The development methods of official GRADE articles and requirements for claiming the use of GRADE – A statement by the GRADE guidance group
2023; Elsevier BV; Volume: 159; Linguagem: Inglês
10.1016/j.jclinepi.2023.05.010
ISSN1878-5921
AutoresHolger J. Schünemann, Sue Brennan, Elie A. Akl, Monica Hultcrantz, Pablo Alonso‐Coello, Jun Xia, Marina Davoli, María Ximena Rojas, Joerg J Meerpohl, Signe Flottorp, Gordon Guyatt, Reem A. Mustafa, Miranda Langendam, Philipp Dahm,
Tópico(s)Meta-analysis and systematic reviews
Resumo•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. What is new?Key findings•The Grading of Recommendations Development, Assessment and Evaluation (GRADE) Working Group proposes 7 updated 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).•They 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.What this adds to what is known?•The minimal requirements for claiming the use of GRADE have been updated and separated into assessment of the certainty of a body of evidence and making decisions, including developing recommendations.•We provide a detailed description of how GRADE's methods for developing official GRADE guidance and concepts have evolved and are applied.What is the implication and what should change now?•Those claiming or intending to claim the use of GRADE should review the suggested minimal criteria for its use.•The detailed generic methods of how GRADE guidance and concept articles are developed is available for understanding the group's evolution over more than 2 decades and approaches to tackling critical methodological issues. Key findings•The Grading of Recommendations Development, Assessment and Evaluation (GRADE) Working Group proposes 7 updated 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).•They 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.What this adds to what is known?•The minimal requirements for claiming the use of GRADE have been updated and separated into assessment of the certainty of a body of evidence and making decisions, including developing recommendations.•We provide a detailed description of how GRADE's methods for developing official GRADE guidance and concepts have evolved and are applied.What is the implication and what should change now?•Those claiming or intending to claim the use of GRADE should review the suggested minimal criteria for its use.•The detailed generic methods of how GRADE guidance and concept articles are developed is available for understanding the group's evolution over more than 2 decades and approaches to tackling critical methodological issues. The Grading of Recommendations Development, Assessment and Evaluation (GRADE) approach has been used in large numbers of systematic reviews and guidelines to assess the certainty of evidence and make recommendations [1Atkins D. Best D. Briss P.A. Eccles M. Falck-Ytter Y. Flottorp S. et al.Grading quality of evidence and strength of recommendations.BMJ. 2004; 328: 1490Crossref PubMed Google Scholar, 2Schunemann H.J. Best D. Vist G. Oxman A.D. Group G.W. Letters, numbers, symbols and words: how to communicate grades of evidence and recommendations.CMAJ. 2003; 169: 677-680PubMed Google Scholar, 3Guyatt G.H. Oxman A.D. Vist G.E. Kunz R. Falck-Ytter Y. Alonso-Coello P. et al.GRADE: an emerging consensus on rating quality of evidence and strength of recommendations.BMJ. 2008; 336: 924-926Crossref PubMed Google Scholar, 4Guyatt G. Oxman A.D. Akl E.A. Kunz R. Vist G. Brozek J. et al.GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables.J Clin Epidemiol. 2011; 64: 383-394Abstract Full Text Full Text PDF PubMed Scopus (5582) Google Scholar, 5Alonso-Coello P. Schunemann H.J. Moberg J. Brignardello-Petersen R. Akl E.A. Davoli M. et al.GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: introduction.BMJ. 2016; 353: i2016Crossref PubMed Scopus (428) Google Scholar, 6Zhang Y. Akl E.A. Schunemann H.J. Using systematic reviews in guideline development: the GRADE approach.Res Synth Methods. 2019; 10: 312-329Crossref Scopus (80) Google Scholar]. One of the aims of the 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 [[7]Dixon C. Dixon P.E. Sultan S. Mustafa R. Morgan R.L. Murad M.H. et al.Guideline developers in the United States were inconsistent in applying criteria for appropriate Grading of Recommendations, Assessment, Development and Evaluation use.J Clin Epidemiol. 2020; 124: 193-199Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar]. Although users may believe there are good reasons for modifying the GRADE system, we discourage the use of “modified GRADE” approaches that have not been approved by the GWG because it is contrary to the fundamental goals of developing and implementing a unifying system. Instead, we encourage those interested in contributing to the advancement of the GRADE approach, to do so through the explicit processes that the GWG offers. Indeed, GRADE guidance has grown and evolved considerably over the last 2 decades. Users of GRADE benefit to a great deal from such constructive criticism, suggestions for improvements, and involvement of many different stakeholders in the GWG so that it not only is up to date but also useable in all scenarios. Membership in GRADE is free and open. The GWG has not applied restrictions on membership