REGULAR ARTICLE How to write a guideline: a proposal for a manuscript template that supports the creation of trustworthy guidelines Robby Nieuwlaat,1,2 Wojtek Wiercioch,1,2 Jan L. Brozek,1,2 Nancy Santesso,1,2 Robert Kunkle,3 Pablo Alonso-Coello,4 David R. Anderson,5 Shannon M. Bates,6 Philipp Dahm,7,8 Alfonso Iorio,2,6 Wendy Lim,6 Gary H. Lyman,9 Saskia Middeldorp,10 Paul Monagle,11,12,13,14 Reem A. Mustafa,2,15 Ignacio Neumann,16 Thomas L. Ortel,17,18 Bram Rochwerg,2,6 Sara K. Vesely,19 Daniel M. Witt,20 Adam Cuker,21,22 and Holger J. Sch€ unemann1,2,6 Downloaded from http://ashpublications.org/bloodadvances/article-pdf/5/22/4721/1835799/advancesadv2020003577.pdf by guest on 30 January 2023 1 Michael G. DeGroote Cochrane Canada and McMaster GRADE Centres and 2Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; 3American Society of Hematology, Washington, DC; 4Iberoamerican Cochrane Center, Biomedical Research Institute Sant Pau (IIB Sant Pau-CIBERESP), Barcelona, Spain; 5Department of Medicine, Dalhousie University, Halifax, NS, Canada; 6Department of Medicine, McMaster University, Hamilton, ON, Canada; 7Urology Section, Minneapolis VA Health Care System, Minneapolis, MN; 8Department of Urology, University of Minnesota, Minneapolis, MN; 9Department of Medicine, Fred Hutchinson Cancer Research Center, University of Washington School of Medicine, Seattle, WA; 10Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; 11Department of Paediatrics, University of Melbourne, Melbourne, Australia; 12Department of Haematology, Royal Children’s Hospital, Melbourne, Australia; 13Haematology Research, Murdoch Children’s Research Institute, Melbourne, Australia; 14Kids Cancer Centre, Sydney Children's Hospital, Randwick, Australia; 15Division of Nephrology and Hypertension, Department of Medicine, University of Kansas Medical Center, Kansas City, KS; 16Department of Internal Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile; 17Department of Medicine; 18Department of Pathology, Duke University Medical Center, Durham, NC; 19Department of Biostatistics and Epidemiology, Hudson College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK; 20Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT; 21Department of Medicine; and 22Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA Key Points Trustworthy health guidelines should provide recommendations, document the development process, and highlight implementation information. Our objective was to  The proposed develop a guideline manuscript template to help authors write a complete and useful report. guideline manuscript The McMaster Grading of Recommendations Assessment, Development and Evaluation template is the first detailed template for Centre collaborated with the American Society of Hematology (ASH) to develop guidelines transparent and for the management of venous thromboembolism. A template for reporting the guidelines complete reporting of was developed based on prior approaches and refined using input from other key guidelines. stakeholders. The proposed guideline manuscript template includes: (1) title for guideline  identification, (2) abstract, including a summary of key recommendations, (3) overview of all Consistent application of the template may recommendations (executive summary), and (4) the main text, providing sufficient detail simplify preparing an about the entire process, including objectives, background, and methodological decisions evidence-based from panel selection and conflict-of-interest management to criteria for updating, as well as guideline manuscript supporting information, such as links to online (interactive) tables. The template further and facilitate its use. allows for tailoring to the specific topic, using examples. Initial experience with the ASH guideline manuscript template was positive, and challenges included drafting descriptions of recommendations involving multiple management pathways, tailoring the template for a specific guideline, and choosing key recommendations to highlight. Feedback from a larger group of guideline authors and users will be needed to evaluate its usefulness and refine. The proposed guideline manuscript template is the first detailed template for transparent and complete reporting of guidelines. Consistent application of the template may simplify the preparation of an evidence-based guideline manuscript and facilitate its use. Submitted 28 April 2021; accepted 20 June 2021; prepublished online on Blood Advances The full-text version of this article contains a data supplement. First Edition 14 September 2021; final version published online 18 November 2021. DOI ß 2021 by The American Society of Hematology. Licensed under Creative Commons 10.1182/bloodadvances.2020003577. Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), Data sharing requests should be sent to Robby Nieuwlaat (e-mail: nieuwlr@mcmaster. permitting only noncommercial, nonderivative use with attribution. All other rights ca). reserved. 