Contrast-enhanced ultrasound studies registered on ClinicalTrials.gov: A cross-sectional analysis of characteristics, early discontinuation, and reporting results

IF 3.6 2区医学 Q1 MEDICINE, GENERAL & INTERNAL Journal of Evidence‐Based Medicine Pub Date : 2023-06-01 DOI:10.1111/jebm.12531

Wuyongga Bao, Youlin Long, Jiayan Huang, Min Liao, Jie Yang, Liang Du, Qiang Lu

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Abstract

Objective

Contrast-enhanced ultrasound offers numerous potential applications in diagnostic and interventional radiology. However, systematic studies on the status of clinical studies are limited. Hence, the aim of this study was to analyze the characteristics of registered contrast-enhanced ultrasound studies on ClinicalTrials.gov and identify features associated with early discontinuation and results reporting.

Methods

A data set containing all contrast-enhanced ultrasound clinical studies from ClinicalTrials.gov registered was downloaded. Then, a cross-sectional descriptive study of clinical contrast-enhanced ultrasound studies was conducted. Cox and logistic regression of early discontinuation and reported results, respectively, were also performed.

Results

A total of 225 studies were identified; 174 were interventional and 51 were observational. Regarding the outcomes measure, 175 (77.78%) were diagnosis-oriented, and the remaining 50 (22.22%) were interventional radiology studies. The most common regions of interest were abdominal (56%), superficial (14.22%), or vascular (7.11%) organs. As of the contrast agents, SonoVue/Lumason (39.11%) was most frequently used, followed by Definity (20.89%) and Sonazoid (8.89%). Of all contrast-enhanced ultrasound studies, 32 (14.22%) were discontinued early, and 29 (12.89%) completed studies reported their results. Cox regression analysis revealed that a large sample size and US registration were factors reducing early discontinuation risk. Among completed studies, factors associated with reported results were industry funding and US registration.

Conclusion

The findings suggest that the number of contrast-enhanced ultrasound studies has grown over time, but is still small. Developing new advancements in contrast-enhanced ultrasound will require a concerted effort to increase the quality and quantity of clinical studies in this field.

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注册在ClinicalTrials.gov上的对比增强超声研究:特征、早期终止和报告结果的横断面分析

目的对比增强超声在诊断和介入放射学中有许多潜在的应用。然而，对临床研究现状的系统研究却十分有限。因此，本研究的目的是分析ClinicalTrials.gov上注册的对比增强超声研究的特征，并确定与早期停药和结果报告相关的特征。方法下载ClinicalTrials.gov网站注册的所有超声造影临床研究数据集。然后，对临床超声造影研究进行了横断面描述性研究。对早期停药和报告结果分别进行Cox和logistic回归分析。结果共纳入225项研究;174例为干预性，51例为观察性。在结局指标方面，175例(77.78%)以诊断为导向，其余50例(22.22%)为介入放射学研究。最常见的病变区域是腹部(56%)、浅表(14.22%)或血管(7.11%)器官。对比剂中，使用频率最高的是SonoVue/Lumason(39.11%)，其次是Definity(20.89%)和Sonazoid(8.89%)。在所有对比增强超声研究中，32例(14.22%)提前终止，29例(12.89%)完成研究报告其结果。Cox回归分析显示，大样本量和美国注册是降低早期停药风险的因素。在已完成的研究中，与报告结果相关的因素是行业资助和美国注册。结论对比增强超声研究的数量随着时间的推移而增加，但仍然很少。在对比增强超声方面取得新进展需要各方共同努力，以提高该领域临床研究的质量和数量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Evidence‐Based Medicine MEDICINE, GENERAL & INTERNAL-

CiteScore

11.20

自引率

1.40%

发文量

期刊介绍： The Journal of Evidence-Based Medicine (EMB) is an esteemed international healthcare and medical decision-making journal, dedicated to publishing groundbreaking research outcomes in evidence-based decision-making, research, practice, and education. Serving as the official English-language journal of the Cochrane China Centre and West China Hospital of Sichuan University, we eagerly welcome editorials, commentaries, and systematic reviews encompassing various topics such as clinical trials, policy, drug and patient safety, education, and knowledge translation.