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U.S. Department of Health and Human Services

Medical Devices

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Minimum Clinically Important Difference (MCID): Defining Outcome Metrics for Orthopaedic Devices - Public Meeting, November 27-28, 2012

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.

Date, Time and Location

This meeting was 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

Agenda

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

TimeSubjectName of Speaker
6:45-7:45 AMRegistration and check in
(Light breakfast and coffee)		 
7:45-8:00 AMWelcome and IntroductionBarbara Boyan, PhD
Frankllin Bost, MBA
TRIBES Georgia Tech
8:00-8:40 AMFDA Perspective

Danica Marinac-Dabic
FDA/CDRH/OSB/EPI
Mark Melkerson
FDA/CDRH/ODE/DOD

8:40-8:45 AMIntroduction of Webcast & Keynote SpeakerFaisal Mirza, MD, FRCSC
FDA/CDRH/ODE/DSORD/OJDB
8:45-9:45 AMWebcast: History and Overview of PROsGordon Guyatt, MD
McMaster University
9:45-10:00 AMBreak 
Session 1: Patient Variables and Predictors of Outcome
10:00-10:30 AMMCID Methodology and ClinimetricsJeff Sloan, PhD Mayo Clinic
10:30-10:45 AMPatient Predictors of OutcomeAileen Davis, PhD Toronto Western Research Inst.
10:45-11:00 AMGender IssuesLaura Tosi, MD Children's National Medical Center
11:00-11:15 AMPediatricsRobert Campbell, MD Children’s Hospital of Philadelphia
11:15-11:30 AMMeasuring PainRon Hays, PhD UCLA School of Public Health
11:30-11:45 AMAdjusting for Prognostic VariablesTraci Leong, PhD Emory University
11:45-12:15 PMQ&A and Panel Wrap upDeborah J. Moore Carticept, Inc.
12:15-1:15 PMBreak for lunch 
Session 2: Outcome Instruments
1:15-1:35 PMMuskuloskeletal and Rheumatological Perspective on Outcome InstrumentsMarc Hochberg, MD, MPH University of Maryland Medical
1:35-1:50 PMLower Extremity Outcome InstrumentsWilliam Obremskey , MD Vanderbilt Orthopaedics
1:50-2:05 PMUpper Extremity Outcome InstrumentsCharles Day, MD, MBA Harvard University
2:05-2:20 PMArthroplasty Outcome InstrumentsRichard Coutts, MD University of California, San Diego
2:20-2:35 PMOutcome Instruments and MCID: Evidence Appraisal and Contribution of RegistriesArt Sedrakyan, MD, PhD Weill Cornell Medical College
2:35-2:50 PMQ&A and Panel Wrap upLynne Jones, MD Johns Hopkins University
2:50-3:00 PMBreak 
Session 3: Industry Perspective
3:00-3:25 PMOverviewKathryn Wyrwich, PhD United Biosource Corp. Center for Health Outcomes Research
3:25-3:40 PMSmall Company PerspectiveJames Ryaby, PhD Ryaby Associates LLC  
3:40-3:55 PMIncorporating Outcome Evidence in PracticeGreg Brown, MD, PhD from the University of Minnesota
3:55-4:10 PMRole of the ConsultantJanice Hogan, JD Hogan and Lovells
4:10-4:30 PMIndustry Perspective on Patient Factors that Affect OutcomesDavid Appleby Smith & Nephew
4:30-5:00 PMQ&A and Panel Wrap upCharles Turkelson, PhD Center for Medical Technology Policy
5:00-5:30 PMClinician Scientist Perspective & Concluding Remarks and AdjournmentMike Keith, MD MetroHealth Medical Center

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

TimeSubjectName of Speaker
6:30-7:45 AMRegistration and check in (Light breakfast and coffee) 
7:45-8:15 AMIntroduction and Opening Remarks with Brief Overview and Summary of Day 1Krishna Asundi, PhD FDA/CDRH/ODE/DSORD
8:15-8:30 AMBreakout Instructions and Questions to Be Addressed in SessionsDave McGurl FDA/CDRH/ODE/DSORD
Breakout Sessions: Site Specific Outcome Scores and Best Practices
8:30-11:00 AMHips-Room G512Marc Hochberg, MD, MPH Alexis Wright, PhD
8:30-11:00 AMKnees-Room G514  Morgan H. Jones, MD William Mihalko, MD, PhD
8:30-11:00 AMPediatrics-Room G508Jacqueline Francis, MD, MPH Laura Tosi, MD
8:30-11:00 AMShoulder/Elbow-Room G264Gerald Williams, MD
8:30-11:00 AMWrist/Hand-Room G258Mike Keith, MD
8:30-11:00 AMFoot/Ankle-Room G256Kenneth Hunt, MD
11:00-11:15 AMBreak-Reconvene in the AtriumAtrium
11:15-12:30 PMRecommendations From Each Group (10 min)Barbara Boyan, PhD TRIBES Georgia Tech
12:30-1:00 PMSummary, Concluding Remarks and Thank youFaisal Mirza, MD, FRCSC Franklin Bost, MBA
1:00 PMAdjourn 

Transcripts

Contact Us

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

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