Analysis of a Research Study

Design and Analysis of a Research Study
The purpose of this assignment is to use the material you have learned in class to develop a research study involving a health topic. In this project, you will use your knowledge about research design to propose a study that will address a key public health issue. You may work in a group or alone. You (and your fellow group members) must pick a specific exposure and outcome that interests you and develop a research hypothesis. Your group will design an appropriate study to test your hypothesis using the epidemiologic concepts covered in class. You will then analyze mock data and evaluate your findings.

Tasks:

Each week following lecture, you will complete a specific section of this worksheet.

Once the worksheet is complete you will receive an excel worksheet with a mock dataset to analyze.

After analyzing your data you will interpret the data and identify the strengths and limitations of your study.

You will then right a research abstract to describe all of your work.

Deliverables: Upon completion of this assignment, you will turn in:

The worksheet

Complete the following sections to design your research study. You should be able to complete questions 1-4 after the experimental research lecture. After each subsequent lecture, you can add the evaluation of the study design we reviewed. After all study designs have been evaluated, choose the design that would work the best to test your hypothesis.

1. State your hypothesis

2. Why did you choose this topic (what is its importance or relevance to the field?

3. Study Variables a. Define your Exposure:

i. What is your exposure of interest? ii. What is your control group (or second exposure for comparison)?

b. Define your outcome i. What is the outcome you are interested in studying? ii. What is your case definition?

c. Other variables of interest? i. Are there any other variables you think are important to consider? (ex: age, sex/gender, disease severity, etc…)

4. Evaluate the utility of each of the following study designs in testing your hypothesis? a. Experimental i. Would this study design work? ii. What are the benefits of using an experimental design? iii. What are the limitations of using an experimental design?

b. Cohort

i. Would this study design work?

ii. Would use a prospective or retrospective design? Why?

iii. What are the benefits of using a cohort design? iv. What are the limitations of using a cohort design?

c. Case Control i. Would this study design work? ii. What are the benefits of using a case-control design?

iii. What are the limitations of using a case-control design?

d. Cross Sectional i. Would this study design work?

ii. What are the benefits of using a cross sectional design?

iii. What are the limitations of using a cross sectional design?

5. Which of these study designs would you select to conduct your study in the real world?

6. Do you need IRB approval for your study? ___Yes ____No Why?

7. Do you need a Data Safety Monitoring Board for your study? ___Yes ____No Why?

8. Define your population: a. Who will you study? b. Who will you exclude from you study?

9. Enrollment: a. How many people will you study? b. Describe how you will enroll your subjects into your study:

10. Study Design Tools: a. What tools would you use to strengthen your study (make sure they are appropriate for the study design you selected): i. Randomization ii. Random allocation ((choose this one) iii. Restriction ((choose this one)) iv. Stratification v. Matching vi. Blinding vii. Double Blinding b. Describe how you will use the tools selected above: Congratulations! You have conducted your study. Submit the information above to receive your data. Once you have data you can proceed to the next page.

11. Results: a. What calculation will you use to determine the measure of association? i. Odds Ratio ii. Prevalence Ratio iii. Relative Risk ((choose this)) b. Complete the 2×2 table below with a summary of your data: Outcome No Outcome Total Exposed Not Exposed Total c. Calculate your measure of association (show your work):

12. Conclusions:

a. Interpret your findings:

b. Circle the guidelines for causality that provide evidence that your results is accurate and state why: i. Temporal Relationship: ______________________________________________________

ii. Strength of Association: _____________________________________________________

iii. Dose-Response Relationship: _________________________________________________

iv. Replication of Findings: ______________________________________________________

v. Biologic Plausability

vi. Consideration of Alternate Explanations: ________________________________________

vii. Cessation of Exposure: _______________________________________________________

viii. Specificity of the Association: __________________________________________________

ix. Consistency with other Knowledge: ______________________________________________

c. List at least 3 limitations that may have effected your study results:

d. What would you change about your study design to improve future research?

13. Draw a flow chart for your study: