出版后的批评和临床知识的形成
1The Lancet, 32 Jamestown Rd, London NW1 7BY, England. richard.horton@lancet.com
JAMA
|June 1, 2002
概括
发表后对重大临床试验的批评往往被忽视. 重要的试验缺陷没有纳入实践指南,削弱了他们的有效性,扭曲了医学知识.
科学领域:
- 医学研究方法论医学研究方法论.
- 临床试验分析临床试验分析
- 基于证据的医学是基于证据的医学.
背景情况:
- 写给编辑的信件对于出版后的同行评审和作者问责至关重要.
- 本研究检查了三项主要随机试验的批判性评论:高血压最佳治疗 (HOT),卡波普利尔预防项目 (CAPPP) 和瑞典高血压2型老年患者试验 (STOP-2).
研究的目的:
- 评估医学文献中三个突出的随机试验的关键足迹.
- 调查对这些试验的批评对随后的临床知识和实践指南的影响程度.
主要方法:
- 发表的批评HOT,CAPPP和STOP-2试验的公开信件的定性评估.
- 根据作者回复,确定商定的弱点和未得到回复的批评.
- MEDLINE寻找审判后发布的实践指南,以评估批评的纳入.
主要成果:
- 在出版和2000年10月之间,HOT出现在9/36指南中,CAPPP出现在6/36中,STOP-2出现在没有.
- HOT收到了14条批评,其中只有1条 (缺乏功率) 在指导方针中提到.
- CAPPP收到了14条批评,其中只有1条 (不平衡) 在指导方针中提到; STOP-2收到了12条批评,反应很少.
- 超过一半的通讯批评未得到试验作者回复.
结论:
- 作者没有解决对主要临床试验的关键反的很大一部分.
- 在初级研究试验中发现的缺陷在随后的实践指南中基本上被忽视了.
- 未能整合批判性评论破坏了临床指导方针的可靠性,并扭曲了医学知识.
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