Core area | Core domains | Studies including one or more outcomes in core domain, n (%) | Outcomes included in core domain, n (%) |
Death | Mortality/survival | 10 (39) | 10 (2) |
Physiological/clinical | Blood and lymphatic system outcomes | 0 | 0 |
Cardiac outcomes | 5 (19) | 5 (1) | |
Congenital, familial and genetic outcomes | 0 | 0 | |
Endocrine outcomes | 1 (4) | 1 (<1) | |
Ear and labyrinth outcomes | 0 | 0 | |
Eye outcomes | 8 (31) | 9 (2) | |
Gastrointestinal outcomes | 1 (4) | 2 (<1) | |
General outcomes* | 19 (73) | 42 (8) | |
Hepatobiliary outcomes | 1 (4) | 1 (<1) | |
Immune system outcomes | 0 | 0 | |
Infection and infestation outcomes | 3 (12) | 3 (1) | |
Injury and poisoning outcomes | 1 (4) | 1 (<1) | |
Metabolism and nutrition outcomes | 26 (100) | 63 (13) | |
Musculoskeletal and connective tissue outcomes | 1 (4) | 1 (<1) | |
Outcomes relating to neoplasms: benign, malignant and unspecified (including cysts and polyps) | 0 | 0 | |
Nervous system outcomes | 4 (15) | 4 (1) | |
Pregnancy, puerperium and perinatal outcomes | 0 | 0 | |
Renal and urinary outcomes | 11 (42) | 13 (3) | |
Reproductive system and breast outcomes | 0 | 0 | |
Psychiatric outcomes | 5 (19) | 7 (1) | |
Respiratory, thoracic and mediastinal outcomes | 1 (4) | 1 (<1) | |
Skin and subcutaneous tissue outcomes | 0 | 0 | |
Vascular outcomes | 10 (39) | 12 (2) | |
Life impact | Social functioning | 14 (54) | 28 (6) |
Role functioning | 16 (62) | 20 (4) | |
Physical functioning | 24 (92) | 72 (14) | |
Emotional functioning/well-being | 24 (92) | 106 (21) | |
Cognitive functioning | 12 (46) | 15 (3) | |
Global quality of life | 3 (12) | 3 (1) | |
Perceived health status | 5 (19) | 5 (1) | |
Delivery of care | 18 (69) | 43 (9) | |
Personal circumstance | 7 (27) | 12 (2) | |
Resource use | Economic | 0 | 0 |
Hospital | 0 | 0 | |
Need for intervention | 9 (35) | 10 (2) | |
Societal/carer burden | 2 (8) | 2 (<1) | |
Adverse events | Adverse events/effects | 8 (31) | 10 (2) |
*The COMET taxonomy defines ‘general outcomes’ to include those affecting the whole body, which cannot be attributed to a certain body system, for example, fatigue, malaise, pain (unspecified, not associated with a particular body system), fever (not attributable to infection), anthropometric measures (eg, weight), ‘global’ measures, ‘symptoms’ (not associated with a particular body system), ‘physical health’ and fitness.45
COMET, Core Outcome Measures in Effectiveness Trials.