Table 3 The quality of reporting of trialsi in accordance with CONSORT criteria [14,15] [13]
Consort item # | Text in italics = consort criteria relevant to cluster randomised trials only. | Trials that reported information as outlined by CONSORTii Cluster RCTs are in bold. |
|---|---|---|
1. Design | How participants were allocated to interventions (eg "random allocation", "randomised", or "randomly assigned"), specifying that allocation was based on clusters. | A, B, C, E, G, H, J, K, L |
2. Background | Scientific background and explanation of rationale, including rationale for using a cluster design. | A, B, C, E, G, H, J, K |
3. Participants | Eligibility criteria for participants and clusters and the settings and locations where data were collected. | A, B, C, E, G, H, J, K, L |
4. Interventions | Precise details of the interventions intended for each group, whether they pertain to the individual level, the cluster level, or both, and how and when they were actually administered. | A, B C, D, E, F, G, H, I, J, K, L |
5. Objectives | Specific objectives and hypotheses and whether they pertain to the individual level, the cluster level, or both. | A, B C, D, E, F, G, H, I, J, K, L |
6. Outcomes | Clearly defined primary and secondary outcome measures, and whether they pertain to the individual level, the cluster level, or both. | B, F, G, H, K, L |
| Â | And, when applicable, any methods used to enhance the quality of measurements (eg, multiple observations, training of assessors) | Not assessed/judged |
7a. Sample size | How total sample size was determined including method of calculation, number of clusters, cluster size, a coefficient of intracluster correlation (ICC or k), and an indication of its uncertainty). | B, E, J, K, L |
7b. Sample size | And, when applicable, calculation of interim analyses and stopping rules. | K (no other article calculated interim analyses) |
8. Sequence generation | Method used to generate the random allocation sequence, including details of any restriction, (eg blocking, stratification, matching). | A, B, C, E, F, H, K, L |
9. Allocation concealment | Method used to implement the random sequence (eg, numbered containers or central telephone), specifying that allocation was based on cluster rather than individuals and clarifying whether the sequence was concealed until interventions were assigned. | None |
10. Implementation | Who generated the allocation sequence, who enrolled participants and who assigned participants to their groups. | G, H |
11a. Blinding | Whether or not participants, those administering the interventions and those assessing the outcomes were blinded to group assignment. | J, K |
11b. Blinding | If done, how the success of blinding was evaluated. | F (no others assessed blinding) |
12a. Statistical methods | Statistical methods used to compare groups for primary outcome(s), indicating how clustering was taken into account. | A, B, C, D, E, F, G, H, J, K, L |
12b. Statistical methodsiii | Methods for additional analyses, such as subgroup analyses and adjusted analyses | F |
13. Participant flowiv | Flow of clusters and individual participants through each stage. Specifically for each group report the numbers of clusters and participants randomly assigned, receiving intended treatment, completing the study protocol and analysed for the primary outcome. | B, D, F, H (see footnote for further explanation) |
| Â | Describe protocol deviations from study as planned, together with reasons. | Not assessed/judged |
14. Recruitment | Dates defining the periods of recruitment and follow-up | B, F, G, H, K, L |
15. Baseline data | Baseline demographic and clinical characteristics for the individual and cluster levels as applicable. | A, B C, E, G, H, I, J, K, L |
16. Numbers analysedv | Number of clusters and participants (denominator) in each group included in [recovery] analyses and whether analysis [not specific to recovery] was by "intention to treat". State the results in absolute numbers when feasible (eg, 10/20 not 50%) | B, D, F, J, L |
7. Outcomes and estimationv | For [recovery analyses], a summary of results for each group for the individual or cluster level as applicable and the estimated effect size and its precision (eg, 95% CI)". | None |
18. Ancillary analyses | Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those prespecified and those exploratory. | None (N/A for L) |
19. Adverse events | All important adverse events or side effects in each intervention group. | None |
20. Interpretation | Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes. | None |
21. Generalisability | Generalisability (external validity) to individuals and/or clusters (as relevant) of the trial findings. | A, C, D, E, F, G, H, I, J, K, L |
22. Overall evidence | General interpretation of results in the context of current evidence | A, B, D, E, F, G, H, I, J, K, L |