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Guide for Authors - Regulations for the publication of Clinical Guidelines
Clinical Practice Guidelines (CPG) are documents usually dealing with a broad field of knowledge by a multidisciplinary group of experts. Their purpose is to establish a series of clinical guidelines, evaluating both evidence and biases from a critical and balanced standpoint.
The GRADE group methodology will be followed for the formulation of CPG recommendations. This methodology proposes explicit consideration of a series of factors for passing from evidence to recommendation and includes: the evaluation of evidence quality; the consideration of the balance between intervention benefits and risks; the incorporation of patient outlook and the consideration of the use of resources and costs.
General norms of guideline creation
1. Objectives:
- Main, secondary, target population.
2. Section where the methodology is described.
3. Section with questions to be answered.
For formulating questions the following PICO framework is usefulPICO: Patient, Intervention, Comparison and Outcome.
- The item begins by indicating the recommendation applied to this question, followed by its justification with a 4-point defined framework.
- Next, a summary of the evidence is developed for that question, and a systematic review (including meta-analysis if applicable).
The rating of each piece of evidence is made with the application of the GRADE framework.
- To do this, the outcome variables of interest must be defined.
- A score will be assigned to each one.
4. Summary of recommendations:
- This facilitates a quick read.
5. Discussion of recommendations.
6. Final conclusions.
Development of manuals
NICE guidelines.
GRADE guidelines:
- GRADE guidelines: 1. Introduction: GRADE evidence profiles and summary of findings tables.
- GRADE guidelines: 2. Framing the question and deciding on important outcomes.
- GRADE guidelines: 3. Rating the quality of evidence.
- GRADE guidelines: 4. Rating the quality of evidence¿study limitations (risk of bias).
- GRADE guidelines: 5. Rating the quality of evidence¿publication bias.
- GRADE guidelines: 6. Rating the quality of evidence¿imprecision.
- GRADE guidelines: 7. Rating the quality of evidence¿inconsistency.
- GRADE guidelines: 8. Rating the quality of evidence¿indirectness.
- GRADE guidelines: 9. Rating up the quality of evidence.
- GRADE guidelines: 10. Considering resource use and rating the quality of economic evidence.
- GRADE guidelines: 11. Making an overall rating of confidence in effect estimates for a single outcome and for all outcomes.
- GRADE guidelines: 12. Preparing Summary of Findings tables¿binary outcomes.
- GRADE guidelines: 13. Preparing Summary of Findings tables and evidence profiles¿continuous outcomes.
Fisterra (in Spanish).
Self-assessment of the CPG
The CPG authors must undertake a prior self-assessment of the Guide, in keeping with the AGREE. methodology items. They must then provide a document (AGREE checklist) with the self-assessment outcomes of each item.
Fisterra: How to assess a Clinical Practice Guideline (In Spanish).
AGREE Checklist.
Guideline example
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Revista Española de Anestesiología y Reanimación
Revista Española de Anestesiología y Reanimación (English Edition) is a member and subscribes the principles of, the Committee on Publication Ethics (COPE)
www.publicationethics.org.
www.publicationethics.org.
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