Department of Neurosurgery, Erasmus MC Stroke Center, Erasmus MC University Medical Centre, Rotterdam, the Netherlands.
Department of Neurology and Neurosurgery, UMC Utrecht Brain Center, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.
JAMA Netw Open. 2023 Sep 5;6(9):e2331798. doi: 10.1001/jamanetworkopen.2023.31798.
Testing new medical devices or procedures in terms of safety, effectiveness, and durability should follow the strictest methodological rigor before implementation.
To review and analyze studies investigating devices and procedures used in intracranial aneurysm (IA) treatment for methods and completeness of reporting and to compare the results of studies with positive, uncertain, and negative conclusions.
Embase, MEDLINE, Web of Science, and The Cochrane Central Register of Clinical Trials were searched for studies on IA treatment published between January 1, 1995, and the October 1, 2022. Grey literature was retrieved from Google Scholar.
All studies making any kind of claims of safety, effectiveness, or durability in the field of IA treatment were included.
Using a predefined data dictionary and analysis plan, variables ranging from patient and aneurysm characteristics to the results of treatment were extracted, as were details pertaining to study methods and completeness of reporting. Extraction was performed by 10 independent reviewers. A blinded academic neuro-linguist without involvement in IA research evaluated the conclusion of each study as either positive, uncertain, or negative. The study followed Preferring Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
The incidence of domain-specific outcomes between studies with positive, uncertain, or negative conclusions regarding safety, effectiveness, or durability were compared. The number of studies that provided a definition of safety, effectiveness, or durability and the incidence of incomplete reporting of domain-specific outcomes were evaluated.
Overall, 12 954 studies were screened, and 1356 studies were included, comprising a total of 410 993 treated patients. There was no difference in the proportion of patients with poor outcome or in-hospital mortality between studies claiming a technique was safe, uncertain, or not safe. Similarly, there was no difference in the proportion of IAs completely occluded at last follow-up between studies claiming a technique was effective, uncertain, or noneffective. Less than 2% of studies provided any definition of safety, effectiveness, or durability, and only 1 of the 1356 studies provided a threshold under which the technique would be considered unsafe. Incomplete reporting was found in 546 reports (40%).
In this systematic review and meta-analysis of IA treatment literature, studies claiming safety, effectiveness, or durability of IA treatment had methodological flaws and incomplete reporting of relevant outcomes supporting these claims.
在实施新的医疗设备或程序之前，应按照最严格的方法学严格标准测试其安全性、有效性和耐用性。
回顾和分析颅内动脉瘤 (IA) 治疗中使用的设备和程序的研究，以评估其报告方法和完整性，并比较具有阳性、不确定和阴性结论的研究结果。
Embase、MEDLINE、Web of Science 和 The Cochrane Central Register of Clinical Trials 检索了 1995 年 1 月 1 日至 2022 年 10 月 1 日期间发表的颅内动脉瘤治疗相关研究。从 Google Scholar 检索灰色文献。
纳入了在颅内动脉瘤治疗领域声称具有安全性、有效性或耐用性的所有研究。
使用预定义的数据字典和分析计划，从患者和动脉瘤特征到治疗结果等变量进行了提取，并详细记录了研究方法和报告完整性。提取由 10 位独立审查员完成。一位未参与颅内动脉瘤研究的盲法学术神经语言学家评估了每项研究的结论，结论为阳性、不确定或阴性。该研究遵循了系统评价和荟萃分析的 Preferred Reporting Items 指南。
比较了安全性、有效性或耐用性方面具有阳性、不确定或阴性结论的研究中特定领域结果的发生率。评估了提供安全性、有效性或耐用性定义的研究数量以及特定领域结果报告不完整的发生率。
共筛选出 12954 篇文章，纳入 1356 篇文章，共计 410993 例接受治疗的患者。声称某种技术安全、不确定或不安全的研究中，不良结局或住院死亡率的患者比例没有差异。同样，声称某种技术有效的研究中，完全闭塞的颅内动脉瘤比例与不确定或无效的研究也没有差异。不到 2%的研究提供了任何关于安全性、有效性或耐用性的定义，而在 1356 项研究中，只有 1 项研究提供了技术被认为不安全的阈值。在 546 份报告中发现了不完整的报告（40%）。
在这项对颅内动脉瘤治疗文献的系统评价和荟萃分析中，声称颅内动脉瘤治疗安全性、有效性或耐用性的研究存在方法学缺陷和相关结果报告不完整，无法支持这些结论。
