Lessons Learned From the Design and Implementation of Myocardial Infarction Adjudication Tailored for HIV Clinical Cohorts
Lessons Learned From the Design and Implementation of Myocardial Infarction Adjudication Tailored for HIV Clinical Cohorts
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DOI：
10.1093/aje/kwu010
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发表时间：
2014-04-15
影响因子：
5
通讯作者：
Kitahata, M. M.
中科院分区：
文献类型：
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作者：
Crane, H. M.;Heckbert, S. R.;Kitahata, M. M.
我们开发、实施并评估了人类免疫缺陷病毒队列研究的心肌梗死（MI）判定方案。潜在事件通过艾滋病研究网络综合临床系统数据存储中心集中识别，使用心肌梗死诊断和/或心脏酶实验室结果（1995 - 2012）。网站收集了去识别的信息包，包括医生笔记和心电图、程序和实验室测试的结果。与使用的特定抗逆转录病毒药物有关的信息进行了盲法审查。两名专家审查了每个包，如果出现差异，则进行第三次审查。审稿人将可能/确定的MIs分为原发性或继发性，并确定了MIs的继发性原因。计算各鉴别/确定方法的阳性预测值和灵敏度。在1119例被判定的潜在事件中，294例（26例）为明确/可能的MIs。继发性MIs（48例）几乎与原发性MIs（52例）一样多，通常是败血症或使用可卡因的结果。在确诊或可能患有MIs的患者中，78例肌钙蛋白浓度升高（阳性预测值57,95可信区间：52,62）；然而，只有44人被临床诊断为心肌梗死（阳性预测值为45,95，可信区间为39,51）。我们发现中央诊断是至关重要的，单独的临床诊断不足以确定心肌梗死。超过一半的最终确定为心肌梗死的事件没有通过临床诊断确定。在传统的心血管疾病队列中使用的裁决方案促进了跨队列比较，但没有解决诸如确定人类免疫缺陷病毒感染者中可能常见的继发性MIs等问题。
We developed, implemented, and evaluated a myocardial infarction (MI) adjudication protocol for cohort research of human immunodeficiency virus. Potential events were identified through the centralized Centers for AIDS Research Network of Integrated Clinical Systems data repository using MI diagnoses and/or cardiac enzyme laboratory results (19952012). Sites assembled de-identified packets, including physician notes and results from electrocardiograms, procedures, and laboratory tests. Information pertaining to the specific antiretroviral medications used was redacted for blinded review. Two experts reviewed each packet, and a third review was conducted if discrepancies occurred. Reviewers categorized probable/definite MIs as primary or secondary and identified secondary causes of MIs. The positive predictive value and sensitivity for each identification/ascertainment method were calculated. Of the 1,119 potential events that were adjudicated, 294 (26) were definite/probable MIs. Almost as many secondary (48) as primary (52) MIs occurred, often as the result of sepsis or cocaine use. Of the patients with adjudicated definite/probable MIs, 78 had elevated troponin concentrations (positive predictive value 57, 95 confidence interval: 52, 62); however, only 44 had clinical diagnoses of MI (positive predictive value 45, 95 confidence interval: 39, 51). We found that central adjudication is crucial and that clinical diagnoses alone are insufficient for ascertainment of MI. Over half of the events ultimately determined to be MIs were not identified by clinical diagnoses. Adjudication protocols used in traditional cardiovascular disease cohorts facilitate cross-cohort comparisons but do not address issues such as identifying secondary MIs that may be common in persons with human immunodeficiency virus.