PDF(Pubmed)
Abstract：
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.
摘要：
急性髂股深静脉血栓形成和慢性髂股静脉阻塞会对患者造成重大伤害，并且越来越多地通过血管内静脉介入治疗。包括经皮机械血栓切除术和支架置入术。然而,这些治疗要素的研究尚未设计和报道足够严谨,以支持有关其临床效用的可靠结论.在这个项目中,可信的基于共识的陈述方法被用来发展，通过一个结构化的过程，基于共识的声明，以指导未来的静脉干预研究人员。起草了30份声明，涵盖与静脉研究描述和设计相关的主要主题，安全结果评估，疗效结果评估，以及评估经皮静脉血栓切除术和支架放置的特定主题。使用改进的德尔菲技术达成共识，由血管疾病方面的医师专家组成的小组对这些陈述进行了投票,并成功地在所有30项陈述中达到了>80%的共识(一致或强烈一致)的预定阈值.希望这些声明的指导意见能提高标准化程度,客观性,在临床研究中，血管内介入治疗急性髂股深静脉血栓形成和慢性髂股静脉阻塞的临床结果报告中，以患者为中心的相关性，从而增强静脉患者的护理。