23 NOVEMBER 2021 • VOLUME 5, NUMBER 22 4721 Introduction facilitate and standardize the development process as much as possi- ble, and this software is continually improved. Deliverables generated using this software include GRADE evidence profiles, evidence-to- The development of evidence-based guidelines involves a structured decision (EtD) tables, and guideline implementation and dissemination process of content prioritization, evidence synthesis, making informed tools. There is also a section intended to help facilitate writing the judgments, writing reports for end users, and disseminating the guide- guideline manuscript, which currently provides recommended docu- lines. This can be time consuming, but tools to standardize and facil- ment section headings only. itate each step of the process are increasingly available.1 Despite this, there is still important variation in guideline reporting that can be con- Ten ASH VTE guideline panels addressed topics that included 20 to fusing for end users.2 Although checklists for adequately reporting 30 recommendations per guideline. The guideline panel chairs and guidelines are available, providing practical writing tools has the vice-chairs proposed to adopt a manuscript template for summarizing Downloaded from http://ashpublications.org/bloodadvances/article-pdf/5/22/4721/1835799/advancesadv2020003577.pdf by guest on 30 January 2023 potential to enhance completeness and transparency for guideline panel recommendations for dissemination in peer-reviewed journals. authors, as well as understanding by end users.1,3,4 The approach for developing this template was determined by ASH in collaboration with a methodology working group composed of Practical guidance for guideline development is available through the McMaster GRADE group members and guideline panelists. checklist created by the Guidelines International Network (GIN) and McMaster University4 and implemented in GRADEpro software The first ASH guideline template was drafted by H.J.S. and J.B. based (www.gradepro.org). Item 15 of this checklist addresses “Reporting on unpublished guideline templates used for various organizations, and peer review” and provides pointers for guideline formatting, including the World Allergy Organization (WAO), World Health Orga- authorship, and peer review. In addition, tools like the AGREE II instru- nization, government guideline groups, and the existing template sec- ment describe in detail items that need to be reported to be able to tions in GRADEpro.7–17 The draft was then iteratively refined using adequately assess and use a guideline.3 Since publication of the input from the ASH VTE Guidelines Methodology Working Group, GIN-McMaster checklist, other sources for guidance on guideline ASH staff, scientific journal editors, patients, and guideline panel reporting have been issued. Among them, the RIGHT (Reporting chairs and vice-chairs. Further comments from the ASH Guideline Items for practice Guidelines in HealThcare) Working Group provided Oversight Subcommittee and ASH staff were incorporated, after a tool containing essential items, and the CheckUp panel provided a which the draft was discussed with guideline panel chairs and vice- checklist for reporting updates of guidelines partly based on AGREE chairs. Repeated edits were incorporated as needed based on dis- II.1,5 Although checklists can enhance standardization and quality of cussion between the ASH VTE Guidelines Methodology Working reporting, they still require guideline authors to translate individual Group and those involved in guideline development. components into an actual narrative manuscript that meets the requirements for publication in peer-reviewed journals. Also, when The guideline manuscript template was considered final once all rele- preparing a manuscript for publication in a peer-reviewed journal, vant parties provided feedback and the ASH VTE Guidelines Method- there is a need to observe space constraints, adopt a writing style, ology Working Group considered it ready for use. Important changes and meet reader expectations that are not covered in existing guid- relevant for all guidelines were allowed after guideline panel chairs and ance. Therefore, practical guidance for what a guideline should con- vice chairs started using the template. tain is lacking. A guideline manuscript template, grounded in an optimal development and reporting checklist, can make the task of guideline authors more efficient, ensure high-quality standardized Results guideline reports, and optimize transparency and understanding by Development of the manuscript template took 7 months, from May to end users. At present, no such practical template exists for guideline November of 2016. The final template was available at the end of authors. November of 2016, well before guideline chairs started writing the The McMaster GRADE Center collaborated with the American Soci- guideline manuscripts. The