Table 4.
Comparison of clinical trial registration outcomes and qualitative literature outcomes by domain.
| Outcome Domain | Trial registry entries (n=38) | Qualitative studies (n=6) | ||
| Total number of unique outcomes within domain (number of verbatim outcomes) | Number of studies reporting one or more outcomes in the domain (%) | Total number of unique outcomes within domain (number of verbatim outcomes) | Number of studies reporting one or more outcomes in the domain (%) | |
| 1. Mortality/survival | 1 (1) | 1 (3) | 1(1) | 1 (17) |
| 2. Blood and lymphatic system outcomes | 1 (1) | 1 (3 | 0 (0) | 0 (0) |
| 3. Cardiac outcomes | 1 (2)* | 2 (5) | 1 (1) | 1 (17) |
| 4. Congenital, familial and genetic outcomes | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| 5. Endocrine outcomes | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| 6. Ear and labyrinth outcomes | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| 7. Eye outcomes | 1 (5)* | 5 (14) | 1 (17)* | 5 (83) |
| 8. Gastrointestinal outcomes | 0 (0) | 0 (0) | 1 (5) | 2 (33) |
| 9. General outcomes | 8 (37) | 17 (46) | 9 (23) | 6 (100) |
| 10. Hepatobiliary outcomes | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| 11. Immune system outcomes | 1 (14) | 9 (24) | 1 (1) | 1 (17) |
| 12. Infection and infestation outcomes | 1 (2) | 1 (3) | 0 (0) | 0 (0) |
| 13. Injury and poisoning outcomes | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| 14. Metabolism and nutrition outcomes | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| 15. Musculoskeletal and connective tissue outcomes | 0 (0) | 0 (0) | 6 (8) | 2 (33) |
| 16. Outcomes relating to neoplasms: benign, malignant and unspecified (including cysts and polyps) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| 17. Nervous system outcomes | 1 (1) | 1 (3) | 2 (2) | 2 (33) |
| 18. Pregnancy, puerperium and perinatal outcomes | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| 19. Renal and urinary outcomes | 1 (1) | 1 (3) | 1 (1) | 1 (17) |
| 20. Reproductive system and breast outcomes | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| 21. Psychiatric outcomes | 3 (3) | 2 (5) | 3(7) | 4 (67) |
| 22. Respiratory, thoracic and mediastinal outcomes | 10 (146) | 33 (89) | 12 (22) | 6 (100) |
| 23. Skin and subcutaneous tissue outcomes | 1 (6)* | 6 (16) | 1 (18)* | 4 (67) |
| 24. Vascular outcomes | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| 25. Physical functioning | 5 (23) | 13 (35) | 8 (14) | 4 (67) |
| 26. Social functioning | 1 (18) | 12 (32) | 3 (7) | 4 (67) |
| 27. Role functioning | 5 (16) | 7 (19) | 7 (9) | 3 (50) |
| 28. Emotional functioning/wellbeing | 3 (20) | 15 (41) | 12 (16) | 6 (100) |
| 29. Cognitive functioning | 1 (2) | 2 (5) | 3 (4) | 3 (50) |
| 30. Global quality of life | 2 (6) | 5 (14) | 1 (1) | 1 (17) |
| 31. Perceived health status | 1 (12) | 6 (16) | 1 (1) | 1 (17) |
| 32. Delivery of care | 5 (11) | 9 (24) | 2 (3) | 2 (33) |
| 33. Personal circumstances | 0 (0) | 0 (0) | 4 (6) | 4 (67) |
| 34. Economic | 1 (1) | 1(3) | 0 (0) | 0 (0) |
| 35. Hospital | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| 36. Need for intervention | 1 (1) | 1 (3) | 0 (0) | 0 (0) |
| 37. Societal/carer burden | 0 (0) | 0 (0) | 1 (3) | 2 (33) |
| 38. Adverse events/effects | 1 (35)** | 19 (51) | 1 (9) | 5 (83) |
*For the purpose of the Delphi survey outcomes considered to be extra-pulmonary organ involvement were grouped into one larger unique outcome “extra pulmonary organ involvement” rather than more granular outcomes within the domain.
**Some studies included treatment specific adverse events. However, for the purpose of the Delphi survey adverse events were grouped under a “side effects of treatment “ outcome.