Formulating a recommendation (even if the level of evidence is low) should always be the aim. The other options (not to formulate a recommendation, formulate a “only in research recommendation” or formulate a recommendation without grading) should be exceptions.
Recommendation with grading
The panellists should not be afraid with the formulation of recommendations even if evidence is poor. Absence of a statistically significant effect is no proof that an intervention does not work. It is only proven that an intervention doesn’t work if the confidence interval around the effect estimation excludes a minimally important difference or decision threshold. Even when confidence in effect estimate is low and/or desirable and undesirable consequences are closely balanced, GRADE encourages to make recommendations (inevitably weak) to avoid clinicians frustration with the lack of guidance. (Andrews et al., 2013) As the US Preventative Services Task Force states : “Even though evidence is insufficient, the clinician must still provide advice, patient must make choices, and policy makers must establish policies”.(Petitti et al., 2009)
Decede NOT to formulate a recommendation could be proposed2:
- When the confidence in effect estimates is so low that the panellists feel a recommendation is too speculative.
- When “although the confidence in effect estimates is moderate or even high, the trade-offs are so closely balanced, and the values and preferences and ressource implications not known or too variable, that the panel has great difficulty deciding on the direction of the recommendation”.
But as said above, choosing not to make recommendation might be an exception. And if the panel chooses to make no recommendation, the reason (low confidence in effect estimate or close balance between harm and benefit) should be specified.(Andrews et al., 2013)
“Only in research” recommendation
“Only in research” recommendation will be appropriate when 3 conditions are met(Andrews et al., 2013) :
- There is insufficient evidence supporting an intervention for a panel to recommend its use;
- Further research has a large potential for reducing uncertainty about the effects of the intervention;
- Further research is deemed good value for the anticipated costs.
Recommendation without grading
In some cases, grading a recommendation can be superfluous, but the eligibility criteria to choose this option still have to be determined by the KCE and are currently under discussion.