PUBH 350 EPIDEMIOLGIC STUDY - GROUP PROJECT The purpose of this exercise is to give you an opportunity to design an epidemiologic study, and in so doing, think through a series of methodological issues. Students will be assigned to groups of three or four for this project. I am aware of the pit-falls of group projects, but I want you to work as a group for this exercise for two reasons: first, many real world projects are completed by a team and you need to know how to help make a team effective; second, this project requires a great deal of effort - more than is normally expected by a single individual - thus, by working as a team the tasks can be shared. I will ask for feedback at the end of the semester about the relative contributions of members of the team. For this exercise your group will develop a proposal for an epidemiologic study. You will have parts of at least one class period to discuss your proposal with my input, but you should expect to spend a considerable amount of time on your own and with other group members outside of class. Each group will be required to present their project to the class during Week 14. Presentations are required to be between 15-20 minutes in length, and all members of the group must participate. Make sure to adhere to the minimum time limit first, I am not as concerned if you go over time a little bit in a class of this size. In addition to the presentation, your group will submit a typed copy of your proposal with any supplementary material. The typed proposal is required to be 5+ pages (not including the supplemental material or references) and must contain at least 5 references to scientific journals. Use the typed proposal as a document to build your presentation. PART ONE During your first discussion of this exercise, several decisions must be made, and tasks assigned. These are: 1. 2. 3. 4. 5. 6. What factor(s) do you, as a group, want to consider? What disease(s) do you, as a group, want to study? What type of study design would be the most logical to use? Who will perform the literature search (could be more than one)? Outline the various components of the proposal. Who will develop the initial drafts of the various components? Keep in mind that the final product will be a proposal. We do not have time in this course to actually develop the questionnaires to be used, or to collect and analyze the data. However, the proposal you design must be realistic and possible to perform if funded. PART TWO At this stage, you as a group should review and integrate the various components of your study proposal. Give careful attention to each of the components - make sure that they are complete, accurate, precise and in balance with the rest of the proposal. Make final task assignments. There will be only one typewritten report submitted by your group. Be sure to list your references. STUDY DESIGN COMPONENTS Please organize your final report into sections that correspond to each of the following components and include a discussion of each of the following items as appropriate in your project: A. Background: 1. Literature review: Summarize what other current studies have found relating to your proposal topic. Why is this project important? 2. Purpose: What question(s) do you hope to answer? 3. Causality: Discuss which (if any) of the steps required to prove causality you'll be able to address at the completion of the study. B. Methods: 1. Reference population: Describe the group to whom your findings will apply. This is the same group from which you will draw your sample. 2. Sampling methods: Define how you will identify study subjects and how many subjects you plan to study. 3. Overall study design: Describe the data you need to collect and how you plan on collecting it (coordinate with Instruments, below). Include a timetable of events. Make sure you name your study design (cross-sectional, case-control, cohort, other). 4. Factor(s): Define the factor(s) you are planning to consider which might be associated with the disease(s) you are proposing to study. 5. Disease(s): Define the disease(s) or other outcome(s) you plan on studying. 6. Relationship: Describe the relationship that you expect to observe between the factor(s) and disease(s). This section should be based on previous studies. 7. Safeguards: Discuss safeguards of confidentiality, participant risk, and data quality. 8. Analyses: State the major analytical techniques to be used. 9. Limitations: List the possible criticisms inherent in your proposal and how you plan on responding to them. 10. Further research: Present some logical follow-up studies you would suggest to confirm your findings or to elaborate on your study. C. Resources needed: 1. Instruments: List data collection instruments needed and/or list variables to be measured. 2. Equipment: List any special equipment that might be needed (assume standard office equipment is available already). 3. Personnel: List specific personnel needed for this study, including their principle qualifications