Table 4.

Items to report in the abstract for cluster randomised social and psychological intervention trials [33]

Section	CONSORT Abstract item	Relevant CONSORT Cluster extension item
Title	Identification of the study as randomised	Identification of study as cluster randomised
Authors	Contact details for the corresponding author
Trial design	Description of the trial design (e.g. parallel, cluster, noninferiority)
Methods
Participants	Eligibility criteria for participants and the settings where the data were collected	Eligibility criteria for clusters
Interventions	Interventions intended for each group
Objective	Specific objective or hypothesis	Whether objective or hypothesis pertains to the cluster level, the individual participant level, or both
Outcomes	Clearly defined primary outcome for this report	Whether the primary outcome pertains to the cluster level, the individual participant level, or both
Randomisation	How participants were allocated to interventions	How clusters 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 of participants randomised to each group	Number of clusters randomised to each group
Recruitment	Trial status
Number analysed	Number of participants analysed in each group	Number of clusters analysed in each group
Outcomes	For the primary outcome, a result for each group and the estimated effect size and its precision	Results at the cluster or individual level as applicable for each primary outcome
Harms	Important adverse events or side effects
Conclusions	General interpretation of the results
Trial registration	Registration number and name of trial register
Funding	Source of funding