Swedish Agency for Health Technology Assessment and Assessment of Social Services
Critical issues for clinical guidelines
Health care and social services guidelines must be well-founded, clear and feasible to implement. The quality of the guidelines must be assessed using the AGREE tool, which raises the following questions.
Are both the scope and the purpose clear? Guidelines should clearly state the conditions or problems that they cover: to what patients or service users should the guideline apply and for which purpose – what effects are expected.
Who has been involved? It must be made clear what people and concerned professions did or did not participate when the recommendations were formulated, and in what way patients and users participated.
Have affiliations and conflict of interest been properly reported and handled? Special interests among initiators, authors, experts, reference groups and reviewers must be declared and addressed. The degree of independence of all contributors, special interest groups and sponsoring organisations must be described.
What is the factual basis? Recommendations concerning various interventions in health care and social services must be evidence-based. Guidelines must clearly describe the methods used to identify and aggregate the evidence. An exhaustive literature search should be included, as well as a systematic review and synthesis of results. If the guideline is based on calculations of cost-effectiveness and analyses of ethical and legal aspects, a description of the processes involved must be provided.
How have the relevance and reliability of the documentation been assessed? It must clearly be stated what scientific evidence or other basis was used to examine the benefits and risks of recommended interventions. Both the strengths and limitations of the evidence must be clearly presented. A description of how this material was assessed for relevance to the issue, scientific reliability (risk of random and systematic errors) and topicality must be provided. Recognised methodology must be used in this process.
What process has been used? The authors must describe the process used to formulate the recommendations and to resolve disagreements among participants. The factual basis on for each recommendation must be clearly described, and the recommendations must be specific and unambiguous. Various options for management of conditions or health problems must be clearly presented. Recommendations must be reviewed by external independent experts prior to publication, and review methodology described.
Can the recommendations be applied and followed up? It should be clear what circumstances and resources are required to implement the recommendations – and what factors can be expected to facilitate or obstruct their implementation. Suitable follow-up of expected and unexpected effects should be provided. It should also be clear how long the recommendations are expected to apply and how future needs for updating will be managed. • RL
Further reading
More about the AGREE tool: https://www.agreetrust.org/agree-ii/Brouwers M, et al for the AGREE Next Steps Consortium. AGREE II: Advancing guideline development... Can Med Assoc J, 2010. doi:10.1503/cmaj.090449.
