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Methodology

GRADE Methodology

The international standard for rating certainty of evidence and strength of recommendations. We work with it from the inside: our CEO co-wrote part of the methodological series that defines it.

Foundation

It separates two questions people almost always confuse

The first: how confident are we about the effect? The second: how strong should the recommendation be? They are not the same. High-certainty evidence can still lead to a conditional recommendation, and low-certainty evidence to a strong one when the balance of benefits and harms is decisive.

GRADE forces you to spell that reasoning out and write it down. That is why the World Health Organization, Cochrane and more than a hundred organisations worldwide adopted it: not because it produces better answers, but because it produces answers you can audit.

Workshop on subgroup analysis with GRADE

How it is rated

The four levels of certainty

High

High certainty

Future research is very unlikely to change the estimate of effect. You can decide with confidence.

Moderate

Moderate certainty

The true effect is probably close to the estimate, but it could differ in a way that matters.

Low

Low certainty

Confidence in the estimate is limited. The true effect may be substantially different.

Very low

Very low certainty

Very little confidence in the estimate. Any decision must explicitly acknowledge that uncertainty.

Five reasons to rate certainty down

  • Risk of bias in the included studies
  • Inconsistency between results
  • Indirectness relative to the question
  • Imprecision in the estimates
  • Publication bias

Three reasons to rate it up

  • Large magnitude of effect
  • Dose-response gradient
  • Confounders that would work against the observed effect

Evidence to Decision

From evidence to decision

Certainty of evidence is only one criterion. An evidence-to-decision framework makes the panel take a position on each of these points, in writing, before it issues the recommendation.

Problem and priority

Is the problem a priority for the population and the system?

Benefits and harms

What is the balance between desirable and undesirable effects?

Certainty of evidence

How much confidence do we have in the effect estimates?

Values and preferences

How much variability is there in what patients consider important?

Resources and cost-effectiveness

What does it cost, and what do you give up by spending there?

Equity, acceptability and feasibility

Does it widen or narrow gaps? Is it acceptable and implementable in context?

Application

When you need GRADE

You are issuing recommendations others must follow

National guidelines, scientific society guidelines, institutional protocols. If a recommendation does not state its certainty and its strength, the first challenge dismantles it.

You must justify a coverage decision

A committee deciding what gets funded needs to know whether it is acting on high or very low certainty evidence. GRADE puts that in writing.

You have contradictory literature and a deadlocked committee

Rating certainty outcome by outcome usually reveals that the disagreement was not about the data, but about which outcome matters most.

You are adapting an international guideline to the local context

GRADE-ADOLOPMENT lets you adopt or adapt existing recommendations without repeating the whole synthesis, documenting what changed and why.

Our practice

We know GRADE from the inside

GRADE publishes its guidance as a numbered series in Journal of Clinical Epidemiology. Our CEO co-wrote articles 19 and 20 of that series and the GRADE-ADOLOPMENT framework, now the standard procedure for adopting and adapting existing guidelines.

That changes the conversation: we are not interpreting a handbook, we helped write it. When a borderline case appears, and it always does, we know the methodological intent behind the rule, not just its wording.

That method went on to shape the ARIA-EAACI, American Society of Hematology and World Allergy Organization guidelines, and the adaptation of chronic kidney disease guidelines to the Saudi context.

He directs the Colombia GRADE Network and works with the World Health Organization in Geneva as methodologist for the iCAM guideline. From 2022 to 2026 he sat on its Guideline Review Committee, which reviews and approves WHO guidelines. He also co-wrote the WHO Europe manual on contextualising guidelines (2023) and the PAHO guide to adapting guidelines (2023).

Panel facilitation

Structured facilitation, documented voting and formal management of conflicts of interest.

Evidence profiles

Summary of Findings tables and complete GRADE profiles, reproducible and ready for publication.

Training with certification

Applied GRADE workshops built on your institution's own documents and questions.

Shall we look at your case?

Thirty minutes with one of our methodologists, to look at your case and work out whether GRADE is the right framework.