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在过去20年间,全球减肥手术随机对照试验中的表征变化和研究浪费:横截面研究
Ze-Ning Huang1,2,3, Wen-Wu Qiu1,2,3, Qi-Chen He1,2,3
1Department of Gastric Surgery.
International journal of surgery (London, England)
|December 20, 2023
概括
全球减肥手术随机对照试验 (RCT) 呈现越来越多的趋势,但83.6%的研究浪费. 专注于体重变化和更大的入学率可以减轻这种浪费在未来的减肥手术RCT中.
科学领域:
- 腹部外科 腹部外科
- 临床试验 临床试验
- 手术创新 在外科创新.
背景情况:
- 随机对照试验 (RCT) 显著影响减肥手术的临床实践.
- 全球特征和研究浪费在减肥手术中的RCT仍未得到充分研究.
研究的目的:
- 分析减肥手术RCT的全球趋势和特征.
- 识别和量化减肥手术中的研究浪费RCT.
- 确定预测该领域研究浪费的因素.
主要方法:
- 进行了对临床试验.gov的系统搜索,寻找腹手术RCT.
- 包括在2000年1月至2022年12月期间注册的RCT,重点是Roux-en-Y胃绕道和袖子胃切除术.
- 分析了326个RCT,以了解趋势,出版率,报告质量,设计缺陷和研究浪费.
主要成果:
- 全球减肥手术RCT每年增加,欧洲领先,其次是亚洲和北美.
- 在分析的171个RCT中,83.6%的RCT显示研究浪费.
- 充分的报告和更大的招生人数 (>100名参与者) 是防止研究浪费的保护因素.
结论:
- 这项研究提供了二十年来减肥手术RCT特征的第一个全球概述.
- 在减肥手术RCT中存在大量的研究浪费负担.
- 结果提供了基于证据的建议,以更有效和合理的减肥手术RCT设计和执行.
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