TY - JOUR
T1 - Clinically Meaningful Change for Physical Performance
T2 - Perspectives of the ICFSR Task Force
AU - The ICFSR Task Force
AU - Guralnik, Jack
AU - Bandeen-Roche, K.
AU - Bhasin, S. A.R.
AU - Eremenco, S.
AU - Landi, F.
AU - Muscedere, J.
AU - Perera, S.
AU - Reginster, J. Y.
AU - Woodhouse, L.
AU - Vellas, B.
N1 - Funding Information:
Conflicts of interest: The Task Force was partially funded by one educational grant from the Aging In Motion Coalition and registration fees from industrial participants (Biogen, Biophytis, Cytokinetics, Glaxosmithkline, Longeveron, Pfizer and Rejuvenate Biomed NV). These corporations placed no restrictions on this work. S. Eremenco, F. Landi declare there are no conflicts. Dr. Guralnik reports personal fees from Pluristem , personal fees from Viking Therapeutics, personal fees from Novartis Pharma, outside the submitted work. K. Bandeen-Roche reports grants from National Institutes of Health, during the conduct of the study. S.A.R. Bhasin reports grants from AbbVie, grants from Alivegen, grants from MIB, other from FPT, other from AbbVie, outside the submitted work. J. Muscedere is Scientific Director for the Canadian Frailty Network, a non-for profit network funded by the Government of Canada. S. Perera has received Travel expenses to the International Conference on Frailty and Sarcopenia Task Force meeting in February 2019 in Miami Beach, FL paid by Alliance for Aging Research. J.Y. Reginster reports grants and personal fees from IBSA-GENEVRIER, grants and personal fees from MYLAN, grants and personal fees from RADIUS HEALTH, personal fees from PIERRE FABRE, grants from CNIEL, personal fees from DAIRY RESEARCH COUNCIL (DRC), outside the submitted work. B. Vellas reports grants from Nestle, Nutricia, Novartis outside the submitted work.
Publisher Copyright:
© 2019, The Author(s).
PY - 2020/1
Y1 - 2020/1
N2 - For clinical studies of sarcopenia and frailty, clinically meaningful outcome measures are needed to monitor disease progression, evaluate efficacy of interventions, and plan clinical trials. Physical performance measures including measures of gait speed and other aspects of mobility and strength have been used in many studies, although a definition of clinically meaningful change in performance has remained unclear. The International Conference on Frailty and Sarcopenia Research Task Force (ICFSR-TF), a group of academic and industry scientists investigating frailty and sarcopenia, met in Miami Beach, Florida, USA in February 2019 to explore approaches for establishing clinical meaningfulness in a manner aligned with regulatory authorities. They concluded that clinical meaningful change is contextually dependent, and that both anchor- based and distribution-based methods of quantifying physical function are informative and should be evaluated relative to patient-reported outcomes. In addition, they identified additional research needed to enable setting criteria for clinical meaningful change in trials.
AB - For clinical studies of sarcopenia and frailty, clinically meaningful outcome measures are needed to monitor disease progression, evaluate efficacy of interventions, and plan clinical trials. Physical performance measures including measures of gait speed and other aspects of mobility and strength have been used in many studies, although a definition of clinically meaningful change in performance has remained unclear. The International Conference on Frailty and Sarcopenia Research Task Force (ICFSR-TF), a group of academic and industry scientists investigating frailty and sarcopenia, met in Miami Beach, Florida, USA in February 2019 to explore approaches for establishing clinical meaningfulness in a manner aligned with regulatory authorities. They concluded that clinical meaningful change is contextually dependent, and that both anchor- based and distribution-based methods of quantifying physical function are informative and should be evaluated relative to patient-reported outcomes. In addition, they identified additional research needed to enable setting criteria for clinical meaningful change in trials.
KW - Sarcopenia
KW - aging
KW - clinically meaningful change
KW - disability
KW - frailty
KW - outcome measures
KW - physical performance
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U2 - 10.14283/jfa.2019.33
DO - 10.14283/jfa.2019.33
M3 - Article
C2 - 32150208
AN - SCOPUS:85081529820
SN - 2260-1341
VL - 9
SP - 9
EP - 13
JO - The Journal of frailty & aging
JF - The Journal of frailty & aging
IS - 1
ER -