and subscribing for membership takes place through our website. In that context, members of the GWG frequently receive inquiries about the requirements that should be met for a group to state its approach as compliant with GRADE. Based on the “suggested criteria for the use and application of GRADE” that are available on the GWG website since 2008, we propose that the items summarized in Table 1 should be met to 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). A GRADE project group is currently preparing a reporting checklist and guidance for how to report following these and other GRADE principles.Table 1Suggested minimal requirements for stating that the GRADE system or approach was usedaRequirements 5–7 apply only if GRADE is used for developing recommendations or other types of decisions.1.The certainty in the evidence (also known as quality of evidence or confidence in the estimates) should be consistent with the operationalizations used by the GWG [[1]Atkins D. Best D. Briss P.A. Eccles M. Falck-Ytter Y. Flottorp S. et al.Grading quality of evidence and strength of recommendations.BMJ. 2004; 328: 1490Crossref PubMed Google Scholar,8Hultcrantz M. Rind D. Akl E.A. Treweek S. Mustafa R.A. Iorio A. et al.The GRADE Working Group clarifies the construct of certainty of evidence.J Clin Epidemiol. 2017; 87: 4-13Abstract Full Text Full Text PDF PubMed Scopus (337) Google Scholar, 9Guyatt G.H. Oxman A.D. Kunz R. Vist G.E. Falck-Ytter Y. Schunemann H.J. What is “quality of evidence” and why is it important to clinicians?.BMJ. 2008; 336: 995-998Crossref PubMed Google Scholar, 10Guyatt G. Oxman A.D. Sultan S. Brozek J. Glasziou P. Alonso-Coello P. et al.GRADE guidelines 11-making an overall rating of confidence in effect estimates for a single outcome and for all outcomes.J Clin Epidemiol. 2012; 66: 151-157Abstract Full Text Full Text PDF PubMed Scopus (521) Google Scholar]. Conceptually, GRADE has provided the following definition “The certainty that the true effect, accuracy measure, or association lies on 1 side of a particular threshold, or in a particular range.” [[11]Schünemann H.J. Neumann I. Hultcrantz M. Brignardello-Petersen R. Zeng L. Murad M.H. et al.GRADE Guidance article 35: update on rating imprecision for assessing contextualized certainty of evidence and making decisions.J Clin Epidemiol. 2022; 150: 225-242Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar,[12]Schunemann H.J. Interpreting GRADE's levels of certainty or quality of the evidence: GRADE for statisticians, considering review information size or less emphasis on imprecision?.J Clin Epidemiol. 2016; 75: 6-15Abstract Full Text Full Text PDF PubMed Scopus (50) Google Scholar] And for evidence from reviews of qualitative research: “an assessment of the extent to which the review finding is a reasonable representation of the phenomenon of interest.”2.Explicit consideration should be given to each of the GRADE domains for assessing the certainty in the evidence (i.e., risk of bias, imprecision, inconsistency, indirectness, publication bias, large effects, dose response gradients, and residual plausible opposing bias), although different terminology may be used to describe these domains (e.g., limitations in the detailed study design or execution instead of risk of bias).3.The certainty in the body of evidence should be assessed for each critical or important outcome for a decision (also called main outcomes) using GRADE's categories (e.g., high, moderate, low, and/or very low), with definitions for each category that are consistent with the definitions published by the GWG [[8]Hultcrantz M. Rind D. Akl E.A. Treweek S. Mustafa R.A. Iorio A. et al.The GRADE Working Group clarifies the construct of certainty of evidence.J Clin Epidemiol. 2017; 87: 4-13Abstract Full Text Full Text PDF PubMed Scopus (337) Google Scholar]. These outcomes should describe both desirable and undesirable health effects (also called benefits and harms or efficacy and safety outcomes).4.GRADE evidence tables (e.g., evidence profiles or summary of findings tables) should be used to present the results of evidence synthesis and an assessment of certainty in evidence, and these should be based on systematic reviews (we refer to systematic reviews as a methodology that is also used in health technology assessments and other evidence synthesis following such methodology) [[13]Schunemann H.J. Reinap M. Piggott T. Laidmae E. Kohler K. Pold M. et al.The ecosystem of health decision making: from fragmentation to synergy.Lancet Public Health. 