临床研究报告数据并没有实质性地改变点估计,但在科系统性审查中提高了准确性
Julian Hirt1, Dawid Pieper2, Monika Becker3
1Pragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland; Department of Health, Eastern Switzerland University of Applied Sciences, St.Gallen, Switzerland; Medical Faculty, Institute of Health and Nursing Science, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
将临床研究报告 (CSR) 数据添加到元分析中可以提高数据的完整性和精度. 虽然总体结果仍然相似,但CSR增强了证据综合,以便在腹膜透析治疗中更好地做出临床决策.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學.
- 临床流行病学临床流行病学
- 药物监督 药物监督 药物监督
背景情况:
- 分析通常依赖于已公布的数据,这些数据可能缺乏完整性.
- 临床研究报告 (CSR) 提供了详细的数据,这些数据并不总是出现在出版物中.
- 将企业社会责任数据整合到元分析中的影响需要调查.
研究的目的:
- 评估将CSR数据纳入出版物和作者数据的影响.
- 评估对数据完整性和元分析结果的影响.
- 为了比较使用出版物数据与出版物加上CSR数据的元分析.
主要方法:
- 对19项随机对照试验的系统综述和元分析,比较腹腔透析中的冰凝和葡萄糖溶液.
- 再次分析结果 (死亡率,技术失败,生活质量,超过,SAE,腹膜炎,液体过载),仅使用出版数据,然后添加CSR数据.
- 两个数据组之间的包括试验,聚合点估计和置信区间 (CI) 的比较.
主要成果:
- 添加CSR数据通常会提高数据的完整性,除了生活质量和1-2年超过.
- 积分估计没有显著差异,但当包括CSR数据时,CIs对SAE和3-6个月的超过缩小了CI.
- 企业社会责任数据导致了统计学上显著的好处,有利于对3-6个月超过的冰烯.
结论:
- 企业社会责任数据集成提高了数据的完整性和准确性,提高了元分析中的效果估计.
- 虽然CSR并没有显著改变总体的元分析结果,但它改善了证据综合.
- 获取CSR数据对于优化证据综合和为临床决策提供信息至关重要.
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