1. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking 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. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking 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. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking 1.How is this disease distributed? Health-related conditions and behaviors are not distributed uniformly in a population. They have unique distributions that can be described by how they are distributed in terms of person, place, and time. 2.What hypotheses might explain the distribution of disease? Clues for formulating hypotheses can be found by observing the way a health-related condition or behavior is distributed in a population. 3.Is there an association between the hypothesized cause and the disease? 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. 4.Is the association causal? Causation is only one explanation for an association between an exposure and a disease. Because observational studies are complicated by factors not controlled by the observer, other explanations also must be considered. 5.What should be done when preventable causes of disease are found? Policy decisions are based on more than the scientific evidence. Because of competing values - social, economic, ethical, environmental, cultural, and political factors may also be considered. Essential QuestionsEnduring Understandings Where are we?

4. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Laboratory

5. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Epidemiologists’ Laboratory

6. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Our Epidemiology Laboratory

7. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking An epidemiologic experiment in which subjects are assigned into groups to receive or not receive a hypothesized beneficial intervention. Review - Controlled Trial

8. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking 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. Review - Controlled Trial

9. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Total Tested Negative for Heroin Tested Positive for Heroin Tested Risk of NOT Using Heroin Relative Risk Review: Testing a Hypothesis that a drug regimen will stop heroin addicts from using heroin. Urine tests were opiate negative 3.6 times as frequently in the Buprenorphine group compared to the placebo group Bupe & Naloxone Bupe Placebo 109 105 109 17.8% 20.7 % 5.8% 3.6 3.1 Urine tests were opiate negative 3.1 times as frequently in the combination group compared to the placebo group

10. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Naturally occurring circumstances in which groups of people within a population have been exposed to different levels of the hypothesized cause of an outcome. Natural Experiment

11. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking 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. Observational Study

12. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Naturally occurring circumstances in which groups of people within a population have been exposed to different levels of the hypothesized cause of an outcome. Observational Study of a Natural Experiment 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. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Sensation Seeking A person’s search for an optimal level of arousal or stimulus. Exposure

14. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Exposure Low Sensation Seekers High Sensation Seekers

15. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Sensation Seeking Low Sensation Seekers High Sensation Seekers

16. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Sensation Seeking Low Sensation Seekers High Sensation Seekers

17. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Sensation Seeking Low Sensation Seekers High Sensation Seekers

18. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Sensation Seeking HSS TV Shows LSS TV Shows

19. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking http://www.bbc.co.uk/science/humanbody/mind/surveys/sensation/index.shtml Sensation Seeking Scale

20. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Brief Sensation Seeking Scale

21. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Brief Sensation Seeking Scale 8 Items Strongly Disagree Neither Disagree Nor Disagree Strongly Agree 12345 5-Point Scale

22. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Brief Sensation Seeking Scale 8 - 40 25

23. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Brief Sensation Seeking Scale 1.I would like to explore strange places. 2.I would like to take off on a trip with no pre-planned routes or timetables. 3.I get restless when I spend too much time at home. 4.I prefer friends who are excitingly unpredictable. 5.I like to do frightening things. 6.I would like to try bungee jumping. 7.I like wild parties. 8. I would love to have new and exciting experiences, even if they are illegal. Strongly Disagree Neither Disagree Nor Disagree Strongly Agree 12345

24. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Rules for Filling out the Brief Sensation Seeking Scale If you do not wish to participate, do not. Rules Do not look at anyone else’s paper. Do not write your name on the sheet of paper. Fold your paper in half as soon as you are done.

25. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Time to Fill Out the Scale If you do not wish to participate, do not. Rules Do not look at anyone else’s paper. Do not write your name on the sheet of paper. Fold your paper in half as soon as you are done.

26. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking What do we mean when we say that there is an association between two things? Associated TiedRelated Linked Things that are associated are linked in some way that makes them turn up together. Review - Things That Turn Up Together

27. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Suicide Higher in Areas with Guns Smoking Linked to Youth Eating Disorders Snacks Key to Kids’ TV- Linked Obesity: China Study Family Meals Are Good for Mental Health Lack of High School Diploma Tied to US Death Rate Study Links Spanking to Aggression Breakfast Each Day May Keep Colds Away Study Concludes: Movies Influence Youth Smoking Study Links Iron Deficiency to Math Scores Kids Who Watch R-Rated Movies More Likely to Drink, Smoke Pollution Linked with Birth Defects in US Study Depressed Teens More Likely to Smoke High Sensation Seeking Is Linked To ?________________? Things That Turn Up Together

28. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking High Sensation Seeking Is Linked to __________________ Things That Turn Up Together

29. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking High Sensation Seeking Low Sensation Seeking High Sensation Seeking Is Linked to __________________ Things That Turn Up Together ExposureExposure

30. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking High Sensation Seeking Low Sensation Seeking Outcome Things That Turn Up Together High Sensation Seeking Is Linked to __________________ Outcome No Outcome

31. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Brief Sensation Seeking Scale 5-Point Scale Strongly Disagree Neither Disagree Nor Disagree Strongly Agree 12345 Range: 8 - 40 HSS 24 to 40 LSS 8 to 23

32. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Quick Review How are we determining groups of LSS and HSS? Assignment? Naturally Occurring?

33. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking 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

34. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Groups of HSS and LSS Students LSSHSS 24 to 40 LSS 8 to 23

35. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Brief Sensation Seeking Scale XX

36. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking High Sensation Seeking Low Sensation Seeking Things That Turn Up Together High Sensation Seeking Is Linked to __________________ Outcome No Outcome Total

37. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking High Sensation Seeking Low Sensation Seeking Things That Turn Up Together High Sensation Seeking Is Linked to __________________ Outcome No Outcome Total a b c d

38. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking a b c d High Sensation Seeking Low Sensation Seeking Total Things That Turn Up Together

39. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Things That Turn Up Together a b c d High Sensation Seeking Low Sensation Seeking Watches TV Show Does Not Watch TV Show Total

40. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Conducting an Observational “Study” in Class

41. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking 2x2 Table Worksheet - Enter Study # 1

42. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking 2x2 Table Worksheet 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. Rules Place a check in 2x2 table for Study # 1

43. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Collect

44. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking High Sensation Seeking Score 24 to 40 Low Sensation Seeking Score 8 to 23 abcd 2x2 Table Worksheet

45. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Sort

46. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Count

47. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Study # 1 Sort Enter Count Collect

48. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking a b c d High Sensation Seeking Low Sensation Seeking Watches TV Show Does Not Watch TV Show Total Things That Turn Up Together 1

49. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking a b c d High Sensation Seeking Low Sensation Seeking Watches TV Show Does Not Watch TV Show Total Things That Turn Up Together or Risk of Watching TV Show % % 1

50. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking a b c d High Sensation Seeking Low Sensation Seeking Watches TV Show Does Not Watch TV Show Total Things That Turn Up Together High sensation seekers were ___ times as likely to watch __________ compared to low sensation seekers. Relative Risk or Risk of Watching TV Show % % 1

51. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking 1NoneExposure is not associated with the outcome. Greater than 1 (>1) PositiveExposure is associated with a greater likelihood of the outcome. Less than 1 (<1) NegativeExposure is associated with a lower likelihood of the outcome. AssociationRelative RiskInterpretation Relative Risk Relative Risk: The ratio of the risk of an outcome among the exposed to the risk of the outcome among the unexposed.

52. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Sensation Seeking – Study # 2 High Sensation Seeking Is Associated with __________________

53. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking a b c d High Sensation Seeking Low Sensation Seeking Yes – bungee jumping No – bungee jumping Total Relative Risk or Risk of XXXXX % % 1 High sensation seekers were ___ times as likely to _______________ compared to low sensation seekers. Study # 2 2

54. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Study # 2 Re-Distribute the 2x2 Table Worksheets

55. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Study # 2 Sort Enter Count Collect Place a check in 2x2 table 2

56. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking a b c d High Sensation Seeking Low Sensation Seeking Yes – bungee jumping Total Relative Risk or Risk of XXXXX % % 1 High sensation seekers were ___ times as likely to _______________ compared to low sensation seekers. Study # 2 2

57. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking A hypothesis can be tested by comparing the frequency of an outcome in selected groups of people with and without an exposure to determine if the exposure and the outcome are associated. Big Epidemiological Idea

58. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Sensation Seeking – More Studies High Sensation Seeking Is Associated with __________________

59. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking a b c d High Sensation Seeking Low Sensation Seeking Yes – bungee jumping No – bungee jumping Total Relative Risk or Risk of XXXXX % % 1 High sensation seekers were ___ times as likely to _______________ compared to low sensation seekers. Study # X X

60. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Study # X Re-Distribute the 2x2 Table Worksheets

61. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Study # X Sort Enter Count Collect Place a check in 2x2 table X

62. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking a b c d High Sensation Seeking Low Sensation Seeking Yes – bungee jumping Total Relative Risk or Risk of XXXXX % % 1 High sensation seekers were ___ times as likely to _______________ compared to low sensation seekers. Study # X X

63. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking … and the application of this study to the control of health problems.

64. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Big Ideas in this Lesson (3-4) 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. Re-Cap

65. DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking 6. Where are we?Next Lesson Controlled Trial Cohort Study Case-Control Cross-Sectional Observational Experimental Study Designs in Epidemiology