template was used to report 15 already ety of Hematology (ASH) to develop 10 guidelines on various topics published and 2 upcoming ASH guidelines.18-32 Guideline manu- related to the prevention, diagnosis, and treatment of venous thrombo- script authors tailored parts to their guideline’s specific requirements, embolism (VTE). The aim of this article is to describe the development for example the treatment of pediatric VTE and also sickle cell disease of the guideline manuscript template for the ASH guidelines project, guidelines simplified or combined sections on Benefits and Harms which may function as a practical tool for guideline developers beyond and Burden when very limited evidence was available. Substantial ASH. changes to the template would have been allowed but were not requested after it was brought into use. Methods The checklist created by the GIN and McMaster GRADE Center pro- Manuscript template vides guidance toward developing trustworthy guidelines at each step See Supplement 1 for the complete guideline manuscript template, of the process and forms the backbone for guidance in the GRADE and note the following characteristics: Handbook.4,6 The GRADE approach includes items that relate to aspects of question formulation, evidence assessment, and formulat- 1. The Title clearly identifies the manuscript as a guideline and ing recommendations and are integrated in the GIN-McMaster check- includes the year of publication. Author Information meets list.4 GRADEpro software (https://gradepro.org/) was designed to journal-specific criteria. 4722 NIEUWLAAT et al 23 NOVEMBER 2021 • VOLUME 5, NUMBER 22 2. The Abstract focuses on the guideline’s objective, target audi- included focusing on key drivers for recommendations and avoiding ence, general development methods, number of recommen- repetition and redundancies, clear wording for recommendations dations, and selected key recommendations. comparing multiple management pathways, deciding how to tailor 3. The Summary of Recommendations functions as an executive their specific guideline, and deciding which key recommendations summary, which includes an introduction for the topic at hand, and considerations to focus on in the Abstract. A reported advantage interpretation of strong and conditional recommendations, was that the template’s standardized layout facilitated multiple authors to work on the same guideline manuscript. Finally, guidance for includ- and all guideline recommendations, including important ing advice on future research for each specific recommendation was justifications. much appreciated by ASH guideline panels, because this helps to fur- 4. The Main Text provides the guideline’s specific objectives, ther develop the evidence base and check whether progress has description of the health problem, methodology regarding been made in subsequent guideline iterations. panel composition and coordination, guideline funding and Downloaded from http://ashpublications.org/bloodadvances/article-pdf/5/22/4721/1835799/advancesadv2020003577.pdf by guest on 30 January 2023 conflict-of-interest management, formulation of questions, Discussion evidence review, including assessment of the certainty, rec- ommendation development, document review process, and We have reported the approach used to develop a guideline manu- script template for widespread use, based on the GIN-McMaster guidance for using the guidelines. For each recommendation, checklist, input from a multidisciplinary team of guideline developers the summary of evidence, benefits, harms, other EtD judge- and users, and extensive previous experience in guideline develop- ments, and main conclusion and research needs are reported; ment and reporting. This practical tool will assist guideline authors online supplements and direct links to evidence profiles (EPs) by facilitating and standardizing manuscripts while enhancing trans- and EtDs can be used for more complete or different presen- parency and will help guideline users by providing a consistent format tations of evidence and judgments. Further, guideline recom- and wording. The headers of the different sections of the template mendations are compared with what other guidelines have manuscript are integrated into GRADEpro software, which provides recommended to clarify potential differences. Limitations of the backbone for a detailed manuscript and makes GRADEpro a com- the guideline-development process are reported, and a plan plete tool for every step of the guideline development process. By for guideline adaptation and updating is provided, as well as making these tools freely available, we aim to accelerate standardized advice for future research. guideline reporting. The template has been used for 15 published ASH guidelines involving .200 authors,18-32 and it will be used for Meeting checklist requirements additional ASH guidelines, as well as other ongoing guidelines under development by the McMaster GRADE Centre. For