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. 2015 Jul 2;58(1):43–58. doi: 10.1002/bimj.201300274

Table 2.

Thresholds for determining the extent of an effect

Extent category Outcome category
All‐cause mortality Serious (or severe) symptoms (or late complications) and adverse events, as well as quality of lifea ) Nonserious (or nonsevere) symptoms (or late complications) and adverse events
Major 0.85 0.75 and risk ≥ 5%b ) Not applicable
Considerable 0.95 0.90 0.80
Minor 1.00 1.00 0.90
a

Precondition (as for all patient‐reported outcomes): use of a validated or established instrument, as well as a validated or established response criterion.

b

Risk must be at least 5% for at least one of the two groups compared.