Challenges in Testosterone Measurement, Data Interpretation, and Methodological Appraisal of Interventional Trials.
Challenges in Testosterone Measurement, Data Interpretation, and Methodological Appraisal of Interventional Trials.
复制标题
DOI：
10.1016/j.jsxm.2016.04.068
复制
发表时间：
2016-07
期刊：
影响因子：
--
通讯作者：
Mulhall JP
中科院分区：
文献类型：
--
作者：
Trost LW;Mulhall JP
男性性腺功能减退症是一种常见的疾病，越来越多的文献对诊断，影响和管理。考虑到从生理学和检测角度来看T的显著变异性，彻底了解影响T值的因素和研究方法对于适当解释报告的研究结果至关重要。然而，尽管有大量的T出版物，但没有参考资料，可以整合适当解释T研究所需的所有相关和潜在混杂因素。创建一个资源文件，回顾T变异性的来源，自由与总T，分析技术和问卷调查，以及与解释结果相关的研究方法。对所有发表的关于T变异性、检测技术和T特异性问卷的T文献进行PubMed检索。结果在其对解释T文献结局和方法的影响的背景下进行了总结。各种因素对T变异性的影响及其与研究方法和结果的相关性。有几个因素影响测量的T水平，包括年龄，昼夜节律，地理，遗传，生活方式的选择，共病条件和个体内的每日变异性。游离T（fT）相对于总T的效用是有争议的，必须使用适当的阈值水平进行比较。在各种分析技术中，质谱法和平衡透析法是金标准。计算的fT经验估计值也被普遍使用和接受。性腺功能减退症特异性问卷在性腺功能减退症筛查中的效用有限，其作为量化症状的客观终点的作用仍不清楚。研究方法的许多方面可能直接或间接影响报告的结局，包括设计（随机化、前瞻性、回顾性）、持续时间、研究人群（年龄、共病）、低T阈值、使用的治疗药物、选择的客观指标/终点和统计学解释。对T文献的批判性评价需要了解导致T变异性的众多因素、研究设计和方法以及测定技术和客观测量量表的局限性。
Male hypogonadism is a common condition with an increasing body of literature on diagnosis, implications, and management. Given the significant variability in T from a physiologic and assay perspective, a thorough understanding of factors impacting T values and study methodology are essential to appropriately interpret reported study outcomes. However, despite the large number of T publications, there are no reference materials, which consolidate all relevant and potentially confounding factors necessary to appropriately interpret T studies. To create a resource document that reviews sources of T variability, free versus total T, assay techniques and questionnaires, and study methodology relevant to interpreting outcomes. A PubMed search was performed of all T literature published on T variability, assay techniques, and T-specific questionnaires. Results were summarized in the context of their impact on interpreting T literature outcomes and methodology. The effect of various factors on T variability and their relevance to study methodology and outcomes. Several factors impact measured T levels including aging, circadian rhythms, geography, genetics, lifestyle choices, comorbid conditions, and intra-individual daily variability. The utility of free T (fT) over total T is debatable and must be compared using appropriate threshold levels. Among various assay techniques, mass spectrometry and equilibrium dialysis are gold standards. Calculated empirical estimates of fT are also commonly utilized and accepted. Hypogonadism-specific questionnaires have limited utility in screening for hypogonadism, and their role as objective end-points for quantifying symptoms remains unclear. Numerous aspects of study methodology may directly or indirectly impact reported outcomes including design (randomized, prospective, retrospective), duration, populations studied (age, comorbid conditions), low T threshold, therapeutic agent utilized, objective measures/end-points selected, and statistical interpretation. Critical appraisal of T literature requires an understanding of numerous factors resulting in T variability, study design and methodology, and limitations of assay techniques and objective measurement scales.
登录
查看更多内容
2001 年至 2011 年美国雄激素处方趋势。
影响因子：
39
作者：
Baillargeon, Jacques;Urban, Randall J.;Ottenbacher, Kenneth J.;Pierson, Karen S.;Goodwin, James S.
通讯作者：
Goodwin, James S.
DOI：
10.1073/pnas.87.10.3640
发表时间：
1990-05-01
影响因子：
11.1
作者：
ANDERSSON, S;RUSSELL, DW
通讯作者：
RUSSELL, DW
影响因子：
--
作者：
Almeida, Osvaldo P.;Yeap, Bu B.;Flicker, Leon
通讯作者：
Flicker, Leon
DOI：
10.1519/jsc.0b013e31817bd45d
发表时间：
2008-09-01
影响因子：
3.2
作者：
Cadore, Eduardo Lusa;Rodrigues Lhullier, Francisco Luiz;Martins Kruel, Luiz Fernando
通讯作者：
Martins Kruel, Luiz Fernando
影响因子：
5.8
作者：
Bhasin, Shalender;Pencina, Michael;Vasan, Ramachandran S.
通讯作者：
Vasan, Ramachandran S.