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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
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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.

关键词:
最小的临床相关差异.临床怀孕 临床怀孕累积活产率是指累积的活产率.活生生的出生率是多少检索出来的卵细胞

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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.