1. 5 Different Observational Datasets: Pros & Cons
Jay Giri, MD MPH
Assistant Professor of Medicine
Director, Peripheral Intervention
Associate Director, Penn Cardiovascular Quality, Outcomes, & Evaluative Research Center
Hospital of the University of Pennsylvania

2. Disclosure Statement of Financial Interest
I, Jay Giri DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

3. Observational vs. RCT External validity vs. internal validity
RCT – controls for treatment-selection bias

4. Therapies Do Not Benefit Everyone

5. An Example: Prasugrel vs. Clopidogrel
Wiviott S, NEJM 2015

6. Why Outcomes?
Direct relationship with quality assessment and continuous quality improvement
Increasing interest in Big Data
Close synergies with clinical care
Possible (but not easy) to be an expert clinician and productive outcomes researcher

7. Datasets Administrative Database Registry
Sub-Analysis of Randomized Trial
DIY
Meta-Analysis
Cohort Level
Patient-Level

8. Administrative Database
Pros
Very large numbers
Unselected Populations
Cons
Covariates may not be rich for your question
Innacurate Codes
No outcome adjudication

9. Registries Pros Cons Large numbers, relatively unselected
Well-designed clinical research forms for a given disease process, rich covariates
Trained data abstractors
Often, built-in statistical support
Cons
No endpoint adjudication
Often Cross-Sectional

10. Sub-Analysis of RCT Pros Cons High quality data collection
Often independent endpoint adjudication (including Core Labs)
Cons
Limited by primary experiment hypotheses
Smaller total numbers
Selected patient population
Access to Data limited to trialists

11. DIY Pros Cons Ability to dive deeper into the data
Investigator can select and assay covariates and outcomes with any degree of rigor
Cons
Small numbers
Time

12. Meta-Analysis
How heterogenous are the inclusion criteria and methods for your component studies?

13. Thank You! Peter Groeneveld, MD, MS Robert Yeh, MD, MS
Penn Center for Cardiovascular Outcomes, Quality & Evaluative Research (CAVOQER)