Delphi Consensus on Reporting Standards in Clinical Studies for Endovascular Treatment of Acute Iliofemoral Venous Thrombosis and Chronic Iliofemoral Venous Obstruction.
Delphi Consensus on Reporting Standards in Clinical Studies for Endovascular Treatment of Acute Iliofemoral Venous Thrombosis and Chronic Iliofemoral Venous Obstruction.
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DOI：
10.1161/circinterventions.123.012894
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发表时间：
2023-07
影响因子：
5.6
通讯作者：
Kolluri, Raghu
中科院分区：
文献类型：
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作者：
Vedantham, Suresh;Gloviczki, Peter;Carman, Teresa L.;Zelman Lewis, Sandra;Schneider, Peter A.;Sabri, Saher S.;Kolluri, Raghu
急性髂股深静脉血栓形成和慢性髂股静脉阻塞对患者造成重大伤害，越来越多地采用血管内静脉介入治疗，包括经皮机械取栓和支架置入术。然而，这些治疗元素的研究还没有足够严格的设计和报告，以支持对其临床效用的自信结论。在本项目中，采用基于共识的可信赖声明方法，通过结构化的过程，开发基于共识的声明，以指导未来静脉干预的研究人员。起草了30份声明，包括与静脉研究描述和设计、安全性结果评估、疗效结果评估以及评估经皮静脉血栓切除术和支架置入术相关的主要主题。使用改进的德尔菲技术来达成共识，一个血管疾病专家小组对这些陈述进行了投票，并成功地在所有30个陈述中达到了预定的80%共识（同意或强烈同意）的阈值。希望这些声明的指导能够提高急性髂股深静脉血栓形成和慢性髂股静脉阻塞在临床研究中血管内介入治疗临床结果报告的规范化、客观性和以患者为中心的相关性，从而提高静脉患者的护理水平。
Acute iliofemoral deep vein thrombosis and chronic iliofemoral venous obstruction cause substantial patient harm and are increasingly managed with endovascular venous interventions, including percutaneous mechanical thrombectomy and stent placement. However, studies of these treatment elements have not been designed and reported with sufficient rigor to support confident conclusions about their clinical utility. In this project, the Trustworthy consensus-based statement approach was utilized to develop, via a structured process, consensus-based statements to guide future investigators of venous interventions. Thirty statements were drafted to encompass major topics relevant to venous study description and design, safety outcome assessment, efficacy outcome assessment, and topics specific to evaluating percutaneous venous thrombectomy and stent placement. Using modified Delphi techniques for consensus achievement, a panel of physician experts in vascular disease voted on the statements and succeeded in reaching the predefined threshold of >80% consensus (agreement or strong agreement) on all 30 statements. It is hoped that the guidance from these statements will improve standardization, objectivity, and patient-centered relevance in the reporting of clinical outcomes of endovascular interventions for acute iliofemoral deep venous thrombosis and chronic iliofemoral venous obstruction in clinical studies and thereby enhance venous patient care.
DOI：
10.1016/j.jvsv.2021.01.017
发表时间：
2021-09
期刊：
Journal of vascular surgery. Venous and lymphatic disorders
影响因子：
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作者：
Lee A;Gu CS;Vedantham S;Kearon C;Blostein M;Kahn SR
通讯作者：
Kahn SR