Cauley Jane A, Fluharty Laura, Ellenberg Susan S, Gill Thomas M, Ensrud Kristine E, Barrett-Connor Elizabeth, Cifelli Denise, Cunningham Glenn R, Matsumoto Alvin M, Bhasin Shalender, Pahor Marco, Farrar John T, Cella David, Rosen Raymond C, Resnick Susan M, Swerdloff Ronald S, Lewis Cora E, Molitch Mark E, Crandall Jill P, Stephens-Shields Alisa J, Strorer Thomas W, Wang Christina, Anton Stephen, Basaria Shehzad, Diem Susan, Tabatabaie Vafa, Dougar Darlene, Hou Xiaoling, Snyder Peter J
Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh.
Center for Clinical Epidemiology & Biostatistics, and.
J Gerontol A Biol Sci Med Sci. 2015 Sep;70(9):1105-11. doi: 10.1093/gerona/glv031. Epub 2015 Apr 15.
We describe the recruitment of men for The Testosterone (T) Trials, which were designed to determine the efficacy of T treatment.
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).
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/m(2). Mean (standard deviation) total T (ng/dL) was 212.0 (40.0).
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.
我们描述了为睾酮（T）试验招募男性参与者的情况，该试验旨在确定T治疗的疗效。
年龄≥65岁、平均有两次晨间总T值<275 ng/dL且单次值均不>300 ng/mL、有行动受限、性功能障碍和/或活力低下的症状及客观证据的男性符合入选条件。男性必须符合这三项主要试验（身体功能、性功能、活力）中至少一项的入选标准并登记参加。
主要通过在美国12个社区进行大规模邮件招募男性：联系各站点的男性中有82%是因邮件回复而联系的。对回复者通过电话进行筛查以确定其是否符合入选条件。在51,085次电话筛查中，53.5%符合进一步筛查条件。在23,889次初次筛查就诊（SV1）中，2,781名（11.6%）男性符合第二次筛查就诊（SV2）条件，其中2,261名（81.3%）完成了SV2。在SV2时, 931名（41.2%）男性符合一项或多项试验的标准、T水平标准且无其他排除因素。其中，790名（84.6%）被随机分组；99名（12.5%）参加了所有三项试验，348名（44%）参加了两项试验。他们平均年龄为72岁，平均体重指数（BMI）为31.0 kg/m²。平均（标准差）总T（ng/dL）为212.0（40.0）。
尽管电话筛查与登记的比例为65比1，但我们仍达到了每项试验的招募目标。招募有症状的低睾酮水平老年男性虽困难但可行。
