Nomali Mahin, Yaseri Mehdi, Nedjat Saharnaz, Azizi Fereidoun, Mansournia Mohammad Ali, Navid Hossein, Danaei Goodarz, Woodward Mark, Fahimfar Noushin, Steyerberg Ewout, Khalili Davood
Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
Endocrine Research Center, Research Institute for Endocrine Disorders, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
J Clin Epidemiol. 2025 Jun;182:111736. doi: 10.1016/j.jclinepi.2025.111736. Epub 2025 Feb 25.
We aimed to evaluate the performance of the revised World Health Organization (WHO) models in predicting the 10-year risk of cardiovascular disease (CVD) in Iran, as part of the Middle East and North Africa (MENA) region.
We analyzed data from the Tehran Lipid and Glucose Study (TLGS), including 5162 participants (2241 men) aged 40-80 years without CVD at baseline (the third examination, 2006-2008), for the occurrence of CVD (myocardial infarction (MI), coronary heart disease (CHD) death, and stroke). We assessed the statistical performance of original and regionally recalibrated models, both laboratory- and non-laboratory-based, using discrimination (C-statistic) calibration (calibration plot and observed-to-expected[O:E] ratio) and clinical performance applying net benefit (NB), a measure of true positives (TP) penalized for a weight of false positives (FP), a decimal value representing the expected proportion of TP outcomes among total population.
During the 10-year follow-up, 307 CVD events occurred. The cumulative incidence of CVD was 9.0% (95% CI: 8.0%-10.0%) in men and 4.0% (3.0%-5.0%) in women. For the laboratory-based model, the C-statistic was 0.72 (0.68-0.75) in men and 0.83 (0.80-0.86) in women; for the nonlaboratory-based model, it was 0.70 (0.66-0.73) and 0.82 (0.79-0.86) for men and women, respectively. The lab model underpredicted the risk (O:E = 1.20 [1.00-1.33] for men and 1.40 [1.13-1.60] for women). At the risk threshold of 10%, NB for the lab model was 0.03 (0.02-0.04) for men and 0.01 (0.004-0.01) for women; these values became zero or negative for thresholds over 20%. Regionally recalibrated models overestimated the risk (O:E < 1) and showed lower NB.
The loss of specificity was not sufficiently offset by the increase in sensitivity provided by the regionally recalibrated models compared to the original models.
In this study, we assessed the performance of the World Health Organization (WHO) cardiovascular disease (CVD) risk models in Iran, which is part of the Middle East and North Africa (MENA) region. Regarding the statistical performance of the models, both the original and regionally recalibrated WHO models had good discriminative ability. Concerning calibration, another component of statistical performance, the original models underestimated the actual risk, while the recalibrated version overestimated it. Regarding the clinical performance of the models, both the original and regionally recalibrated versions were clinically useful at the risk threshold of 10%.
作为中东和北非（MENA）地区的一部分，我们旨在评估修订后的世界卫生组织（WHO）模型在预测伊朗心血管疾病（CVD）10年风险方面的表现。
我们分析了德黑兰脂质与血糖研究（TLGS）的数据，该研究纳入了5162名年龄在40 - 80岁之间、基线时（2006 - 2008年第三次检查）无CVD的参与者（2241名男性），以观察CVD（心肌梗死（MI）、冠心病（CHD）死亡和中风）的发生情况。我们使用区分度（C统计量）、校准（校准图和观察值与预期值[O:E]比率）以及应用净效益（NB）评估原始模型和区域重新校准模型的统计性能，净效益是衡量真阳性（TP）因假阳性（FP）权重而受到惩罚的指标，是一个代表总人群中TP结果预期比例的小数值。
在10年随访期间，发生了307例CVD事件。男性CVD的累积发病率为9.0%（95%CI：8.0% - 10.0%），女性为4.0%（3.0% - 5.0%）。对于基于实验室的模型，男性的C统计量为0.72（0.68 - 0.75），女性为0.83（0.80 - 0.86）；对于非基于实验室的模型，男性和女性分别为0.70（0.66 - 0.73）和0.82（0.79 - 0.86）。实验室模型低估了风险（男性O:E = 1.20 [1.00 - 1.33]，女性O:E = 1.40 [1.13 - 1.60]）。在10%的风险阈值下，实验室模型的男性净效益为0.03（0.02 - 0.04），女性为0.01（0.004 - 0.01）；对于超过20%的阈值，这些值变为零或负数。区域重新校准的模型高估了风险（O:E < 1）且净效益较低。
与原始模型相比，区域重新校准的模型所提供的敏感性增加并未充分抵消特异性的损失。
在本研究中，我们评估了世界卫生组织（WHO）心血管疾病（CVD）风险模型在伊朗（中东和北非（MENA）地区的一部分）的表现。关于模型的统计性能，原始的和区域重新校准的WHO模型都具有良好的区分能力。关于校准，统计性能的另一个组成部分，原始模型低估了实际风险，而重新校准的版本高估了风险。关于模型的临床性能，原始版本和区域重新校准版本在10%的风险阈值下在临床上都是有用的。
