The GRADE Approach

Key Components of the GRADE Approach

Defining the Clinical Question
• The PICO format provides a standardized structure to frame clinical questions:
  • Population
  • Intervention
  • Comparison
  • Outcome
• Clearly defined clinical questions form the foundation of the Systematic Review and CPG.
  • Example: In children and adolescents diagnosed with ADHD (P), what is the effect of cognitive behavioral therapy (I) compared to stimulant medication (C) for reduction in ADHD symptoms (O)?
• Clinical questions addressed in the systematic review and CPG are prioritized based on their relevance to patients, caregivers, and clinical practice.
• Outcomes are ranked by their relative importance for decision-making, categorized as critical, important, or not important for decision-making, based on the GRADE approach.
Assessing the Certainty of the Evidence
• The certainty of the evidence rating promotes consistency and transparency and reduces bias in CPGs. It reflects the degree of confidence that effect estimates are close to the truth for systematic reviews and are adequate to support specific recommendations in CPGs.
• Ratings of evidence certainty range from very low to high.
• Various factors can lower or increase the certainty of the evidence. The GRADE Working Group provides clear guidance for evaluating these factors and determining overall certainty.

Presenting the Evidence & Formulating Recommendations
• Panels utilize the GRADE Evidence-to-Decision Framework to support a structured and transparent decision-making process.
• Key Considerations influencing recommendation direction and strength:
  • Certainty of the evidence
  • Balance of benefits and harms
  • Patient (and caregiver) values and preferences
  • Resource use
• Additional considerations include the impact of an approach on health equity, acceptability, and feasibility. 
• This process ensures that the recommendations reflect the evidence and real-world considerations that affect decisions for care.
  
• GRADE categorizes recommendation direction as “for” or “against.”
• GRADE categorizes recommendation strength as:
  • Strong: The benefits of the intervention clearly outweigh the harms (or vice versa). Most patients and caregivers would want to receive the recommended course of action, while a small proportion would not.
  • Conditional: The balance of benefits and harms is less certain, requiring shared decision-making. Most patients and caregivers would want to receive the suggested course of action, while many would not.
• The direction and strength of recommendations are clearly communicated using standardized wording.
  • Strong recommendations use the wording “The Guideline Panel recommends [for or against] …”
  • Conditional recommendations use the wording “The Guideline Panel suggests [for or against] 
• To support interpretation, the GRADE Book (Table 6.1) outlines the practical implications of strong and conditional recommendations. 
  
  

  Implications	Strong Recommendation   “The Guideline Panel recommends [for or against] …”	Conditional Recommendation   “The Guideline Panel suggests [for or against] …”
  For patients	Most individuals in this situation would want the recommended course of action and only a small proportion would not.	The majority of individuals in this situation would want the suggested course of action, but many would not.
  For clinicians	Most individuals should receive the recommended course of action. Adherence to this recommendation according to the guideline could be used as a quality criterion or performance indicator. Formal decision aids are not likely to be needed to help individuals make decisions consistent with their values and preferences.	Recognize that different choices will be appropriate for different patients, and that you must help each patient arrive at a management decision consistent with her or his values and preferences. Decision aids may well be useful helping individuals making decisions consistent with their values and preferences. Clinicians should expect to spend more time with patients when working towards a decision.
  For policy makers	The recommendation can be adapted as policy in most situations including for the use as performance indicators.	Policy making will require substantial debates and involvement of many stakeholders. Policies are also more likely to vary between regions. Performance indicators would have to focus on the fact that adequate deliberation about the management options has taken place.