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临床研究中与肺栓塞相关死亡的定义、判定和报告:系统评价。

Definitions, adjudication, and reporting of pulmonary embolism-related death in clinical studies: A systematic review.

机构信息

Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Department of Medicine, University of Ottawa, Ottawa, ON, Canada.

出版信息

J Thromb Haemost. 2019 Oct;17(10):1590-1607. doi: 10.1111/jth.14570. Epub 2019 Jul 31.

DOI:10.1111/jth.14570
PMID:31301689
Abstract

BACKGROUND

Pulmonary embolism (PE)-related death is a component of the primary outcome in many venous thromboembolism (VTE) studies. The absence of a standardized definition for PE-related death hampers study outcome evaluation and between-study comparisons.

OBJECTIVES

To summarize definitions for PE-related death used in recent VTE studies and to assess the PE-related death rate.

PATIENTS/METHODS: A systematic literature search was conducted on 26 April 2018 from 1 January 2014 up to the search date in MEDLINE, Embase, and CENTRAL. Cohort studies and randomized trials in which PE-related death was included in the primary outcome were eligible. Screening of titles, abstracts, and full-text articles, and data extraction were independently performed in duplicate by two authors. Study outcomes included the definition for PE-related death, VTE case-fatality rate, and death due to PE rate. Descriptive statistics were used to analyze the data.

RESULTS

Of the 6807 identified citations, 83 studies were included of which 27% were randomized trials, 31% were prospective, and 42% retrospective cohort studies. Thirty-five studies (42%) had a central adjudication committee. Thirty-eight (46%) reported a definition for PE-related death of which the most frequently used components were "autopsy-confirmed PE" (50%), "objectively confirmed PE before death" (55%), and "unexplained death" (58%). Median VTE case-fatality rate was 1.8% (interquartile range, 0.0-13).

CONCLUSIONS

Only half of the included studies reported definitions for PE-related death, which were very heterogeneous. Case-fatality rate of VTE events varied widely across studies. Standardization of the definition and guidance on adjudication and reporting of PE-related death is needed.

摘要

背景

肺栓塞(PE)相关死亡是许多静脉血栓栓塞症(VTE)研究中主要结局的组成部分。由于缺乏 PE 相关死亡的标准化定义,妨碍了研究结果的评估和研究之间的比较。

目的

总结最近 VTE 研究中使用的 PE 相关死亡定义,并评估 PE 相关死亡率。

患者/方法:于 2018 年 4 月 26 日对 MEDLINE、Embase 和 CENTRAL 进行了系统的文献检索,检索时间范围为 2014 年 1 月 1 日至检索日期。纳入的研究为包含 PE 相关死亡作为主要结局的队列研究和随机试验。两名作者独立对标题、摘要和全文文章进行筛选,并进行数据提取。研究结果包括 PE 相关死亡的定义、VTE 病死率和因 PE 导致的死亡率。采用描述性统计方法分析数据。

结果

在 6807 篇被识别的文献中,有 83 项研究被纳入,其中 27%为随机试验,31%为前瞻性研究,42%为回顾性队列研究。35 项研究(42%)设有中央裁决委员会。38 项研究(46%)报告了 PE 相关死亡的定义,最常使用的组件包括“尸检证实的 PE”(50%)、“死亡前客观证实的 PE”(55%)和“不明原因的死亡”(58%)。VTE 病死率的中位数为 1.8%(四分位距,0.0-13)。

结论

只有一半的纳入研究报告了 PE 相关死亡的定义,这些定义差异很大。不同研究中 VTE 事件的病死率差异很大。需要对 PE 相关死亡的定义进行标准化,并指导 PE 相关死亡的裁决和报告。

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