Teacher Note: Module 2 Overview

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Teacher Note Module 2
Overview Content Area Hypothesis-Testing
Cross-Sectional Study Essential Questions How
can I select groups of people and collect
data/evidence from them that will test my
hypothesis? If my causal hypothesis is correct,
how would the exposure and outcome be distributed
in these groups? Enduring Understanding
Causal hypotheses can be tested by conducting
investigations of the exposures and outcomes of
selected groups of people as they go about their
lives. Information from these observational
studies can be used to determine if an exposure
and an outcome are associated. Because
observational studies are complicated by factors
not controlled by the observer, when an
association is found, other explanations in
addition to causality also must be considered.

• Core Concepts
• Testing hypotheses
• Association
• Exposure/outcome
• Control group
• 2x2 table
• Observational studies
• Study design/study plan
• Study samples
• Prevalence rate
• Prevalence ratio
• Statement of effect

Lessons 2-1 Looking for Associations 2-2
Cross-sectional Studies 2-3 Developing Hypothesis
and Study Questions 2-4 Respect Part II 2-5
Planning Study Conduct 2-6 Cross-Sectional Study
- In Class 2-7 Cross-Sectional Study In School
Revised Sept 14, 2011
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Teacher Note Enduring Epidemiological
Understandings for the Epidemiology and the
Energy Balance Equation Curriculum  

•  
• Health and disease are not distributed
  haphazardly in a population. There are patterns
  to their occurrence that can be identified
  through surveillance. Analysis of the patterns
  of health and disease distribution can provide
  clues for formulating hypotheses about their
  possible causes.
• Causal hypotheses can be tested by conducting
  investigations of the exposures and outcomes of
  selected groups of people as they go about their
  lives. Information from these observational
  studies can be used to determine if an exposure
  and an outcome are associated. Because
  observational studies are complicated by factors
  not controlled by the observer, other
  explanations also must be considered.

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Teacher Note Authentic Assessment for Module 2
of the Epidemiology and the Energy Balance
Equation Curriculum
Students will conduct, analyze, and interpret
observational, cross-sectional studies among
students in their class and then among students
outside their class. Working in teams, students
will have the opportunity to demonstrate their
abilities to select a reasonable hypothesis of
interest to them, design study questions about
exposure and outcome, obtain informed consent,
collect and manage data, calculate and compare
prevalence rates, make accurate statements about
whether their data support that hypothesis, and
consider alternate explanations for what they
observed. Reporting of results will be required,
such as a written report, an item for the school
newspaper, or an oral presentation or poster for
students, teachers, and/or parents. Specific
performance criteria will be used to help ensure
that the experiences allow a genuine, realistic,
and fair assessment of students comprehension of
the Module 2 Enduring Epidemiological
Understanding.
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Teacher Note Photos of Worksheets for Lesson
2-4
2-4a
2-4b
2-3a
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Start of Lesson 2-4 (estimate 1 class period)
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Review

• Big Ideas in Lesson 2-3
• A good study plan includes
  careful thought about
  choice of
  exposure and outcome variables and high-quality
  questions to measure them.
• Additional questions about other characteristics
  of participants can be asked in order to better
  understand study results.
• A well-planned study has a user-friendly
  questionnaire to administer to participants.

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2-3a - Update Your Checklist
   
