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Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis: A phase 3 study (OPTIMIST-2).西米普明联合索磷布韦治疗慢性丙型肝炎病毒1型感染合并肝硬化患者:一项3期研究(OPTIMIST-2)。
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Long-term effectiveness of potent antiretroviral therapy in preventing AIDS and death: a prospective cohort study.强效抗逆转录病毒疗法预防艾滋病和死亡的长期有效性:一项前瞻性队列研究。
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医疗服务提供者确认电子健康记录是否收到直接作用抗病毒药物治疗丙型肝炎病毒感染。

Provider verification of electronic health record receipt and nonreceipt of direct-acting antivirals for the treatment of hepatitis C virus infection.

机构信息

Veterans Aging Cohort Study Coordinating Center, VA Connecticut Healthcare System, West Haven, CT, USA; Internal Medicine, Yale University School of Medicine, New Haven, CT, USA; Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, UK.

Division of Infectious Diseases, Atlanta VA Medical Center, Decatur, GA, USA; School of Medicine, Emory University, Atlanta, GA, USA.

出版信息

Ann Epidemiol. 2018 Nov;28(11):808-811. doi: 10.1016/j.annepidem.2018.08.007. Epub 2018 Aug 23.

DOI:10.1016/j.annepidem.2018.08.007
PMID:30195616
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6318448/
Abstract

PURPOSE

Pharmacoepidemiologic studies using electronic health record data could serve an important role in assessing safety and effectiveness of direct-acting antiviral therapy for chronic hepatitis C virus (HCV) infection, but the validity of these data needs to be determined. We evaluated the accuracy of pharmacy fill records in the national Veterans Health Administration (VA) Corporate Data Warehouse (CDW) as compared to facility-level electronic health record.

METHODS

Patients prescribed a direct-acting antiviral regimen at five VA sites between 2014 and 2016 were randomly selected and reviewed. A random sample of patients with chronic HCV infection without evidence of HCV treatment during the study period also underwent chart review. We calculated positive predictive value and negative predictive value overall and by site.

RESULTS

Of the 501 patients who received a total of 2416 prescriptions, 494 were validated using data extracted from CDW 6 months after the study period, yielding a positive predictive value of 98.6% (95% confidence interval, 97.6%-99.6%). Of the 100 patients with chronic HCV infection without prescriptions for HCV treatment, 99 were confirmed not to have received antiviral treatment (negative predictive value, 99.0%; 95% confidence interval, 97.1%-100%).

CONCLUSIONS

These findings provide assurance to researchers who use national VA CDW data for retrospective cohort studies that the CDW contains accurate information on HCV therapies in the modern treatment era.

摘要

目的

利用电子健康记录数据进行药物流行病学研究,可以在评估慢性丙型肝炎病毒 (HCV) 感染的直接作用抗病毒治疗的安全性和有效性方面发挥重要作用,但这些数据的有效性需要确定。我们评估了国家退伍军人健康管理局 (VA) 企业数据仓库 (CDW) 中的药房配药记录与机构级电子健康记录的准确性。

方法

在 2014 年至 2016 年期间,在五个 VA 地点随机选择并审查了接受直接作用抗病毒方案治疗的患者。还对在研究期间没有 HCV 治疗证据的慢性 HCV 感染患者进行了随机样本的图表审查。我们计算了整体和按地点的阳性预测值和阴性预测值。

结果

在接受了总共 2416 种处方的 501 名患者中,有 494 名患者使用研究结束后 6 个月从 CDW 提取的数据进行了验证,阳性预测值为 98.6%(95%置信区间,97.6%-99.6%)。在 100 名没有 HCV 治疗处方的慢性 HCV 感染患者中,有 99 名患者经证实未接受抗病毒治疗(阴性预测值为 99.0%;95%置信区间,97.1%-100%)。

结论

这些发现为使用国家 VA CDW 数据进行回顾性队列研究的研究人员提供了保证,即 CDW 包含了现代治疗时代 HCV 治疗的准确信息。