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Cited by 686Clinical practice guidelines implementationHealth Sciences Research and EducationDelphi Technique in Research

Guidelines 2.0: Systematic development of a comprehensive checklist for a successful guideline enterprise

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Schünemann, Holger J., Wiercioch, Wojtek, Etxeandia, Itziar, Falavigna, Maicon, Santesso, Nancy, Mustafa, Reem, Ventresca, Matthew, Brignardello-Petersen, Romina +16 more·2014·Canadian Medical Association Journal
DOI 10.1503/cmaj.131237PMC PMC3928232
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Abstract

BACKGROUND: Although several tools to evaluate the credibility of health care guidelines exist, guidance on practical steps for developing guidelines is lacking. We systematically compiled a comprehensive checklist of items linked to relevant resources and tools that guideline developers could consider, without the expectation that every guideline would address each item. METHODS: We searched data sources, including manuals of international guideline developers, literature on guidelines for guidelines (with a focus on methodology reports from international and national agencies, and professional societies) and recent articles providing systematic guidance. We reviewed these sources in duplicate, extracted items for the checklist using a sensitive approach and developed overarching topics relevant to guidelines. In an iterative process, we reviewed items for duplication and omissions and involved experts in guideline development for revisions and suggestions for items to be added. RESULTS: We developed a checklist with 18 topics and 146 items and a webpage to facilitate its use by guideline developers. The topics and included items cover all stages of the guideline enterprise, from the planning and formulation of guidelines, to their implementation and evaluation. The final checklist includes links to training materials as well as resources with suggested methodology for applying the items. INTERPRETATION: The checklist will serve as a resource for guideline developers. Consideration of items on the checklist will support the development, implementation and evaluation of guidelines. We will use crowdsourcing to revise the checklist and keep it up to date.

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  • Panel members disclosed all potential conflicts of interest, and conflicts were managed according to AGA and ACG policies, the National Academy of Medicine, and Guidelines International Network standards.

    “Panel members disclosed all potential conflicts of interest. Conflicts were managed according to AGA and ACG policies, the National Academy of Medicine, and Guidelines International Network standards.”

    From American Gastroenterological Association-American College of Gastroenterology Clinical Practice Guideline: Pharmacological Management of Chronic Idiopathic Constipation (2023) · cites this paper as [13]

    The checklist’s conflict-of-interest guidance recommends declarations by prospective panel members and a policy for managing conflicts (sections 7 and 5). It does not establish that the citing document’s panel members actually disclosed all potential conflicts or that their conflicts were managed under AGA, ACG, National Academy of Medicine, or Guidelines International Network standards. (LLM, conf=0.84)

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Research works printed but not linked: 12

  1. Program in evidence-based care document assessment and review protocol. Hamilton (ON): Cancer Care Ontario; 2012. Available: www.cancercare.on.ca/about/programs/pebc /document__review/ (accessed 2013 Apr. 22).
  2. COGS: the conference on guideline standardization. New Haven (CT): Yale Center for Medical Informatics; 2003. Available: gem.med.yale.edu/cogs/statement.do (accessed 2013 Apr. 22).
  3. To help direct the evidence review, ensure that the guideline protocol outlines the target population, target condition, outcomes and key questions considered. 1, 2, 5, 23, 33, 35, 42, 44, 66, 90
  4. Considering the importance of outcomes and interventions, values, preferences and utilities 1. Decide whether the relative importance of outcomes and interventions, values, preferences or utilities of consumers and stakeholders (e.g., patients and target audience) to inform decisions and deliberations during the guideline development will be elicited indirectly or directly (e.g., review of the published literature v. consultation with consumers). 1-3, 5, 7, 20, 33, 35, 37, 43-46, 56, 72, 79, 93
  5. If an existing systematic review is updated or requires updating, determine how new evidence will be included and how those who conducted the review will be contacted and possibly involved in the update. 37, 45, 57, 92
  6. If a new systematic review is required, conduct an assessment to determine whether adequate resources (e.g., time and funding) are available to conduct a full systematic review. 37, 39, 45, 77
  7. If resources are limited, consider applying a rapid assessment methodology and explicitly describe the methodology, noting important limitations, uncertainties, and the need and urgency to undertake a full systematic review. 32, 37, 45, 77
  8. Conduct a review of the final draft of the guideline report(s) by all members of the guideline development group, allowing sufficient opportunity for feedback, editing and revisions. 5, 32, 33, 42, 43, 45, 85, 97
  9. Initiate organizational (i.e., internal) peer review. 5, 9, 32-37, 41-45, 56, 85, 97
  10. Decide on the method(s) for external peer review to review the final document(s) for accuracy, practicality, clarity, organization and usefulness of the recommendations, as well as to ensure input from broader and important perspectives that the guideline group did not encompass (e.g., invited peer review, public consultation period with incorporation of feedback and responses from the guideline development group, peer review provided by peer-reviewed journal). 1-3, 5, 9, 32-35, 37-46, 56, 57, 70, 85, 97
  11. Document the internal and external peer review process and, if applicable, publish consultation comments and the guideline development group's responses. 2, 9, 23, 32-34, 41-43, 45, 46, 56, 85, 97
  12. Dissemination and implementation 1. Prepare an active dissemination plan with various approaches to enhance the adoption of the guideline (e.g., make guideline available online, develop formal relationships with those in health care systems responsible for guideline dissemination and implementation to support guideline uptake, conduct press conference, develop social media strategy, disseminate guideline at professional society meetings, publish guideline in journal that is accessed by target audience). 3, 5, 9, 20, 34-40, 42, 44-47, 56, 57, 84, 98

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Authors
Schünemann, H. J., Wiercioch, W., Etxeandia, I., Falavigna, M., Santesso, N., Mustafa, R., Ventresca, M., Brignardello-Petersen, R., Laisaar, K.-T., Kowalski, S., Baldeh, T., Zhang, Y., Raid, U., Neumann, I., Norris, S. L., Thornton, J., Harbour, R., Treweek, S., Guyatt, G., Alonso-Coello, P., Reinap, M., Brožek, J., Oxman, A., & Akl, E. A.
Affiliations
University of Freiburg (DE)
ORCID
Venue
Canadian Medical Association Journal
Publisher
CMA Impact Inc.
Published
2013-12-16
Volume
186
Issue
3
Pages
E123-E142
ISSN
  • 0820-3946 (ISSN-L)
  • 1488-2329
DOI
10.1503/cmaj.131237
PMC
PMC3928232
OpenAlex
W2160757315
Cited by
686
References
70
Citations by year
2026: 43 · 2025: 89 · 2024: 66 · 2023: 65 · 2022: 89 · 2021: 52 · 2020: 78 · 2019: 41 · 2018: 53 · 2017: 35 · 2016: 33 · 2015: 25 · 2014: 15
FWCI
24.88
Type
journal article
Language
en
Open access
Locations
  • Canadian Medical Association Journal (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
McMaster University
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
  • Health Sciences › Health Professions › General Health Professions › Health Sciences Research and Education
  • Social Sciences › Sociology and Political Science › Delphi Technique in Research
Keywords
clinical guideline development, guideline development, guideline implementation, guideline evaluation, guideline development methodology, crowdsourcing
MeSH terms
Data Collection, Humans, Statistics as Topic, Practice Guidelines as Topic, Evidence-Based Medicine, Checklist

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