Accuracy of Medical Claims for Identifying Cardiovascular and Bleeding Events After Myocardial Infarction A Secondary Analysis of the TRANSLATE-ACS Study
Accuracy of Medical Claims for Identifying Cardiovascular and Bleeding Events After Myocardial Infarction A Secondary Analysis of the TRANSLATE-ACS Study
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DOI：
10.1001/jamacardio.2017.1460
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发表时间：
2017-07-01
期刊：
影响因子：
24
通讯作者：
Wang, Tracy Y.
中科院分区：
文献类型：
--
作者：
Guimaraes, Patricia O.;Krishnamoorthy, Arun;Wang, Tracy Y.
重要性实用的临床试验设计建议使用医疗索赔数据来确定临床事件;然而，在识别潜在事件方面，收费诊断的准确性尚不清楚。实验目的：比较通过医疗索赔与通过医生裁定识别事件时事件的1年累积发生率，并使用医生裁定作为标准来评估收费识别事件的准确性。和参与者这项临床试验的事后分析评估了12365名参加二磷酸腺苷受体抑制剂治疗的患者在急性心肌梗死（MI）1年内在233家美国医院的所有再住院的医疗索赔表和记录：2010年4月1日至2012年10月31日期间急性冠脉综合征后治疗模式和事件纵向评估（TRANSLATE-ACS）研究。14例患者（0.1%）在首次住院期间死亡，并从分析中排除。根据国际疾病分类第九版、临床修改诊断和医疗账单中的程序代码确定复发性MI、卒中和出血事件。这些事件由研究医生通过病历审查，使用预先规定的复发性MI和卒中标准以及闭塞冠状动脉的链激酶和组织纤溶酶原激活剂全球利用（GUSTO）量表的出血定义独立裁定。在统一法案-04索赔表上报告医疗索赔;从入组TRANSLATE-ACS的患者访问的所有医院收集索赔。出院后12个月内医疗索赔确定的事件和医生裁定的事件之间的一致性采用。统计数据。结果12365例急性心肌梗死患者中，男性8890例（71.9%），平均年龄60岁（11.6岁）。通过医疗索赔确定的事件的1年累积发生率为MI 4.3%、卒中0.9%和出血5.0%。基于医生裁定的MI、卒中和出血的发生率分别为4.7%、0.9%和5.4%。医疗索赔确定和医生裁定的事件之间的协议是适度的，与。MI为0.76（95% CI，0.73 - 0.79），卒中事件为0.55（95% CI，0.41 - 0.68）。相比之下，医疗索赔确定和医生裁定的出血事件之间的一致性较差，的0.24（95%CI，0.19至0.30）的任何住院出血事件和0.15（95%CI，0.11至0.20）的中度或重度出血的GUSTO scale.CONCLUSIONS和相关性事件发生率在MI后1年的MI，中风，出血时，医疗索赔被用来确定事件时，比由医生裁定。医疗索赔诊断在识别MI和卒中入院方面仅适度准确，但对出血事件的准确性有限。可能需要一种替代方法来确保心血管研究中的良好安全性监测。
IMPORTANCE Pragmatic clinical trial designs have proposed the use of medical claims data to ascertain clinical events; however, the accuracy of billed diagnoses in identifying potential events is unclear.OBJECTIVES To compare the 1-year cumulative incidences of events when events were identified by medical claims vs by physician adjudication and to assess the accuracy of bill-identified events using physician adjudication as the criterion standard.DESIGN, SETTING, AND PARTICIPANTS This post hoc analysis of a clinical trial assessed the medical claims forms and records for all rehospitalizations at 233 US hospitals within 1 year of the index acutemyocardial infarction (MI) of 12 365 patients enrolled in the Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) study between April 1, 2010, and October 31, 2012. Fourteen patients (0.1%) died during the index hospitalization and were excluded from analysis. Recurrent MI, stroke, and bleeding events were identified per the International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis and procedural codes in medical bills. These events were independently adjudicated by study physicians through medical record reviews using the prespecified criteria of recurrent MI and stroke and the bleeding definition by the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) scale. Medical claims were reported on a Uniform Bill-04 claims form; claims were collected from all hospitals visited by patients enrolled in TRANSLATE-ACS. Agreement between medical claims-identified events and physician-adjudicated events over the 12 months after discharge was assessed with the. statistic. Data were analyzed from January 30, 2015, to March 2, 2017.MAIN OUTCOMES AND MEASURES Event rates within 1 year after MI.RESULTS Among 12 365 patients with acute MI, 8890 (71.9%) were men and mean (SD) age was 60 (11.6) years. The cumulative 1-year incidence of events identified by medical claims was 4.3% for MI, 0.9% for stroke, and 5.0% for bleeding. Incidence rates based on physician adjudication were 4.7% for MI, 0.9% for stroke, and 5.4% for bleeding. Agreement between medical claims-identified and physician-adjudicated events was modest, with a. of 0.76 (95% CI, 0.73 to 0.79) for MI and 0.55 (95% CI, 0.41 to 0.68) for stroke events. In contrast, agreement between medical claims-identified and physician-adjudicated bleeding events was poor, with a. of 0.24 (95% CI, 0.19 to 0.30) for any hospitalized bleeding event and 0.15 (95% CI, 0.11 to 0.20) for moderate or severe bleeding on the GUSTO scale.CONCLUSIONS AND RELEVANCE Event rates at 1 year after MI were lower for MI, stroke, and bleeding when medical claims were used to identify events than when adjudicated by physicians. Medical claims diagnoses were only modestly accurate in identifying MI and stroke admissions but had limited accuracy for bleeding events. An alternative approach may be needed to ensure good safety surveillance in cardiovascular studies.