Table 1: CONSORT 2010 checklist of information to include when reporting a cluster randomised trial Section/Topic Item No Standard Checklist item Extension for cluster designs Page No * Title and abstract 1a Identification as a randomised trial in the title Identification as a cluster randomised trial in the title 1 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts), See table 2 2-3 Introduction Background and objectives 2a Scientific background and explanation of rationale Rationale for using a cluster design 4, 6 2b Specific objectives or hypotheses Whether objectives pertain to the the cluster level, the individual participant level or both 4-5 Methods Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio Definition of cluster and description of how the design features apply to the clusters 5-6 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons N/A Participants 4a Eligibility criteria for participants Eligibility criteria for clusters 5 4b Settings and locations where the data were collected 5 Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Whether interventions pertain to the cluster level, the individual participant level or both 6-7 Outcomes 6a Completely defined primary and secondary outcome measures, including how and Whether outcome measures pertain to the cluster level, the individual participant level or both 7
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
Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups For each group, number of clusters included in each analysis 23 Outcomes and estimation 17a For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Results at the individual or cluster level as applicable and a coefficient of intracluster correlation (ICC or k) for each primary outcome 12, 24-25 17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended N/A Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 12, 24-25 Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) N/A Discussion Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 15 Generalisability 21 Generalisability (external validity, applicability) of the trial findings Generalisability to clusters and/or individual participants (as relevant) 13-14 Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 12-14 Other information Registration 23 Registration number and name of trial registry 3 Protocol 24 Where the full trial protocol 8