Mercuri Mathew, Baigrie Brian, Upshur Ross E G
Department of Medicine, Division of Emergency Medicine, McMaster University, Hamilton, Canada.
Institute for the History and Philosophy of Science and Technology, University of Toronto, Toronto, Canada.
J Eval Clin Pract. 2018 Oct;24(5):1232-1239. doi: 10.1111/jep.12857. Epub 2018 Jan 5.
The evidence based medicine movement has championed the need for objective and transparent methods of clinical guideline development. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) framework was developed for that purpose. Central to this framework is criteria for assessing the quality of evidence from clinical studies and the impact that body of evidence should have on our confidence in the clinical effectiveness of a therapy under examination. Grades of Recommendation, Assessment, Development, and Evaluation has been adopted by a number of professional medical societies and organizations as a means for orienting the development of clinical guidelines. As a result, the method of GRADE has implications on how health care is delivered and patient outcomes. In this paper, we reveal several issues with the underlying logic of GRADE that warrant further discussion. First, the definitions of the "grades of evidence" provided by GRADE, while explicit, are functionally vague. Second, the "criteria for assigning grade of evidence" is seemingly arbitrary and arguably logically incoherent. Finally, the GRADE method is unclear on how to integrate evidence grades with other important factors, such as patient preferences, and trade-offs between costs, benefits, and harms when proposing a clinical practice recommendation. Much of the GRADE method requires judgement on the part of the user, making it unclear as to how the framework reduces bias in recommendations or makes them more transparent-both goals of the programme. It is our view that the issues presented in this paper undermine GRADE's justificatory scheme, thereby limiting the usefulness of GRADE as a tool for developing clinical recommendations.
循证医学运动倡导临床指南制定需要客观和透明的方法。为此目的制定了推荐分级、评估、制定与评价（GRADE）框架。该框架的核心是评估临床研究证据质量的标准，以及该证据体系对我们对所审查治疗方法临床有效性信心的影响。许多专业医学协会和组织已采用推荐分级、评估、制定与评价作为指导临床指南制定的一种手段。因此，GRADE方法对医疗保健的提供方式和患者结局有影响。在本文中，我们揭示了GRADE潜在逻辑中的几个问题，值得进一步讨论。首先，GRADE提供的“证据等级”定义虽然明确，但在功能上含糊不清。其次，“证据等级分配标准”看似随意，且在逻辑上可能不一致。最后，GRADE方法在提出临床实践建议时，对于如何将证据等级与其他重要因素（如患者偏好）以及成本、收益和危害之间的权衡进行整合并不明确。GRADE方法的许多内容需要使用者进行判断，这使得该框架如何减少建议中的偏差或使其更透明（这是该计划的两个目标）变得不明确。我们认为，本文提出的问题破坏了GRADE的论证体系，从而限制了GRADE作为制定临床建议工具的实用性。
