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Title
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Identification of the study as randomised
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Authors
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Contact details for the corresponding author
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Trial design
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Description of the trial design (e.g. parallel, cluster, noninferiority)
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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]
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Methods
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Participants
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Eligibility criteria for participants and the settings where the data were collected
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When applicable, eligibility criteria for the setting of intervention delivery and the eligibility criteria for the persons who delivered the interventions
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Interventions
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Interventions intended for each group
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Objective
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Specific objective or hypothesis
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If pre-specified, how the intervention was hypothesised to work
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Outcomes
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Clearly defined primary outcome for this report
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Randomisation
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How participants were allocated to interventions
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Awareness of assignment
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Who was aware of intervention assignment after allocation (for example, participants, providers, those assessing outcomes), and how any masking was done
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Results
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Number randomly assigned
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Number randomised to each group
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Recruitment
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Trial status
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Interventions
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Extent to which interventions were actually delivered by providers and taken up by participants as planned
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Number analysed
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Number analysed in each group
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Outcomes
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For the primary outcome, a result for each group and the estimated effect size and its precision
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Harms
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Important adverse events or side effects
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Conclusions
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General interpretation of the results
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Trial registration
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Registration number and name of trial register
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Funding
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Source of funding
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