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How do I repair an applicability judgement that ignored setting differences?

November 2, 2026
applicability judgementindirectness assessmentGRADE certainty ratingtrial generalizabilitysystematic review revision

Repair the judgement by comparing trial settings and baseline characteristics with the target population, naming the differences the original judgement ignored, then revising both the applicability statement and its certainty implication. Cochrane guidance on applicability and indirectness and the GRADE approach to rating certainty at the outcome level give you the structure for this revision.

  1. List the trial's setting and baseline characteristics: care level, delivery arrangements, participant inclusion criteria, and the distribution of key prognostic factors. Record each item next to the corresponding feature of your target population so the comparison is explicit.
  2. Mark each mismatch and decide whether it plausibly changes the effect for your population. A difference in care setting or baseline risk that could shift absolute effects is the kind of gap that belongs in the indirectness note; a difference with no plausible effect on the outcome can be recorded and set aside.
  3. Rewrite the applicability judgement to state which population and setting the evidence directly addresses and which differences remain. Replace a blanket statement with the specific mismatch and its expected direction.
  4. Carry the revision into the certainty rating for the affected outcome. GRADE rates certainty with explicit criteria at the outcome level, so an indirectness concern you now acknowledge should be reflected in that outcome's rating and explained in the footnote.
  5. Document the revised indirectness note with the original judgement, the differences found, the reason each matters, and the resulting certainty implication, so a reader can trace the change.

A useful check is whether the revised note would let a reader predict how the effect might differ in their own setting. If it only restates that settings differ, add the mechanism: which characteristic, affecting which outcome, in which direction.

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