Module 3 Introduction Content Area: Analytical Epidemiology

1. Module 3 Introduction Content Area: Analytical Epidemiology Essential Question (Generic): Is there an association between the hypothesized cause and the disease? Essential Question (Drug Abuse Specific): Is there an association between the hypothesized cause and drug use? Enduring Epidemiological Understanding: Causal hypotheses can be tested by observing exposures and diseases of people as they go about their daily lives. Information from these observational studies can be used to make and compare rates and identify associations. Synopsis In Module 3, students explore how hypotheses are tested epidemiologically. Students begin to uncover and develop the following epidemiological concepts and skills: the meaning of the term “association;” the need for a control group; uses of the 2x2 table in calculating risks and relative risks; experimental study design; the importance of ethics in human research; observational study designs used in epidemiology; and the strengths and limitations of each design. Lesson 3-1: Associations and the 2x2 Table Lesson 3-2: Experimental Study - Buprenorphine Example Lesson 3-3: An Actual Randomized Controlled Trial Lesson 3-4: Observational Studies of Natural Experiments - Sensation-Seeking Example Lesson 3-5: Fundamentals of Study Design Lesson 3-6: Study Design Exercises

2. Module 3 - Analytical Epidemiology • Lesson 3-6 Study Design Exercises • Content • Reinforcement of study design concepts with an exercise to identify “What is My Design?” • An Epi Team challenge that pulls together the study design elements, called “Connections between Designs, Flow Diagrams, and 2x2 Tables” • Reinforcement of relative strengths and limitations of each study design with a key exercise that examines “Which Design is Best?” • Big Ideas • The flow diagrams show how each study design is carried out in time • Each study design can be expressed in a 2x2 table format that connects to the depiction in the flow diagram • Each study design has strengths, limitations, and trade-offs. Usually, the studies with greater scientific rigor also have higher costs and time to completion. Choice of study designs depends on several circumstances. This project is supported by a Science Education Drug Abuse Partnership Award, Grant Number 1R24DA016357-01, from the National Institute on Drug Abuse, National Institutes of Health.

3. Where are we? Essential Questions Enduring Understandings

4. Review Controlled Trial Experimental Cohort Study Observational Case-Control Cross-Sectional

5. DZ DZ E DZ E DZ E DZ DZ Random Assignment DZ DZ E E DZ DZ DZ DZ E E E Review - Flow diagrams of the Four Study Designs Controlled Trial Case-Control Study Healthy People Healthy People Cohort Study Cross-Sectional Study E Healthy People Healthy People E

6. EPI Team Challenges

7. DZ DZ E Controlled Trial Case-Control Study DZ E Healthy People DZ E DZ DZ Random Assignment Healthy People Healthy People DZ DZ E Cohort Study Cross-Sectional Study E - - - - DZ E DZ Healthy People DZ DZ E E E E EPI Team Challenge: What’s My Design?

8. DZ “fit” 2x2 Table Flow Diagram DZ DZ DZ E Healthy People b a E c d DZ - E Healthy People DZ E EPI Team Challenge: Connections Between Flow Diagrams and 2x2 Tables &

9. DZ DZ E Controlled Trial Case-Control Study DZ E Healthy People DZ E DZ DZ Random Assignment Healthy People Healthy People DZ DZ E Cohort Study Cross-Sectional Study E - - - - DZ E DZ Healthy People DZ DZ E E E E EPI Team Challenge: Which Design Is Best?

10. EPI Team Challenge - What’s My Design?

11. Cross-Sectional Study Cohort Study Case-Control Study Controlled Trial DZ DZ E DZ DZ E E DZ E DZ DZ Random Assignment Healthy People Healthy People Healthy People Healthy People DZ DZ E E E - - - - E DZ DZ DZ E E ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ Time Time Time Time What’s My Design? Controlled Trial Case-Control Study Cohort Study Cross-Sectional Study

12. Assign treatment and control groups. Give exposure to treatment group, but not controls. Follow through time and compare risk of disease in treatment group with risk of disease in control group. Epidemiologist is involved during the entire time from exposure to disease. What’s My Design? Practice Clue Trial

13. What’s My Design? Begin Epi Team Challenge Clue 1 Assign treatment and control groups. Trial

14. E Flow Diagram DZ E E Observational Study - DZ E What’s My Design? Clue 2 Case-Control Study

15. Flow Diagram Observational Study What’s My Design? Clue 3 Cohort, Case-Control, and Cross-Sectional Studies

16. DZ Flow Diagram DZ E Observational Study - E What’s My Design? Clue 4 Cross Sectional Study

17. What’s My Design? Clue 5 Follow through time and compare risk of disease in exposed group with risk of disease in the unexposed group. Trial and Cohort Study

18. Flow Diagram Non-Observational Study E Random Assignment Healthy People Healthy People E - What’s My Design? Clue 6 Trial

