Title |
Identification of the study as randomised |
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Authors |
Contact details for the corresponding author |
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Trial design |
Description of the trial design (e.g. parallel, cluster, noninferiority) |
If the unit of random assignment is not the individual, refer to CONSORT for Cluster Randomised Trials and report the items included in its extension for abstracts [8] |
Methods |
Participants |
Eligibility criteria for participants and the settings where the data were collected |
When applicable, eligibility criteria for the setting of intervention delivery and the eligibility criteria for the persons who delivered the interventions |
Interventions |
Interventions intended for each group |
|
Objective |
Specific objective or hypothesis |
If pre-specified, how the intervention was hypothesised to work |
Outcomes |
Clearly defined primary outcome for this report |
|
Randomisation |
How participants were allocated to interventions |
|
Awareness of assignment |
Who was aware of intervention assignment after allocation (for example, participants, providers, those assessing outcomes), and how any masking was done |
|
Results |
Number randomly assigned |
Number randomised to each group |
|
Recruitment |
Trial status |
|
Interventions |
|
Extent to which interventions were actually delivered by providers and taken up by participants as planned |
Number analysed |
Number analysed in each group |
|
Outcomes |
For the primary outcome, a result for each group and the estimated effect size and its precision |
|
Harms |
Important adverse events or side effects |
|
Conclusions |
General interpretation of the results |
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Trial registration |
Registration number and name of trial register |
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Funding |
Source of funding |
|