Abstract

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.