Table 4 Reporting assessment of included studies based on the CONSORT items (n = 1458)
Section/topic | Item number and description | Fully reported | Partially reported | Not reported |
|---|---|---|---|---|
Title and abstract | 1a. Identification as a randomized trial in the title | 13 (0.89) | – | 1445 (99.11) |
1b. Structured summary of trial design, methods, results, and conclusions | See Table 5 | |||
Introduction | ||||
Background | 2a. Scientific background and explanation of rationale | 1356 (93.00) | – | 102 (7.00) |
Objectives | 2b. Specific objectives or hypotheses | 535 (36.69) | – | 923 (63.31) |
Methods | ||||
Trial design | 3a. Description of trial design (such as parallel, factorial) including allocation ratio | 4 (0.27) | 63 (4.32) | 1391 (95.40) |
3b. Important changes to methods after trial commencement (such as eligibility criteria), with reasons | 13 (0.89) | – | 1445 (99.11) | |
Participants | 4a. Eligibility criteria for participants | 861 (59.05) | 458 (31.41) | 139 (9.53) |
4b. Settings and locations where the data were collected | 1046 (71.74) | 91 (6.24) | 321 (22.02) | |
Interventions | 5. The interventions for each group with sufficient details to allow replication, including how and when they were actually administered | 1094 (75.03) | 358 (24.55) | 6 (0.41) |
Outcomes | 6a. Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | 3 (0.21) | 596 (40.88) | 859 (58.92) |
6b. Any changes to trial outcomes after the trial commenced, with reasons | 1458 (100) | – | – | |
Sample size | 7a. How sample size was determined | 5 (0.34) | 3 (0.21) | 1450 (99.45) |
7b. When applicable, explanation of any interim analyses and stopping guidelines | 41 (2.81) | – | 1417 (97.19) | |
Sequence generation | 8a. Method used to generate the random allocation sequence | 522 (35.80) | 835 (57.27) | 101 (6.93) |
8b. Type of randomization; details of any restriction (such as blocking and block size) | 11 (0.75) | 511 (35.05) | 936 (64.20) | |
Allocation concealment mechanism | 9. Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned | 16 (1.10) | 507 (34.77) | 935 (64.13) |
Implementation | 10. Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 6 (0.41) | – | 1452 (99.59) |
Blinding | 11a. If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how a | 1 (0.07) | 9 (0.62) | 1445 (99.31) |
11b. If relevant, description of the similarity of interventions b | 13 (76.47) | 4 (23.53) | – | |
Statistical methods | 12a. Statistical methods used to compare groups for primary and secondary outcomes | 16 (1.10) | 1185 (81.28) | 257 (17.63) |
12b. Methods for additional analyses, such as subgroup analyses and adjusted analyses | 0 (0) | – | 1458 (100) | |
Results | ||||
Participant flow | 13a. For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome | 1278 (87.65) | 173 (11.87) | 7 (0.48) |
13b. For each group, losses and exclusions after randomization, together with reasons | 53 (3.64) | 31 (2.13) | 1374 (94.24) | |
Recruitment | 14a. Dates defining the periods of recruitment and follow-up | 238 (16.32) | 1034 (70.92) | 186 (12.76) |
14b. Why the trial ended or was stopped | 0 (0) | – | 1458 (100) | |
Baseline data | 15. A table showing baseline demographic and clinical characteristics for each group | 1456 (99.86) | – | 2 (0.14) |
Numbers analyzed | 16. For each group, the number of participants (denominator) included in each analysis and whether the analysis was by originally assigned groups | 1279 (87.72) | – | 179 (12.28) |
Outcomes and estimation | 17a. For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) | 0 (0) | 1450 (99.45) | 8 (0.55) |
17b. For binary outcomes, the presentation of both absolute and relative effect sizes is recommended | 0 (0) | – | 1458 (100) | |
Ancillary analyses | 18. Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | 0 (0) | – | 1458 (100) |
Harms | 19. All-important harms or unintended effects in each group | 550 (37.72) | 23 (1.58) | 885 (60.70) |
Discussion | ||||
Limitations | 20. Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | 193 (13.24) | – | 1265 (86.76) |
Generalizability | 21. Generalizability (external validity, applicability) of the trial findings | 9 (0.62) | – | 1449 (99.38) |
Interpretation | 22. Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence | 1458 (100) | – | – |
Other information | ||||
Registration | 23. Registration number and name of trial registry | 3 (0.21) | – | 1455 (99.79) |
Protocol | 24. Where the full trial protocol can be accessed, if available | 1 (0.07) | 1 (0.07) | 1456 (99.86) |
Funding | 25. Sources of funding and other support (such as the supply of drugs), role of funders | 3 (0.21) | 282 (19.34) | 1173 (80.45) |