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 3-4 Sensation-Seeking • Content • Description of natural experiments and the need for observational studies • Demonstration of how the 2x2 table is also used to study associations in observational studies • Use of “sensation-seeking” as a characteristic that may predict high risk behaviors • Repeated calculations of relative risks to test hypotheses about the relationships between sensation-seeking and various behaviors • Big Ideas • By necessity, factors that are hypothesized to be harmful can only be studied in humans by taking advantage of natural experiments and performing observational studies • The community is the epidemiologist’s laboratory • A measure of “sensation-seeking” in individuals can be scored by answering a set of questions that ask people to choose preferred situations and activities • In a group study, the degree of sensation seeking is likely to be associated with the degree of risk-taking behaviors 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. Laboratory

5. Epidemiologists’ Laboratory

6. Our Epidemiology Laboratory

7. Review - Controlled Trial An epidemiologic experiment in which subjects are assigned into groups to receive or not receive a hypothesized beneficial intervention.

8. Review - Controlled Trial We conducted a randomized, placebo controlled, multi-center trial to evaluate the safety and efficacy of a sublingual-tablet formulation of buprenorphine and naloxone in an office-based setting.

9. Review: Testing a Hypothesis that a drug regimen will stop heroin addicts from using heroin. Tested Negative for Heroin Tested Positive for Heroin Tested Risk of NOT Using Heroin Relative Risk Total Bupe & Naloxone 17.8% 3.1 109 20.7 % 3.6 Bupe 105 5.8% Placebo 109 Urine tests were opiate negative 3.1 times as frequently in the combination group compared to the placebo group Urine tests were opiate negative 3.6 times as frequently in the Buprenorphine group compared to the placebo group

10. Natural Experiment Naturally occurring circumstances in which groups of people within a population have been exposed to different levels of the hypothesized cause of an outcome.

11. Observational Study An epidemiologic study of a natural experiment in which the investigator is not involved in the intervention other than to record, classify, count, and statistically analyze results.

12. Observational Study of a Natural Experiment Naturally occurring circumstances in which groups of people within a population have been exposed to different levels of the hypothesized cause of an outcome. Epidemiologic studies of natural experiments in which the investigator is not involved in the intervention other than to record, classify, count, and statistically analyze results.

13. Exposure Sensation Seeking A person’s search for an optimal level of arousal or stimulus.

14. Exposure Low Sensation Seekers High Sensation Seekers

15. Sensation Seeking Low Sensation Seekers High Sensation Seekers

16. Sensation Seeking Low Sensation Seekers High Sensation Seekers

17. Sensation Seeking Low Sensation Seekers High Sensation Seekers

18. Sensation Seeking HSS TV Shows LSS TV Shows

19. Sensation Seeking Scale http://www.bbc.co.uk/science/humanbody/mind/surveys/sensation/index.shtml

20. Brief Sensation Seeking Scale

21. Neither Disagree Nor Disagree Strongly Agree Strongly Disagree Strongly Agree Strongly Disagree 1 2 3 4 5 Brief Sensation Seeking Scale 8 Items 5-Point Scale

22. 8 - 40 25 Brief Sensation Seeking Scale

23. Brief Sensation Seeking Scale Neither Disagree Nor Disagree Strongly Agree Strongly Disagree Strongly Agree Strongly Disagree 1 2 3 4 5 • I would like to explore strange places. • I would like to take off on a trip with no pre-planned routes or timetables. • I get restless when I spend too much time at home. • I prefer friends who are excitingly unpredictable. • I like to do frightening things. • I would like to try bungee jumping. • I like wild parties. • 8. I would love to have new and exciting experiences, even if they are illegal.

24. Rules for Filling out the Brief Sensation Seeking Scale Rules If you do not wish to participate, do not. Do not write your name on the sheet of paper. Do not look at anyone else’s paper. Fold your paper in half as soon as you are done.

