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Endovascular Therapy for Aortic Diseases

Introduction of COS-STAD recommendations and its application of TCM

Core Outcome Set (COS) is an important approach to address problems in which the outcomes are inconsistent, non-essential and reporting biased in clinical researches. In order to ensure the standardization of the COS development process, the Core Outcome Measures in Effectiveness Trials (COMET) has initiatively developed the Core Outcome Set-STAndards for Development (COS-STAD). The recommendation includes 11 minimum standards, involving 3 common key domains: the scope, the stakeholders, and the consensus process. The COS-STAD is used by COS developers for standardizing research design, determining the quality of the methodology to develop a COS. Based on the background and conditions of clinical practice and clinical trials in China, especially the characteristics of the development of Core Outcome Set of Traditional Chinese Medicine (TCM-COS), this paper interprets the recommendations of COS-STAD, providing a reference for the potential users of COS in China.

译文：核心指标集研制标准：COS-STAD 推荐

背景 核心指标集（Core Outcome Set，COS）的应用是为确保研究人员测量并报告那些与其研究最可能相关的结局指标。目前，已开展数百个 COS 研究，但还没有对这些研究进行正式的质量评价。核心指标集研制标准（Core Outcome Set-STAndards for Development，COS-STAD）项目目的是制定国际工作组公认的 COS 研究最低设计标准，而对于 COS 研究的最终报告还有其他具体指南：COS-STAR（Core Outcome Set-STAndards for Reporting，COS-STAR）。 方法与结果 一个由经验丰富的 COS 研制者、方法学家、期刊编辑、COS 潜在使用者（临床试验员、系统评价员和临床指南制定者）及患者代表组成的国际组织制定了 COS-STAD 推荐，用以帮助改善 COS 的研制质量，并为判断已经形成的 COS 所采用的方法是否恰当提供评估支撑。通过公开的专家问卷调查产生了一份初始条目清单，并经两轮德尔菲（Delphi）问卷调查优化，共有近 250 名来自关键利益相关方的代表参加。参与者使用一个 1～9 分的量表为每个条目的重要性打分。某个条目可以进入到最低标准集合的共识原则是，每个相关方的投票参与者中至少有 70%对该条目打分为 7～9 分。德尔菲调查之后，还要与代表多个相关方的研究管理组进行共识讨论。COS-STAD 包含 11 条最低标准，是所有 COS 研究项目的最低设计建议规范。本推荐重点包括 3 个关键领域：范围、相关方和共识过程。 结论 COS-STAD 项目确立了 11 条最低标准，供 COS 研制者设计研究项目和 COS 使用者判断已形成的 COS 研究方法学是否应用合理。

Endovascular treatment outcomes of chronic thoracoabdominal aortic dissection

ObjectiveTo evaluate the feasibility, safety and efficacy of endovascular treatment for chronic thoracoabdominal aortic dissection. MethodsThe patients with chronic thoracoabdominal aortic dissection who underwent total endovascular treatment at Shanghai City First People’s Hospital between December 2021 and March 2024 were retrospectively analyzed. The patients were divided into single-trunk group and double-trunk group according to the treatment methods. Clinical data including demographic characteristics, preoperative risk factors, surgical details, postoperative complications and long-term follow-up data were collected. Outcome measures mainly included surgical success rate, in-hospital mortality, endoleak rate and incidence of branch restenosis. ResultsThirty-four patients with thoracoabdominal aortic dissection were treat with total endovascular treatment. That success rate of operation was 100%. The in-hospital mortality was 2.94%. the incidence of paraplegia was 0.00%. the incidence of cerebral infarction was 2.94%. The incidence of type Ⅲ endoleak was 5.88%. The incidence of branch artery stenosis was 8.82%. The incidence of dissection progression was 8.82%. The reintervention rate was 14.71%. In the aspect of reconstruction of splanchnic artery branches, fenestration stent was the main method in the single-trunk group, and branch stent was the main method in the double-trunk group, the difference was statistically significant (P<0.05). There was no significant difference in perioperative and mid-term follow-up results between the two groups (P>0.05). ConclusionTotal endovascular treatment is a safe and effective treatment option for patients with thoracoabdominal aortic dissection.