Table 3.
Comparison of clinical practice guideline development processes using the Appraisal of Guidelines for REsearch & Evaluation (AGREE) II criteria
AGREE II criterion | WHO * | National Institute of Health and Care Excellence (NICE)† | European Society of Clinical Nutrition and Metabolism (ESPEN)‡ | Academy of Nutrition and Dietetics (AND) |
---|---|---|---|---|
Scope & Practice | Guideline groups are asked to identify clear, actionable objectives for the guidelines and research questions that are framed in a way that enables a systematic literature search (e.g. PICO) | Guideline groups are not provided specific direction regarding setting guideline objectives but determine the target population as part of the scoping process. Specific questions are developed using an available framework (e.g. PIC, SPICE, PICOT etc). | Guideline groups are not provided specific direction regarding setting guideline objectives. Specific questions are developed using the PICO format, and in this way, the target population for the guideline is defined. | The scope of the guideline is determined and used as the framework to execute the supporting systematic review. All guidelines are supported by systematic reviews. Systematic review questions are framed considering the NCP model and conform with PICOT format(63). |
Stakeholder Involvement | The end user as well as the service users and individuals whose health and well-being will be affected by the guidelines must be identified early so that representatives from these groups can be part of the Guideline Development Group. Additionally, the GDG includes technical experts and must represent diverse perspectives with adequate geographic and gender representation. | Guideline groups must be multidisciplinary with representation from practitioners, professionals, providers, commissioners, researchers and lay members with relevant experience.. | The guideline working group is determined by the Guidelines Editorial Board and is based primarily on academic expertise but with consideration for gender balance, geographic location and prior experience in developing guidelines. | Subject matter experts vote on recommendation statements. A blinded interdisciplinary external review is conducted with 8–10 subject experts. Names and credentials are listed. Further stakeholder input is sought using targeted or open public comment or focus groups. Individuals or groups may provide specific comments to the drafted recommendations. |
Rigour of Development | Recommendations are developed based on a systematic review of the literature using explicit methods. The GRADE approach is used to assess the overall evidence quality and to develop recommendations. Guidelines must undergo external peer review before publication and should include a ‘review by’ date but need not include a procedure for update. | Recommendations are developed based on a systematic, transparent and reproducible process for searching, screening and reviewing the evidence. The GRADE approach is recommended, but other critical appraisal frameworks may be approved in advance. Draft guidelines are posted for consultation with registered stakeholders and there is a clear process for updates. | Recommendations are developed based on a systematic review of the literature with documentation. Publications are classified according to evidence level, recommendation grade and form of recommendation during the Scottish Intercollegiate Guideline Network grading system. Guideline recommendations are published open access in ESPEN’s journal, but are not externally reviewed as part of that process. | Systematic review questions are investigated according to the AND’s methodology(64) which includes the GRADE methodology and PRISMA guidelines(65,66). Evidence is considered in the context of NCP and GRADE’s evidence-to-decision framework., as well as feasibility and resource use. Recommendations are designed to be clear, specific, structured, transparent and actionable. |
Clarity of Presentation | Each recommendation is accompanied by: 1. Strength of the recommendation (strong or conditional/weak), including justification 2. Quality of the evidence on which they are based 3. A set of remarks that explain context for understanding and implementation 4. Summary of the evidence |
Recommendations are action-oriented, precise, concise, person-centred and use wording that reflects the strength of the recommendation (e.g. must v. offer v. consider). | Each recommendation is accompanied by: 1. Evidence Level 2. Recommendation Grade 3. Form of Recommendation, and 4. Classification of the strength of consensus |
Recommendations are ‘operationalised’ using the nutrition care process, related terminology and informatics tools. Each guideline includes five major components: 1) executive summary 2) introduction 3) scope 4) major recommendations 5) dissemination and implementation. |
Applicability | Factors affecting feasibility, implementation and resource implications are considered as part of the GRADE process. Guidelines should include outcome measures that can be used to monitor effectiveness and impact. | Levers and barriers to guideline implementation are considered and the guideline group works with NICE teams to produce tools and resources that support implementation. A requirement for criteria used to monitor the guidelines is not described in the manual. | The Standard Operating Procedures for guidelines do not mention an assessment of facilitators or barriers to using the guidelines, an exploration of resource implications or monitoring criteria. There is a section that suggests activities and tools that support guideline implementation. | Stakeholder input highlights concerns surrounding feasibility of the recommendations, patient-centred language and other important factors. Ongoing evaluation of the guidelines’ use supports adoption and allows monitoring of application |
Editorial Independence | Guideline funders cannot participate in the development process or influence the recommendations. All members of the guideline group must complete a declaration of interests form and there is a process for managing conflicts of interest. | All members of the guideline group are required to declare potential conflicts of interest, which are managed in accordance with a NICE policy. | Guidelines are funded by ESPEN and may be supported indirectly by industry funding through unrestricted grants. All group members declare a competing interests before participation but there is no description of how conflicts are managed. Pharmaceutical employees are excluded from the systematic literature review and consensus meetings. | Guidelines do not receive industry funding and the AND is the primary source of support. Inter-agency partnerships are sought, where possible, to reduce duplication and maximise efficiency of resources. Examples include National Kidney Foundation, the American Council on Exercise and Dietetic Practice Groups of AND. |
PICO = population, intervention, comparator, outcome; PIC=population, intervention, comparator; SPICE = setting, perspective, intervention, comparison, evaluation; PICOT=population, intervention, comparator, outcome, treatment; NCP = Nutrition Care Process; GRADE = Grading of Recommendations, Assessment, Development and Evaluations; PRISMA = Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
World Health Organization. WHO Handbook for Guideline Development – 2nd ed. 2014 Dec 14. Available from: https://www.who.int/publications/i/item/9789241548960.
National Institute for Health Care Excellence. Developing NICE guidelines: the manual (PMG20). Process and methods. 2014 Oct 31 (last updated 2022 Jan 18). Accessed 2022 Aug 22. Available from: https://www.nice.org.UK/process/pmg20/chapter/introduction.
Bischoff SC, Singer P, Koller M, Barazzoni R, Cederholm T, et al. Standard operating procedures for ESPEN guidelines and consensus papers. Clin Nutr. 2015;34:1043–41. Available from: https://www.espen.org/files/ESPEN-Guidelines/0__Standard_operating_procedures_for_ESPEN_guidelines_and_consensus_papers_2.pdf.