Core Outcome Measures in Effectiveness Trials

Physiological or clinical outcomes

Physiological outcomes are categorised according to the underlying cause or affected body system, grouped using the MedDRA System Organ Classes (SOCs). Users are advised to search the MedDRA categories listed within Bioportal to identify the relevant domain within which to classify outcomes (see http://bioportal.bioontology.org/ontologies/MEDDRA/?p=classes&conceptid=root). For example,

  • "Endocrine outcomes" are those associated with endocrine disorders.
  • Sleep outcomes may be classified as "nervous system outcomes", "psychiatric outcomes" or "metabolism and nutrition disorders", depending on cause.
  • "Outcomes related to neoplasms” include those relating to physiological function, signs and symptoms caused by benign, malignant and unspecified (including cysts and polyps) neoplasms, including solid and non-solid tumours. Examples of such outcomes include "time to recurrence", "response rate" and "clearance of resection margins".
  • "General outcomes" include those affecting the whole body which cannot be attributed to a certain body system, for example, fatigue, chills, flu like symptoms, malaise, anorexia, pain (unspecified, not associated with a particular body system), fever (not attributable to infection), anthropometric measures (e.g. weight), "global" measures, "symptoms" (not associated with a particular body system), "physical health" and fitness.
  • Laboratory parameters (for example, from blood samples) and scientific measures (for example, pharmacokinetic outcomes) should be classified within the physiological domain that captures the reason for the assessment (rather than within the "blood and lymphatic system" category, for example).
  • “Injury” outcomes such as "gastrointestinal injury" should be classified under the appropriate physiological/clinical domain ("gastrointestinal") rather than within the "injury/poisoning" domain – and recorded as an adverse event.
  • Bleeding events should be classified as "vascular" outcomes, rather than "injury" or "blood and lymphatic system".

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