Daily Rules, Proposed Rules, and Notices of the Federal Government
If you need special accommodations due to a disability, please contact Joyce Raines at 301-796-5709, email:
To register for the public workshop, please visit the Georgia Institute of Technology's TRIBES Web site at
For more information on the public workshop, please see FDA's Medical Devices News & Events--Workshops and Conferences calendar at
Evidence-based medicine guidelines advise the use of PRO instruments for assessing the successes of clinical treatment in practice and clinical investigations. However, the selection of a valid instrument and accurate estimation of its respective clinically meaningful differences remain challenging particularly with orthopaedic device-related procedures. The MCID approach has been proposed to overcome this problem for PRO instruments. There have been various methodological approaches to determine MCID for particular PRO instruments but consistency in the literature remains elusive in orthopaedics and, thus, is the focus of this workshop.
Topics to be discussed at the public workshop include, but are not limited to:
1. Current high-quality validated PRO instruments used in orthopaedic extremity device-related procedures and published MCID values, if any, for the various PRO instruments.
2. The impact of variables such as gender, racial/ethnic diversity, age, body mass index, timeliness, patient expectations, and patient satisfaction on PRO response and how this affects MCID calculation within these diverse populations and particular target subgroups of interest.
3. Methodology for determining the MCID for validated PRO instruments in a consistent, reliable, and reproducible manner that is least cumbersome.
4. Current evidence on how the MCID, pertaining to a particular PRO instrument that is used in device-related orthopaedic extremity surgery, may affect patient outcomes and device regulation.
5. Potential standard metric by which to gauge patient outcomes across the spectrum of devices, target populations, and variables of interest, in order to streamline evidence-based scientific rationales for regulatory guidance of clinical trials and device study design.
Approximately 45 days after the workshop, presentation slides will be available at