Consensus manuscripts play an essential role in guiding clinical practice, especially in areas where evidence is evolving or where multiple management approaches exist. Consensus statements are often perceived as opinion-driven and biased rather than evidence-based. This is more likely when the funding for the exercise is provided by a pharma or medical device manufacturer. This also leads to rejection by leading or high-impact-factor journals.
Incorporating evidence grading and strength of recommendation adds rigor, transparency, and credibility to the process. Consensus recommendations that incorporate grading and strength are more widely accepted and perceived as high-quality recommendations rather than being influenced by the sponsor.
Grading evidence ensures that readers can differentiate between high-quality data that is based on randomized controlled trials vs insights based on expert opinion or observational studies. This allows clinicians to understand not only what is recommended, but also why and to what degree of certainty.
A strength of recommendation allows clinicians to prioritize recommendations that are strongly backed by evidence. By assigning a strength of recommendation, clinicians can prioritize interventions that are strongly supported by evidence over those that are suggested with caution. This is especially valuable in high-stakes therapeutic areas, where treatment choices have direct implications for patient outcomes.
Most leading guideline development bodies (e.g., GRADE, AHA/ACC, ESC, WHO) use standardized evidence grading frameworks. Incorporating similar methodology in a consensus manuscript aligns it with these recognized standards, increasing acceptability, dissemination, and eventual uptake in clinical practice.
How to Incorporate Evidence Grading and Strength of Recommendation
- Choose a Framework
Select a validated system such as:- GRADE (Grading of Recommendations, Assessment, Development and Evaluations): Separates quality of evidence (high, moderate, low, very low) from strength of recommendation (strong or weak).
- Oxford Centre for Evidence-Based Medicine (OCEBM) Levels of Evidence: Classifies evidence hierarchically, from systematic reviews of RCTs to expert opinion.
- ESC/AHA/ACC System: Uses Classes of Recommendation (I, IIa, IIb, III) and Levels of Evidence (A, B, C).
- Systematic Evidence Review
Conduct a structured literature review to identify and grade relevant studies. Summarize the body of evidence underpinning each recommendation. - Assign Quality of Evidence
For each statement, explicitly note the quality of supporting data (e.g., “High: multiple RCTs with consistent results” vs. “Low: expert consensus only”). - Define Strength of Recommendation
Clearly state whether the recommendation is strong, moderate, or weak, depending on the balance of benefit versus risk, quality of evidence, and clinical applicability. - Document the Process
In the methods section, outline how evidence was assessed, how consensus was achieved, and how final grading decisions were made. This adds to the credibility of the manuscript. - Use Standardized Tables
Present recommendations in tabular form with columns for the statement, class/strength, and level of evidence. This improves clarity and usability for clinicians.
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