2022; 7: e378-e390Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar]. At a minimum, the evidence that was assessed and the methods that were used to identify and appraise that evidence using GRADE should be clearly described.The next 3 requirements apply only to GRADE for making decisions or recommendations.5.Explicit criteria (both health related and contextual), as described in the GRADE Evidence to Decision (EtD) frameworks, should form the basis for recommendations or decisions. Explicit judgements should be made for each criterion that is chosen, including those that may be added, and the evidence used to inform each of those judgements should be provided. Additional considerations that influence the recommendation or decision should also be documented and be accessible [[5]Alonso-Coello P. Schunemann H.J. Moberg J. Brignardello-Petersen R. Akl E.A. Davoli M. et al.GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: introduction.BMJ. 2016; 353: i2016Crossref PubMed Scopus (428) Google Scholar].6.Guideline developers should describe the magnitude and balance of desirable and undesirable health effects of the options that are considered, the value of each outcome, and the certainty of the evidence for the aforementioned EtD criteria. Other EtD criteria, such as resources use, equity, acceptability, and feasibility that are used, may vary, depending on the type of recommendation or decision [[5]Alonso-Coello P. Schunemann H.J. Moberg J. Brignardello-Petersen R. Akl E.A. Davoli M. et al.GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: introduction.BMJ. 2016; 353: i2016Crossref PubMed Scopus (428) Google Scholar,[14]Alonso-Coello P. Oxman A.D. Moberg J. Brignardello-Petersen R. Akl E.A. Davoli M. et al.GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: clinical practice guidelines.BMJ. 2016; 353: i2089Crossref PubMed Scopus (552) Google Scholar,[15]Schunemann H.J. Mustafa R. Brozek J. Santesso N. Alonso-Coello P. Guyatt G. et al.GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health.J Clin Epidemiol. 2016; 76: 89-98Abstract Full Text Full Text PDF PubMed Scopus (218) Google Scholar], and the mandate of the group that is making the recommendation or decision.7.A recommendation should have 1 of 2 strengths (strong or conditional, also called weak) and 1 of 2 directions (for or against). The definitions for each category should be consistent with the definitions used by the GWG (although different terminology may be used, such as strong and discretionary) [[16]Andrews J.C. Schunemann H.J. Oxman A.D. Pottie K. Meerpohl J.J. Coello P.A. et al.GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength.J Clin Epidemiol. 2013; 66: 726-735Abstract Full Text Full Text PDF PubMed Scopus (841) Google Scholar,[17]Andrews J. Guyatt G. Oxman A.D. Alderson P. Dahm P. Falck-Ytter Y. et al.GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations.J Clin Epidemiol. 2013; 66: 719-725Abstract Full Text Full Text PDF PubMed Scopus (891) Google Scholar].a Requirements 5–7 apply only if GRADE is used for developing recommendations or other types of decisions. Open table in a new tab To describe the appropriate application of GRADE, the GWG produces guidance and concept articles that include new or updates to prior guidance. The GWG does that to reflect and respond to the evolving nature of evidence synthesis and decision-making science and reflect methodological advances [[18]McGowan J. Akl E.A. Coello P.A. Brennan S. Dahm P. Davoli M. et al.Update on the JCE GRADE series and other GRADE article types.J Clin Epidemiol. 2021; 140: 163-164Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar]. That means that while certain aspects of GRADE are foundational and static, GRADE continues to be a dynamic approach with ongoing products that adapt to different settings, circumstances and sectors. Given the described suggested minimal requirements, users of GRADE will appropriately ask how GRADE guidance and concept articles that form the basis of these requirements are developed and approved. Thus, in this article, we also provide a detailed description of the GWG's current methods and processes for developing official GRADE guidance and concepts, as well as by whom and how they are authored. For a Video tutorial describing this work please see the online e-content. First, the process to develop our official concept and guidance publications is rigorous, systematic, transparent and inclusive [[5]Alonso-Coello P. Schunemann H.J. Moberg J. Brignardello-Petersen R. Akl E.A. Davoli M. et al.GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: introduction.BMJ. 2016; 353: i2016Crossref PubMed Scopus (428) Google Scholar,[11]Schünemann H.J. Neumann I. Hultcrantz M. Brignardello-Petersen R. Zeng L. Murad M.H. et al.GRADE Guidance article 35: update on rating imprecision for assessing contextualized certainty of evidence and making decisions.J Clin Epidemiol. 2022; 150: 225-242Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar,[18]McGowan J. Akl E.A. Coello P.A. Brennan S. Dahm P. Davoli M. et al.Update on the JCE GRADE series and other GRADE article types.J Clin Epidemiol. 2021; 140: 163-164Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar]. Guidance articles require the availability of real examples of how to apply the guidance. If solutions to challenges require additional field testing and operationalization before broad application, the GWG typically develops first a concept article, which may or may not eventually lead to official GRADE guidance articles that include detailed operationalization of the GRADE approach. Thus, GRADE concept and guidance articles have a different background and purposes (see McGowan et al. [[18]McGowan J. Akl E.A. Coello P.A. Brennan S. Dahm P. Davoli M. et al.Update on the JCE GRADE series and other GRADE article types.J Clin Epidemiol. 