Table 2 CONSORT checklist items for assessment from abstracts of included RCTs
Items | Assessment criteria | Assessment of individual journals, n(%) | Overall, n(%) (n = 271) | |||
|---|---|---|---|---|---|---|
|  |  | NEJM (n = 113) | Lancet (n = 80) | JAMA (n = 43) | BMJ (n = 35) |  |
Title | Study identified as randomized in title | 5 (4.4) | 79 (98.6) | 41 (95.3) | 34 (97.1) | 159 (58.7) |
| Â | Mentioned random/randomized in abstract | 110 (97.3) | 80 (100) | 43 (100) | 35 (100) | 268 (98.9) |
Authors | Addresses including postal and emails | 75 (66.4) | 54 (67.5) | 33 (76.7) | 29 (82.9) | 191 (70.5) |
| Â | Only postal address | 24 (21.2) | 26 (32.5) | 7 (16.3) | 6 (17.1) | 64 (23.6) |
Trial design | Descriptions provided (parallel, factorial, crossover, etc.) | 21 (18.6) | 23 (28.8) | 9 (20.9) | 10 (28.6) | 63 (23.3) |
Methods | Â | Â | Â | Â | Â | Â |
Participants | Eligibility criteria with settings of data collection | 29 (25.7) | 61 (76.3) | 40 (93.0) | 35 (100) | 165 (60.9) |
| Â | Only eligibility criteria provided | 111 (98.2) | 80 (100) | 43 (100) | 35 (100) | 269 (99.3) |
Interventions | Details including denomination, usage, course of treatment for both groups | 97 (85.8) | 74 (92.5) | 40 (93.0) | 35 (100) | 246 (90.8) |
Objective | Specific objective/hypothesis | 40 (35.4) | 80 (100) | 42 (97.7) | 35 (100) | 197 (72.7) |
| Â | Only background described | 73 (64.6) | - | 1 (0.9) | - | 74 (27.3) |
Outcome | Clearly defined primary outcome | 99 (87.6) | 80 (100) | 43 (100) | 35 (100) | 257 (94.8) |
Randomization | Reported the method of random sequence generation | 8 (7.1) | 71 (88.6) | 3 (7.0) | 2 (5.7) | 84 (31.0) |
| Â | Allocation concealment | - | 31 (38.6) | - | 1 (2.9) | 32 (11.8) |
Blinding | Generic description* | 40 (35.4) | 26 (32.5) | 20 (46.5) | 16 (45.7) | 102 (37.6) |
| Â | Detailed description++ | 2 (1.8) | 46 (57.5) | 6 (14.0) | 3 (8.6) | 57 (21.0) |
Results | Â | Â | Â | Â | Â | Â |
Numbers randomized | Number of participants randomized in each group | 58 (51.3) | 79 (98.6) | 32 (74.4) | 22 (62.9) | 191 (70.5) |
Numbers analyzed | Number of participants analyzed for each group | 58 (51.3) | 77 (96.3) | 30 (69.8) | 21 (60.0) | 186 (68.7) |
Outcomes | Primary outcome result for each group | 87 (76.9) | 78 (97.5) | 39 (90.7) | 24 (68.6) | 228 (84.1) |
| Â | For primary outcome, effect size and confidence interval reported (in total) | 35 (31.0) | 54 (67.5) | 24 (55.8) | 15 (42.9) | 128 (47.2) |
| Â | Effect size and confidence interval (trials with binary outcome) | 26 (out of 50) (52.0) | 33 (out of 45) (73.3) | 12 (out of 19) (63.2) | 10 (out of 15) (66.7) | 81 (out of 127) (63.8) |
| Â | Effect size and confidence interval (trials with continuous outcome) | 0 (out of 8) | 8 (out of 13)(61.5) | 5 (out of 10)(50.0) | 2 (out of 6)(33.3) | 15 (out of 37) (40.5) |
Harms | Adverse event or side effect reported | 53 (46.9) | 50 (62.5) | 7 (16.3) | 6 (17.1) | 116 (42.8) |
Conclusions | Discussed benefit or harm from the intervention | 28 (24.8) | 13 (16.3) | 5 (11.6) | 9 (25.7) | 55 (20.3) |
| Â | Stated only the benefit from the intervention | 84 (74.3) | 65 (81.3) | 38 (88.4) | 25 (71.4) | 212 (78.2) |
Trial registration | Reported registration number and name of trial register | 113 (100) | 78 (97.5) | 43 (100) | 35 (100) | 269 (99.3) |
Funding | Reported the source of funding | 52 (46.0) | 77 (96.3) | - | - | 129 (47.6) |