Procedural complication rate

Method

Complications recorded after an interventional procedure (percutaneous thermal or chemical ablation, biopsy, catheterisation), counted per patient or per session and graded by the trial stated classification such as CIRSE or Clavien-Dindo. The denominator, patients or sessions, is recorded on the edge.

The method is part of the endpoint identity. Studies measuring the same quantity by a different method are held as separate endpoints.

Notes

Belongs to procedures, not to substances. The near-miss is adverse event occurrence with an oral or enteral supplement: needle-track haemorrhage after an ablation and nausea after a capsule share the word adverse and nothing else, base rates differ by an order of magnitude, and the causal chain is mechanical rather than pharmacological. Note also that the per-session denominator is not interchangeable with per-patient when patients receive multiple sessions, which inflates or deflates the rate by the mean session count.