Baseline data 15 A table showing baseline Baseline characteristics for the demographic and clinical individual and cluster levels as characteristics for each applicable for each group 16 For each group, number of For each group, number of Numbers analysed participants (denominator) clusters included in each analysis included in each analysis and whether the analysis was by original assigned groups Outcomes and 17a For each primary and Results at the individual or cluster estimation secondary outcome, results level as applicable and a for each group, and the coefficient of intracluster estimated effect size and its correlation (ICC or k) for each precision (such as 95% primary outcome confidence interval) 17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) Discussion Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Generalisability 21 Generalisability (external Generalisability to clusters and/or validity, applicability) of the individual participants (as trial findings relevant) Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence Other information
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 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 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 17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) Discussion Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Generalisability 21 Generalisability (external validity, applicability) of the trial findings Generalisability to clusters and/or individual participants (as relevant) Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence Other information
CONSORT%20Extension%20for%20Cluster%20Trials%202012%20Checklist.docx