Lesson 2-5: Planning Study Conduct 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 1 Revised Sept 14, 2011

Lesson 2-5: Planning Study Conduct Teacher Note: Enduring Epidemiological Understandings for the Epidemiology and the Energy Balance Equation Curriculum 1.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. 2.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. 2

Lesson 2-5: Planning Study Conduct Teacher Note: Authentic Assessment for Module 2 of the Epidemiology and the Energy Balance Equation Curriculum 3 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.

Lesson 2-5: Planning Study Conduct 4 Teacher Note: Photos of Worksheets for Lesson a 2-3a

Lesson 2-5: Planning Study Conduct Start of Lesson 2-5 (estimate 1 class period) 5

Lesson 2-5: Planning Study Conduct 6 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 Review

Lesson 2-5: Planning Study Conduct 2-3a - Update Your Checklist 7 Notebook Study 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

Lesson 2-5: Planning Study Conduct Part of 2-3a Expectations for Successful Completion of Activities in Lesson Notebook Study #Study Plan Component Met Some- what Met Not Met 2-5 Plans for Study Conduct – Having assignments for study day  A reasonable plan for 1)approaching potential study subjects; 2) reading the informed consent script; 3) guiding study participants if they have questions; and 4) responsible gathering of completed questionnaires □□□

Lesson 2-5: Planning Study Conduct 9 Planning for Study Conduct All plans should be set before the study begins. This means listing the steps in study conduct and assigning responsibilities. The plans include decisions about who will have contact with study participants, who will give instructions, who will perform each of the tasks in data collection, handling, and analysis, and how all ethical concerns are going to be addressed.

Lesson 2-5: Planning Study Conduct 10 1.Set the date and time of the study, and provide any necessary prior notification to teachers, students, and others. (teacher) 2.Make final preparations for study team 3.Conduct cross-sectional study. 4.Determine a secure, safe place to keep questionnaires 5.Sort all questionnaires filled out by participants 6.Perform all data analyses and interpretations 7.Shred questionnaires after completion of analysis and report-out 2-5a Assignments for Day of Study Notebook Study

Lesson 2-5: Planning Study Conduct 2-3a Checklist – Study Planning Components and Expectations 11 Notebook Study

Lesson 2-5: Planning Study Conduct 12 Big Idea in Lesson 2-5 Before the study begins, all materials should be ready and all tasks listed and assigned Re-Cap