2021; 140: 163-164Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar]) but follow similar development and approval approaches. We will describe them together but highlight idiosyncrasies. The development of GRADE concepts and guidance begins with registering a topic, for example, new guidance on dose response gradients, through a new or an existing GRADE project group (Fig. 1). GRADE project groups include between approximately 5 and 100 people from the existing GWG membership or new potential members with interest or specific expertise in the topic of interest. These project groups have terms of reference that need first to be approved by the GRADE Guidance Group, a group of 10 elected GRADE members and the 2 GRADE cochairs. The GRADE Guidance Group manages the administrative and methodological priorities arising (and not to be confused with GRADE guidance articles which are a topic of this commentary). The background for this prospective approval process is to avoid duplication of efforts, and make sure the goals and objectives are broadly aligned with those of the GWG overall. At the time of approval, a project-specific liaison is chosen from the GRADE Guidance Group. This is a GRADE Guidance Group member with relevant expertise or interest in the area, who will contribute to the project and provide regarding the development and approval process detailed below. Once a project group is approved, its initiation is formally announced, thereby allowing any interested individual, from within the GWG and from those that are intending to become members, to become involved. Following approval of the terms of reference, the methods and process to developing official GRADE articles include:1)A project group member, supported by a writing group, identifies the issues to be addressed through meetings and online communication and they find examples that represent challenges and require methodological solutions. This includes brainstorming and feedback;2)The writing group prepares for online meetings and email communication, as well as presentations to small and larger audiences of multidisciplinary experts in the GWG. This process is iterative in that it includes multiple rounds of feedback and revisions, involving the small writing group, then the project group and, finally, the entire GWG. Typically, those groups work iteratively on real or hypothetical examples;3)The writing group may also conduct systematic reviews of the literature on specific topics, if scoping of the literature suggests that relevant empirical evidence or primary research exists [19Cuello-Garcia C.A. Morgan R.L. Brozek J. Santesso N. Verbeek J. Thayer K. et al.A scoping review and survey provides the rationale, perceptions, and preferences for the integration of randomized and nonrandomized studies in evidence syntheses and GRADE assessments.J Clin Epidemiol. 2018; 98: 33-40Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar, 20Morgano G.P. Mbuagbaw L. Santesso N. Xie F. Brozek J.L. Siebert U. et al.Defining decision thresholds for judgments on health benefits and harms using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) frameworks: a protocol for a randomised methodological study (GRADE-THRESHOLD).BMJ Open. 2022; 12e053246PubMed Google Scholar, 21Mustafa R.A. Wiercioch W. Falavigna M. Zhang Y. Ivanova L. Arevalo-Rodriguez I. et al.Decision making about healthcare-related tests and diagnostic test strategies. Paper 3: a systematic review shows limitations in most tools designed to assess quality and develop recommendations.J Clin Epidemiol. 2017; 92: 29-37Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar, 22Piggott T. Morgan R.L. Cuello-Garcia C.A. Santesso N. Mustafa R.A. Meerpohl J.J. et al.GRADE notes: extremely serious, GRADE's terminology for rating down by 3-levels.J Clin Epidemiol. 2019; 120: 116-120Abstract Full Text Full Text PDF PubMed Scopus (24) Google Scholar]. These reviews serve to identify existing methodological concepts or guidance that should be considered for the topics. For many challenges, concepts or guidance does not exist, and GRADE develops de novo approaches–a key reason for its success in the field;4)The writing group agrees on a first draft of the content of the article for presentation to the project group (either in one or many dedicated project group meetings or in small group meetings during the GWG's in-person, online or hybrid meetings). Feedback is collected systematically on the suggested approach from attendees of these meeting, both through rigorous minute-taking and recorded meetings, as well as critical review of draft presentations or manuscripts by members of the writing group or project group, before a topic is ready for presentation to the entire GWG membership;5)To produce and approve official GRADE concepts or guidance articles, the GWG requests at least 1, and very often multiple, presentations for discussion and at least 1 and up to 3 for approval at separate GWG meetings (see below). These discussions are chaired by a member of the GGG who is not conflicted (i.e., not involved in the document being discussed). The first presentation, typically by the lead author, requires a slide set, and ideally, a draft article, both to be made available to the entire GWG in attendance of the meeting. This happens typically 1 to 2 weeks before a meeting. The second presentation or any subsequent of up to 3 attempts