Table 4 Items to report in the abstract for cluster randomised social and psychological intervention trials [8]
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 | Â |
Trial design | Description of the trial design (e.g. parallel, cluster, noninferiority) | Â |
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 | Â |
Trial registration | Registration number and name of trial register | Â |
Funding | Source of funding | Â |