Qureshi Adnan I, Zahoor Kamran, Bhatti Ibrahim A, Merchant Rameez, Beall Jonathan, Cassarly Christy N, Gajewski Byron, Martin Renee L, Suarez Jose I
Zeenat Qureshi Stroke Institute, Columbia, MO, USA.
Department of Neurology, University of Missouri, Columbia, MO, USA.
Neurosurg Rev. 2025 Apr 29;48(1):394. doi: 10.1007/s10143-025-03516-y.
Exclusion criteria are designed to optimize the scientific yield and safety of clinical trials. However, periodic analysis is necessary to understand the impact on trial complexity, enrollment, generalizability, and costs. We analyzed the types of exclusion criteria used among clinical trials performed in subarachnoid hemorrhage (SAH) patients and impact upon exclusion of patients.
We identified trials involving SAH patients that provided a list of exclusion criteria and determined the number and proportion of those trials which used various exclusion criteria, proportion of excluded patients for each of the exclusion criteria and whether Consolidated Standards of Reporting Trials (CONSORT) was used. We also used target trial emulation approach and applied arbitrary trial exclusion criteria to a single center cohort of SAH patients to determine proportions of patients excluded for each of the reasons for exclusion.
A total of 109 trials involving SAH patients were identified, of which 68(62.3%) provided a list of the exclusion criteria. The median number of exclusion criteria was 6 (range 2-9). The most common exclusion criteria were pregnancy (n = 31 trials), SAH due to other causes (trauma, fusiform or mycotic aneurysm, n = 26 trials) and significant liver disease/hepatic insufficiency (n = 19 trials). CONSORT was used in 16(23.5%) trials and 18 (16.5%) trials provided the proportion of patients excluded according to each of the exclusion criteria. In a single center cohort, the highest proportion of patients were excluded because no aneurysm was identified on imaging (23%) followed by withdrawal of care (9.6%) and need for dual anti-platelet treatment (8.6%). The in-hospital mortality was higher in patients who were excluded as compared with those who were included in the hypothetical trial (22 [30.1%] of 73 and 0 [0%] of 31 patients).
Our analysis on exclusion criteria used and proportion of patients excluded in clinical trials involving SAH patients will assist in future trial enrollment, completion, and generalizability. Standardized reporting using CONSORT in clinical trials involving SAH patients is strongly recommended.
排除标准旨在优化临床试验的科学产出和安全性。然而，定期分析对于了解其对试验复杂性、入组情况、普遍性和成本的影响是必要的。我们分析了蛛网膜下腔出血（SAH）患者临床试验中使用的排除标准类型以及对患者排除的影响。
我们识别了涉及SAH患者且提供排除标准列表的试验，确定使用各种排除标准的试验数量和比例、每个排除标准排除患者的比例以及是否使用了《报告试验的统一标准》（CONSORT）。我们还采用目标试验模拟方法，将任意试验排除标准应用于一个单中心SAH患者队列，以确定因每种排除原因而被排除患者的比例。
共识别出109项涉及SAH患者的试验，其中68项（62.3%）提供了排除标准列表。排除标准的中位数为6（范围2 - 9）。最常见的排除标准是妊娠（31项试验）、其他原因导致的SAH（创伤、梭形或霉菌性动脉瘤，26项试验）和严重肝病/肝功能不全（19项试验）。16项（23.5%）试验使用了CONSORT，18项（16.5%）试验提供了根据每个排除标准排除患者的比例。在一个单中心队列中，患者被排除的最高比例是因为影像学未发现动脉瘤（23%），其次是放弃治疗（9.6%）和需要双重抗血小板治疗（8.6%）。与假设试验中纳入的患者相比，被排除患者的院内死亡率更高（73例中有22例[30.1%]，31例中有0例[0%]）。
我们对涉及SAH患者的临床试验中使用的排除标准及排除患者比例的分析将有助于未来试验的入组、完成和普遍性。强烈建议在涉及SAH患者的临床试验中使用CONSORT进行标准化报告。