2-3 Study Hypothesis - Statement of a hypothesized association between an exposure and an outcome
2-3 Study Variables - Developing questions about exposure and outcome , and additional questions about participants
2-3 Questionnaire - Preparing a one-page sheet that study participants will fill out (typed and copies made)
2-4 Draft Informed Consent Script - Preparing a script to be read to possible study participants (typed and copies made)
2-5 Plans for Study Conduct Having assignments for study day
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Part of 2-3a
Expectations for Successful Completion
of Activities in
Lesson 2-4
Study Plan Component Met Some-what Met Not Met
2-4 Draft Informed Consent Script - Preparing a script to be read to possible study participants (typed and copies made) Appropriately filled-out sections of script template and any additions as appropriate ? ? ?
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Review - Lesson 1-4 Respect Part I
Review as needed
and as time allows
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Review - Lesson 1-4 Respect Part I
In our school studies, we do not have
a
representative sample
Review as needed
and as time allows
Simulated Research
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Review - Principles for Protecting
Human Research
Participants
Review as needed
and as time allows
Participants and Investigators
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Review - The Belmont Report
Review as needed
and as time allows
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Review - Definition of Informed Consent
Review as needed
and as time allows
An agreement that is given by a potential
research participant following an explanation of
all relevant information needed to make a
decision about participating in a study.
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Review - Elements of Informed Consent

• Purpose of the study
• What study participants will experience
• Reasonably foreseeable risks
• Potential benefits to participant
• Potential benefits to others
• Confidentiality protections
• Compensation
• Contact information for questions
• Right to refuse or withdraw
• (participation is VOLUNTARY)

Review as needed
and as time allows
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Experience in Ethics Training

• The National Institutes of Health (NIH) has a
  website with ethics training for professionals
  who conduct human health research
• Completion of this training and passing several
  quizzes is mandatory for any human health
  research funded by a federal grant
• Organizations that are not using federal funding
  see the value of this training and participate
  voluntarily (for example the National Science
  Foundation (NSF)

OPTIONAL may be best suited for high school
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Experience in Ethics Training
OPTIONAL may be best suited for high school

http//phrp.nihtraining.com/users/login.php
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Experience in Ethics Training
OPTIONAL may be best suited for high school

http//phrp.nihtraining.com/users/login.php
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Discussion of Experience in Ethics Training
OPTIONAL may be best suited for high school
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Informed Consent Script for a Cross-Sectional
Study
Informed Consent Script
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2-4a
Developing an Informed Consent Script
for a
Cross-Sectional Study
How should we fill in the blanks
and perhaps further adapt this script
to fit our cross-sectional
study?
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My name is __________________________ and I am
participating in the conduct of a brief survey
among students in our school. The survey is
about behaviors that may affect your health.
To conduct this survey, I would like you to
consider completing a brief questionnaire. It
has ________ questions and will take
approximately __________ minutes to complete.
We would like to ask you some question regarding
___________________________ and
________________________________.   This study is
being carried out for educational purposes only.
It is not an actual study from which firm
conclusions will be made.   If there are any
risks assumed by participating, they are no
greater than those you encounter in daily life.
There are no benefits to you for participating
and there is no compensation.   DO NOT write your
name on this survey. The answers you give will be
kept private. No one will know what you write.
To further protect your privacy, all
questionnaires will be destroyed at the end of
the analysis. Our study team wants you to
know that your participation is voluntary, and
that you can stop participating at any time
without consequence. If you are not comfortable
answering a question, just leave it blank. You
can refuse to participate now you can change
your mind after starting to participate or,
after completing the survey, you can decide not
to submit it. . Make sure to read every
question. Circle one answer for each question.
When you are finished, fold your paper in half so
your answers cannot be seen, and wait for us to
collect the surveys.   Do you have any
questions?   Thank you very much for your help.
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2-4b
Self-Assessment of
Draft
Informed Consent Script
Are the proper elements in our script?
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Typed and copies made for each study team member
and the teacher
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Re-Cap

• Big Ideas in Lesson 2-4
• Participants in research or
  simulated research
  need to be
  protected by investigators from
  any harm or
  disrespect

• The Belmont Report (US) establishes principles of
  treating study participants with respect,
  including the principle of informed consent
• An informed consent script allows classmates (or
  other research participants) to make a voluntary
  decision about whether or not they wish to
  participate based on their own goals and values
• The National Institutes of Health (NIH) has
  online training to teach researchers about the
  importance of informed consent and other ethical
  principles