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考虑到辅助生殖技术中临床重要差异最小的情况
Juan Enrique Schwarze1, Frank Broekmans2, Shiv Gupta3
1Merck Healthcare KGaA, Darmstadt, Germany.
Fertility and sterility
|June 27, 2025
概括
确定最小临床重要差异 (MCID) 对于解释辅助生殖技术研究结果至关重要. 将MCID定义为一种相对措施,事先报告,提高了一致性和以患者为中心的解释.
科学领域:
- 生殖医学 生殖医学
- 临床试验设计 临床试验设计
- 生物统计学 生物统计学
背景情况:
- 解释研究结果需要考虑统计和临床意义.
- 最小临床重要差异 (MCID) 是确定有利于患者的结果的关键.
- 辅助生殖技术 (ART) 研究使用各种基准,如怀孕率和活产率,以评估治疗差异.
研究的目的:
- 评估已发表文献中关于临床重要差异最小值 (MCID) 的报告情况.
- 在定义MCID时研究绝对与相对差异的实用性.
- 为了提高在ART中解释治疗效果的一致性.
主要方法:
- 专家意见被用来解决这个话题.
- 该研究涉及对MCID报告实践的批判性审查.
- 专注于MCID在辅助生殖技术中的应用.
主要成果:
- 对ART的MCID确定是主观的,并且根据绝对或相对差异选择而有所不同.
- 不一致和重叠的MCID导致对治疗疗效的不同解释.
- 对于比较研究,建议明确定义,合理的MCID值,表达为相对指标.
结论:
- 应预先定义MCID并将其作为相对指标报告,以便在不同患者群体之间进行一致的解释.
- 绝对措施也应该报告,以确保全面的报告.
- 在ART中标准化MCID报告可以提高研究结果的临床相关性.
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