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
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DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking Module 3 Introduction Content Area: Analytical Epidemiology Essential Question.
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DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Module 3 IntroductionContent Area: Analytical EpidemiologyEssential 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 TableLesson 3-2: Experimental Study - Buprenorphine ExampleLesson 3-3: An Actual Randomized Controlled TrialLesson 3-4: Observational Studies of Natural Experiments - Sensation-Seeking ExampleLesson 3-5: Fundamentals of Study DesignLesson 3-6: Study Design Exercises
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 behaviorsThis 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.
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 Questions Enduring Understandings
Where are we?
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Laboratory
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Epidemiologists’ Laboratory
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Our Epidemiology Laboratory
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
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
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
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
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
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.
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
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Exposure
Low
Sensation Seekers
High
Sensation Seekers
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Sensation Seeking
Low
Sensation Seekers
High
Sensation Seekers
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Sensation Seeking
Low
Sensation Seekers
High
Sensation Seekers
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Sensation Seeking
Low
Sensation Seekers
High
Sensation Seekers
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Sensation Seeking
HSS TV Shows
LSS TV Shows
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Brief Sensation Seeking Scale
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Brief Sensation Seeking Scale
8 Items
Strongly Disagree
Strongly Disagree
Neither Disagree
Nor Disagree
Strongly Agree
Strongly Agree
1 2 3 4 5
5-Point Scale
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Brief Sensation Seeking Scale
8 - 40
25
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
Strongly Disagree
Neither Disagree
Nor Disagree
Strongly Agree
Strongly Agree
1 2 3 4 5
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.
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.
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
Tied Related
Linked
Things that are associatedare linked in some way that makes them
turn up together.
Review - Things That Turn Up Together
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
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
High Sensation Seeking Is Linked to __________________
Things That Turn Up Together
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
Exposure
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
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Brief Sensation Seeking Scale
5-Point Scale
Strongly Disagree
Strongly Disagree
Neither Disagree
Nor Disagree
Strongly Agree
Strongly Agree
1 2 3 4 5
Range: 8 - 40
HSS
24 to 40
LSS
8 to 23
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?
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 1: Collect all folded sheets and put into large
envelopes
Step 2: Count the numbers of students in the LSS and HSS
groups
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Groups of HSS and LSS Students
LSS HSS
HSS
24 to 40
LSS
8 to 23
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Brief Sensation Seeking Scale
XX
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 __________________
OutcomeNo
Outcome Total
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 __________________
OutcomeNo
Outcome Total
a b
c d
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
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
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Conducting an Observational “Study” in Class
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
2x2 Table Worksheet - Enter Study # 1
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
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Collect
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
High Sensation Seeking Score 24 to 40
Low Sensation Seeking Score8 to 23
a b c d
2x2 Table Worksheet
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Sort
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Count
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Study # 1
Sort
Enter
Count
Collect
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
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
or
Risk of Watching
TV Show
%
%
1
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
or
Risk of Watching TV Show
%
%
1
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
1 None Exposure is not associated with the outcome.
Greater than 1 (>1)
Positive Exposure is associated with a greater likelihood
of the outcome.
Less than 1 (<1)
Negative Exposure is associated with a lower likelihood
of the outcome.
AssociationRelative Risk Interpretation
Relative Risk
Relative Risk: The ratio of the risk of an outcome among the exposed to the risk of the outcome among the unexposed.
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Sensation Seeking – Study # 2
High Sensation Seeking Is Associated with __________________
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
or
Risk of XXXXX
%
%
1
High sensation seekers were ___ times as likely to _______________ compared to low sensation seekers.
Study # 2
2
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Study # 2
Re-Distribute the 2x2 Table Worksheets
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
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
Yes – bungee jumping Total Relative Risk
or
or
Risk of XXXXX
%
%
1
High sensation seekers were ___ times as likely to _______________ compared to low sensation seekers.
Study # 2
2
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
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Sensation Seeking – More Studies
High Sensation Seeking Is Associated with __________________
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
or
Risk of XXXXX
%
%
1
High sensation seekers were ___ times as likely to _______________ compared to low sensation seekers.
Study # X
X
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
Study # X
Re-Distribute the 2x2 Table Worksheets
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
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
Yes – bungee jumping Total Relative Risk
or
or
Risk of XXXXX
%
%
1
High sensation seekers were ___ times as likely to _______________ compared to low sensation seekers.
Study # X
X
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
… and the application of this study to the control of health problems.
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
behaviorsThis 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
DrugEpi 3-4 An observational Study of a Natural Experiment: Sensation-Seeking
6.
Where are we?Next Lesson
Controlled Trial
Cohort StudyCase-Control Cross-Sectional
Observational
Experimental
Study Designs in EpidemiologyStudy Designs in Epidemiology