利用医疗保险数据确定女性健康倡议中的冠心病结局。
Use of Medicare data to identify coronary heart disease outcomes in the Women's Health Initiative.
作者信息
Hlatky Mark A, Ray Roberta M, Burwen Dale R, Margolis Karen L, Johnson Karen C, Kucharska-Newton Anna, Manson JoAnn E, Robinson Jennifer G, Safford Monika M, Allison Matthew, Assimes Themistocles L, Bavry Anthony A, Berger Jeffrey, Cooper-DeHoff Rhonda M, Heckbert Susan R, Li Wenjun, Liu Simin, Martin Lisa W, Perez Marco V, Tindle Hilary A, Winkelmayer Wolfgang C, Stefanick Marcia L
机构信息
Stanford University School of Medicine, Stanford, CA.
出版信息
Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):157-62. doi: 10.1161/CIRCOUTCOMES.113.000373. Epub 2014 Jan 7.
BACKGROUND
Data collected as part of routine clinical practice could be used to detect cardiovascular outcomes in pragmatic clinical trials or clinical registry studies. The reliability of claims data for documenting outcomes is unknown.
METHODS AND RESULTS
We linked records of Women's Health Initiative (WHI) participants aged ≥65 years to Medicare claims data and compared hospitalizations that had diagnosis codes for acute myocardial infarction or coronary revascularization with WHI outcomes adjudicated by study physicians. We then compared the hazard ratios for active versus placebo hormone therapy based solely on WHI-adjudicated events with corresponding hazard ratios based solely on claims data for the same hormone trial participants. Agreement between WHI-adjudicated outcomes and Medicare claims was good for the diagnosis of myocardial infarction (κ, 0.71-0.74) and excellent for coronary revascularization (κ, 0.88-0.91). The hormone:placebo hazard ratio for clinical myocardial infarction was 1.31 (95% confidence interval, 1.03-1.67) based on WHI outcomes and 1.29 (95% confidence interval, 1.00-1.68) based on Medicare data. The hazard ratio for coronary revascularization was 1.09 (95% confidence interval, 0.88-1.35) based on WHI outcomes and 1.10 (95% confidence interval, 0.89-1.35) based on Medicare data. The differences between hazard ratios derived from WHI and Medicare data were not significant in 1000 bootstrap replications.
CONCLUSIONS
Medicare claims may provide useful data on coronary heart disease outcomes among patients aged ≥65 years in clinical research studies.
CLINICAL TRIALS REGISTRATION INFORMATION
URL: www.clinicaltrials.gov. Unique identifier: NCT00000611.
背景
作为常规临床实践一部分收集的数据可用于在实用临床试验或临床登记研究中检测心血管结局。用于记录结局的索赔数据的可靠性尚不清楚。
方法与结果
我们将年龄≥65岁的女性健康倡议（WHI）参与者的记录与医疗保险索赔数据相链接，并将具有急性心肌梗死或冠状动脉血运重建诊断代码的住院情况与研究医生判定的WHI结局进行比较。然后，我们仅基于WHI判定事件的激素与安慰剂治疗的风险比与仅基于相同激素试验参与者索赔数据的相应风险比进行比较。WHI判定结局与医疗保险索赔之间对于心肌梗死诊断的一致性良好（κ，0.71 - 0.74），对于冠状动脉血运重建的一致性极佳（κ，0.88 - 0.91）。基于WHI结局，临床心肌梗死的激素与安慰剂风险比为1.31（95%置信区间，1.03 - 1.67），基于医疗保险数据为1.29（95%置信区间，1.00 - 1.68）。冠状动脉血运重建的风险比基于WHI结局为1.09（95%置信区间，0.88 - 1.35），基于医疗保险数据为1.10（95%置信区间，0.89 - 1.35）。在1000次自抽样复制中，源自WHI和医疗保险数据的风险比差异不显著。
结论
医疗保险索赔可为临床研究中年龄≥65岁患者的冠心病结局提供有用数据。
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