Journal Article

The development methods of official GRADE articles and requirements for claiming the use of GRADE – A statement by the GRADE guidance group

Hultcrantz, Monica, Dahm, Philipp, Guyatt, Gordon, Rojas, Maria Ximena, Meerpohl, Joerg J., Mustafa, Reem A., Xia, Jun, Alonso-Coello, Pablo, Akl, Elie A., Davoli, Marina, Schünemann, Holger J., Flottorp, Signe, Brennan, Sue, Langendam, Miranda

2023

Overview

•One of the aims of the Grading of Recommendations Development, Assessment and Evaluation (GRADE) Working Group (GWG) has been to develop a single system that would reduce confusion arising from a legion of multiple conflicting systems for grading evidence and recommendations and serve as unifying lingua franca.•Although GRADE has been widely endorsed, the way it is being used is not infrequently inconsistent with GRADE guidance and some groups have modified the approach.•Based on the suggested criteria for claiming the use and application of GRADE that are available on the GWG website since 2008, we propose 7 items that should be met to appropriately claim that the GRADE approach was used.•These requirements apply to, either assessing certainty of evidence (e.g., in systematic reviews or health technology assessments) and developing recommendations (e.g., in guidelines) or making health care decisions (e.g., coverage, public health or health systems).•The requirements include how the certainty of a body of evidence is defined, assessed for each critical outcome using the GRADE domains, and presented.•Furthermore, they suggest that explicit criteria (both health related and contextual) and evidence as described in the Evidence to Decision (EtD) frameworks should form the basis for recommendations or decisions and explicit judgements should be made for each criterion that is chosen for the EtD process.•A recommendation should have 1 of 2 strengths (strong or conditional, also called weak) and 1 of 2 directions (for or against).•Given these suggested minimal requirements, we also provide a detailed description of the GWG's current methods and processes for developing official GRADE guidance and concept articles, as well as by whom and how they are authored.•Following approval of terms of reference, the methods and process to developing official GRADE articles include: Identification of issues to be addressed through meetings and online communication; iterative presentations to small and larger audiences of multidisciplinary experts in the GWG; identification of real or hypothetical examples; review of the literature on specific topics to identify existing methodological concepts or guidance; presentation to the project group to collect feedback systematically; members of the project group, before presentation to the entire GWG membership for an anonymous vote-based approval; and final approval by the GRADE Guidance Group before peer review and publication.•If the solutions that are described have been applied and deemed appropriately operationalized, GRADE typically develops guidance articles and if they require testing and possibly future alteration, GRADE develops concept articles.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Decision making / Epidemiology / Feedback / Health technology assessment / Internal Medicine / Medical research / Meetings / Public health / Working groups / Writing