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
