在膝关节骨关节炎的生殖动脉栓塞临床试验中报告的共同设计,数据元素和核心结果措施:一个交互式系统审查
Marisabel L Bolsegui1, Sherief Ghozy2, Hassan Kobeissi3
1Department of Vascular and Interventional Radiology, Johns Hopkins Hospital, The Johns Hopkins University, Baltimore, Maryland (M.L.B.).
Academic radiology
|September 18, 2023
概括
膝关节骨关节炎 (OA) 的生殖动脉栓塞 (GAE) 显示出有希望的结果,但研究设计和结果措施各不相同. 标准化是强有力的证据和未来的元分析所需要的.
科学领域:
- 干预性放射学 干预性放射学
- 整形外科 整形外科 整形外科
- 疼痛管理 疼痛管理
背景情况:
- 膝关节动脉栓塞 (GAE) 是一种新兴的膝关节骨关节炎 (OA) 治疗方法.
- 目前关于膝关节OA的GAE研究缺乏标准化的设计元素和结果措施.
- 研究方案的变化阻碍了强有力的证据综合.
研究的目的:
- 审查近期GAE对膝关节OA的试验中的共同设计数据元素 (CDDE) 和核心结果措施 (COM).
- 发现研究方法和结果报告中的不一致性.
- 突出标准化领域,以改善未来的研究.
主要方法:
- 在七个数据库中使用嵌套知识AutoLit平台进行全面的文献搜索.
- 从包含的研究中对主要和次要结果进行分类和标记.
- 综合和检查研究设计元素和结果报告.
主要成果:
- 疼痛是最常见的结果 (95.8%的研究).
- 在研究设计,程序细节,栓塞材料和后续参数中存在显著的变化.
- 在资格标准和不良事件报告中注意到一致性.
结论:
- 研究方案,结果指标和命名规范的标准化对于GAE在膝关节OA的研究至关重要.
- 解决研究设计和报告中的异质性将使更准确的疗效和安全性评估成为可能.
- 为了进行强大的元分析和基于证据的GAE评估,需要使用标准化协议进行进一步的研究.
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