■据报道,在接受基于腺病毒载体的COVID-19疫苗后,血栓形成伴血小板减少综合征(TTS)。然而,在已发表的文献中,没有评估基于国际疾病分类-10-临床修改(ICD-10-CM)算法用于异常部位TTS的准确性的验证研究.
■这项研究的目的是评估临床编码的性能,以1)利用文献综述和临床输入来开发基于ICD-10-CM的算法来识别异常部位TTS作为复合结果,以及2)使用实验室根据BrightonCollaboration的临时病例定义验证算法,病理学,和成像报告在美国食品和药物管理局(FDA)生物制品有效性和安全性(BEST)倡议内的学术健康网络电子健康记录(EHR)。对每个血栓部位多达50例病例进行了验证,以病理学或影像学结果作为金标准计算的阳性预测值(PPV)和95%置信区间(95%CI)。
■算法确定了278个异常部位TTS病例,其中117(42.1%)被选择用于验证。在算法识别和验证队列中,超过60%的患者年龄大于或等于56岁.异常部位TTS的阳性预测值(PPV)为76.1%(95%CI67.2-83.2%),除一个单独的血栓形成诊断代码外,至少为80%。血小板减少症的PPV为98.3%(95%CI92.1-99.5%)。
■这项研究代表了针对异常部位TTS的基于ICD-10-CM的有效算法的第一份报告。验证工作发现,该算法在中到高PPV下执行,这表明该算法可用于观察性研究,包括对COVID-19疫苗和其他医疗产品的主动监测。
UNASSIGNED: Thrombosis with thrombocytopenia syndrome (
TTS) has been reported following receipt of adenoviral vector-based COVID-19 vaccines. However, no validation studies evaluating the accuracy of International Classification of Diseases-10-Clinical Modification (ICD-10-CM)-based algorithm for unusual site TTS are available in the published literature.
UNASSIGNED: The purpose of this study was to assess the performance of clinical coding to 1) leverage literature review and clinical input to develop an ICD-10-CM-based algorithm to identify unusual site
TTS as a composite outcome and 2) validate the algorithm against the Brighton Collaboration\'s interim case definition using laboratory, pathology, and imaging reports in an academic health network electronic health record (EHR) within the US Food and Drug Administration (FDA) Biologics Effectiveness and Safety (BEST) Initiative. Validation of up to 50 cases per thrombosis site was conducted, with positive predictive values (PPV) and 95% confidence intervals (95% CI) calculated using pathology or imaging results as the gold standard.
UNASSIGNED: The algorithm identified 278 unusual site
TTS cases, of which 117 (42.1%) were selected for validation. In both the algorithm-identified and validation cohorts, over 60% of patients were 56 years or older. The positive predictive value (PPV) for unusual site
TTS was 76.1% (95% CI 67.2-83.2%) and at least 80% for all but one individual thrombosis diagnosis code. PPV for thrombocytopenia was 98.3% (95% CI 92.1-99.5%).
UNASSIGNED: This study represents the first report of a validated ICD-10-CM-based algorithm for unusual site
TTS. A validation effort found that the algorithm performed at an intermediate-to-high PPV, suggesting that the algorithm can be used in observational studies including active surveillance of COVID-19 vaccines and other medical products.