Table 3 Focus of the outcome reporting recommendations (n = 1758) identified within 244 eligible documents
From: Outcome reporting recommendations for clinical trial protocols and reports: a scoping review
N (%) | |
|---|---|
Trial document typea | |
Trial reports | 781 (44.4) |
Trial protocols | 758 (43.1) |
General trial reporting | 229 (13.0) |
Ethics boards documents for trial submissions | 21 (1.2) |
Study proposal for a trial in grant application(s) | 1 (0.06) |
Trial type | |
No specific focus explicitly stated | 1369 (77.9) |
All trials | 124 (7.1) |
Specific trial focusa | 265 (15.1) |
Phasea | 102 (5.8) |
Pilot/feasibility | 33 (1.9) |
II | 45 (2.6) |
III | 64 (3.6) |
Designa | 102 (5.8) |
N-of-1 | 44 (2.5) |
Cluster | 16 (0.9) |
Non-inferiority | 14 (0.8) |
Equivalence | 11 (0.6) |
Within person | 10 (0.6) |
Parallel | 9 (0.5) |
Crossover | 6 (0.3) |
Adaptive | 6 (0.3) |
Superiority | 5 (0.3) |
Pragmatic | 3 (0.2) |
Outcomes | |
No specific focus explicitly stated | 911 (51.8) |
All outcomes | 11 (0.6) |
Specific outcome focusa | 836 (47.6) |
Outcome classificationa | 469 (26.7) |
Primary | 458 (26.1) |
Secondary | 326 (18.5) |
“Important” | 7 (0.4) |
Tertiary/exploratory | 6 (0.3) |
Outcome typea | 474 (27.0) |
Patient-reported outcome | 288 (16.4) |
Harm/adverse event | 116 (6.6) |
Biological marker | 41 (2.3) |
Efficacy outcome | 33 (1.9) |
Composite outcome | 13 (0.7) |
Survival/time-to-event outcome | 11 (0.6) |
Surrogate outcome | 8 (0.5) |
Clinician-reported outcome | 7 (0.4) |
Continuous outcome | 4 (0.2) |
Binary outcome | 3 (0.2) |
“Unintended” outcome | 1 (0.06) |