measures, including how and when they were assessed 6b Any changes to trial outcomes after the trial commenced, with reasons Sample size 7a How sample size was Method of calculation, number of determined 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 7b When applicable, explanation of any interim analyses and stopping guidelines Randomisation: Sequence 8a Method used to generate the random allocation sequence generation 8b Type of randomisation; Details of stratification or details of any restriction matching if used (such as blocking and size) Allocation 9 Mechanism used to Specification that allocation was concealment implement the random based on clusters rather than mechanism allocation sequence (such as individuals and whether allocation sequentially numbered concealment (if any) was at the containers), describing any cluster level, the individual steps taken to conceal the participant level or both sequence until interventions were assigned Implementation 10 Who generated the random Replace by 10a, 10b and 10c allocation sequence, who enrolled participants, and who assigned participants to interventions 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
measures, including how and when they were assessed 6b Any changes to trial outcomes after the trial commenced, with reasons Sample size 7a How sample size was determined 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 7b When applicable, explanation of any interim analyses and stopping guidelines Randomisation: Sequence generation 8a Method used to generate the random allocation sequence 8b Type of randomisation; details of any restriction (such as blocking and size) Details of stratification or matching if used Allocation concealment mechanism 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 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 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Replace by 10a, 10b and 10c 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
CONSORT%20Extension%20for%20Cluster%20Trials%202012%20Checklist.docx