D'Andria Ursoleo Jacopo, Bugo Samuele, Losiggio Rosario, Bottussi Alice, Agosta Viviana Teresa, Monaco Fabrizio
Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, 20132 Milan, Italy.
J Clin Med. 2024 Sep 12;13(18):5421. doi: 10.3390/jcm13185421.
Out-of-hospital cardiac arrest (OHCA) poses a substantial public health concern. A collective evaluation of clinical trials is crucial for understanding systemic trends and progress within a specific research area of interest, ultimately shaping future directions. We performed a comprehensive analysis of the characteristics of trials in the adult OHCA population registered on ClinicalTrials.gov. Aided by medical subject headings (MeSH), we systematically searched the ClinicalTrials.gov database. Trends over time were assessed with the Cochran-Mantel-Haenszel test. The association between publication year and annual number was assessed with the Pearson correlation coefficient. Out of 152 trials spanning the 2003-2023 period, 29.6% were observational and 70.4% were interventional. Compared with the observational trials, interventional trials were more often randomized (RCT) and achieved full publication status in 84% of cases ( = 0.03). The primary focus of interventional trials was "procedures" (43%), "devices" (23%), and "drugs" (21%). Observational studies focused on "biomarkers" (16%) and "diagnostic test" (13%) ( < 0.001). A decrement in the number of interventional trials with a sample size ≥100 patients across three temporal study points was observed. Nevertheless, published studies predominantly had a sample size ≥100 patients (76%), in contrast to unpublished trials ( ≤ 0.001). An increase in the number of interventional studies funded by the "academic/university" sector was also recorded. Clinical trials on OHCA primarily involved interventions aimed at treatment and were more often randomized, single-center, with small (<100) sample sizes, and funded by the "academic/university" sector.
院外心脏骤停(OHCA)是一个重大的公共卫生问题。对临床试验进行综合评估对于了解特定感兴趣研究领域的系统趋势和进展至关重要,最终会塑造未来的方向。我们对在ClinicalTrials.gov上注册的成人OHCA人群试验的特征进行了全面分析。借助医学主题词(MeSH),我们系统地搜索了ClinicalTrials.gov数据库。使用 Cochr an - Mantel - Haenszel检验评估随时间的趋势。使用Pearson相关系数评估发表年份与年度数量之间的关联。在2003年至2023年期间的152项试验中,29.6%为观察性试验,70.4%为干预性试验。与观察性试验相比,干预性试验更常为随机对照试验(RCT),并且在84%的情况下实现了完整发表状态(P = 0.03)。干预性试验的主要重点是“程序”(43%)、“设备”(23%)和“药物”(21%)。观察性研究关注“生物标志物”(16%)和“诊断测试”(13%)(P < 0.001)。在三个时间研究点观察到样本量≥100例患者的干预性试验数量有所减少。然而,与未发表的试验相比,已发表的研究主要样本量≥100例患者(76%)(P ≤ 0.001)。还记录到由“学术/大学”部门资助的干预性研究数量有所增加。OHCA的临床试验主要涉及旨在治疗的干预措施,并且更常为随机、单中心、样本量小(<100)且由“学术/大学”部门资助。