Table 2 Completeness of reporting of CONSORT items and additional variables
From: Transparency and reporting characteristics of COVID-19 randomized controlled trials
Consort item | Checklist item | Complete reporting overall (n = 251) | Complete reporting in preprints (n = 130) | Complete reporting in journal publications (n = 121) | Absolute risk reduction in % [95% confidence interval) |
|---|---|---|---|---|---|
Section 6a, outcome | Completely defined pre-specified primary outcome measures, including how and when they were assessed | 81 (32%) | 39 (30%) | 42 (35%) | 5 [− 7–16] |
Section 8a, sequence generation | Method used to generate the random allocation sequence | 206 (82%) | 107 (82%) | 99 (82%) | 0 [− 10–9] |
Section 9, allocation concealment | Mechanism used to implement the random allocation sequence (e.g., sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned | 143 (57%) | 70 (54%) | 73 (60%) | 6 [− 6–19] |
Section 11a/b, blinding | If done, who was blinded after assignment to interventions (e.g., participants, care providers, those assessing outcomes) and how | 44/111 (40%) | 23/61 (38%) | 21/50 (42%) | 4 [− 14–23] |
Section 13a/b, participant flow | For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome (including losses and exclusions with reasons) | 133 (53%) | 69 (53%) | 64 (53%) | 0 [− 13–12] |
Section 17a, outcomes and estimation | For each primary outcome, results for each group and the estimated effect size and its precision (such as 95% confidence interval) | 127 (51%) | 67 (52%) | 60 (50%)a | − 2 [− 14–11] |
Section 19, harmsb | All important harms or unintended effects in each group | 36 (14%) | 10 (8%) | 26 (21%)a | 13 [5–23] |
Section 23, registrationc | Registration number | 231/239 (91%) | 127/129 (99%) | 104/110 (95%) | − 4 [− 9–1] |
Overall | Overall CONSORT assessment | 15 (6%) | 5 (4%) | 10 (8%) | 4 [− 2–10] |
Additional items | |||||
 Funding | Funding information | 235 (94%) | 125 (96%) | 110 (91%) | − 5 [− 11–1] |
 Conflict of interest | Statement of conflicting interests | 237 (94%) | 125 (96%) | 112 (93%) | − 3 [− 9–2] |
 Ethical approval | Statement of ethical approval | 248 (99%) | 130 (100 %) | 118 (98%) | − 2 [− 5–0] |