Department of Cardiology, The Children's Hospital, Boston, Massachusetts, USA.
JACC Cardiovasc Interv. 2011 Sep;4(9):1037-46. doi: 10.1016/j.jcin.2011.05.021.
This study sought to develop a method to adjust for case mix complexity in catheterization for congenital heart disease to allow equitable comparisons of adverse event (AE) rates.
The C3PO (Congenital Cardiac Catheterization Project on Outcomes) has been prospectively collecting data using a Web-based data entry tool on all catheterization cases at 8 pediatric institutions since 2007.
A multivariable logistic regression model with high-severity AE outcome was built using a random sample of 75% of cases in the multicenter cohort; the models were assessed in the remaining 25%. Model discrimination was assessed by the C-statistic and calibration with Hosmer-Lemeshow test. The final models were used to calculate standardized AE ratios.
Between August 2007 and December 2009, 9,362 cases were recorded at 8 pediatric institutions of which high-severity events occurred in 454 cases (5%). Assessment of empirical data yielded 4 independent indicators of hemodynamic vulnerability. Final multivariable models included procedure type risk category (odds ratios [OR] for category: 2 = 2.4, 3 = 4.9, 4 = 7.6, all p < 0.001), number of hemodynamic indicators (OR for 1 indicator = 1.5, ≥2 = 1.8, p = 0.005 and p < 0.001), and age <1 year (OR: 1.3, p = 0.04), C-statistic 0.737, and Hosmer-Lemeshow test p = 0.74. Models performed well in the validation dataset, C-statistic 0.734. Institutional event rates ranged from 1.91% to 7.37% and standardized AE ratios ranged from 0.61 to 1.41.
Using CHARM (Catheterization for Congenital Heart Disease Adjustment for Risk Method) to adjust for case mix complexity should allow comparisons of AE among institutions performing catheterization for congenital heart disease.
本研究旨在开发一种用于先天性心脏病导管插入术病例组合复杂性调整的方法，以实现不良事件（AE）发生率的公平比较。
自 2007 年以来，C3PO（先天性心脏导管插入术结局项目）一直使用基于网络的数据输入工具，前瞻性地收集 8 家儿科机构所有导管插入术病例的数据。
使用多中心队列中 75%的病例随机样本构建了一个具有高严重度 AE 结局的多变量逻辑回归模型；在剩余的 25%的病例中评估模型。通过 C 统计量评估模型区分度，并通过 Hosmer-Lemeshow 检验评估校准。使用最终模型计算标准化 AE 比值。
2007 年 8 月至 2009 年 12 月，8 家儿科机构共记录了 9362 例病例，其中 454 例（5%）发生高严重度事件。对经验数据的评估产生了 4 个血流动力学脆弱性的独立指标。最终多变量模型包括手术类型风险类别（类别比值比：2=2.4，3=4.9，4=7.6，均 p<0.001）、血流动力学指标数量（1 个指标=1.5，≥2 个指标=1.8，p=0.005 和 p<0.001）以及年龄<1 岁（比值比：1.3，p=0.04）。C 统计量为 0.737，Hosmer-Lemeshow 检验 p=0.74。模型在验证数据集的表现良好，C 统计量为 0.734。机构事件发生率范围为 1.91%至 7.37%，标准化 AE 比值范围为 0.61 至 1.41。
使用 CHARM（先天性心脏病导管插入术风险调整方法）调整病例组合复杂性，应该可以比较进行先天性心脏病导管插入术的机构之间的 AE。
