A composite outcome combines a number of outcomes into a single endpoint. A composite outcome may have benefits in some situations but can lead to errors in others. Heddle and Cook listed a number of questions which can be used to determine if a composite outcome is appropriate for a clinical trial.


Criteria for evaluating the use of a composite outcome:

(1) The components of the composite outcome are associated with the primary objective of the study.

(2) The composite outcome is biologically justifiable (Ross uses biologically plausible).

(3) The components are all meaningful/relevant to patients.

(4) The components are all meaningful/relevant to clinicians.

(5) The components are of equal value and frequency.

(6) The composite outcome is clinically relevant.

(7) The study design specifies that the primary analysis will involve the composite outcome and that a secondary analysis on the components will be reported separately.


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