Sunday, March 11
8:00 AM – 12:00 PM

Generating Reliable Clinical Information – Barriers and Biases in Cohort Studies and  Randomized Controlled Trials

Organized by the ORS Clinical Research Forum Committee

The Clinical Research Forum will focus on the utility of cohort studies and challenges of randomized trials. Speakers will highlight key elements of cohort studies, provide a reference standard in designing observational studies and clarify the difference between cohort studies and registry data. The Forum will continue with an in-depth discussion of the many sources of bias in randomized trials. Finally, a lively debate will weigh the timeliness and importance vs. the drawbacks and challenges of Open Access Data in clinical research. Overall, the Forum will provide an informative, up-to-date and interactive discussion on clinical research in Orthopaedic Surgery.

Session I: Cohort Studies: When Observational Studies Trump Randomized Trials
Moderator:  Joel Gagnier, ND, MSc, PhD, University of Michigan

What is a Cohort Study and What Types of Questions Can it Answer?
David Wasserstein, MD, MSC, MPH, FRCSC, Sunnybrook Health Sciences Centre

What is the Gold Standard in the Design of a Cohort Study?
Marc Swiontkowski, MD, University of Minnesota Medical School

Why are Observational Studies Sometimes More Valid than RCTs?
Carolyn Hettrich, MD, MPH, University of Kentucky

What is the Difference between a Cohort Study and a Registry?
Greg Maletis, MD, Kaiser-Permanente Baldwin Park Medical Center

Panel Discussion

SESSION II:  Common Sources of Bias in Randomized Controlled Studies
Moderator:  Roy K. Aaron, MD, Department of Orthopedics, Warren Alpert Medical School of Brown University

Opportunities for Bias within the Structure of Randomized Controlled Trials
Jennifer Racine, Department of Orthopedics, Warren Alpert Medical School of Brown University

Selection Bias and Outcomes Measure Bias in Randomized Studies
Joel J. Gagnier ND, MSc, PhD, University of Michigan

Bias within Data Analysis in Randomized Controlled Trials
Roy K. Aaron, MD, Department of Orthopedics, Warren Alpert Medical School of Brown University

Panel Discussion

DEBATE: Will the Scientific Community Embrace Open Data in Clinical Research?
Moderator:  Michael Yaszemski, MD, PhD, Mayo Medical Center

Case for the Motion
Michelle Ghert, MD, FRCSC, McMaster University

Case against the Motion
Kurt P. Spindler, MD, Cleveland Clinic Foundation

Panel Discussion