specific examples The proposed manuscript template meets all criteria for reporting, as specified in the GIN-McMaster, RIGHT, and AGREE II checklists, as of guidelines that used the template, please visit the Web site “ASH well as the Institute of Medicine standards.1,3,4,33 Table 1 summarizes Clinical Practice Guidelines on Venous Thromboembolism” (https:// where each checklist domain has been covered in the manuscript www.hematology.org/education/clinicians/guidelines-and-quality- template. care/clinical-practice-guidelines/venous-thromboembolism- guidelines). Important features The manuscript template was designed for reporting a full guideline Throughout the template, placeholders are provided to tailor the man- with transparent description of all considerations and judgments for uscript to the relevant guideline topic while maintaining standardized the entire process. Although not used by ASH to date, small informa- reporting. These include key aspects, such as Summary of Findings tive recommendation units can be published for specific topics, with- tables, standard wording of recommendations, and EtD frameworks out waiting for a full manuscript to be ready, to speed up the that are accessible through links in the Database of GRADE EtDs implementation of up-to-date guidance and development of tools in and Guidelines (guidelines.gradepro.org) and help others to decide practice and facilitate referencing specific recommendations. Specific whether to adopt, adapt, or develop recommendations de novo using sections of the manuscript template could still be used for such small the “adolopment” framework.34 This framework is especially helpful informative recommendation unit publications.35,36 Although the tem- for guideline development organizations with limited resources and plate was developed with the intent to be comprehensive, some who may decide to focus on contextualizing existing recommenda- guideline authors may decide to include additional information to facil- tions rather than going through a full development process. These itate the use of recommendations in practice. links also provide access to relevant online supplemental materials. In our experience, using this template produced long, but detailed, Further, the template includes examples of how to summarize key con- documents, which may be a concern given the typical word limit of siderations that led to the recommendation and allows for comparison journals. However, we preferred to have a comprehensive document of the recommendations with other guidelines on the same topic. A that explicitly reported the key aspects that influenced recommenda- section for future research needs for each specific recommendation tions. Online-only journals may be more flexible with regard to the highlights evidence gaps identified by guideline panels. word limit; if that is not an option, placing sections online only may Guideline author experience be a good compromise. In this regard, it may be a good idea to have discussions with editors in advance about the best way to pub- ASH guideline panel chairs and vice-chairs generally found the tem- lish the guideline using this template. plate very helpful. Because they were given the opportunity to provide input during the template-creation process, few major issues came up Another concern may be the repetitiveness of the information pre- when they started to use the template. Some reported challenges sented for each recommendation. However, practitioners not may 23 NOVEMBER 2021 • VOLUME 5, NUMBER 22 GUIDELINE MANUSCRIPT TEMPLATE 4723 Table 1. Guideline manuscript template conformation to reporting checklists Guideline manuscript Domain GIN-McMaster checklist (step) RIGHT (topic) AGREE II (item) template (page)* Basic information Title — 1 — 1 Authors 15.3 — — 1 Abstract — — — 2 Executive summary — 2 17 3 Abbreviations and acronyms — 3 — 1 Corresponding developer — 4 — 1 Background Downloaded from http://ashpublications.org/bloodadvances/article-pdf/5/22/4721/1835799/advancesadv2020003577.pdf by guest on 30 January 2023 Brief description of the health problem 2.9 5 — 6 Aims of the guideline and specific 2.2 6 1 6 objectives Target populations 8.3, 8.7 7 2&3 6 End users and settings 5 8 6 6 Guideline development groups 3 9 4 7 Evidence Health care questions 8 10 2 9 Systematic reviews 10, 11 11 7, 8 9 Assessment of the certainty of the 12 12 9 10 body of evidence Recommendations Recommendations 13 & 14 13 10, 11, 15, 16, 20 13 Rationale for recommendations 13.6 14 5, 12, 20 13 Evidence to decision process 13.1 15 10, 12 9 Review and quality assurance External review 15.7, 15.8 16 13 12 Quality assurance 15.6 17 — 12 Funding and declaration and management of interests Funding sources and roles of the 7.6 18 22 7 funder Declaration and management of 7 19 23 7 interests Other information Access 16.1 20 — Whole document (eg, citation to guideline, links to EtDs with evidence profiles, and supplements) Suggestions