10c 6 From whom consent was sought (representatives of the cluster, or individual cluster members, or both), and whether consent was sought before or after randomisation Blinding 11a If done, who was blinded 8 after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11b If relevant, description of the 6-7 similarity of interventions Statistical methods 12a 9-10 Statistical methods used to How clustering was taken into compare groups for primary account and secondary outcomes 12b Methods for additional 10 analyses, such as subgroup analyses and adjusted analyses Results Participant flow (a 13a For each group, the numbers For each group, the numbers of 10-11 diagram is strongly of participants who were clusters that were randomly recommended) randomly assigned, received assigned, received intended intended treatment, and treatment, and were analysed for were analysed for the the primary outcome primary outcome 13b 10-11 For each group, losses and For each group, losses and exclusions after exclusions for both clusters and randomisation, together with individual cluster members reasons Recruitment 14a Dates defining the periods of 11, Figure 1 recruitment and follow-up 14b Why the trial ended or was 11 stopped Baseline data 15 23 A table showing baseline Baseline characteristics for the demographic and clinical individual and cluster levels as characteristics for each applicable for each group group
10c From whom consent was sought (representatives of the cluster, or individual cluster members, or both), and whether consent was sought before or after randomisation 6 Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 8 11b If relevant, description of the similarity of interventions 6-7 Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes How clustering was taken into account 9-10 12b Methods for additional analyses, such as subgroup analyses and adjusted analyses 10 Results Participant flow (a diagram is strongly recommended) 13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome For each group, the numbers of clusters that were randomly assigned, received intended treatment, and were analysed for the primary outcome 10-11 13b For each group, losses and exclusions after randomisation, together with reasons For each group, losses and exclusions for both clusters and individual cluster members 10-11 Recruitment 14a Dates defining the periods of recruitment and follow-up 11, Figure 1 14b Why the trial ended or was stopped 11 Baseline data 15 A table showing baseline demographic and clinical characteristics for each group Baseline characteristics for the individual and cluster levels as applicable for each group 23
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