External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants?
External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants?
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DOI：
10.1111/dme.12047
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发表时间：
2013-03-01
影响因子：
3.5
通讯作者：
Wild, S. H.
中科院分区：
文献类型：
--
作者：
Saunders, C.;Byrne, C. D.;Wild, S. H.
目的描述苏格兰2型糖尿病患者符合纳入几项大型血糖控制随机对照试验的资格标准的比例，以告知医生和指南制定者试验结果的普遍性。方法通过文献回顾，确定评估血糖控制对大血管疾病风险影响的大型试验。在一项基于人群的横断面研究中，将每个试验的纳入和排除标准应用于2008年居住在苏格兰的诊断为2型糖尿病的人群（n=180590）的数据，并确定每个试验符合条件的人数和比例。结果共纳入7项试验。符合试验资格标准的2型糖尿病患者比例从3.5%到50.7%不等。试验参与者在诊断糖尿病的年龄和试验招募时比苏格兰研究人群年轻。最高年龄标准的应用排除了最大比例的患者，高达39%的2型糖尿病患者不符合仅基于年龄的最严格标准的试验。结论：我们发现，许多2型糖尿病患者血糖控制的大型试验在以人群为基础的2型糖尿病患者队列中应用时，其外部有效性有限。特别是，试验参与者的年龄分布往往不能反映当代英国人群中2型糖尿病患者的年龄分布。
Aims To describe the proportion of people with Type2 diabetes living in Scotland who meet eligibility criteria for inclusion in several large randomized controlled trials of glycaemic control to inform physicians and guideline developers about the generalizibility of trial results. Methods A literature review was performed to identify large trials assessing the impact of glycaemic control on risk of macrovascular disease. Inclusion and exclusion criteria from each trial were applied to data on the population of people with a diagnosis of Type2 diabetes living in Scotland in 2008 (n=180590) in a population-based cross-sectional study and the number and proportion of people eligible for each trial was determined. Results Seven trials were identified. The proportion of people with Type2 diabetes who met the eligibility criteria for the trials ranged from 3.5 to 50.7%. Trial participants were younger at age of diagnosis of diabetes and at time of trial recruitment than in the Scottish study population. The application of upper age criteria excluded the largest proportion of patients, with up to 39% of people with Type2 diabetes ineligible for a trial with the most stringent criteria based on age alone. Conclusions We found that many of the large trials of glycaemic control among people with Type2 diabetes have limited external validity when applied to a population-based cohort of people with Type2 diabetes. In particular, the age distribution of trial participants often does not reflect that of people with Type2 diabetes in a contemporary British population.