Clinically Important Differences for Mobility Measures Derived from the Testosterone Trials.
Aged
Androgens
/ administration & dosage
Dimensional Measurement Accuracy
Humans
Independent Living
Male
Minimal Clinically Important Difference
Mobility Limitation
Patient Reported Outcome Measures
Physical Functional Performance
Testosterone
/ administration & dosage
Treatment Outcome
Walk Test
/ methods
Walking Speed
clinically important difference
mobility improvement
randomized controlled trials
Journal
Journal of the American Geriatrics Society
ISSN: 1532-5415
Titre abrégé: J Am Geriatr Soc
Pays: United States
ID NLM: 7503062
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
received:
04
06
2020
revised:
22
09
2020
accepted:
22
10
2020
pubmed:
20
11
2020
medline:
18
9
2021
entrez:
19
11
2020
Statut:
ppublish
Résumé
Accurate estimates of clinically important difference (CID) are required for interpreting the clinical importance of treatments to improve physical function, but CID estimates vary in different disease populations. We determined the CID for two common measures of walking ability in mobility-limited older men. Longitudinal, multisite placebo-controlled trial. Men enrolled in the Testosterone Trials who had self-reported mobility limitation and gait speed less than 1.2 m/second (n = 429). Testosterone- and placebo-allocated participants were combined for this study. Mean changes from baseline, adjusting for time-in-intervention and site, were 29.6, 13.2, 12.5, -2.4, and -32.6 m for 6MWD, and 15.4, 7.2, 2.1, -3.4, and -7.2 for PF10 in men who reported their mobility was "very/much better," "little better," "no change," "little worse," or "much worse," respectively. CID estimates using regression, ROC, and eCDF varied from 5.0-29.6 m for 6MWD, and 5.0-15.2 points for PF10. CID estimates vary by the population studied and by the method and precision of measurement. Increases of 16 to 30 m for 6MWD and 5 to 15 points for PF10 over 12 months appear to be clinically meaningful in mobility-limited, older hypogonadal men. These CID estimates may be useful in the design of efficacy trials of therapies to improve physical function.
Sections du résumé
BACKGROUND/OBJECTIVES
Accurate estimates of clinically important difference (CID) are required for interpreting the clinical importance of treatments to improve physical function, but CID estimates vary in different disease populations. We determined the CID for two common measures of walking ability in mobility-limited older men.
DESIGN
Longitudinal, multisite placebo-controlled trial.
SETTING/PARTICIPANTS
Men enrolled in the Testosterone Trials who had self-reported mobility limitation and gait speed less than 1.2 m/second (n = 429). Testosterone- and placebo-allocated participants were combined for this study.
RESULTS
Mean changes from baseline, adjusting for time-in-intervention and site, were 29.6, 13.2, 12.5, -2.4, and -32.6 m for 6MWD, and 15.4, 7.2, 2.1, -3.4, and -7.2 for PF10 in men who reported their mobility was "very/much better," "little better," "no change," "little worse," or "much worse," respectively. CID estimates using regression, ROC, and eCDF varied from 5.0-29.6 m for 6MWD, and 5.0-15.2 points for PF10.
CONCLUSION
CID estimates vary by the population studied and by the method and precision of measurement. Increases of 16 to 30 m for 6MWD and 5 to 15 points for PF10 over 12 months appear to be clinically meaningful in mobility-limited, older hypogonadal men. These CID estimates may be useful in the design of efficacy trials of therapies to improve physical function.
Identifiants
pubmed: 33210287
doi: 10.1111/jgs.16942
pmc: PMC8500528
mid: NIHMS1717479
doi:
Substances chimiques
Androgens
0
Testosterone
3XMK78S47O
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
517-523Subventions
Organisme : NIA NIH HHS
ID : P30 AG031679
Pays : United States
Organisme : NIA NIH HHS
ID : U01 AG030644
Pays : United States
Organisme : NIA NIH HHS
ID : P30 AG021342
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000142
Pays : United States
Organisme : NIH HHS
ID : 5P30AG031679
Pays : United States
Organisme : NIH HHS
ID : P30-AG021342
Pays : United States
Informations de copyright
© 2020 The American Geriatrics Society.
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