Table 1: CONSORT 2010 checklist of information to include when reporting a cluster randomised trial Section/Topic Item Standard Checklist item Extension for cluster Page No designs No * Title and abstract 1a Identification as a Identification as a cluster 1 randomised trial in the title randomised trial in the title 1b Structured summary of trial See table 2 2-3 design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts), Introduction Background and 2a Scientific background and Rationale for using a cluster 4, 6 objectives explanation of rationale design 2b Specific objectives or Whether objectives pertain to the 4-5 hypotheses the cluster level, the individual participant level or both Methods 5-6 Trial design 3a Description of trial design Definition of cluster and (such as parallel, factorial) description of how the design including allocation ratio features apply to the clusters 3b N/A Important changes to methods after trial commencement (such as eligibility criteria), with reasons Participants 4a Eligibility criteria for Eligibility criteria for clusters 5 participants 4b 5 Settings and locations where the data were collected Interventions 5 The interventions for each Whether interventions pertain to 6-7 group with sufficient details the cluster level, the individual to allow replication, participant level or both including how and when they were actually administered Outcomes 6a 7 Completely defined Whether outcome measures primary and pertain to the cluster level, the secondary outcome individual participant level or both measures, including how and
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
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