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) |