The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Screening Trial: rationale and design of a multi-center pragmatic randomized clinical trial of hepatitis C screening in emergency departments.
The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Screening Trial: rationale and design of a multi-center pragmatic randomized clinical trial of hepatitis C screening in emergency departments.
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及早识别丙型肝炎病毒是至关重要的健康优先事项，特别是现在已经有了治疗方案来限制进一步传播，并在长期后遗症发展之前提供治愈。急诊科是丙型肝炎筛查的重要临床机构，因为急诊科为许多没有获得其他形式医疗保健的高危患者提供服务。在这篇文章中，我们描述了确定丙型肝炎(Hep C)筛查试验在急诊科和治疗结果护理协调(DETVET)中的有效性测试的原理和设计。检测丙型肝炎筛查试验是一项多中心、前瞻性、实用型、随机、双臂平行分组优势试验，旨在测试非靶向和靶向丙型肝炎病毒筛查在ED中的比较有效性，其基本假设是在识别新诊断的丙型肝炎病毒时，非靶向筛查优于靶向筛查。这项试验将在丹佛健康医疗中心(丹佛，CO)、约翰·霍普金斯医院(马里兰州巴尔的摩)和密西西比大学医学中心(密西西比大学杰克逊，MS)的急诊室进行，这些地点代表每年约225,000名成人就诊，并使用PRECIS-2实用试验框架设计。完成后，我们将至少登记125,000名随机患者就诊，并进行了13,965次丙型肝炎病毒检测。在丹佛，筛查试验将作为一种渠道，进行一项独特的随机比较有效性试验，以评估与丙型肝炎病毒相关的护理策略。所有站点将进一步促进嵌入式观察性研究，以评估丙型肝炎病毒筛查、与护理的联系和治疗方案中的成本效益、差异和健康的社会决定因素。完成后，检测丙型肝炎筛查试验将是迄今为止规模最大的基于ED的实用临床试验，所有研究加在一起，将为如何最好地进行基于ED的丙型肝炎病毒筛查提供重要信息。ClinicalTrials.gov ID：NCT04003454。注册日期为2019年7月1日。网上版载有补充材料，可在10.1186/s13063-022-06265-1查阅。
Early identification of HCV is a critical health priority, especially now that treatment options are available to limit further transmission and provide cure before long-term sequelae develop. Emergency departments (EDs) are important clinical settings for HCV screening given that EDs serve many at-risk patients who do not access other forms of healthcare. In this article, we describe the rationale and design of The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Screening Trial. The DETECT Hep C Screening Trial is a multi-center prospective pragmatic randomized two-arm parallel-group superiority trial to test the comparative effectiveness of nontargeted and targeted HCV screening in the ED with a primary hypothesis that nontargeted screening is superior to targeted screening when identifying newly diagnosed HCV. This trial will be performed in the EDs at Denver Health Medical Center (Denver, CO), Johns Hopkins Hospital (Baltimore, MD), and the University of Mississippi Medical Center (Jackson, MS), sites representing approximately 225,000 annual adult visits, and designed using the PRECIS-2 framework for pragmatic trials. When complete, we will have enrolled a minimum of 125,000 randomized patient visits and have performed 13,965 HCV tests. In Denver, the Screening Trial will serve as a conduit for a distinct randomized comparative effectiveness trial to evaluate linkage-to-HCV care strategies. All sites will further contribute to embedded observational studies to assess cost effectiveness, disparities, and social determinants of health in screening, linkage-to-care, and treatment for HCV. When complete, The DETECT Hep C Screening Trial will represent the largest ED-based pragmatic clinical trial to date and all studies, in aggregate, will significantly inform how to best perform ED-based HCV screening. ClinicalTrials.gov ID: NCT04003454. Registered on 1 July 2019. The online version contains supplementary material available at 10.1186/s13063-022-06265-1.
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影响因子：
13.8
作者：
Haukoos JS;Lyons MS;Rothman RE;White DAE;Hopkins E;Bucossi M;Ruffner AH;Ancona RM;Hsieh YH;Peterson SC;Signer D;Toerper MF;Saheed M;Pfeil SK;Todorovic T;Al-Tayyib AA;Bradley-Springer L;Campbell JD;Gardner EM;Rowan SE;Sabel AL;Thrun MW;HIV TESTED Trial Investigators
通讯作者：
HIV TESTED Trial Investigators
影响因子：
2
作者：
Gould, AL
通讯作者：
Gould, AL
影响因子：
39.2
作者：
Denniston MM;Jiles RB;Drobeniuc J;Klevens RM;Ward JW;McQuillan GM;Holmberg SD
通讯作者：
Holmberg SD
影响因子：
9.7
作者：
Pitts, Stephen R.;Carrier, Emily R.;Kellermann, Arthur L.
通讯作者：
Kellermann, Arthur L.
影响因子：
7.2
作者：
Thorpe, Kevin E.;Zwarenstein, Merrick;Chalkidou, Kalipso
通讯作者：
Chalkidou, Kalipso