参与者和医生的干预偏好对随机试验的影响:系统性审查
Michael King1, Irwin Nazareth, Fiona Lampe
1Department of Mental Health Sciences, Royal Free and University College Medical School, Royal Free Campus, London, England. m.king@medsch.ucl.ac.uk
JAMA
|March 3, 2005
概括
患者偏好会影响试验参与,但对随机对照试验结果的有效性影响很小. 了解患者选择是有效临床研究的关键.
科学领域:
- 临床医学 临床医学
- 医学研究方法学 医学研究方法学
- 生物统计学 生物统计学
背景情况:
- 随机化是对不偏见的临床试验疗效估计的黄金标准.
- 患者的偏好可能会影响试验招募 (外部有效性) 和结果 (内部有效性).
研究的目的:
- 确定患者偏好对临床试验招募的影响.
- 评估患者偏好对试验结果内部有效性的影响.
主要方法:
- 1966年至2004年间发表的随机试验和队列的系统综述.
- 在多个数据库 (MEDLINE,EMBASE,PsycINFO等) 进行了搜索. 和手工搜索的期刊.
- 提取了关于研究设计,偏好测量,招聘,消耗和结果的数据.
主要成果:
- 患者的偏好影响拒绝参与随机化.
- 在同意随机化参与者的特征中,几乎没有偏见的证据.
- 随机和偏好组之间的结果差异通常很小,特别是在更大的试验中.
结论:
- 患者的偏好显著影响参与随机试验.
- 有有限的证据表明,偏好会对随机试验的内部有效性产生重大影响.
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