TY - JOUR
T1 - Recruitment and screening for the testosterone trials
AU - Cauley, Jane A.
AU - Fluharty, Laura
AU - Ellenberg, Susan S.
AU - Gill, Thomas M.
AU - Ensrud, Kristine E.
AU - Barrett-Connor, Elizabeth
AU - Cifelli, Denise
AU - Cunningham, Glenn R.
AU - Matsumoto, Alvin M.
AU - Bhasin, Shalender
AU - Pahor, Marco
AU - Farrar, John T.
AU - Cella, David
AU - Rosen, Raymond C.
AU - Resnick, Susan M.
AU - Swerdloff, Ronald S.
AU - Lewis, Cora E.
AU - Molitch, Mark E.
AU - Crandall, Jill P.
AU - Stephens-Shields, Alisa J.
AU - Strorer, Thomas W.
AU - Wang, Christina
AU - Anton, Stephen
AU - Basaria, Shehzad
AU - Diem, Susan
AU - Tabatabaie, Vafa
AU - Dougar, Darlene
AU - Hou, Xiaoling
AU - Snyder, Peter J.
N1 - Publisher Copyright:
© The Author 2015. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved.
PY - 2015/9
Y1 - 2015/9
N2 - Background. We describe the recruitment of men for The Testosterone (T) Trials, which were designed to determine the efficacy of T treatment. Methods. Men 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). Results. Men 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/m2. Mean (standard deviation) total T (ng/dL) was 212.0 (40.0). Conclusion: Despite 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.
AB - Background. We describe the recruitment of men for The Testosterone (T) Trials, which were designed to determine the efficacy of T treatment. Methods. Men 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). Results. Men 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/m2. Mean (standard deviation) total T (ng/dL) was 212.0 (40.0). Conclusion: Despite 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.
KW - Hypogonadal men
KW - Physical function
KW - Randomized clinical trials
KW - Recruitment
KW - Sexual function
KW - Testosterone treatment
KW - Vitality
UR - http://www.scopus.com/inward/record.url?scp=84943233776&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84943233776&partnerID=8YFLogxK
U2 - 10.1093/gerona/glv031
DO - 10.1093/gerona/glv031
M3 - Article
C2 - 25878029
AN - SCOPUS:84943233776
SN - 1079-5006
VL - 70
SP - 1105
EP - 1111
JO - Journals of Gerontology - Series A Biological Sciences and Medical Sciences
JF - Journals of Gerontology - Series A Biological Sciences and Medical Sciences
IS - 9
ER -