Section | CONSORT Abstract item | Relevant CONSORT-SPI item |
---|---|---|
Title | Identification of the study as randomised | Â |
Authors | Contact details for the corresponding author | Â |
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 | Â | 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 | Â |
Trial registration | Registration number and name of trial register | Â |
Funding | Source of funding | Â |