Research Project Design Study Design Part 2 Study

Research Project Design Study Design Part 2

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Intervention Studies