儿科医疗器械创新的障碍和促进因素:一个范围审查协议
Lynn Kysh1, Grzegorz Zapotoczny2,3, Lisa Manzanete4
1Innovation Studio, Children's Hospital of Los Angeles, Los Angeles, California, USA.
BMJ open
|June 5, 2024
概括
本范围审查审查对儿科医疗器械临床研究基础设施的障碍和促进因素进行了审查. 调查结果将为改善儿科器械开发和解决不平等问题的战略提供信息.
科学领域:
- 医疗器械开发 医疗器械开发
- 临床研究基础设施 临床研究基础设施
- 儿科健康 儿科健康
背景情况:
- 儿童医疗器械开发落后于成人设备,导致不平等和安全问题.
- 尽管有立法努力,但在儿科医疗器械创新方面仍然存在很大的差距.
- 临床试验是已知的瓶,但有效的研究基础设施组件仍然不清楚.
研究的目的:
- 进行范围审查,以了解儿科医疗器械临床研究的基础设施障碍和促进者.
- 为儿童器械联盟 (PDC) 的多式联络研究战略提供信息.
- 确定影响儿科医疗器械成功开发和实施的关键因素.
主要方法:
- 从2007年到现在的健康科学文献的范围审查.
- 搜索的数据库包括Medline,Embase,Cochrane CENTRAL,Web of Science和IEEE Xplore,并补充了灰色文献.
- 将包括专注于儿科人口 (0-21岁) 和涉及人类研究的医疗器械 (FDA分类) 的研究. 查和数据提取将由两名独立审查员使用Covidence和REDCap进行.
主要成果:
- 本部分应在研究完成后填写.
结论:
- 这项研究将为优化儿科医疗器械临床研究基础设施提供关键的见解.
- 预计这些发现将指导未来的倡议,旨在缩小儿科设备差距并改善患者的治疗结果.
- 传播将通过同行评审的出版物,会议演讲和专业网络进行.
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