for further research 13.5 21 — Each recommendation (EtD) Limitations of the guideline — 22 — 15 Updating the guideline 18 — 14 16 Applicability 14.5 14 14 Whole document (eg, feasibility, barriers for each recommendation) Implementation 16 — 18, 19 Each recommendation (EtD) & 16 (local adaptation) Monitoring 17.3 — 21 Each recommendation (EtD) *Supplement 1; —, not addressed. typically read an entire guideline in one go. More likely, specific recom- and journal editors, it may seem repetitive. Another challenge in this mendations are used to resolve specific clinical questions. This makes regard is the publication of updated recommendations in a living each recommendation a stand-alone product that should include all of guideline process. More recent experience from our group suggests the necessary information. However, the minor downside of this is that that initial publication of all details, possibly with a separate methodol- for those who actually read the whole manuscript, including authors ogy publication, can allow us to focus on the most essential 4724 NIEUWLAAT et al 23 NOVEMBER 2021 • VOLUME 5, NUMBER 22 information regarding changes while referring to previous publications reporting of the guideline-development process and recommenda- for methodology and findings that did not change. tions. Consistent application of the template, which is encouraged, may facilitate writing of guideline manuscripts and enhance end- We acknowledge that there are several limitations to the develop- ment process of the guideline manuscript template. First, the tem- users’ ability to understand, select, and implement recommendations. plate is primarily based on the GIN-McMaster checklist; other guideline developers may use a different approach, although this is a minor limitation because this checklist is the most com- Authorship plete tool that is used worldwide to develop guidelines, and it con- Contribution: R.N., W.W., and H.J.S. designed the reported manu- forms to most criteria of guideline reporting checklists, such as script template, analyzed the manuscript template for agreement RIGHT and AGREE II. Second, we aimed to use an iterative pro- with reporting requirements, and wrote this article; J.L.B., N.S., and cess with input from a multidisciplinary group of guideline devel- R.K. designed the manuscript template and critically reviewed this arti- opers and users, primarily involved in the development of ASH Downloaded from http://ashpublications.org/bloodadvances/article-pdf/5/22/4721/1835799/advancesadv2020003577.pdf by guest on 30 January 2023 cle; P.D., I.N., P.A.-C., A.I., S.K.V., B.R., R.A.M., D.R.A., T.L.O., D.M.W., guidelines. Other guideline developers may have different prefer- G.H.L., S.M., P.M., S.M.B., W.L., and A.C. helped to refine the manu- ences, and other health disciplines may have different needs for script template, provided user experience data, and critically reviewed clear and complete reporting. Third, we primarily report our expe- this article. rience with using the template for multiple guidelines with 1 orga- nization (ASH), but as the template is used more often and by Conflict-of-interest disclosure: R.K. is employed by ASH, which other organizations we aim to improve it further. Fourth, formal funded and disseminated the guidelines discussed in this article. feedback from final users of the guideline or readers of the journal The remaining authors declare no competing financial interests. has not yet been systematically collected. Fifth, the impact on widespread use of a similar template on plagiarism software com- ORCID profiles: W.W., 0000-0001-6576-1650; J.L.B., 0000- monly adopted by several journals at the review stage needs to be 0002-3122-0773; N.S., 0000-0003-0550-4585; P.D., 0000- assessed, and simple linguistic variation of the common part may 0003-2819-2553; A.I., 0000-0002-3331-8766; W.L., 0000- be suggested when using the template. We acknowledge that the 0003-2508-1786; S.M., 0000-0002-1006-6420; S.K.V., 0000- document needs further iterative refinement, and while keeping 0003-3448-0156; D.M.W., 0000-0002-3930-8358; A.C., 0000- the overall format a suite of alternative options may be developed 0002-3595-5697; H.J.S., 0000-0003-3211-8479. (eg, to allow for standardized wording when very limited evidence Correspondence: Robby Nieuwlaat, Department of Health was available). Research Methods, Evidence and Impact, McMaster University, In conclusion, the guideline manuscript template that we developed is HSC-2C, 1280 Main St West, Hamilton, ON L8N 3Z5, Canada; a free to use detailed tool for standardized, complete, and transparent e-mail: nieuwlr@mcmaster.ca. References 1. Chen Y, Yang K, Marusic A, et al; RIGHT (Reporting Items for Practice Guidelines in Healthcare) Working Group. A reporting tool for practice guidelines in health care: the RIGHT Statement. Ann Intern Med. 2017;166(2):128-132. 2. 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