Comparability of Event Adjudication Versus Administrative Billing Claims for Outcome Ascertainment in the DAPT Study: Findings From the EXTEND-DAPT Study.
Comparability of Event Adjudication Versus Administrative Billing Claims for Outcome Ascertainment in the DAPT Study: Findings From the EXTEND-DAPT Study.
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DAPT研究中事件裁定与行政账单索赔在结局确定方面的可比性：来自EXTEND-DAPT研究的结果。
DOI：
10.1161/circoutcomes.120.006589
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发表时间：
2021-01
期刊：
影响因子：
--
通讯作者：
Yeh RW
中科院分区：
文献类型：
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作者：
Faridi KF;Tamez H;Butala NM;Song Y;Shen C;Secemsky EA;Mauri L;Curtis JP;Strom JB;Yeh RW
来自行政索赔的数据可能为临床试验中的终点确定提供有效的替代方案。然而，在心血管疾病患者的试验中，索赔数据与临床事件委员会的裁定相比有多好尚不确定。我们将双重抗血小板治疗（DAPT）研究中接受经皮冠状动脉介入治疗的1，336例≥65岁患者与国家心血管数据登记处（NCDR）CathPCI登记处进行了匹配，该登记处与医疗保险索赔相关，作为使用新数据来源（EXTEND）研究的扩展基于试验的医学治疗评价的一部分。使用事件发生时间分析、敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）和kappa统计量，将裁定的试验终点与住院患者的ICD-9编码的医疗保险索赔数据进行比较。在21个月随访时，试验裁定事件和索赔数据之间主要不良心血管和脑血管事件（合并死亡率、心肌梗死[MI]和卒中）的累积发生率相似（分别为7.9% vs. 7.2%; p = 0.50）。与索赔相比，使用裁定事件的出血率较低（分别为5.0%和8.6%; p <0.001）。综合计费代码识别裁定事件的灵敏度和PPV分别为65.6%和85.7%（MI）、61.5%和47.1%（卒中）以及76.8%和39.3%（出血）。所有结局的特异性和NPV范围为93.7- 99.5%。所有39例裁定死亡均使用医疗保险数据确定。评估MI、卒中和出血事件之间一致性的Kappa统计量分别为0.73、0.52和0.49。在DAPT研究中，索赔数据与MI裁定的一致性中等，一致性较差，但对出血和卒中的特异性较高。死亡人数进行了等同识别。在临床试验中使用索赔数据可能是评估医疗保险患者死亡率的有效方法，并可能有助于检测其他结果，尽管可能需要额外的监测来确保对事件的准确评估。
Data from administrative claims may provide an efficient alternative for endpoint ascertainment in clinical trials. However, it is uncertain how well claims data compares to adjudication by a clinical events committee in trials of patients with cardiovascular disease. We matched 1,336 patients ≥65 years old who received percutaneous coronary intervention in the Dual Antiplatelet Therapy (DAPT) Study with the National Cardiovascular Data Registry (NCDR) CathPCI Registry linked to Medicare claims as part of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study. Adjudicated trial endpoints were compared to Medicare claims data with ICD-9 codes from inpatient hospitalizations using time-to-event analyses, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa statistics. At 21-month follow-up, the cumulative incidence of major adverse cardiovascular and cerebrovascular events (combined mortality, myocardial infarction [MI], and stroke) was similar between trial-adjudicated events and claims data (7.9% vs. 7.2%, respectively; p = 0.50). Bleeding rates were lower using adjudicated events compared with claims (5.0% vs. 8.6%, respectively; p <0.001). The sensitivity and PPV of comprehensive billing codes for identifying adjudicated events were 65.6% and 85.7% for MI, 61.5% and 47.1% for stroke, and 76.8% and 39.3% for bleeding, respectively. Specificity and NPV for all outcomes ranged from 93.7-99.5%. All 39 adjudicated deaths were identified using Medicare data. Kappa statistics assessing agreement between events for MI, stroke, and bleeding were 0.73, 0.52, and 0.49, respectively. Claims data had moderate agreement with adjudication for MI and poor agreement but high specificity for bleeding and stroke in the DAPT Study. Deaths were identified equivalently. Using claims data in clinical trials could be an efficient way to assess mortality among Medicare patients and may help detect other outcomes, though additional monitoring is likely needed to ensure accurate assessment of events.