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Table 5 Items to report in the main text for cluster randomised social and psychological intervention trials [33]

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

Section Item # Cluster extension item
Title 1a Identification as a cluster randomised trial in the title
Abstract 1b See Table 4
Introduction
 Background and objectives 2a Rationale for using a cluster design
2b Whether objectives pertain to the cluster level, the individual participant level, or both
Methods
 Trial design 3a Definition of cluster and description of how the design features apply to the clusters
 Participants 4a Eligibility criteria for clusters
 Interventions 5 Whether interventions pertain to the cluster level, the individual participant level, or both
 Outcomes 6a Whether outcome measures pertain to the cluster level, the individual participant level, or both
 Sample size 7a Method of calculation, number of clusters(s) (and whether equal or unequal cluster sizes are assumed), cluster size, a coefficient of intracluster correlation (ICC or k), and an indication of its uncertainty
 Randomisation
  Sequence generation 8b Details of stratification or matching if used
  Allocation concealment mechanism 9 Specification that allocation was based on clusters rather than individuals and whether allocation concealment (if any) was at the cluster level, the individual participant level, or both
 Implementation 10a Who generated the random allocation sequence, who enrolled clusters, and who assigned clusters to interventions
10b Mechanism by which individual participants were included in clusters for the purposes of the trial (such as complete enumeration, random sampling)
10c From whom consent was sought (representatives of the cluster, individual cluster members, or both) and whether consent was sought before or after randomisation
Analytical methods 12a How clustering was taken into account
Results
 Participant flow (a diagram is strongly recommended) 13a For each group, the numbers of clusters that were randomly assigned, received the intended treatment, and were analysed for the primary outcome
13b For each group, losses and exclusions for both clusters and individual cluster members
 Baseline data 15 Baseline characteristics for the individual and cluster levels as applicable for each group
 Numbers analysed 16 For each group, the number of clusters included in each analysis
 Outcomes and estimation 17a Results at the individual or cluster level as applicable and a coefficient of intracluster correlation (ICC or k) for each primary outcome
 Generalisability 21 Generalisability to clusters or individual participants (as relevant)