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使用扩展复合质量评分 (CQS-2) 的临床治疗试验的分配隐藏评估 - - 一个基于经验的更新
Steffen Mickenautsch1,2, Veerasamy Yengopal3
1Review Centre for Health Science Research, Johannesburg, South Africa.
Frontiers in medicine
|July 3, 2023
概括
这项研究修订了CQS-2/Criterion II,用于评估临床试验中的分配隐藏. 中央分配成为确保足够隐藏的关键标准,导致了新的CQS-2B版本.
科学领域:
- 临床试验方法论 临床试验方法论
- 基于证据的医学基于证据的医学.
- 研究诚信研究诚信
背景情况:
- 分配隐藏对于公正的前性,受控的临床治疗试验至关重要.
- 现有的评估工具,如CQS-2/Criterion II,需要改进,以准确评估分配隐藏.
- 不充分的分配隐藏可能会引入因基线变量失衡而导致的偏差.
研究的目的:
- 修订CQS-2/标准II,用于评估临床试验中的分配隐.
- 建立基于经验证据的充分分配隐的明确标准.
- 引入CQS-2试验评估工具的更新版本.
主要方法:
- 对未充分隐分配的试验的元分析分析了异质性.
- 评估了基线变量失衡对试验结果的影响.
- 从元分析文本中提取了表明适当的分配隐藏的关键词.
主要成果:
- 没有充分隐分配的元分析显示出显著的异质性.
- 中央分配被确定为足够的分配隐藏的主要指标.
- 这项分析支持对CQS-2/Criterion II的重新制定.
结论:
- 修订了CQS-2工具的标准II,以改善分配隐藏评估.
- 更新的评估工具被指定为版本CQS-2B.
- 这一修订旨在提高临床试验评估的可靠性.
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