Evidence map›Paper›PMID 25878029›Full record

ArticleThe journals of gerontology. Series A, Biological sciences and medical sciences2015

Recruitment and Screening for the Testosterone Trials.

Jane A Cauley, Laura Fluharty, Susan S Ellenberg, Thomas M Gill, Kristine E Ensrud, Elizabeth Barrett-Connor, Denise Cifelli, Glenn R Cunningham, Alvin M Matsumoto, Shalender Bhasin and 19 more

Open access · bronzeAbstract read
In one paragraph

Article in The journals of gerontology. Series A, Biological sciences and medical sciences, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 6% 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Recruitment and Screening Methods in Alzheimer's Disease Research: The FIT-AD Trial.The journals of gerontology. Series A, Biological sciences and medical sciences · 2022
    Trial
  3. The Enabling Reduction of Low-Grade Inflammation in Seniors (ENRGISE) Pilot Study: Screening Methods and Recruitment Results.The journals of gerontology. Series A, Biological sciences and medical sciences · 2019
    Trial
  4. Trial
  5. Trial
  6. Trial
  7. Testosterone Treatment and Sexual Function in Older Men With Low Testosterone Levels.The Journal of clinical endocrinology and metabolism · 2016
    Trial
  8. Trial
  9. Effects of Testosterone Treatment in Older Men.The New England journal of medicine · 2016
    Trial
  10. Review
  11. Article
  12. Observational
  13. Article
  14. Article
  15. Article
  16. Lessons From the Testosterone Trials.Endocrine reviews · 2018
    Article
  17. Review
  18. 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

29 authors at 15 institutions in 1 country.

Jane A CauleyDepartment of Epidemiology, Graduate School of Public Health, University of Pittsburgh. jcauley@edc.pitt.edu.
Laura FluhartyCenter for Clinical Epidemiology & Biostatistics, and.
Susan S EllenbergDepartment of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Thomas M GillDivision of Geriatric Medicine, Yale School of Medicine, New Haven, Connecticut.
Kristine E EnsrudDepartment of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis. Minneapolis VA Health Care System, Minnesota.
Elizabeth Barrett-ConnorDivision of Epidemiology, Department of Family and Preventative Medicine, University of California, San Diego School of Medicine, La Jolla.
Denise CifelliCenter for Clinical Epidemiology & Biostatistics, and.
Glenn R CunninghamDivision of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine and Baylor St. Luke's Medical Center, Houston, Texas.
Alvin M MatsumotoGeriatric Research, Education, and Clinical Center, Department of Veterans Affairs Puget Sound Health Care System and Division of Gerontology and Geriatric Medicine, Department of Internal Medicine, University of Washington School of Medicine, Seattle.
Shalender BhasinResearch Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Marco PahorDepartment of Aging & Geriatric Research, University of Florida, Gainesville.
John T FarrarDivision of Geriatric Medicine, Yale School of Medicine, New Haven, Connecticut.
David CellaDepartment of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Raymond C RosenNew England Research Institutes, Inc., Watertown, Massachusetts.
Susan M ResnickLaboratory of Behavioral Neuroscience, National Institute on Aging, National Institutes of Health, Baltimore, Maryland.
Ronald S SwerdloffDivision of Endocrinology, Harbor-University of California at Los Angeles Medical Center and Los Angeles Biomedical Research Institute, Torrance.
Cora E LewisDivision of Preventive Medicine, University of Alabama at Birmingham.
Mark E MolitchDivision of Endocrinology, Metabolism and Molecular Medicine, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.
Jill P CrandallDivisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, New York.
Alisa J Stephens-ShieldsDepartment of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Thomas W StrorerSection of Endocrinology, Diabetes, and Nutrition, Boston Medical Center, Massachusetts.
Christina WangDivision of Endocrinology, Harbor-University of California at Los Angeles Medical Center and Los Angeles Biomedical Research Institute, Torrance.
Stephen AntonDepartment of Aging & Geriatric Research, University of Florida, Gainesville.
Shehzad BasariaResearch Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Susan DiemDepartment of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis.
Vafa TabatabaieDivisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, New York.
Darlene DougarCenter for Clinical Epidemiology & Biostatistics, and.
Xiaoling HouDepartment of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Peter J SnyderDivision of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
University of Pennsylvania · USCenter for Clinical Research (United States) · USAlbert Einstein College of Medicine · USNorthwestern University · USYale University · USBaylor College of Medicine · USBoston Medical Center · USBrigham and Women's Hospital · USHarvard University · USMinneapolis VA Health Care System · USNational Institute on Aging · USNew England Research Institutes · USUniversity of Alabama at Birmingham · USUniversity of Minnesota · USUniversity of Pittsburgh · US

