Clinically Important Differences for Mobility Measures Derived from the Testosterone Trials

Alisa J. Stephens-Shields; John T. Farrar; Susan S. Ellenberg; Thomas W. Storer; Thomas M. Gill; Shehzad Basaria; Marco Pahor; Jane A. Cauley; Kristine E. Ensrud; Peter Preston; David Cella; Peter J. Snyder; Shalender Bhasin

doi:10.1111/jgs.16942

Clinically Important Differences for Mobility Measures Derived from the Testosterone Trials

Alisa J. Stephens-Shields, John T. Farrar, Susan S. Ellenberg, Thomas W. Storer, Thomas M. Gill, Shehzad Basaria, Marco Pahor, Jane A. Cauley, Kristine E. Ensrud, Peter Preston, David Cella, Peter J. Snyder, Shalender Bhasin

Medicine - Veteran's Administration Medical Center

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	517-523
Number of pages	7
Journal	Journal of the American Geriatrics Society
Volume	69
Issue number	2
DOIs	https://doi.org/10.1111/jgs.16942
State	Published - Feb 2021

Bibliographical note

Funding Information:
The Testosterone Trials were supported by a grant from the National Institute on Aging, National Institutes of Health (U01 AG030644), supplemented by funds from the National Heart, Lung and Blood Institute, National Institute of Neurological Diseases and Stroke, and National Institute of Child Health and Human Development. AbbVie (formerly Solvay and Abbott Laboratories) provided funding and donated the study medication and the placebo gel. SB was supported partially by the Boston Claude D. Pepper Older Americans Independence Center grant 5P30AG031679. TMG is the recipient of an Academic Leadership Award (K07AG3587) from the National Institute on Aging. The Yale Field Center was partially supported by the Claude D. Pepper Older Americans Independence Center (P30-AG021342) and CTSI (UL1TR000142). Category 1 Concept and design: Alisa Stephens-Shields and Shalender Bhasin Acquisition of subjects and data: Susan Ellenberg, Thomas Storer, Thomas Gill, Shehzad Basaria, Marco Pahor, Jane Cauley, Kristine Ensrud, Peter Preston, David Cella, and Peter Snyder Analysis and interpretation of data: Alisa Stephens-Shields, Susan Ellenberg, John Farrar, Thomas Gill, Peter Preston, David Cella, and Shalendar Bhasin Category 2 Drafting the article: Alisa J. Stephens-Shields and Shalender Bhasin Revising the article for intellectual content: Susan Ellenberg, John Farrar, Thomas Storer, Thomas Gill, Shehzad Basaria, Marco Pahor, Jane Cauley, Kristine Ensrud, Peter Preston, David Cella, and Peter Snyder Category 3 Final approval of the completed article: Alisa Stephens-Shields, Susan Ellenberg, John Farrar, Thomas Storer, Thomas Gill, Shehzad Basaria, Marco Pahor, Jane Cauley, Kristine Ensrud, Peter Preston, David Cella, Peter J. Snyder, and Shalender Bhasin The funding agencies played no role in the design of the trial, analyses of data, preparation of the manuscript, or in the decision to publish.

Funding Information:
The Testosterone Trials were supported by a grant from the National Institute on Aging, National Institutes of Health (U01 AG030644), supplemented by funds from the National Heart, Lung and Blood Institute, National Institute of Neurological Diseases and Stroke, and National Institute of Child Health and Human Development. AbbVie (formerly Solvay and Abbott Laboratories) provided funding and donated the study medication and the placebo gel. SB was supported partially by the Boston Claude D. Pepper Older Americans Independence Center grant 5P30AG031679. TMG is the recipient of an Academic Leadership Award (K07AG3587) from the National Institute on Aging. The Yale Field Center was partially supported by the Claude D. Pepper Older Americans Independence Center (P30‐AG021342) and CTSI (UL1TR000142).

Publisher Copyright:
© 2020 The American Geriatrics Society

Keywords

clinically important difference
mobility improvement
randomized controlled trials

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Stephens-Shields, A. J., Farrar, J. T., Ellenberg, S. S., Storer, T. W., Gill, T. M., Basaria, S., Pahor, M., Cauley, J. A., Ensrud, K. E., Preston, P., Cella, D., Snyder, P. J., & Bhasin, S. (2021). Clinically Important Differences for Mobility Measures Derived from the Testosterone Trials. Journal of the American Geriatrics Society, 69(2), 517-523. https://doi.org/10.1111/jgs.16942

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abstract = "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.",

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author = "Stephens-Shields, {Alisa J.} and Farrar, {John T.} and Ellenberg, {Susan S.} and Storer, {Thomas W.} and Gill, {Thomas M.} and Shehzad Basaria and Marco Pahor and Cauley, {Jane A.} and Ensrud, {Kristine E.} and Peter Preston and David Cella and Snyder, {Peter J.} and Shalender Bhasin",

