Research Project Design Study Design

1. Research Project DesignStudy Design Part 2

2. Study Design • Observational studies • Descriptive • Analytical • Intervention studies • Medical tests • Exposure / treatment

3. 1.Were groups compared? Yes No Analytical Descriptive 2.How many in study? 3. Treated/exposed? No Yes One A few Many Experimental Observational Case Report Case Series Cross Sectional Clinical Trial 4.Were individuals or populations selected? Individuals Populations Ecological 5.Selected to represent? Prospective Cohort Forward Outcome Population Exposure 6.Timeline Retrospective Cohort Cross Sectional Case Control Cohort Backward

4. Intervention Studies • What they are • How they fit into the greater project design • Regulations and guidelines • Allocating / Assigning / Randomizing • Blinding

5. Intervention Studies • Not case reports • Not case series • Compare groups or tests • Deliberate test, exposure or treatment • Observational studies can lead to intervention studies!

6. Intervention Studies – Medical Test • Risk factors • Diagnosis • Prognosis • Sensitivity, specificity, reproducibility of test • Cost, effect on decisions, risks

7. Intervention Studies – Medical Test • Incurable deadly disease, zoonotic (dogs) • Current test: 100% accurate in dogs and people; 2 days in hospital; USD 2,000 • New test: 50% accurate in dogs; 100% in people; safe; USD 10 • Cost, effect on decisions, risks • Rare disease vs Epidemic

8. Intervention Studies – Exposure • Healthy subjects? • Group 1: no toxin • Group 2: 10 mg of toxin • Group 3: 30 mg of toxin • Group 4: 50 mg of toxin • Follow outcome

9. Intervention Studies – Exposure • Healthy subjects? • Group 1: no intervention • Group 2: provide a pet • Group 3: provide a pet and education • Group 4: provide a pet and place to walk the pet • Follow outcome

10. Intervention Studies – Treatment • Subjects with disease • Group 1: no treatment or known treatment • Group 2: 10 mg of treatment • Group 3: 30 mg of treatment • Follow outcome

11. Intervention Studies – Treatment • Communities and animals with disease • Community 1: no treatment of animals • Community 2: treat animals • Community 3: treat animals and train meat inspectors • Follow disease in community

12. Intervention Studies • What they are • How they fit into the greater project design • Regulations and guidelines • Allocating / Assigning / Randomizing • Blinding

13. Intervention Studies – Regulations • Human subjects • IRB • ICH guidelines; www.ich.org • Good clinical practice • Ability to recreate the study

14. Intervention Studies – Regulations • Animal subjects • IACUC • OECD Good laboratory practice • VICH guidelines; www.vichsec.org

15. Intervention Studies • What they are • How they fit into the greater project design • Regulations and guidelines • Allocating / Assigning / Randomizing • Blinding

16. Intervention Studies – Allocation • Defined subjects • Inclusion and exclusion criteria • Enrollment – informed consent • Does the subject meet the requirements? • Allocate to group • Treat / Expose

17. Intervention Studies – Allocation • Bias • Allocate in blocks • Allocate in matched pairs • Randomization • Random numbers • Coin toss

18. Intervention Studies – Allocation • Bias • Allocate in blocks • Allocate in matched pairs • Randomization • Random numbers • Coin toss

19. Intervention Studies – Blinding • Decrease bias • Unaware of treatment / exposure • Subject • Investigator(s) • Person measuring outcomes

20. Intervention Studies • What they are • How they fit into the greater project design • Regulations and guidelines • Allocating / Assigning / Randomizing • Blinding

21. Intervention Studies