Prevalence of diabetes treatment effect modifiers: the external validity of trials to older adults.
Prevalence of diabetes treatment effect modifiers: the external validity of trials to older adults.
复制标题
糖尿病治疗效果调节因素的患病率：针对老年人的试验的外部有效性。
DOI：
10.1007/bf03325268
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发表时间：
2012
影响因子：
4
通讯作者：
Leff,Bruce
中科院分区：
文献类型：
--
作者：
Weiss,CarlosO;Boyd,CynthiaM;Wolff,JenniferL;Leff,Bruce
背景和目的：潜在的治疗效果修饰因子（TEMs）是具有良好描述的治疗效果修饰机制的特定疾病或病症。TEMs在老年2型糖尿病（DM）患者中的患病率尚不清楚。目的是1)确定预先指定的潜在tem的患病率；2)通过模拟试验验证tem对老年人的潜在影响；3)识别与住院次数相关的TEM组合以检验结构效度。方法：数据来自1999-2004年具有全国代表性的美国国家健康与检查调查：8646名年龄在45-64岁或65岁以上的非住院成年人，包括1443名糖尿病患者。TEMs包括贫血、充血性心力衰竭、肝脏炎症、多种药物、肾功能不全、认知障碍、头晕、频繁精神困扰、行动困难和视力障碍。模拟了一项试验，以检查TEM潜在影响的患病率。透射电镜模式与住院次数之间的横断面关联被估计来评估结构效度。结果：tem的患病率很高，中年人中有19.0% (95% CI 14.8-23.2)，老年人中有38.0% （95% CI 33.4-42.5）。一项具有适度相互作用水平的模拟试验表明，tem的流行可能使3.9-27.2%的老年糖尿病患者的治疗获益无效。与单独患有糖尿病相比，几种具有较高流行率的tem组合会增加住院率。结论：我们提供了可用于评估糖尿病临床试验报告的TEM患病率的国家基准，以及相应的它们对老年人的外部有效性。
Background and aims:Potential treatment effect modifiers (TEMs) are specific diseases or conditions with a well-described mechanism for treatment effect modification. The prevalence of TEMs in older adults with type 2 diabetes mellitus (DM) is unknown. Objectives were to 1) determine the prevalence of pre-specified potential TEMs; 2) demonstrate the potential impact of TEMs in the older adult population using a simulated trial; 3) identify TEM combinations associated with number of hospitalizations to test construct validity.Methods:Data are from the nationally- representative United States National Health and Examination Survey, 1999–2004: 8646 Civilian, non-institutionalized adults aged 45–64 or 65+ years, including 1443 with DM. TEMs were anemia, congestive heart failure, liver inflammation, polypharmacy, renal insufficiency, cognitive impairment, dizziness, frequent mental distress, mobility difficulty, and visual impairment. A trial was simulated to examine prevalence of potential TEM impact. The cross-sectional association between TEM patterns and number of hospitalizations was estimated to assess construct validity.Results:The prevalence of TEMs was substantial such that 19.0% (95% CI 14.8–23.2) of middle-aged adults and 38.0% (95% CI 33.4–42.5) of older adults had any two. A simulated trial with modest levels of interaction suggested the prevalence of TEMs could nullify treatment benefit in 3.9–27.2% of older adults with DM. Compared to having DM alone, hospitalization rate was increased by several combinations of TEMs with substantial prevalence.Conclusions:We provide national benchmarks that can be used to evaluate TEM prevalence reported by clinical trials of DM, and correspondingly their external validity to older adults.