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)
|