for approval requires the final (revised) draft of the article to be made available to all members of the GWG, up to 1 or 2 weeks before the requested approval.6)The process also includes a strictly anonymous voting process at its meetings (held twice yearly and organized by the GRADE Guidance Group). Once an article is deemed ready for approval, 80 percent agreement with concepts or guidance is required for an official GRADE publication. Voting includes the option to abstain if an attendee feels insufficiently informed, e.g., because it is not an area of interest or because they have not read the article. Results of the voting process are recorded and made available as part of the meeting minutes. Attendees, typically between 50 and 200 GRADE members, have a window of 2 weeks following the request for approval to submit additional comments even if a publication is approved. After approval, however, changes are usually made only if specifically agreed on at the GWG meeting, if it means including more examples or if they are considered to have minor impact on the guidance or concepts (e.g., adding an example or wording changes). An article can be voted on up to 3 times. If there is no approval at the third meeting, the article will usually no longer be considered official GWG concepts or guidance (see also below for further details); After any required changes are made by the authors, the article is forwarded to the GRADE Guidance Group for final approval (through a separate voting process), and can then be submitted to a peer reviewed journal, mainly to the Journal of Clinical Epidemiology, but also other journals (such as the British Medical Journal). If the solutions that are described have been applied and deemed appropriately operationalized, GRADE typically develops guidance articles. If they require testing and possibly future alteration, GRADE develops concept articles. As mentioned above, a concept article may result in future guidance [[18]McGowan J. Akl E.A. Coello P.A. Brennan S. Dahm P. Davoli M. et al.Update on the JCE GRADE series and other GRADE article types.J Clin Epidemiol. 2021; 140: 163-164Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar]. So far, over 50 GRADE guidance and concept articles have been published (and all of them together with other material can be found here: https://training.cochrane.org/grade-approach). A MeSH heading for GRADE also exists for those that search for publications about GRADE. The process also provides an opportunity for input and authorship to many individuals–novices and senior–seeking to make contributions to methods of evidence synthesis, assessment of evidence and making recommendations or decisions. This has been a welcome experience and career steppingstone for many individuals with related methodology interests. For named authorship of official GWG articles, ICMJE criteria fulfilling contributions must be met including through the contribution of clarifying examples or important concepts. This multistage process expounds why articles, typically published on behalf of the GWG, usually include many authors. When an article is rejected, the authors typically take it through additional conceptualization or testing. They have the opportunity to present it 2 additional times for approval in a process that once again involves anonymous voting and identical rules for approval. To ultimately achieve a successful outcome, lead authors and the project members should actively engage with other GRADE members to work through any methodological issues, consider alternative options and ultimately reach an agreement. One option is also for an article originally stated to describe GRADE guidance to instead be published as a GRADE concept paper, thereby, acknowledging that further field testing may be necessary. This process that ultimately leads to approval and publication can take more than 1 year. Once an article has been rejected 3 times, it requires special permission by the GRADE Guidance Group for further presentation and consideration of approval. However, this has been rarely necessary. Alternatively, authors have the option of seeking publication in a journal of their choice without claiming official GWG article status. As most scientific approaches to advancing healthcare, the GRADE approach continues to evolve as concept and guidance articles, in response to new evidence and to meet the needs of systematic review authors, guideline developers, health decision makers and other stakeholders. The methods and approval processes for these articles has become increasingly more rigorous and explicit. It includes a refined transparent multistage development and review approach, including steps such as the participation of the GWG members and our introduction of voting processes before an article is submitted for publication. Updates to the methods we describe here, as well as nuances that will be specific to some official GRADE articles are likely to occur. To maximize transparency and describe deviations from these generic methods and processes in specific concept or guidance articles, or to provide updates about what we laid out here, we will strive to include that information in future articles.
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