note = "Funding Information: The Testosterone Trials were supported by a grant from the National Institute on Aging, National Institutes of Health (U01 AG030644), supplemented by funds from the National Heart, Lung and Blood Institute, National Institute of Neurological Diseases and Stroke, and National Institute of Child Health and Human Development. AbbVie (formerly Solvay and Abbott Laboratories) provided funding and donated the study medication and the placebo gel. SB was supported partially by the Boston Claude D. Pepper Older Americans Independence Center grant 5P30AG031679. TMG is the recipient of an Academic Leadership Award (K07AG3587) from the National Institute on Aging. The Yale Field Center was partially supported by the Claude D. Pepper Older Americans Independence Center (P30-AG021342) and CTSI (UL1TR000142). Category 1 Concept and design: Alisa Stephens-Shields and Shalender Bhasin Acquisition of subjects and data: Susan Ellenberg, Thomas Storer, Thomas Gill, Shehzad Basaria, Marco Pahor, Jane Cauley, Kristine Ensrud, Peter Preston, David Cella, and Peter Snyder Analysis and interpretation of data: Alisa Stephens-Shields, Susan Ellenberg, John Farrar, Thomas Gill, Peter Preston, David Cella, and Shalendar Bhasin Category 2 Drafting the article: Alisa J. Stephens-Shields and Shalender Bhasin Revising the article for intellectual content: Susan Ellenberg, John Farrar, Thomas Storer, Thomas Gill, Shehzad Basaria, Marco Pahor, Jane Cauley, Kristine Ensrud, Peter Preston, David Cella, and Peter Snyder Category 3 Final approval of the completed article: Alisa Stephens-Shields, Susan Ellenberg, John Farrar, Thomas Storer, Thomas Gill, Shehzad Basaria, Marco Pahor, Jane Cauley, Kristine Ensrud, Peter Preston, David Cella, Peter J. Snyder, and Shalender Bhasin The funding agencies played no role in the design of the trial, analyses of data, preparation of the manuscript, or in the decision to publish. Funding Information: The Testosterone Trials were supported by a grant from the National Institute on Aging, National Institutes of Health (U01 AG030644), supplemented by funds from the National Heart, Lung and Blood Institute, National Institute of Neurological Diseases and Stroke, and National Institute of Child Health and Human Development. AbbVie (formerly Solvay and Abbott Laboratories) provided funding and donated the study medication and the placebo gel. SB was supported partially by the Boston Claude D. Pepper Older Americans Independence Center grant 5P30AG031679. TMG is the recipient of an Academic Leadership Award (K07AG3587) from the National Institute on Aging. The Yale Field Center was partially supported by the Claude D. Pepper Older Americans Independence Center (P30‐AG021342) and CTSI (UL1TR000142). Publisher Copyright: {\textcopyright} 2020 The American Geriatrics Society",

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doi = "10.1111/jgs.16942",

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AU - Stephens-Shields, Alisa J.

AU - Farrar, John T.

AU - Ellenberg, Susan S.

AU - Storer, Thomas W.

AU - Gill, Thomas M.

AU - Basaria, Shehzad

AU - Pahor, Marco

AU - Cauley, Jane A.

AU - Ensrud, Kristine E.

AU - Preston, Peter

AU - Cella, David

AU - Snyder, Peter J.

AU - Bhasin, Shalender

N1 - Funding Information: The Testosterone Trials were supported by a grant from the National Institute on Aging, National Institutes of Health (U01 AG030644), supplemented by funds from the National Heart, Lung and Blood Institute, National Institute of Neurological Diseases and Stroke, and National Institute of Child Health and Human Development. AbbVie (formerly Solvay and Abbott Laboratories) provided funding and donated the study medication and the placebo gel. SB was supported partially by the Boston Claude D. Pepper Older Americans Independence Center grant 5P30AG031679. TMG is the recipient of an Academic Leadership Award (K07AG3587) from the National Institute on Aging. The Yale Field Center was partially supported by the Claude D. Pepper Older Americans Independence Center (P30-AG021342) and CTSI (UL1TR000142). Category 1 Concept and design: Alisa Stephens-Shields and Shalender Bhasin Acquisition of subjects and data: Susan Ellenberg, Thomas Storer, Thomas Gill, Shehzad Basaria, Marco Pahor, Jane Cauley, Kristine Ensrud, Peter Preston, David Cella, and Peter Snyder Analysis and interpretation of data: Alisa Stephens-Shields, Susan Ellenberg, John Farrar, Thomas Gill, Peter Preston, David Cella, and Shalendar Bhasin Category 2 Drafting the article: Alisa J. Stephens-Shields and Shalender Bhasin Revising the article for intellectual content: Susan Ellenberg, John Farrar, Thomas Storer, Thomas Gill, Shehzad Basaria, Marco Pahor, Jane Cauley, Kristine Ensrud, Peter Preston, David Cella, and Peter Snyder Category 3 Final approval of the completed article: Alisa Stephens-Shields, Susan Ellenberg, John Farrar, Thomas Storer, Thomas Gill, Shehzad Basaria, Marco Pahor, Jane Cauley, Kristine Ensrud, Peter Preston, David Cella, Peter J. Snyder, and Shalender Bhasin The funding agencies played no role in the design of the trial, analyses of data, preparation of the manuscript, or in the decision to publish. Funding Information: The Testosterone Trials were supported by a grant from the National Institute on Aging, National Institutes of Health (U01 AG030644), supplemented by funds from the National Heart, Lung and Blood Institute, National Institute of Neurological Diseases and Stroke, and National Institute of Child Health and Human Development. AbbVie (formerly Solvay and Abbott Laboratories) provided funding and donated the study medication and the placebo gel. SB was supported partially by the Boston Claude D. Pepper Older Americans Independence Center grant 5P30AG031679. TMG is the recipient of an Academic Leadership Award (K07AG3587) from the National Institute on Aging. The Yale Field Center was partially supported by the Claude D. Pepper Older Americans Independence Center (P30‐AG021342) and CTSI (UL1TR000142). Publisher Copyright: © 2020 The American Geriatrics Society

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N2 - 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.

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KW - randomized controlled trials

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Clinically Important Differences for Mobility Measures Derived from the Testosterone Trials

Abstract

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