Minimum Clinically Important Difference (MCID): Defining Outcome Metrics for Orthopaedic Devices – Public Meeting, November 27

The Food and Drug Administration (FDA) is announcing a public meeting entitled Minimum Clinically Important Difference (MCID): Defining Outcome Metrics for Orthopaedic Devices. The purpose of the public meeting is to bring FDA experts together with academic and industry stakeholders to discuss challenges and approaches in defining minimum clinically important difference (MCID) for patient-reported outcome (PRO) instruments used in orthopaedic device-related procedures.

This meeting will be held November 27-28, 2012, beginning at 7:45 am at the following location:

• November 27, 2012
  FDA’s White Oak Campus
  10903 New Hampshire Ave.
  Silver Spring, MD
  Building 31 Conference Center (Great Room)
• November 28, 2012
  FDA’s White Oak Campus
  10903 New Hampshire Ave.
  Silver Spring, MD
  Building 66 (Atrium)
• FDA Campus Information

Tuesday, November 27, 2012 (Building 31; Great Room)

Time
Subject
Name of Speaker
6:45-7:45 AM
Registration and check in
(Light breakfast and coffee)
 
7:45-8:00 AM
Welcome and Introduction
Barbara Boyan, PhD
Frankllin Bost, MBA
TRIBES Georgia Tech
8:00-8:40 AM
FDA Perspective
Danica Marinac-Dabic, MD, PhD
FDA/CDRH/OSB/DEPI
8:40-8:45 AM
Introduction of Webcast Keynote Speaker
Faisal Mirza, MD, FRCSC
FDA/CDRH/ODE/DSORD/OJDB
8:45-9:45 AM
Webcast: History and Overview of PROs
Gordon Guyatt, MD
McMaster University
9:45-10:00 AM
Break
 
Session 1: Patient Variables and Predictors of Outcome
10:00-10:30 AM
MCID Methodology and Clinimetrics
Jeff Sloan, PhD Mayo Clinic
10:30-10:45 AM
Patient Predictors of Outcome
Aileen Davis, PhD Toronto Western Research Inst.
10:45-11:00 AM
Gender Issues
Laura Tosi, MD Children’s National Medical Center
11:00-11:15 AM
Pediatrics
Robert Campbell, MD Children’s Hospital of Philadelphia
11:15-11:30 AM
Measuring Pain
Ron Hays, PhD UCLA School of Public Health
11:30-11:45 AM
Adjusting for Prognostic Variables
Traci Leong, PhD Emory University
11:45-12:15 PM
QA and Panel Wrap up
Deborah J. Moore Carticept, Inc.
12:15-1:15 PM
Break for lunch
 
Session 2: Outcome Instruments
1:15-1:35 PM
Muskuloskeletal and Rheumatological Perspective on Outcome Instruments
Marc Hochberg, MD, MPH University of Maryland Medical
1:35-1:50 PM
Lower Extremity Outcome Instruments
William Obremskey , MD Vanderbilt Orthopaedics
1:50-2:05 PM
Upper Extremity Outcome Instruments
Charles Day, MD, MBA Harvard University
2:05-2:20 PM
Arthroplasty Outcome Instruments
Richard Coutts, MD University of California, San Diego
2:20-2:35 PM
Outcome Instruments and MCID: Evidence Appraisal and Contribution of Registries
Art Sedrakyan, MD, PhD Weill Cornell Medical College
2:35-2:50 PM
QA and Panel Wrap up
Lynne Jones, MD Johns Hopkins University
2:50-3:00 PM
Break
 
Session 3: Industry Perspective
3:00-3:25 PM
Overview
Kathryn Wyrwich, PhD United Biosource Corp. Center for Health Outcomes Research
3:25-3:40 PM
Small Company Perspective
James Ryaby, PhD Ryaby Associates LLC  
3:40-3:55 PM
Large Company Perspective
Erik Erbe, PhD Nuvasive
3:55-4:10 PM
Role of the Consultant
Janice Hogan, JD Hogan and Lovells
4:10-4:30 PM
Industry Perspective on Patient Factors that Affect Outcomes
David Appleby Smith Nephew
4:30-5:00 PM
QA and Panel Wrap up
Charles Turkelson, PhD Center for Medical Technology Policy
5:00-5:30 PM
Clinician Scientist Perspective Concluding Remarks and Adjournment
Mike Keith, MD MetroHealth Medical Center

Wednesday, November 28, 2012 (Building 66 – Atrium)

Time
Subject
Name of Speaker
6:30-7:45 AM
Registration and check in (Light breakfast and coffee)
 
7:45-8:15 AM
Introduction and Opening Remarks with Brief Overview and Summary of Day 1
Krishna Asundi, PhD FDA/CDRH/ODE/DSORD
8:15-8:30 AM
Breakout Instructions and Questions to Be Addressed in Sessions
Dave McGurl FDA/CDRH/ODE/DSORD
Breakout Sessions: Site Specific Outcome Scores and Best Practices
8:30-11:00 AM
Hips-Room G512
Marc Hochberg, MD, MPH Alexis Wright, PhD
8:30-11:00 AM
Knees-Room G514  
Morgan H. Jones, MD William Mihalko, MD, PhD
8:30-11:00 AM
Pediatrics-Room G508
Jacqueline Francis, MD, MPH Laura Tosi, MD
8:30-11:00 AM
Shoulder/Elbow-Room G264
Gerald Williams, MD
8:30-11:00 AM
Wrist/Hand-Room G258
Mike Keith, MD
8:30-11:00 AM
Foot/Ankle-Room G256
Kenneth Hunt, MD
11:00-11:15 AM
Break-Reconvene in the Atrium
Atrium
11:15-12:30 PM
Recommendations From Each Group (10 min)
Barbara Boyan, PhD TRIBES Georgia Tech
12:30-1:00 PM
Summary, Concluding Remarks and Thank you
Faisal Mirza, MD, FRCSC Franklin Bost, MBA
1:00 PM
Adjourn
 

TRIBES will charge a registration fee for non-federal employees to cover its share of the expenses associated with the workshop. The registration fee is $230 for non-federal employees. Registration is available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by November 13, 2012. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on Day 1 of the public workshop will be provided beginning at 6:45 a.m. The onsite registration fee is $275.

Dr. Faisal Mirza, Medical Officer
Orthopaedic Device Evaluation Regulation and Research
FDA/CDRH/ODE/DSORD/OJDB
10903 New Hampshire Avenue
White Oak Building 66, Suite 1558
Silver Spring, MD
Phone: 301-796-6910 or 6311; Fax: 301-847-8117