PAPER SECTION And topic |
Item | Descriptor | Reported on Page # |
---|---|---|---|
TITLE & ABSTRACT | 1 | How participants were allocated to interventions | 1, 2 |
INTRODUCTION Background |
2 | Scientific background and explanation of rationale. | 3–9, 12 |
METHODS Participants |
3 | Eligibility criteria for participants and the settings and locations where the data were collected. | 9,10 |
Interventions | 4 | Precise details of the interventions intended for each group and how and when they were actually administered. | 13–14 |
Objectives | 5 | Specific objectives and hypotheses. | 8–9 |
Outcomes | 6 | Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements | 10–12 |
Sample size | 7 | How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules. | 9–10 |
Randomization -- Sequence generation | 8 | Method used to generate the random allocation sequence, including details of any restrictions | 10 |
Randomization -- Allocation concealment | 9 | Method used to implement the random allocation sequence | 10 |
Randomization -- Implementation | 10 | Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups. | 10 |
Blinding (masking) | 11 | Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated. | 13,18 |
Statistical methods | 12 | Statistical methods used to compare groups for primary outcome(s); Methods for additional analyses, such as subgroup analyses and adjusted analyses. | 15–16 |
RESULTS Participant flow |
13 | Flow of participants through each stage Describe protocol deviations from study as planned, together with reasons. | 9–10,36 |
Recruitment | 14 | Dates defining the periods of recruitment and follow-up. | 9 |
Baseline data | 15 | Baseline demographic and clinical characteristics of each group. | 9–10, 17 |
Numbers analyzed | 16 | Number of participants (denominator) in each group included in each analysis and whether the analysis was by "intention-to-treat". | 9–10, 15–16 |
Outcomes and estimation | 17 | For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision | 18–21 |
Ancillary analyses | 18 | Address multiplicity by reporting any other analyses performed | 17, 20–21 |
Adverse events | 19 | All important adverse events or side effects in each intervention group. | n/a |
DISCUSSION Interpretation |
20 | Interpretation of the results | 21–24 |
Generalizability | 21 | Generalizability (external validity) of the trial findings. | 24 |
Overall evidence | 22 | General interpretation of the results in the context of current evidence. | 21–24 |