识别和报告手术创新的修改:对IDEAL/IDEAL-D研究的系统审查
James Olivier1, Daisy Elliott2, Kerry Avery2
1NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, Bristol, UK james.olivier@nhs.net.
BMJ open
|June 30, 2025
概括
报告手术创新的修改对于患者安全至关重要. 这次审查发现报告实践不一致,强调需要标准化指导方针来改善评估和学习.
科学领域:
- 手术创新研究的研究.
- 医疗器械评估 医疗器械评估
- 卫生技术评估 卫生技术评估
背景情况:
- 创意,开发,评估,评估和长期跟进 (IDEAL) 框架指导了外科创新研究.
- 在定义和报告创新程序和设备的修改方面存在挑战.
- 不一致的修改报告可能会阻碍评估并危及患者的安全.
研究的目的:
- 系统地审查使用IDEAL框架的研究.
- 识别和分类在外科创新研究中报告的修改.
- 评估报告这些修改的现行做法,以提供未来指导.
主要方法:
- 对报告外科创新的研究进行系统审查和专题综合.
- 搜索了Web of Science和Scopus的研究,引用了IDEAL框架出版物.
- 提取了研究特征和从包含的研究中修改的字面文本.
主要成果:
- 包括104项研究 (2011-2023年),报告了425项修改.
- 修改涉及程序 (66.6%),设备 (22.1%) 和患者选择 (11.3%).
- 报告在IDEAL阶段有很大的差异,在2a阶段发现了大多数修改.
结论:
- 发现了关于外科创新研究修改的不一致报告.
- 标准化报告对于有效的评估和患者安全至关重要.
- 调查结果将为补充IDEAL框架更好的修改报告的检查清单提供信息.
更多相关视频
06:05The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
Published on: February 19, 2021
1.4K
05:41Left Anterior Descending Coronary Artery Ligation for Ischemia-Reperfusion Research: Model Improvement via Technical Modifications and Quality Control
Published on: December 16, 2022
3.7K
相关概念视频
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
182
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
182
01:19Pharmacovigilance
1.0K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.0K