Abstract：
OBJECTIVE: Randomized controlled trials (RCTs) are the preferred source of evidence for the relative effect of healthcare interventions summarized in knowledge syntheses. Nonrandomized studies of interventions (NRSI) may provide replacement, sequential, or complementary evidence to RCTs. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach can provide different options for properly using RCTs and NRSI integrated in health syntheses. In this article, we discuss different implications on the certainty of evidence when authors consider the use of NRSI and RCTs in systematic reviews using GRADE. Although this is a GRADE-related article, it is not an official GRADE guidance or concept article.
METHODS: We present case studies used during GRADE working group meetings for discussion of the effects of using NRSI and RCTs on GRADE domains and on the certainty of evidence. Several concepts were discussed through iterative feedback with experts in GRADE methods and Cochrane authors. We compared suggested solutions for possible scenarios that can be met in evidence syntheses informing decisions and future guidance.
RESULTS: Different scenarios for the use of RCTs and NRSI in evidence syntheses are presented, focusing on how different GRADE ratings between RCTs and NRSI affect the overall assessment of the evidence and possible health recommendations.
CONCLUSIONS: Considering differences and similarities grounded in the GRADE approach between NRSI and RCTs may help complement one another and maximize the value of knowledge syntheses and health recommendations.
METHODS: We present case studies used during GRADE working group meetings for discussion of the effects of using NRSI and RCTs on GRADE domains and on the certainty of evidence. Several concepts were discussed through iterative feedback with experts in GRADE methods and Cochrane authors. We compared suggested solutions for possible scenarios that can be met in evidence syntheses informing decisions and future guidance.
RESULTS: Different scenarios for the use of RCTs and NRSI in evidence syntheses are presented, focusing on how different GRADE ratings between RCTs and NRSI affect the overall assessment of the evidence and possible health recommendations.
CONCLUSIONS: Considering differences and similarities grounded in the GRADE approach between NRSI and RCTs may help complement one another and maximize the value of knowledge syntheses and health recommendations.
摘要：
目的：随机对照试验（RCT）是知识综合中总结的医疗保健干预措施相对效果的首选证据来源。非随机干预研究(NRSI)可能提供替代，顺序，或RCT的补充证据。建议的分级，评估,开发和评估（GRADE）方法可以为正确使用RCT和NRSI提供不同的选择。在这篇文章中,当作者考虑在使用GRADE的系统评价中使用NRSI和RCT时,我们讨论了对证据确定性的不同含义.虽然这是一篇与GRADE相关的文章,它不是官方的GRADE指南或概念文章。
方法：我们提供了在GRADE工作组会议期间使用的案例研究，以讨论使用NRSI和RCTs对GRADE领域和证据确定性的影响。通过与GRADE方法专家和Cochrane作者的迭代反馈讨论了几个概念。我们比较了在证据综合中可以满足的可能方案的建议解决方案，以告知决策和未来指导。
结果：介绍了在证据综合中使用RCT和NRSI的不同方案，重点关注RCT和NRSI之间的不同等级评分如何影响对证据和可能的健康建议的总体评估。
结论：考虑NRSI和RCT之间基于GRADE方法的差异和相似性可能有助于相互补充，并最大限度地提高知识综合和健康建议的价值。
方法：我们提供了在GRADE工作组会议期间使用的案例研究，以讨论使用NRSI和RCTs对GRADE领域和证据确定性的影响。通过与GRADE方法专家和Cochrane作者的迭代反馈讨论了几个概念。我们比较了在证据综合中可以满足的可能方案的建议解决方案，以告知决策和未来指导。
结果：介绍了在证据综合中使用RCT和NRSI的不同方案，重点关注RCT和NRSI之间的不同等级评分如何影响对证据和可能的健康建议的总体评估。
结论：考虑NRSI和RCT之间基于GRADE方法的差异和相似性可能有助于相互补充，并最大限度地提高知识综合和健康建议的价值。
