Table 3.
Reporting Categoryb | Completely Reported n (% of Applicable Trials) |
Partially Reported n (% of Applicable Trials) |
Not Reported n (% of Applicable Trials) |
Category Not Applicable n |
---|---|---|---|---|
Background | ||||
Background/rationale | 310 (93.1) | 12 (3.6) | 1 (0.3) | 0 |
Methods | ||||
Interventions | 310 (93.1) | 12 (3.6) | 1 (0.3) | 0 |
Trial design | 275 (82.6) | 27 (8.1) | 21 (6.3) | 0 |
Primary outcome | 266 (79.9) | 54 (16.2) | 3 (0.9) | 0 |
Statistical methods | 253 (76.0) | 16 (4.8) | 54 (16.2) | 0 |
Participant criteria | 246 (73.9) | 57 (17.1) | 19 (5.7) | 0 |
Secondary outcome | 201 (63.8) | 43 (13.6) | 71 (22.5) | 8 |
Trial phase | 183 (55.0) | 1 (0.3) | 139 (41.7) | 0 |
Blinding | 119 (55.6) | 35 (16.4) | 60 (28.0) | 109 |
Randomization | 116 (54.7) | 54 (25.5) | 42 (19.8) | 111 |
Sample size | 94 (28.2) | 19 (5.7) | 210 (63.1) | 0 |
Results | ||||
Primary endpoint | 295 (88.6) | 14 (4.2) | 14 (4.2) | 0 |
Harms/side effects | 232 (69.7) | 11 (3.3) | 80 (24.0) | 0 |
Participant flow | 200 (60.1) | 87 (26.1) | 36 (10.8) | 0 |
Deaths | 190 (57.1) | 2 (0.6) | 131 (39.3) | 0 |
Recruitment period | 168 (50.5) | 5 (1.5) | 150 (45.0) | 0 |
Severity of harms | 153 (45.9) | 16 (4.8) | 154 (46.2) | 0 |
Conclusion | ||||
Generalizability | 300 (90.1) | 17 (5.1) | 6 (1.8) | 0 |
Interpretation | 272 (81.7) | 43 (12.9) | 8 (2.4) | 0 |
Limitations | 191 (57.4) | 66 (19.8) | 66 (19.8) | 0 |
Other | ||||
Protocol | 295 (88.6) | 7 (2.1) | 21 (6.3) | 0 |
Funding | 276 (82.9) | 5 (1.5) | 42 (12.6) | 0 |
Registration | 244 (73.3) | 6 (1.8) | 73 (21.9) | 0 |
Ten non-English-language publications were excluded from our analysis of completeness score. Percentages exclude trials with non-applicable reporting categories.
Reporting categories modified for early-phase clinical trials from CONSORT (Moher et al., 2010, Schulz et al., 2010).