Core Outcome Measures in Effectiveness Trials

Composite outcomes

  • Outcomes which cover multiple domains (e.g. if the questions included in a HRQL measurement tool relate to more than one domain) should be classified in all relevant domains.
  • Similarly, composite survival outcomes (e.g. disease-free survival) need to be classified according to the condition/disease as well as under Mortality/survival. Amputation-free survival would be classified under Need for further intervention and Mortality/survival.
  • "Time to treatment failure" may be defined as specifically including events relating to relapse, progression, death, etc. In this case, this outcome should be classified within the Delivery of care domain and all other domains relating to the included event types (for example, "treatment failure due to inefficacy or side effects" would be categorised within the relevant physiological domain and AE domain, as well as the Delivery of care domain).

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