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Table 4 Items to report in the abstract for cluster randomised social and psychological intervention trials [33]

From: Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension

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