Reporting elements | Number (%) |
---|---|
1. Identification of the study as randomized | 100 (57 %) |
2. Abstract specifies whether specific description of the trial design was included (e.g., parallel, cluster, non-inferiority) | 34 (20 %) |
3. Abstract specifies the eligibility criteria for participants relating to demographics, clinical diagnosis, and comorbid conditions. | 171 (98 %) |
4. Abstract specifies the setting in which the trial took place (e.e., primary, secondary, tertiary centers) | 24 (14 %) |
5. Abstract specifies medication intervention intended for each study group | 174 (100 %) |
6. Abstract specifies the objective or hypothesis of the study | 166 (95 %) |
7. Abstract clearly states the primary outcome or endpoint in the study | 151 (87 %) |
8. Abstract describes over what period of time the primary outcome or endpoint was assessed | 29 (17 %) |
9. Abstract describes the method by which participants were assigned to interventions to ensure adequate concealment (e.g., use of computer or random number table) | 22 (13 %) |
10. Abstract specifies whether participants, care givers, and those assessing the outcomes were masked or blinded to the group allocation | 42 (24 %) |
11. Abstract reports absolute numbers of patients randomized to each group | 80 (46 %) |
12. Abstract reports the status of the trial and whether it is ongoing, closed to recruitment or closed to follow up | 39 (22 %) |
13. Abstract reports either absolute numbers analyzed in each group or indicates this is an intention-to-treat analysis | 45 (26 %) |
14. Abstract reports trial results as a summary of the outcome for each group and the contrast between the groups (examples include relative risk, odds ratio, hazard ratio, confidence intervals) | 152 (87 %) |
15. Abstract explicitly describes any important or unexpected adverse events | 129 (74 %) |
16. Abstract states conclusions of the trial consistent with reported results. | 168 (97 %) |
17. Abstract reports registration number and name of trial register | 46 (26 %) |
18. Abstract lists funding source for study | 31 (18 %) |