Table 5 Items to report in the main text for cluster randomised social and psychological intervention trials [8]
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 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, 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 and/or individual participants (as relevant) |