系统性审查的发布协议:比较已做的事情与计划的事情
Chris A Silagy1, Philippa Middleton, Sally Hopewell
1Monash Institute of Health Services Research, Monash Medical Centre, Clayton, Victoria, Australia.
发表的研究协议对于最小化偏见至关重要. 然而,这项研究发现,许多Cochrane评论与其协议发生了显著的变化,特别是在方法方面,引发了对潜在偏见引入的担忧.
科学领域:
- 医学研究方法学 医学研究方法学
- 基于证据的医学基于证据的医学.
- 系统审查是系统的审查.
背景情况:
- 发表研究协议对于透明度和减少偏见至关重要,通过预先指定假设和方法.
- 确保在系统审查中遵守已公布的协议有助于保持科学完整性.
研究的目的:
- 评估已公布的科克莱恩审查协议及其相应完成的审查之间的变化程度.
- 评估这些变化对系统审查中引入偏见的潜在影响.
主要方法:
- 一个回顾性比较分析47个Cochrane评论及其以前发表的协议.
- 由两个评级人员进行的独立评估,将协议部分的变化分类为没有,轻微或重大.
主要成果:
- 大多数经过审查的科克伦研究 (47项中的43项) 显示,它们的方案发生了重大变化.
- 方法部分显示了最实质性的变化,68%的评论有重大变化.
- 确定引入偏见的变化包括改变目标,添加比较,新结果和修改研究设计和参与者的纳入标准.
结论:
- 发表的研究协议经常演变,在整个审查过程中作为代文档.
- 与协议相比,Cochrane审查中的众多修改表明可能存在由结果影响的偏见.
- 关于协议审查差异原因的透明度对于保持系统审查的可信度至关重要.
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