Effects of diabetes definition on global surveillance of diabetes prevalence and diagnosis: a pooled analysis of 96 population-based studies with 331,288 participants.
Effects of diabetes definition on global surveillance of diabetes prevalence and diagnosis: a pooled analysis of 96 population-based studies with 331,288 participants.
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DOI：
10.1016/s2213-8587(15)00129-1
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发表时间：
2015-08
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NCD Risk Factor Collaboration (NCD-RisC)
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作者：
NCD Risk Factor Collaboration (NCD-RisC)
糖尿病的定义基于不同的生物标志物，包括空腹血糖（FPG）、口服葡萄糖耐量试验（2 hOGTT）中的2小时血糖和HbA 1c。我们评估了不同诊断定义对糖尿病人群患病率的影响，以及在不同地区基于人群的健康检查调查数据的汇总分析中，将先前未诊断的个体分类为糖尿病患者与未诊断的糖尿病患者。我们使用了来自96项基于人群的健康检查调查的数据，这些调查测量了至少两种用于定义糖尿病的生物标志物。使用HbA 1c（HbA 1c ≥ 6.5%或有糖尿病诊断史或使用胰岛素或口服降血糖药物）定义糖尿病，并与仅使用FPG或FPG或2 hOGTT定义（FPG ≥ 7.0 mmol/L或2 hOGTT ≥ 11.1 mmol/L或有糖尿病史或使用胰岛素或口服降血糖药物）进行比较。我们考虑到复杂的调查设计和调查样本权重，计算了糖尿病患病率。我们用图形和回归分析比较了不同定义的糖尿病患病率。我们计算了基于HbA 1c的糖尿病诊断的敏感性和特异性，并与基于先前未诊断的个体（即，排除有糖尿病史或使用胰岛素或口服降糖药物的患者）中的血糖的诊断进行了比较。我们计算了每项调查的敏感性和特异性，然后使用随机效应模型汇总结果。我们评估了异质性的敏感性的来源，荟萃回归的研究特征选择了先验。基于FPG或2 hOGTT的人群糖尿病患病率与仅基于FPG的患病率相关（r= 0.98），但在不同患病率水平下高出2-6个百分点。在42.8%的年龄性别调查组中，基于HbA 1c的患病率低于基于FPG的患病率，而在另外41.6%的年龄性别调查组中，基于HbA 1c的患病率高于基于FPG的患病率;在另外15.6%的年龄性别调查组中，两种定义提供了相似的患病率估计值。基于葡萄糖和基于HbA 1c的患病率之间关系的研究差异部分与参与者的年龄有关，其次是人均国内生产总值的自然对数，调查年份，平均BMI，以及调查人群是国家，国家以下还是来自特定社区。定义为HbA 1c ≥ 6.5%的糖尿病合并敏感性为52.8%（95% CI 51.3 - 54.3%），合并特异性为99.74%（99.71 ~ 99.78%）与FPG ≥ 7.0 mmol/L相比，诊断既往未确诊的受试者;与基于FPG或2 hOGTT定义的糖尿病相比，敏感性为30.5%（28.7 - 32.3%）。所有预先选择的研究水平特征均不能解释HbA 1c与FPG敏感性的异质性。糖尿病的不同生物标志物和定义可以提供糖尿病人群患病率的不同估计值，并将先前未诊断为患有糖尿病的人差异化地识别。在健康调查中仅使用基于HbA 1c的定义不会识别出相当大比例的先前未诊断的人，这些人使用基于葡萄糖的测试被认为患有糖尿病。Wellcome Trust，美国国立卫生研究院。
Diabetes has been defined on the basis of different biomarkers, including fasting plasma glucose (FPG), 2-h plasma glucose in an oral glucose tolerance test (2hOGTT), and HbA1c. We assessed the effect of different diagnostic definitions on both the population prevalence of diabetes and the classification of previously undiagnosed individuals as having diabetes versus not having diabetes in a pooled analysis of data from population-based health examination surveys in different regions. We used data from 96 population-based health examination surveys that had measured at least two of the biomarkers used for defining diabetes. Diabetes was defined using HbA1c (HbA1c ≥6·5% or history of diabetes diagnosis or using insulin or oral hypoglycaemic drugs) compared with either FPG only or FPG-or-2hOGTT definitions (FPG ≥7·0 mmol/L or 2hOGTT ≥11·1 mmol/L or history of diabetes or using insulin or oral hypoglycaemic drugs). We calculated diabetes prevalence, taking into account complex survey design and survey sample weights. We compared the prevalences of diabetes using different definitions graphically and by regression analyses. We calculated sensitivity and specificity of diabetes diagnosis based on HbA1c compared with diagnosis based on glucose among previously undiagnosed individuals (ie, excluding those with history of diabetes or using insulin or oral hypoglycaemic drugs). We calculated sensitivity and specificity in each survey, and then pooled results using a random-effects model. We assessed the sources of heterogeneity of sensitivity by meta-regressions for study characteristics selected a priori. Population prevalence of diabetes based on FPG-or-2hOGTT was correlated with prevalence based on FPG alone (r=0·98), but was higher by 2–6 percentage points at different prevalence levels. Prevalence based on HbA1c was lower than prevalence based on FPG in 42·8% of age–sex–survey groups and higher in another 41·6%; in the other 15·6%, the two definitions provided similar prevalence estimates. The variation across studies in the relation between glucose-based and HbA1c-based prevalences was partly related to participants' age, followed by natural logarithm of per person gross domestic product, the year of survey, mean BMI, and whether the survey population was national, subnational, or from specific communities. Diabetes defined as HbA1c 6·5% or more had a pooled sensitivity of 52·8% (95% CI 51·3–54·3%) and a pooled specificity of 99·74% (99·71–99·78%) compared with FPG 7·0 mmol/L or more for diagnosing previously undiagnosed participants; sensitivity compared with diabetes defined based on FPG-or-2hOGTT was 30·5% (28·7–32·3%). None of the preselected study-level characteristics explained the heterogeneity in the sensitivity of HbA1c versus FPG. Different biomarkers and definitions for diabetes can provide different estimates of population prevalence of diabetes, and differentially identify people without previous diagnosis as having diabetes. Using an HbA1c-based definition alone in health surveys will not identify a substantial proportion of previously undiagnosed people who would be considered as having diabetes using a glucose-based test. Wellcome Trust, US National Institutes of Health.