Ammann Eric M, Cuker Adam, Carnahan Ryan M, Perepu Usha S, Winiecki Scott K, Schweizer Marin L, Leonard Charles E, Fuller Candace C, Garcia Crystal, Haskins Cole, Chrischilles Elizabeth A
College of Public Health Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania Carver College of Medicine, University of Iowa University of Iowa Hospitals and Clinics Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland Iowa City VA Health Care System Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts Medical Scientist Training Program, University of Iowa, Iowa City, Iowa.
Medicine (Baltimore). 2018 Feb;97(8):e9960. doi: 10.1097/MD.0000000000009960.
The Sentinel Distributed Database (SDD) is a database of patient administrative healthcare records, derived from insurance claims and electronic health records, sponsored by the US Food and Drug Administration for evaluation of medical product outcomes. There is limited information on the validity of diagnosis codes for acute venous thromboembolism (VTE) in the SDD and administrative healthcare data more generally.In this chart validation study, we report on the positive predictive value (PPV) of inpatient administrative diagnosis codes for acute VTE-pulmonary embolism (PE) or lower-extremity or site-unspecified deep vein thrombosis (DVT)-within the SDD. As part of an assessment of thromboembolic adverse event risk following treatment with intravenous immune globulin (IGIV), charts were obtained for 75 potential VTE cases, abstracted, and physician-adjudicated.VTE status was determined for 62 potential cases. PPVs for lower-extremity DVT and/or PE were 90% (95% CI: 73-98%) for principal-position diagnoses, 80% (95% CI: 28-99%) for secondary diagnoses, and 26% (95% CI: 11-46%) for position-unspecified diagnoses (originating from physician claims associated with an inpatient stay). Average symptom onset was 1.5 days prior to hospital admission (range: 19 days prior to 4 days after admission).PPVs for principal and secondary VTE discharge diagnoses were similar to prior study estimates. Position-unspecified diagnoses were less likely to represent true acute VTE cases.
哨兵分布式数据库(SDD)是一个患者医疗管理记录数据库,数据来源于保险理赔和电子健康记录,由美国食品药品监督管理局发起,用于评估医疗产品的疗效。关于SDD中急性静脉血栓栓塞症(VTE)诊断编码的有效性以及更广泛的医疗管理数据,相关信息有限。在这项图表验证研究中,我们报告了SDD中急性VTE - 肺栓塞(PE)或下肢或部位未明确的深静脉血栓形成(DVT)住院管理诊断编码的阳性预测值(PPV)。作为评估静脉注射免疫球蛋白(IGIV)治疗后血栓栓塞不良事件风险的一部分,我们获取了75例潜在VTE病例的图表,进行了摘要提取,并由医生进行判定。确定了62例潜在病例的VTE状态。下肢DVT和/或PE的PPV,主要诊断为90%(95%CI:73 - 98%),次要诊断为80%(95%CI:28 - 99%),部位未明确的诊断为26%(95%CI:11 - 46%)(源自与住院相关的医生申报)。平均症状出现时间为入院前1.5天(范围:入院前19天至入院后4天)。主要和次要VTE出院诊断的PPV与先前研究估计值相似。部位未明确的诊断不太可能代表真正的急性VTE病例。
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