Woodward M, Hirakawa Y, Kengne A-P, Matthews D R, Zoungas S, Patel A, Poulter N, Grobbee R, Cooper M, Jardine M, Chalmers J
George Institute for Global Health, University of Sydney, Sydney, Australia.
George Institute for Global Health, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Diabetes Obes Metab. 2016 Mar;18(3):289-94. doi: 10.1111/dom.12614. Epub 2016 Jan 15.
To formulate a combined cardiovascular risk score in diabetes that could be useful both to physicians and healthcare funders.
Data were derived from the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation Observational (ADVANCE-ON) study, a randomized controlled trial (mean duration 5 years) with a post-randomization follow-up (mean 4.9 years), that included 11 140 high-risk patients with diabetes. The outcome analysed was the occurrence of either fatal or non-fatal macrovascular or renal disease. A Cox regression model was used to determine weightings in the risk score. The resultant score was recalibrated to each of three major global regions, as covered by the ADVANCE-ON study.
Over a median of 9.9 years, 1145 patients experienced at least one component of the combined outcome event. The resultant score, the AD-ON risk score, incorporated 13 demographic or clinical variables. Its discrimination was modest [c-statistic = 0.668 (95% confidence interval 0.651, 0.685)] but its calibration was excellent (predicted and observed risks coincided well, within disparate global regions). In terms of the integrated discrimination improvement index, its performance was marginally superior, over a 10-year risk horizon, to existing risk scores in clinical use, from a restricted version of the same data, for macrovascular and renal disease separately.
The AD-ON risk score has advantages over the existing vascular risk scores in diabetes that used data from the original ADVANCE trial, which treat macrovascular and renal diseases separately. These advantages include its simplicity of use and global application.
制定一种适用于糖尿病患者的综合心血管疾病风险评分,该评分对医生和医疗保健资助者均有用。
数据来源于糖尿病与血管疾病行动:培哚普利吲达帕胺缓释片与格列齐特缓释片对照评估观察性研究(ADVANCE-ON),这是一项随机对照试验(平均持续时间5年),随机分组后进行随访(平均4.9年),纳入了11140例糖尿病高危患者。分析的结局是致命或非致命的大血管或肾脏疾病的发生情况。使用Cox回归模型确定风险评分中的权重。根据ADVANCE-ON研究覆盖的三个主要全球区域对最终得分进行重新校准。
在中位数为9.9年的时间里,1145例患者经历了至少一项综合结局事件的组成部分。最终得出的评分即AD-ON风险评分纳入了13个人口统计学或临床变量。其区分度一般[c统计量=0.668(95%置信区间0.651,0.685)],但校准效果极佳(预测风险与观察到的风险在不同全球区域内吻合良好)。就综合区分改善指数而言,在10年风险范围内,其表现略优于临床使用的现有风险评分,这些现有评分来自同一数据的受限版本,分别针对大血管疾病和肾脏疾病。
AD-ON风险评分相较于使用原始ADVANCE试验数据的现有糖尿病血管风险评分具有优势,原始试验分别处理大血管疾病和肾脏疾病。这些优势包括使用简便和全球适用性。