Hippisley-Cox Julia, Coupland Carol
Division of Primary Care, University of Nottingham, Nottingham NG2 7RD, UK
ClinRisk, Leeds, West Yorkshire, UK.
BMJ. 2017 Nov 20;359:j5019. doi: 10.1136/bmj.j5019.
To derive and validate updated QDiabetes-2018 prediction algorithms to estimate the 10 year risk of type 2 diabetes in men and women, taking account of potential new risk factors, and to compare their performance with current approaches. Prospective open cohort study. Routinely collected data from 1457 general practices in England contributing to the QResearch database: 1094 were used to develop the scores and a separate set of 363 were used to validate the scores. 11.5 million people aged 25-84 and free of diabetes at baseline: 8.87 million in the derivation cohort and 2.63 million in the validation cohort. Cox proportional hazards models were used in the derivation cohort to derive separate risk equations in men and women for evaluation at 10 years. Risk factors considered included those already in QDiabetes (age, ethnicity, deprivation, body mass index, smoking, family history of diabetes in a first degree relative, cardiovascular disease, treated hypertension, and regular use of corticosteroids) and new risk factors: atypical antipsychotics, statins, schizophrenia or bipolar affective disorder, learning disability, gestational diabetes, and polycystic ovary syndrome. Additional models included fasting blood glucose and glycated haemoglobin (HBA1c). Measures of calibration and discrimination were determined in the validation cohort for men and women separately and for individual subgroups by age group, ethnicity, and baseline disease status. Incident type 2 diabetes recorded on the general practice record. In the derivation cohort, 178 314 incident cases of type 2 diabetes were identified during follow-up arising from 42.72 million person years of observation. In the validation cohort, 62 326 incident cases of type 2 diabetes were identified from 14.32 million person years of observation. All new risk factors considered met our model inclusion criteria. Model A included age, ethnicity, deprivation, body mass index, smoking, family history of diabetes in a first degree relative, cardiovascular disease, treated hypertension, and regular use of corticosteroids, and new risk factors: atypical antipsychotics, statins, schizophrenia or bipolar affective disorder, learning disability, and gestational diabetes and polycystic ovary syndrome in women. Model B included the same variables as model A plus fasting blood glucose. Model C included HBA1c instead of fasting blood glucose. All three models had good calibration and high levels of explained variation and discrimination. In women, model B explained 63.3% of the variation in time to diagnosis of type 2 diabetes (R), the D statistic was 2.69 and the Harrell's C statistic value was 0.89. The corresponding values for men were 58.4%, 2.42, and 0.87. Model B also had the highest sensitivity compared with current recommended practice in the National Health Service based on bands of either fasting blood glucose or HBA1c. However, only 16% of patients had complete data for blood glucose measurements, smoking, and body mass index. Three updated QDiabetes risk models to quantify the absolute risk of type 2 diabetes were developed and validated: model A does not require a blood test and can be used to identify patients for fasting blood glucose (model B) or HBA1c (model C) testing. Model B had the best performance for predicting 10 year risk of type 2 diabetes to identify those who need interventions and more intensive follow-up, improving on current approaches. Additional external validation of models B and C in datasets with more completely collected data on blood glucose would be valuable before the models are used in clinical practice.
为了推导和验证更新后的QDiabetes - 2018预测算法,以估计男性和女性患2型糖尿病的10年风险,同时考虑潜在的新风险因素,并将其性能与当前方法进行比较。前瞻性开放队列研究。从英格兰1457家全科诊所常规收集的数据纳入QResearch数据库:1094例用于开发评分,另外363例用于验证评分。1150万年龄在25 - 84岁且基线时无糖尿病的人群:887万在推导队列中,263万在验证队列中。在推导队列中使用Cox比例风险模型为男性和女性分别推导10年评估的单独风险方程。考虑的风险因素包括QDiabetes中已有的因素(年龄、种族、贫困程度、体重指数、吸烟、一级亲属糖尿病家族史、心血管疾病、治疗的高血压和经常使用皮质类固醇)以及新的风险因素:非典型抗精神病药物、他汀类药物、精神分裂症或双相情感障碍、学习障碍、妊娠期糖尿病和多囊卵巢综合征。其他模型包括空腹血糖和糖化血红蛋白(HBA1c)。在验证队列中分别针对男性和女性以及按年龄组、种族和基线疾病状态划分的各个亚组确定校准和区分度的测量指标。全科诊所记录中记录的2型糖尿病发病情况。在推导队列中,在4272万人年的观察期内随访期间确定了178314例2型糖尿病发病病例。在验证队列中,从1432万人年的观察期内确定了62326例2型糖尿病发病病例。所有考虑的新风险因素均符合我们的模型纳入标准。模型A包括年龄、种族、贫困程度、体重指数、吸烟、一级亲属糖尿病家族史、心血管疾病、治疗的高血压和经常使用皮质类固醇,以及新的风险因素:非典型抗精神病药物、他汀类药物、精神分裂症或双相情感障碍、学习障碍,以及女性的妊娠期糖尿病和多囊卵巢综合征。模型B包括与模型A相同的变量加上空腹血糖。模型C包括HBA1c而非空腹血糖。所有三个模型均具有良好的校准度、高水平的解释变异和区分度。在女性中,模型B解释了2型糖尿病诊断时间变异的63.3%(R),D统计量为2.69,Harrell's C统计量值为0.89。男性的相应值分别为58.4%、2.42和0.87。与基于空腹血糖或HBA^1c范围的英国国家医疗服务体系当前推荐做法相比,模型B也具有最高的敏感性。然而,只有16%的患者具有血糖测量、吸烟和体重指数的完整数据。开发并验证了三个更新的QDiabetes风险模型以量化2型糖尿病的绝对风险:模型A不需要血液检测,可用于识别需要进行空腹血糖(模型B)或HBA1c(模型C)检测的患者。模型B在预测2型糖尿病10年风险以识别需要干预和更密切随访的人群方面表现最佳,优于当前方法。在将模型B和C用于临床实践之前,在血糖数据收集更完整的数据集中对其进行额外的外部验证将很有价值。