McEwan Phil, Foos Volker, Palmer James L, Lamotte Mark, Lloyd Adam, Grant David
Centre for Health Economics, Swansea University, Wales, UK; Health Economics and Outcomes Research Ltd., Monmouth, UK.
Health Economics and Outcomes Research, IMS Health, Basel, Switzerland.
Value Health. 2014 Sep;17(6):714-24. doi: 10.1016/j.jval.2014.07.007.
The IMS CORE Diabetes Model (CDM) is a widely published and validated simulation model applied in both type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) analyses. Validation to external studies is an important part of demonstrating model credibility.
Because the CDM is widely used to estimate long-term clinical outcomes in diabetes patients, the objective of this analysis was to validate the CDM to contemporary outcomes studies, including those with long-term follow-up periods.
A total of 112 validation simulations were performed, stratified by study follow-up duration. For long-term results (≥15-year follow-up), simulation cohorts representing baseline Diabetes Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS) cohorts were generated and intensive and conventional treatment arms were defined in the CDM. Predicted versus observed macrovascular and microvascular complications and all-cause mortality were assessed using the coefficient of determination (R(2)) goodness-of-fit measure.
Across all validation studies, the CDM simulations produced an R(2) statistic of 0.90. For validation studies with a follow-up duration of less than 15 years, R(2) values of 0.90 and 0.88 were achieved for T1DM and T2DM respectively. In T1DM, validating against 30-year outcomes data (DCCT) resulted in an R(2) of 0.72. In T2DM, validating against 20-year outcomes data (UKPDS) resulted in an R(2) of 0.92.
This analysis supports the CDM as a credible tool for predicting the absolute number of clinical events in DCCT- and UKPDS-like populations. With increasing incidence of diabetes worldwide, the CDM is particularly important for health care decision makers, for whom the robust evaluation of health care policies is essential.
IMS核心糖尿病模型（CDM）是一个广泛发表且经过验证的模拟模型，应用于1型糖尿病（T1DM）和2型糖尿病（T2DM）分析。与外部研究进行验证是证明模型可信度的重要部分。
由于CDM被广泛用于估计糖尿病患者的长期临床结局，本分析的目的是将CDM与当代结局研究进行验证，包括那些具有长期随访期的研究。
共进行了112次验证模拟，按研究随访持续时间分层。对于长期结果（≥15年随访），生成了代表基线糖尿病控制与并发症试验（DCCT）和英国前瞻性糖尿病研究（UKPDS）队列的模拟队列，并在CDM中定义了强化治疗组和常规治疗组。使用决定系数（R²）拟合优度测量评估预测的与观察到的大血管和微血管并发症以及全因死亡率。
在所有验证研究中，CDM模拟产生的R²统计值为0.90。对于随访持续时间少于15年的验证研究，T1DM和T2DM的R²值分别为0.90和0.88。在T1DM中，根据30年结局数据（DCCT）进行验证，R²为0.72。在T2DM中，根据20年结局数据（UKPDS）进行验证，R²为0.92。
本分析支持CDM作为预测DCCT和UKPDS样人群临床事件绝对数量的可靠工具。随着全球糖尿病发病率的增加，CDM对医疗保健决策者尤为重要，对他们来说，对医疗保健政策进行有力评估至关重要。
