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Clinically Meaningful Change for Physical Performance: Perspectives of the ICFSR Task Force.

J Guralnik1, K Bandeen-Roche, S A R Bhasin

  • 1Jack Guralnik, University of Maryland School of Medicine, Baltimore, MD, USA, jguralnik@epi.umaryland.edu.

The Journal of Frailty & Aging
|March 10, 2020
PubMed
Summary

Establishing clinically meaningful outcome measures for sarcopenia and frailty is crucial for clinical trials. The International Conference on Frailty and Sarcopenia Research Task Force (ICFSR-TF) explored methods to define meaningful change in physical performance.

Keywords:
Sarcopeniaagingclinically meaningful changedisabilityfrailtyoutcome measuresphysical performance

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Area of Science:

  • Gerontology
  • Clinical Trials
  • Rehabilitation Medicine

Background:

  • Clinically meaningful outcome measures are essential for sarcopenia and frailty research.
  • Current physical performance measures lack clear definitions for meaningful change.
  • Standardizing outcome measures aids in monitoring disease progression and intervention efficacy.

Purpose of the Study:

  • To explore approaches for establishing clinical meaningfulness in physical performance measures for sarcopenia and frailty.
  • To align methods with regulatory authorities for clinical trial design.
  • To identify research gaps in defining meaningful change in physical function.

Main Methods:

  • Convened the International Conference on Frailty and Sarcopenia Research Task Force (ICFSR-TF) in February 2019.
  • Discussed anchor-based and distribution-based methods for quantifying physical function.
  • Considered patient-reported outcomes in evaluating meaningfulness.

Main Results:

  • Clinical meaningful change is context-dependent.
  • Both anchor-based and distribution-based methods are informative for physical function.
  • Patient-reported outcomes are crucial for evaluating meaningfulness.

Conclusions:

  • Further research is needed to set criteria for clinical meaningful change in trials.
  • Integrating various methods enhances the validity of outcome measures.
  • Standardized, meaningful outcome measures will improve the reliability of sarcopenia and frailty research.