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用于膝关节骨关节炎的膝内侧动脉栓塞临床试验中报告的常见设计、数据元素和核心结局测量:一项交互式系统评价。

Common Design, Data Elements and Core Outcome Measures Reported on Clinical Trials of Genicular Artery Embolization for Knee Osteoarthritis: An Interactive Systematic Review.

机构信息

Department of Vascular and Interventional Radiology, Johns Hopkins Hospital, The Johns Hopkins University, Baltimore, Maryland (M.L.B.).

Department of Radiology, Mayo Clinic, Rochester, Minnesota (S.G., H.K., R.K., D.F.K.).

出版信息

Acad Radiol. 2024 Mar;31(3):977-993. doi: 10.1016/j.acra.2023.08.029. Epub 2023 Sep 16.

Abstract

RATIONALE AND OBJECTIVES

Genicular artery embolization (GAE) is an emerging, potentially effective treatment option in patients with knee osteoarthritis (OA). This study aimed to describe the current state of common design data elements (CDDEs) and core outcome measures (COMs) in recent trials of GAE for knee OA.

MATERIALS AND METHODS

A comprehensive search of seven online databases were searched within the Nested Knowledge AutoLit living review platform, followed by categorization of primary and secondary outcomes. Studies were tagged with the relevant outcomes of interest in each article. Results were synthesized and examined for the CDDEs.

RESULTS

Pain is the most frequent reported outcome, present in 23 of the 24 studies (95.8%). However, there is considerable variability in the description of in the study designs, procedural techniques, embolic materials, time points, and MRI parameters. Greater consistency is observed in eligibility criteria, and adverse events reporting. Although findings thus far have been favorable, current data is still constrained by the heterogeneity of the study design, embolization area nomenclature, limited follow-up, and in many cases, the absence of control group.

CONCLUSION

To enhance the potential for future meta-analyses and robust, evidence-based evaluations of GAE as a treatment for knee OA, further research is required to address the identified shortcomings. By establishing more standardized protocols, the efficacy and safety of GAE can be more accurately assessed and understood.

摘要

背景与目的

关节内动脉栓塞术(GAE)是一种新兴的、可能有效的治疗膝关节骨关节炎(OA)的方法。本研究旨在描述膝关节 OA 行 GAE 治疗的近期试验中常见的设计数据元素(CDDEs)和核心结局测量(COMs)的现状。

材料与方法

在嵌套知识自动文献检索平台的七个在线数据库中进行了全面检索,随后对主要和次要结局进行了分类。对每篇文章中感兴趣的相关结局进行了标记。对 CDDEs 进行了综合分析和研究。

结果

疼痛是报道最频繁的结局,在 24 项研究中的 23 项(95.8%)中均有报道。然而,在研究设计、手术技术、栓塞材料、时间点和 MRI 参数的描述方面存在很大的差异。在入选标准和不良事件报告方面,一致性较好。尽管到目前为止研究结果是有利的,但由于研究设计的异质性、栓塞区域命名法、随访时间有限,以及在许多情况下缺乏对照组,目前的数据仍然受到限制。

结论

为了提高作为膝关节 OA 治疗方法的 GAE 进行未来荟萃分析和基于证据的评估的潜力,需要进一步研究来解决已确定的缺陷。通过建立更标准化的方案,可以更准确地评估和理解 GAE 的疗效和安全性。

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