Development and validation of risk prediction equations to estimate future risk of blindness and lower limb amputation in patients with diabetes: cohort study.
Development and validation of risk prediction equations to estimate future risk of blindness and lower limb amputation in patients with diabetes: cohort study.
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DOI：
10.1136/bmj.h5441
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发表时间：
2015-11-11
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影响因子：
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通讯作者：
Coupland C
中科院分区：
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作者：
Hippisley-Cox J;Coupland C
是否有可能开发并外部验证风险预测方程来估计25-84岁糖尿病患者10年内失明和下肢截肢的风险？方法：这是一项前瞻性队列研究，使用1998-2014年研究期间英国全科诊所和临床实践研究数据链（CPRD）数据库中常规收集的数据。这些方程是通过763个QResearch实践（n= 455475名糖尿病患者）建立的，并在254个不同的QResearch实践（n= 142419）和357个CPRD实践（n= 206050）中得到验证。使用Cox比例风险模型推导出男性和女性失明和截肢的单独风险方程，这些方程可以在10年后进行评估。在两个验证队列中计算校准和鉴别的度量。研究结果和局限性用于量化男性和女性糖尿病患者失明和截肢绝对风险的风险预测方程已经开发出来并得到了外部验证。QResearch衍生队列随访期间新增下肢截肢4822例，新增失明8063例。在两个验证队列中，风险方程都得到了很好的校准。在体外CPRD队列中，男性对截肢（D统计量为1.69,Harrell’s C统计量为0.77）和失明（D统计量为1.40,Harrell’s C统计量为0.73）的鉴别性较好，女性和QResearch验证队列的结果相似。这些算法是基于患者可能知道的变量，或者是常规记录在全科医学计算机系统中的变量。它们可用于识别高危患者，以便进行预防或进一步评估。局限性包括缺乏正式裁决的结果、信息偏差和数据缺失。该研究补充说，1型或2型糖尿病患者失明和截肢的风险增加，但通常没有对其个人风险程度的准确评估。新的算法计算了糖尿病患者在10年内发生这些并发症的绝对风险，并考虑了他们的个人风险因素。JH-C是诺丁汉大学和埃格顿医疗信息系统联合合作的非盈利组织QResearch的联席董事，也是ClinRisk有限公司的有偿董事。CC是ClinRisk有限公司的有偿顾问统计师。
Study question Is it possible to develop and externally validate risk prediction equations to estimate the 10 year risk of blindness and lower limb amputation in patients with diabetes aged 25-84 years? Methods This was a prospective cohort study using routinely collected data from general practices in England contributing to the QResearch and Clinical Practice Research Datalink (CPRD) databases during the study period 1998-2014. The equations were developed using 763 QResearch practices (n=454 575 patients with diabetes) and validated in 254 different QResearch practices (n=142 419) and 357 CPRD practices (n=206 050). Cox proportional hazards models were used to derive separate risk equations for blindness and amputation in men and women that could be evaluated at 10 years. Measures of calibration and discrimination were calculated in the two validation cohorts. Study answer and limitations Risk prediction equations to quantify absolute risk of blindness and amputation in men and women with diabetes have been developed and externally validated. In the QResearch derivation cohort, 4822 new cases of lower limb amputation and 8063 new cases of blindness occurred during follow-up. The risk equations were well calibrated in both validation cohorts. Discrimination was good in men in the external CPRD cohort for amputation (D statistic 1.69, Harrell’s C statistic 0.77) and blindness (D statistic 1.40, Harrell’s C statistic 0.73), with similar results in women and in the QResearch validation cohort. The algorithms are based on variables that patients are likely to know or that are routinely recorded in general practice computer systems. They can be used to identify patients at high risk for prevention or further assessment. Limitations include lack of formally adjudicated outcomes, information bias, and missing data. What this study adds Patients with type 1 or type 2 diabetes are at increased risk of blindness and amputation but generally do not have accurate assessments of the magnitude of their individual risks. The new algorithms calculate the absolute risk of developing these complications over a 10 year period in patients with diabetes, taking account of their individual risk factors. Funding, competing interests, data sharing JH-C is co-director of QResearch, a not for profit organisation which is a joint partnership between the University of Nottingham and Egton Medical Information Systems, and is also a paid director of ClinRisk Ltd. CC is a paid consultant statistician for ClinRisk Ltd.