Sorbonne University, GRC 29, AP-HP, DMU DREAM, Department of Anesthesiology and critical care, Pitié-Salpêtrière Hospital, Paris, France.
Centre of Trauma Sciences, Blizard Institute, Queen Mary University of London, London, UK.
Crit Care. 2023 Sep 22;27(1):363. doi: 10.1186/s13054-023-04637-w.
While numerous randomized controlled trials (RCTs) have been conducted in the field of trauma, a substantial portion of them are yielding negative results. One potential contributing factor to this trend could be the lack of agreement regarding the chosen definitions across different trials. The primary objective was to identify the terminology and definitions utilized for the characterization of multiple trauma patients within randomized controlled trials (RCTs).
A systematic review of the literature was performed in MEDLINE, EMBASE and clinicaltrials.gov between January 1, 2002, and July 31, 2022. RCTs or RTCs protocols were eligible if they included multiple trauma patients. The terms employed to characterize patient populations were identified, and the corresponding definitions for these terms were extracted. The subsequent impact on the population recruited was then documented to expose clinical heterogeneity.
Fifty RCTs were included, and 12 different terms identified. Among these terms, the most frequently used were "multiple trauma" (n = 21, 42%), "severe trauma" (n = 8, 16%), "major trauma" (n = 4, 8%), and trauma with hemorrhagic shock" (n = 4, 8%). Only 62% of RCTs (n = 31) provided a definition for the terms used, resulting a total of 21 different definitions. These definitions primarily relied on the injury severity score (ISS) (n = 15, 30%), displaying an important underlying heterogeneity. The choice of the terms had an impact on the study population, affecting both the ISS and in-hospital mortality. Eleven protocols were included, featuring five different terms, with "severe trauma" being the most frequent, occurring six times (55%).
This systematic review uncovers an important heterogeneity both in the terms and in the definitions employed to recruit trauma patients within RCTs. These findings underscore the imperative of promoting the use of a unique and consistent definition.
虽然创伤领域已经进行了大量的随机对照试验（RCT），但其中相当一部分得出了阴性结果。造成这种趋势的一个潜在因素可能是不同试验之间对所选定义缺乏一致性。主要目标是确定用于描述随机对照试验（RCT）中多发创伤患者的术语和定义。
对 MEDLINE、EMBASE 和 clinicaltrials.gov 中的文献进行了系统评价，检索时间为 2002 年 1 月 1 日至 2022 年 7 月 31 日。如果 RCT 或 RCT 方案纳入了多发创伤患者，则符合纳入标准。确定用于描述患者人群的术语，并提取这些术语的相应定义。随后记录对纳入人群的影响，以揭示临床异质性。
共纳入 50 项 RCT，确定了 12 个不同的术语。在这些术语中，使用最频繁的是“多发创伤”（n=21，42%）、“严重创伤”（n=8，16%）、“主要创伤”（n=4，8%）和“创伤伴失血性休克”（n=4，8%）。只有 62%的 RCT（n=31）为使用的术语提供了定义，共定义了 21 个不同的定义。这些定义主要依赖于损伤严重程度评分（ISS）（n=15，30%），显示出重要的潜在异质性。术语的选择对研究人群有影响，影响 ISS 和院内死亡率。纳入了 11 项方案，有 5 个不同的术语，其中“严重创伤”最为常见，出现了 6 次（55%）。
这项系统评价揭示了 RCT 中用于招募创伤患者的术语和定义存在重要的异质性。这些发现强调了推广使用独特和一致定义的必要性。
