Table 3.
Focus of the outcome reporting recommendations (n = 1758) identified within 244 eligible documents
| 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) |
aNot mutually exclusive