CHU Nantes, Pôle Anesthésie Réanimations, Nantes Université, Nantes, France.
INSERM, MethodS in Patients-centered outcomes and HEalth Research, Nantes Université, Univ Tours, CHU Nantes, CHU Tours, Nantes, France.
J Neurotrauma. 2024 Oct;41(19-20):2238-2247. doi: 10.1089/neu.2023.0417. Epub 2024 Aug 2.
Traumatic brain injury (TBI) is a leading cause of death and disability worldwide. Randomized controlled trials (RCTs) are the cornerstone to evaluate the efficacy of an intervention. To assess the methodology of clinical research, we performed a systematic review that evaluated the different outcomes used in RCTs targeting the early phase of moderate-to-severe adult TBI from 1983 to October 31, 2023. We extracted each outcome and organized them according to the COMET and OMERACT framework (core area, broad domains, target domains, and finally outcomes). A total of 190 RCTs were included, including 52,010 participants. A total of 557 outcomes were reported and classified between the following core areas: pathophysiological manifestations [169 RCTs (88.9%)], life impact [117 RCTs (61.6%)], death [94 RCTs (49.5%)], resource use [72 RCTs (37.9%)], and adverse events [41 RCTs (21.6%)]. We identified 29 broad domains and 89 target domains. Among target domains, physical functioning [111 (58.4%)], mortality [94 (49.5%)], intracranial pressure target domain [68 (35.8%)], and hemodynamics [53 (27.9%)] were the most frequent. Outcomes were mostly clinician-reported [177 (93.2%)], while patient-reported outcomes were rarely reported [11 (5.8%)]. In our review, there was significant heterogeneity in the choice of end-points in TBI clinical research. There is an urgent need for consensus and homogeneity to improve the quality of clinical research in this area.
创伤性脑损伤（TBI）是全球范围内导致死亡和残疾的主要原因。随机对照试验（RCT）是评估干预措施疗效的基石。为了评估临床研究的方法学，我们进行了一项系统评价，评估了 1983 年至 2023 年 10 月 31 日针对中重度成人 TBI 早期阶段的 RCT 中使用的不同结局。我们提取了每个结局，并根据 COMET 和 OMERACT 框架（核心领域、广泛领域、目标领域，最后是结局）对其进行了组织。共纳入 190 项 RCT，包括 52010 名参与者。共报告和分类了 557 个结局，分为以下核心领域：病理生理表现[169 项 RCT（88.9%）]、生活影响[117 项 RCT（61.6%）]、死亡[94 项 RCT（49.5%）]、资源利用[72 项 RCT（37.9%）]和不良事件[41 项 RCT（21.6%）]。我们确定了 29 个广泛领域和 89 个目标领域。在目标领域中，身体功能[111 项（58.4%）]、死亡率[94 项（49.5%）]、颅内压目标领域[68 项（35.8%）]和血液动力学[53 项（27.9%）]最为常见。结局主要由临床医生报告[177 项（93.2%）]，而患者报告结局很少报告[11 项（5.8%）]。在我们的综述中，TBI 临床研究中终点的选择存在显著异质性。迫切需要达成共识和同质化，以提高该领域临床研究的质量。
