Meeting to Address Use of Clinical Outcome Measures for Orthopedic Devices

US regulators plan to hold a workshop later this month to discuss the use of clinical outcome metrics for orthopedic medical devices.

The 27 November workshop, co-sponsored by the US Food and Drug Administration (FDA) and the Georgia Institute of Technology's Translational Research Institute for Biomedical Engineering and Sciences (TRIBES), is focused specifically on two key topics: minimum clinically important differences (MCID) and patient-reported outcomes (PRO) instruments.

An MCID is defined as the smallest difference that would matter to either a clinician or a patient, and FDA noted in its Federal Register posting that the use of streamlined evidence-based scientific rationales is useful for generating regulatory guidance for clinical trials and study designs.

"However, the selection of a valid instrument and accurate estimation of its respective clinically meaningful differences remain challenging, particularly with orthopaedic device-related procedures," FDA explained in the notice. "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 for discussion at the meeting are set to include an overview of current PRO instruments, the impact of patient expectations and physical attributes on PRO response and its affect on MCID calculation, the consistent and cost-effective validation of PROs, whether a single standard metric could be used across a broad spectrum of PROs, and how MDICs may affect patient outcomes and device regulation.