放弃"M":最小重要的差异和变化不是工具的独立属性,并且不能使用统计方法作为单个值确定
Andrew Vickers1, Kyle Nolla2, David Cella2
1Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.
概括
对于患者报告结果 (PRO) 仪器的最小重要差异 (MID) 并不是固有的属性. 为了准确的解释,MID必须在每个临床研究的具体背景下确定.
科学领域:
- 临床研究方法论临床研究方法论
- 患者报告的结果.
背景情况:
- 患者报告结果 (PRO) 仪器提供得分,这使得很难确定治疗差异的临床意义.
- 最少重要的差异 (MID) 对于设计和解释临床试验至关重要.
研究的目的:
- 调查MID概念作为PRO仪器的内在特征.
- 探索定义MID的统计基础.
主要方法:
- 对MIDs的经验和方法论文献进行了叙事审查.
主要成果:
- 基于和基于分布的MID估计方法都是有问题的.
- 基于的方法受到患者对相对于一般问题的变化感知的限制.
- 基于分布的方法依赖于样本特定的变异性,缺乏对个体患者相关性的明确理由.
结论:
- 最少重要的差异 (MID) 应在每个研究的具体背景下进行估计.
- 建议考虑"重要差异" (ID),并根据具体情况逐个解释"最小"方面.
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