Table 1 Elements of abstract reporting
Manuscript section | CONSORT recommendations | Elements included in current analysis | Abstract reporting element number |
|---|---|---|---|
Title | 1. Identification of the study as randomized | Identification of the study as randomized | 1 |
Authors | 2. Contact details for the corresponding author | Not included in the current analysisa | |
Trial design | 3. Description of the trial design (e.g., parallel, cluster, non-inferiority) | Abstract specifies whether specific description of the trial design was included (e.g., parallel, cluster, non-inferiority) | 2 |
Methods | 4. Eligibility criteria for participants and the settings where the data were collected | Abstract specifies the eligibility criteria for participants relating to demographics, clinical diagnosis, and co morbid conditions. | 3 |
Abstract specifies the setting in which the trial took place (for example primary, secondary, tertiary centers) | 4 | ||
5. Interventions intended for each group | Abstract specifies medication intervention intended for each study group | 5 | |
6. Specific objective or hypothesis | Abstract specifies the objective or hypothesis of the study | 6 | |
7. Clearly defined primary outcome for this report | Abstract clearly states the primary outcome or endpoint in the study | 7 | |
Abstract describes over what period of time the primary outcome or endpoint was assessed | 8 | ||
8. How participants were allocated to interventions | Abstract describes the method by which participants were assigned to interventions to ensure adequate concealment (e.g. use of computer or random number table) | 9 | |
9. Whether or not participants, care givers, and those assessing the outcomes were blinded to group assignment | Abstract specifies whether participants, care givers, and those assessing the outcomes were masked or blinded to the group allocation | 10 | |
Results | 10. Number of participants randomized to each group | Abstract reports absolute numbers of patients randomized to each group | 11 |
11. Trial status | Abstract reports the status of the trial and whether it is ongoing, closed to recruitment or closed to follow-up | 12 | |
12. Number of participants analyzed in each group | Abstract reports either absolute numbers analyzed in each group or indicates this is an intention to treat analysis | 13 | |
13. For the primary outcome, a result for each group and the estimated effect size and its precision | 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) | 14 | |
Harms | 14. Important adverse events or side effects | Abstract explicitly describe any important or unexpected adverse events | 15 |
Conclusions | 15. General interpretation of results | Abstract states conclusions of the trial consistent with reported results. | 16 |
16. Registration number and name of trial register | Abstract reports registration number and name of trial register | 17 | |
17. Source of funding | Abstract lists funding source for study | 18 |