privacy concerns.
• b. The data is always in the same format.
• c. There is no benefit to linking data.
• d. It is too easy to do.

Answer: a. Data interoperability and patient privacy concerns.

22. Which source of RWD is most likely to contain detailed clinical notes and physician rationale for treatment decisions?

• a. A medical claims database
• b. A patient-reported outcomes survey
• c. An Electronic Health Record (EHR)
• d. A wearable device

Answer: c. An Electronic Health Record (EHR)

23. The use of diagnostic codes (like ICD-10) in claims data is a form of:

• a. Unstructured data
• b. Structured data
• c. Free text data
• d. Inaccurate data

Answer: b. Structured data

24. 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

25. A pharmacist’s role in the ecosystem of Real-World Data is:

• a. Only as a consumer of the evidence generated from it.
• b. Only as a generator of data through documentation.
• c. As both a generator and a critical consumer of data and evidence.
• d. A pharmacist has no role.

Answer: c. As both a generator and a critical consumer of data and evidence.

26. The increasing use of EHRs has dramatically _______ the availability of RWD for research.

• a. decreased
• b. had no impact on
• c. increased
• d. eliminated

Answer: c. increased

27. A key question when using RWD is whether the data are “fit for purpose,” meaning:

• a. The data is expensive.
• b. The data is relevant and of sufficient quality to answer the specific research question.
• c. The data is easy to access.
• d. The data comes from a single source.

Answer: b. The data is relevant and of sufficient quality to answer the specific research question.

28. An active learning session on study designs is part of the EBP curriculum.

• a. True
• b. False

Answer: a. True

29. The data from a product registry for a new biologic agent would be considered:

• a. Real-World Data
• b. Phase I trial data
• c. Pre-clinical data
• d. Anecdotal data

Answer: a. Real-World Data

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

• a. True
• b. False

Answer: a. True

31. Which of the following is a potential source of bias in a study using EHR data?

• a. Only sick patients have their labs drawn, leading to unrepresentative data.
• b. Some physicians document more thoroughly than others.
• c. A diagnosis may be listed on a problem list but may not be active.
• d. All of the above.

Answer: d. All of the above.

32. Using RWD allows researchers to study medication effects in a population that is typically more ____ than an RCT population.

• a. homogenous and healthy
• b. diverse and complex (with more comorbidities)
• c. small
• d. controlled

Answer: b. diverse and complex (with more comorbidities)

33. The principles of pharmacoepidemiology are foundational to understanding how to analyze RWD.

• a. True
• b. False

Answer: a. True

34. A study using RWD to compare two drugs is susceptible to confounding by indication.

• a. True
• b. False

Answer: a. True

35. A pharmacist accurately verifying a patient’s allergy list contributes to:

• a. Higher quality RWD and better functioning of clinical decision support systems.
• b. Alert fatigue.
• c. Increased healthcare costs.
• d. A slower dispensing process.

Answer: a. Higher quality RWD and better functioning of clinical decision support systems.

36. A limitation of using pharmacy claims data to measure adherence is that:

• a. It shows when a prescription was filled, but not if the patient actually took the medication.
• b. It is not accurate for dates.
• c. It does not include the name of the drug.
• d. It is too detailed.

Answer: a. It shows when a prescription was filled, but not if the patient actually took the new medication.

37. The term “data provenance” refers to:

• a. The process of analyzing data.
• b. The process of storing data.
• c. The metadata describing the origin, history, and movement of a piece of data.
• d. The cost of data.

Answer: c. The metadata describing the origin, history, and movement of a piece of data.

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

• a. True
• b. False

Answer: a. True

39. A pharmacist using an EHR to identify all patients on a recently recalled medication is using RWD for what purpose?

• a. A clinical trial
• b. Public health surveillance and intervention
• c. Billing
• d. Marketing

Answer: b. Public health surveillance and intervention

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 quality of RWD can be improved by:

• a. Using standardized terminologies (e.g., SNOMED CT, RxNorm).
• b. Minimizing the use of free-text fields.
• c. Training clinicians on proper documentation.
• d. All of the above.

Answer: d. All of the above.

42. Which of the following CANNOT be easily determined from most RWD sources?

• a. The date a prescription was dispensed.
• b. A patient’s diagnosis code.
• c. The patient’s underlying reason or motivation for being non-adherent.
• d. The patient’s age.

Answer: c. The patient’s underlying reason or motivation for being non-adherent.

43. A pharmacist’s ability to critically appraise all forms of evidence is a core professional competency.

• a. True
• b. False

Answer: a. True

44. “Big Data” in healthcare refers to:

• a. The large, complex datasets that constitute Real-World Data.
• b. The physical size of a hospital’s servers.
• c. A single clinical trial.
• d. The cost of medications.

Answer: a. The large, complex datasets that constitute Real-World Data.

45. Before using RWD for a research study, a researcher must:

• a. Obtain appropriate ethical and IRB approval.
• b. De-identify the data to protect patient privacy.
• c. Develop a clear study protocol.
• d. All of the above.

Answer: d. All of the above.

46. A major benefit of RWD is its ability to track drug safety issues:

• a. Only before a drug is approved.
• b. Over the long term, after a drug is on the market.
• c. Only in healthy volunteers.
• d. Only in a small number of patients.

Answer: b. Over the long term, after a drug is on the market.

47. A study on RWD is only as good as the quality of the data it uses.

• 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 purpose of leveraging RWD is to:

• a. Replace randomized controlled trials.
• b. Supplement the evidence from RCTs to get a more complete picture of a drug’s effects.
• c. Make healthcare research more complicated.
• d. Increase the amount of data entry for clinicians.

Answer: b. Supplement the evidence from RCTs to get a more complete picture of a drug’s effects.

50. The ultimate reason for a pharmacist to understand RWD is to:

• a. Be a better consumer and contributor to health information for the benefit of patient care.
• b. Become a data scientist.
• c. Pass the EBP final exam.
• d. Design their own EHR system.

Answer: a. Be a better consumer and contributor to health information for the benefit of patient care.