19. What’s My Design? Clue 7 Select a group of people with disease and a similar group of people without disease. Case-Control Study

20. DZ Flow Diagram Observational Study E DZ DZ DZ E - DZ What’s My Design? Clue 8 Cohort Study

21. What’s My Design? Clue 9 Epidemiologist is involved during the entire time from exposure to disease. Trial and Cohort Study

22. Follow through time and compare risk of disease in treatment group with risk of disease in control group. Give exposure to treatment group, but not controls. What’s My Design? Clue 10 Trial

23. What’s My Design? Clue 11 Select a study sample. Trial, Cohort Study, Case-Control Study, and Cross-Sectional Study

24. What’s My Design? Clue 12 Epidemiologist gathers data only at that one point in time. Cross-Sectional Study

25. Flow Diagram DZ - DZ What’s My Design? Clue 13 Case-Control Study

26. DZ Flow Diagram DZ DZ DZ What’s My Design? Clue 14 Cohort Study and Trial

27. Select a group of people with disease and a similar group of people without the disease. Ask both groups about their exposures in the past. Compare percent of exposed people in the two groups. Epidemiologist is involved after disease has occurred and relies on subjects’ memories to gather information about exposure. What’s My Design? Clue 15 Case-Control Study

28. Select a healthy study sample. Observe who has and has not been exposed. Follow through time and compare risk of disease in exposed group to risk of disease in unexposed group. Epidemiologist is involved during the entire time from exposure to disease. What’s My Design? Clue 16 Cohort Study

29. Select a study sample. Ask each person about both exposure and disease at that point in time. Disease risk in exposed group is compared to disease risk in unexposed group. Epidemiologist gathers data only at that one point in time. What’s My Design? Clue 17 Cross-Sectional Study

30. What’s My Design? End Epi Team Challenge

31. Designs, Flow Diagrams, and 2x2 Tables

32. DZ “fit” 2x2 Table Flow Diagram DZ DZ DZ E Healthy People b a E c d DZ - E Healthy People DZ E EPI Team Challenge: Designs, Flow Diagrams, and 2x2 Tables &

33. DZ E DZ Random Assignment Healthy People Healthy People DZ E DZ Controlled Trial Where do these people “fit” in the 2x2 table? DZ DZ E a E 2x2 Table Flow Diagram

34. DZ E DZ Random Assignment Healthy People Healthy People DZ E DZ Controlled Trial Where do these people “fit” in the 2x2 table? DZ DZ E b E 2x2 Table Flow Diagram

35. DZ E DZ Random Assignment Healthy People Healthy People DZ E DZ Controlled Trial Where do these people “fit” in the 2x2 table? DZ DZ E E c 2x2 Table Flow Diagram Flow Diagram

36. DZ E DZ Random Assignment Healthy People Healthy People DZ E DZ Flow Diagram Controlled Trial Where do these people “fit” in the 2x2 table? DZ DZ E E d 2x2 Table

37. DZ E DZ DZ E DZ Cohort Study Where are these people in the flow diagram? DZ DZ E Healthy People Healthy People E c 2x2 Table Flow Diagram

38. DZ E DZ DZ E DZ Cohort Study Where are these people in the flow diagram? DZ DZ E Healthy People Healthy People a E 2x2 Table Flow Diagram

39. DZ E DZ DZ E DZ Cohort Study Where are these people in the flow diagram? DZ DZ E Healthy People Healthy People E d 2x2 Table Flow Diagram

40. DZ E DZ DZ E DZ Cohort Study Where are these people in the flow diagram? DZ DZ E Healthy People Healthy People b E 2x2 Table Flow Diagram

41. E DZ E E DZ E Case-Control Study Where do these people go in the 2x2 table? DZ DZ E a E Flow Diagram 2x2 Table

42. E DZ E E DZ E Case-Control Study Where do these people go in the 2x2 table? DZ DZ E E c Flow Diagram 2x2 Table

43. E DZ E E DZ E Case-Control Study Where do these people go in the 2x2 table? DZ DZ E b E Flow Diagram 2x2 Table

44. E DZ E E DZ E Case-Control Study Where do these people go in the 2x2 table? DZ DZ E E d Flow Diagram 2x2 Table

45. DZ DZ E E Cross-Sectional Study Where do these people go in the 2x2 table? DZ DZ Flow Diagram E a E 2x2 Table

46. DZ DZ E E Cross-Sectional Study Where do these people go in the 2x2 table? DZ DZ Flow Diagram E E c 2x2 Table

47. DZ DZ E E Cross-Sectional Study Where do these people go in the 2x2 table? DZ DZ Flow Diagram E E d 2x2 Table

48. DZ DZ E E Cross-Sectional Study Where do these people go in the 2x2 table? DZ DZ Flow Diagram E b E 2x2 Table

49. Designs, Flow Diagrams, and 2x2 Tables End Epi Team Challenge

50. EPI Team Challenge - Which Design is Best?