Evidence map›Paper›PMID 33210287›Full record

Trial reportJournal of the American Geriatrics Society2021

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 and 3 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Geriatrics Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Optimizing the Design of Clinical Trials to Evaluate the Efficacy of Function-Promoting Therapies.The journals of gerontology. Series A, Biological sciences and medical sciences · 2023
    Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 1 country.

Alisa J Stephens-ShieldsDepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
John T FarrarDepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Susan S EllenbergDepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Thomas W StorerResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0002-5974-9791
Thomas M GillSection of Geriatric Medicine, Yale School of Medicine, New Haven, Connecticut, USA.ORCID 0000-0002-6450-0368
Shehzad BasariaResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Marco PahorDepartment of Aging & Geriatric Research, University of Florida, Gainesville, Florida, USA.
Jane A CauleyDepartment of Epidemiology, University of Pittsburgh, Graduate School of Public Health, Pittsburgh, Pennsylvania, USA.
Kristine E EnsrudDepartment of Medicine, Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota, USA.ORCID 0000-0002-9069-3036
Peter PrestonCenter for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
David CellaDepartment of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Peter J SnyderDivision of Endocrinology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Shalender BhasinSection of Geriatric Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
University of Pennsylvania · USBrigham and Women's Hospital · USYale University · USNorthwestern University · USUniversity of Florida · USUniversity of Minnesota · USUniversity of Pittsburgh · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Yale Study Support Suite (YES3): Dashboard and Web Portal Software Supporting Research Workflow through integrated, customizable REDCap External ModulesP30AG021342 · NIA · YALE UNIVERSITY · PI Albert C Shaw · 2002 to 2026
$37.9M
Testosterone TrialU01AG030644 · NIA · UNIVERSITY OF PENNSYLVANIA · PI SNYDER, PETER J. · 2009 to 2015
$32.4M
Yale University Clinical and Translational Science Award ProgramUL1TR000142 · NCATS · YALE UNIVERSITY · PI SHERWIN, ROBERT S · 2012 to 2015
$31.8M
TUFTS--FIELDINGP30AG031679 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI SHALENDER BHASIN · 2008 to 2026
$23.9M
NCATS NIH HHS UL1 TR000142NCATS NIH HHS UL1 TR001863NIA NIH HHS P30 AG021342NIA NIH HHS P30 AG031679NIA NIH HHS U01 AG030644NIH HHS 5P30AG031679NIH HHS P30-AG021342
6 · The paper itself

Abstract

BACKGROUND/

objectivesAccurate 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.

designLongitudinal, multisite placebo-controlled trial. SETTING/

participantsMen 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.

resultsMean 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.

conclusionCID 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.

Indexed as

Mobility LimitationPhysical Functional PerformanceAgedAndrogensDimensional Measurement AccuracyHumansIndependent LivingMaleMinimal Clinically Important DifferencePatient Reported Outcome MeasuresTestosteroneTreatment OutcomeWalking SpeedWalk TestAndrogensTestosteroneclinically important differencemobility improvementrandomized controlled trials

Identifiers

PMID33210287
PMCPMC8500528
OpenAlexW3101348087

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.