Funding

Yale Study Support Suite (YES3): Dashboard and Web Portal Software Supporting Research Workflow through integrated, customizable REDCap External ModulesP30AG021342 · NIA · YALE UNIVERSITY · PI Lauren Ferrante · 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
VARIABILITY, STABILITY & SMOOTHNESS OF WALKINGP30AG024827 · NIA · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JENNIFER S BRACH · 2004 to 2026
$28.6M
University of Florida Older Americans Independence Center (OAIC)P30AG028740 · NIA · UNIVERSITY OF FLORIDA · PI Stephen D Anton · 2007 to 2026
$22.8M
Core-010UL1TR001073 · NCATS · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI KELLER, MARLA J, SHAMOON, HARRY · 2013 to 2017
$21.3M
University of Alabama at Birmingham's Diabetes Research CenterP30DK079626 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI BARBARA A GOWER · 2013 to 2026
$19.5M
PACTTE-Partnership for Anemia: Clinical and Translational Trials in the ElderlyU01AG034661 · NIA · DUKE UNIVERSITY · PI COHEN, HARVEY JAY · 2009 to 2018
$14.7M
UAB Diabetes Research and Training CenterP60DK079626 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GARVEY, W TIMOTHY · 2008 to 2012
$8.4M
The Bone Trial of the Testosterone TrialR01AG037679 · NIA · UNIVERSITY OF PENNSYLVANIA · PI SNYDER, PETER J. · 2011 to 2015
$2.9M
Research Training in Disability &Disabling DisordersK24AG021507 · NIA · YALE UNIVERSITY · PI GILL, THOMAS MICHAEL · 2003 to 2012
$1.6M
Intramural NIH HHSNCATS NIH HHS UL1 TR000142NCATS NIH HHS UL1 TR001073NIA NIH HHS K24 AG021507NIA NIH HHS K24-AG021507NIA NIH HHS P30 AG021342NIA NIH HHS P30-AG021342NIA NIH HHS P30 AG024827NIA NIH HHS P30 AG028740NIA NIH HHS R01 AG037679NIA NIH HHS U01 AG030644NIA NIH HHS U01AG030644NIA NIH HHS U01 AG034661NIDDK NIH HHS DK079626NIDDK NIH HHS P30 DK079626NIDDK NIH HHS P60 DK079626
6 · The paper itself

Abstract

backgroundWe describe the recruitment of men for The Testosterone (T) Trials, which were designed to determine the efficacy of T treatment.

methodsMen were eligible if they were ≥65 years, had an average of two morning total T values <275 ng/dL with neither value >300 ng/mL, and had symptoms and objective evidence of mobility limitation, sexual dysfunction, and/or low vitality. Men had to be eligible for and enroll in at least one of these three main trials (physical function, sexual function, vitality).

resultsMen were recruited primarily through mass mailings in 12 U.S. communities: 82% of men who contacted the sites did so in response to mailings. Men who responded were screened by telephone to ascertain eligibility. Of 51,085 telephone screens, 53.5% were eligible for further screening. Of 23,889 initial screening visits (SV1), 2,781 (11.6%) men were eligible for the second screening visit (SV2), which 2,261 (81.3%) completed. At SV2, 931 (41.2%) men met the criteria for one or more trials, the T level criterion and had no other exclusions. Of these, 790 (84.6%) were randomized; 99 (12.5%) in all three trials and 348 (44%) in two trials. Their mean age was 72 years and mean body mass index (BMI) was 31.0 kg/m(2). Mean (standard deviation) total T (ng/dL) was 212.0 (40.0).

conclusionDespite the telephone screening to enrollment ratio of 65 to 1, we met the recruitment goals for each trial. Recruitment of symptomatic older men with low testosterone levels is difficult but feasible.

Indexed as

Patient SelectionAgedHumansInterviews as TopicLibidoMaleMobility LimitationMulticenter Studies as TopicRandomized Controlled Trials as TopicTestosteroneTestosteroneHypogonadal menPhysical functionRandomized clinical trials.RecruitmentSexual functionTestosterone treatmentVitality

Identifiers

PMID25878029
PMCPMC4861649
OpenAlexW2071426095

What OpenQuestion holds

Textmetadata
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.