Epidemiologic Study Designs Worksheet
Part 1: Study Designs and Measures of Association (32 pts)
Read the following research scenarios. Identify the study design and justify your choice. Then determine the appropriate measure of association related to it.
An online survey was emailed to every 10th student in a university directory. Each student was asked about their age, sex, race/ethnicity, and alcohol consumption during the preceding 7 days. Over 50% of the students completed the survey and 71% reported drinking at least once.
1. Identify the study design (2 pts)
2. Justify your choice (4 pts)
3. Determine the appropriate measure of association (2 pts)
Using electronic medical records at a large research hospital, 500 patients diagnosed with sepsis are matched to 500 patients who do not have sepsis based on sex, age, and reason for admission. Researchers assess length of stay in the hospital and intensive care unit (ICU) admission for possible association to sepsis.
4. Identify the study design (2 pts)
5. Justify your choice (4 pts)
6. Determine the appropriate measure of association (2 pts)
A random sample of men from four hospital systems were given a colonoscopy. Half of the men diagnosed with colorectal cancer were assigned to a novel drug treatment and the other half were assigned to the gold standard treatment (surgery and radiation). Both groups were followed for 5 years to monitor recurrent cancer and survival.
7. Identify the study design (2 pts)
8. Justify your choice (4 pts)
9. Determine the appropriate measure of association (2 pts)
Data and biologic materials have been collected from 5,000 participants coming from 250 families in Jackson, Mississippi since 2000. Participants provided extensive medical and social history and had an array of physical and biochemical measurements and diagnostic procedures at baseline and two follow-up periods. Annual follow-up interviews and surveillance monitor incidence of heart failure, stroke, and coronary heart disease.
10. Identify the study design (2 pts)
11. Justify your choice (4 pts)
12. Determine the appropriate measure of association (2 pts)
Part 2: Case-Control Study Design (20 pts)
Review the following research question and consider issues related to the design of a case-control study to test the hypothesis. Answer in complete sentences.
Is there an association between eating cantaloupe from the farmer’s market and salmonella infection?
13. How will you define a “case”? Are there any special considerations? (4 pts)
14. Where would you find the cases? (4 pts)
15. Describe a suitable control population and where you would find them. (4 pts)
16. What factors/characteristics would you attempt to measure similarly from each study participant? (4 pts)
17.What difficulties might you encounter in measuring these factors/characteristics? (4 pts)
Part 3: Cohort Study Design (20 pts)
Review the following research question and consider issues related to the design of a cohort study to test the hypothesis. Answer in complete sentences.
Does occupational exposure to radiation increase risk for cancer mortality among healthcare workers?
13. How will you define a “cohort”? Are there any special considerations? (4 pts)
14. Where would you find the cohort? (4 pts)
15. How would you measure exposure to radiation? Were would you find this data? (4 pts)
16. How would you measure the outcome of cancer mortality? Where would you find this data? (4 pts)
17. Describe how long you would follow-up with the cohort and any difficulties you might encounter. (4 pts)
Part 4: Randomized Controlled Trial Study Design (20 pts)
Review the following research question and consider issues related to the design of a randomized controlled trial (RCT) to test the hypothesis. Answer in complete sentences.
What is the efficacy of a new vaccine to prevent respiratory syncytial virus (RSV) as compared to placebo?
13. Describe the inclusion and exclusion criteria you might use for this research scenario. (4 pts)
14. What is the importance of randomization in an intervention trial? What does it accomplish? (4 pts)
15. How might you implement randomization in this research scenario? (4 pts)
16. To minimize opportunities for bias, how might you implement blinding in this research scenario? (4 pts)
17.What ethical considerations should be taken into account for this RCT? (4 pts)
*Worksheet continues on next page*
Part 5: Pros and Cons of Case-Control and Cohort Studies (8 pts)
Different study designs have particular advantages and disadvantages. Contrast the case-control and cohort study designs (assuming primary data collection) with respect to the following factors. Answers can be short statements.
Factor
Case-Control
Cohort
18. Cost (2 pts)
19. Time required for completion of study (2 pts)
20. Design issues (recruitment and selection of participants) (2 pts)
21. Difficulties in obtaining information (measurement and follow-up) (2 pts)
*End of worksheet*
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