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在中国草药中使用PRECIS-2,对刺激性肠综合征进行随机对照试验:基于文献的方法探索
Minjing Luo1,2, Yingqiao Wang2, Jinghan Huang2
1Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
随机对照试验 (RCT) 的实用性一致性与中国草药 (CHM) 对刺激性肠综合征 (IBS) 的研究中的效果大小正相关. 在CHM IBSRCT中更高的实用主义一致性表明,对现实世界患者护理的结果更适用.
科学领域:
- 综合医学是一个整体医学.
- 临床试验方法论 临床试验方法论
- 胃肠病学 胃肠病学
背景情况:
- 随机对照试验 (RCT) 的实用主义评估了试验干预措施对现实环境的适用性.
- 调查实用主义的一致性对于理解中国草药 (CHM) 对易怒肠综合征 (IBS) 发现的概括性至关重要.
研究的目的:
- 检查RCT设计特征中的实用主义的一致性与IBS中CHM干预的结果效果大小之间的关联.
- 确定影响心脏病综合征CHMRCT实用主义的因素.
主要方法:
- 在八个数据库中系统搜索CHM在IBS上的RCT.
- 通过使用实用解释连续性指标摘要2 (PRECIS-2) 工具对试验实用性的独立评估,由六名审查员进行.
- 使用变化系数计算实用主义一致性,并通过线性回归模型进行分析.
主要成果:
- 在分析中包括了78个RCT.
- 在二进制 (r = -0.413,P = 0.005) 和连续结果 (r = -0.779,P < 0.001) 中,实用主义的一致性和效果大小之间发现了显著的正相关性.
- 与个性化干预和标准/常规治疗对照的试验显示,与固定干预和安慰剂对照相比,PRECIS-2得分分别更高.
结论:
- 在CHM IBS RCT中,PRECIS-2工具在9个领域的实用主义的一致性与结果的效果大小具有正相关性.
- 确保在试验设计中保持一致的务实主义,提高了治疗IBS的CHM干预措施的临床适用性和影响.
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