25. Time to Fill Out the Scale Rules If you do not wish to participate, do not. Do not write your name on the sheet of paper. Do not look at anyone else’s paper. Fold your paper in half as soon as you are done.

26. Review - Things That Turn Up Together Tied Related Associated Linked What do we mean when we say that there is anassociationbetween two things? Things that are associatedare linked in some way that makes themturn up together.

27. Things That Turn Up Together Suicide Higher in Areas with Guns Smoking Linked to Youth Eating Disorders Family Meals Are Good for Mental Health Study Links Iron Deficiency to Math Scores Study Concludes: Movies Influence Youth Smoking High Sensation Seeking Is Linked To ?________________? Lack of High School Diploma Tied to US Death Rate Study Links Spanking to Aggression Depressed Teens More Likely to Smoke Snacks Key to Kids’ TV- Linked Obesity: China Study Breakfast Each Day May Keep Colds Away Pollution Linked with Birth Defects in US Study Kids Who Watch R-Rated Movies More Likely to Drink, Smoke

28. Things That Turn Up Together High Sensation Seeking Is Linked to __________________

29. Exposure Things That Turn Up Together High Sensation Seeking Low Sensation Seeking High Sensation Seeking Is Linked to __________________

30. Outcome Things That Turn Up Together No Outcome Outcome High Sensation Seeking Low Sensation Seeking High Sensation Seeking Is Linked to __________________

31. Brief Sensation Seeking Scale 5-Point Scale Range: 8 - 40 Neither Disagree Nor Disagree Strongly Agree Strongly Disagree Strongly Agree Strongly Disagree 1 2 3 4 5 LSS 8 to 23 HSS 24 to 40

32. Quick Review How are we determining groups of LSS and HSS? Assignment? Naturally Occurring?

33. Groups of HSS and LSS Students Step 1: Collect all folded sheets and put into large envelopes Step 2: Count the numbers of students in the LSS and HSS groups Step 1: Collect all folded sheets and put into large envelopes

34. Groups of HSS and LSS Students LSS HSS LSS 8 to 23 HSS 24 to 40

35. XX Brief Sensation Seeking Scale

36. Things That Turn Up Together No Outcome Outcome Total High Sensation Seeking Low Sensation Seeking High Sensation Seeking Is Linked to __________________

37. Things That Turn Up Together No Outcome Outcome Total High Sensation Seeking a b c d Low Sensation Seeking High Sensation Seeking Is Linked to __________________

38. Things That Turn Up Together Total High Sensation Seeking a b c d Low Sensation Seeking

39. Things That Turn Up Together Does Not Watch TV Show Watches TV Show Total High Sensation Seeking a b c d Low Sensation Seeking

40. Conducting an Observational “Study” in Class THE DRILL

41. 2x2 Table Worksheet - Enter Study # 1

42. 2x2 Table Worksheet Place a check in 2x2 table for Study # 1 Rules If you do not wish to participate, do not. Do not look at anyone else’s paper. Do not write your name on the sheet of paper. Do not label the 2x2 table. Only place 1 check in the appropriate 2x2 table. Fold your paper in half as soon as you are done.

43. Collect

44. 2x2 Table Worksheet a b c d High Sensation Seeking Score 24 to 40 Low Sensation Seeking Score 8 to 23

45. Sort

46. Count

47. Study # 1 The Drill Enter Collect Count Sort

48. Things That Turn Up Together Does Not Watch TV Show 1 Watches TV Show Total High Sensation Seeking a b c d Low Sensation Seeking

49. Risk of Watching TV Show % or % or Things That Turn Up Together Does Not Watch TV Show 1 Watches TV Show Total High Sensation Seeking a b c d Low Sensation Seeking

50. Risk of Watching TV Show Relative Risk % or % or Things That Turn Up Together Does Not Watch TV Show 1 Watches TV Show Total High Sensation Seeking a b c d Low Sensation Seeking High sensation seekers were ___ times as likely to watch __________ compared to low sensation seekers.