Table 4 Reporting quality metrics for seven primary results papers
Reporting quality criteria N (%) | Total (N = 7) | Year of publication | Journal endorsement of CONSORT guidelines | Statistician involvement | |||
|---|---|---|---|---|---|---|---|
2012 or earlier (N = 4) | 2013 onwards (N = 3) | High/medium (N = 4) | Low/none (N = 3) | Yes (N = 5) | No (N = 2) | ||
Description of sample size method | 4 (57.1) | 2 (50.0) | 2 (66.7) | 2 (50.0) | 2 (66.7) | 2 (40.0) | 2 (100.0) |
Was clustering clearly accounted for in sample size calculation | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Specification of the required number of clusters | 2 (50.0) | 1 (50.0) | 1 (50.0) | 1 (50.0) | 1 (50.0) | 1 (50.0) | 1 (50.0) |
Specification of the assumed cluster size | 2 (50.0) | 1 (50.0) | 1 (50.0) | 1 (50.0) | 1 (50.0) | 1 (50.0) | 1 (50.0) |
Specification of whether equal or unequal cluster sizes are assumed | 1 (25.0) | 1 (50.0) | 0 (0.0) | 0 (0.0) | 1 (50.0) | 0 (0.0) | 1 (50.0) |
Variability in cluster size accounted for | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Specification of the ICC used for the sample size | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Indication of the uncertainty of the ICC | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
Accounted for the uncertainty in the ICC | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
Other CONSORT metrics | |||||||
Details of how clustering was accounted for in the analysis | 6 (85.7) | 4 (100.0) | 2 (66.7) | 4 (100.0) | 2 (66.7) | 5 (100.0) | 1 (50.0) |
Specification of the number of clusters randomised | 7 (100.0) | 4 (100.0) | 3 (100.0) | 4 (100.0) | 3 (100.0) | 5 (100.0) | 2 (100.0) |
Specification of the number of clusters receiving intended treatment | |||||||
Explicit | 5 (71.4) | 3 (75.0) | 2 (66.7) | 4 (100.0) | 1 (33.3) | 4 (80.0) | 1 (50.0) |
Implied | 2 (28.6) | 1 (25.0) | 1 (33.3) | 0 (0.0) | 2 (66.7) | 1 (20.0) | 1 (50.0) |
Specification of the number of clusters analysed for the primary outcome at the primary endpoint | |||||||
Explicit | 2 (28.6) | 1 (25.0) | 1 (33.3) | 2 (50.0) | 0 (0.0) | 2 (40.0) | 0 (0.0) |
Implied | 5 (71.4) | 3 (75.0) | 2 (66.7) | 2 (50.0) | 3 (100.0) | 3 (60.0) | 2 (100.0) |
Details of cluster-level losses and exclusions | |||||||
Explicit | 3 (42.9) | 2 (50.0) | 1 (33.3) | 2 (50.0) | 1 (33.3) | 2 (40.0) | 1 (50.0) |
Implied | 4 (57.1) | 2 (50.0) | 2 (66.7) | 2 (50.0) | 2 (66.7) | 3 (60.0) | 1 (50.0) |
Details of individual-level losses and exclusions | 4 (57.1) | 2 (50.0) | 2 (66.7) | 2 (50.0) | 2 (66.7) | 2 (40.0) | 2 (100.0) |
Individual-level baseline characteristics presented | 7 (100.0) | 4 (100.0) | 3 (100.0) | 4 (100.0) | 3 (100.0) | 5 (100.0) | 2 (100.0) |
Cluster-level baseline characteristics presented | 2 (28.6) | 2 (50.0) | 0 (0.0) | 1 (25.0) | 1 (33.3) | 1 (20.0) | 1 (50.0) |
Coefficients of intracluster correlation provided for primary outcomes | |||||||
All | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Some | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Coefficients of intracluster correlation provided for secondary outcomes | |||||||
All | 0 (0.0)a | 0 (0.0) | 0 (0.0)a | 0 (0.0) | 0 (0.0)a | 0 (0.0) | 0 (0.0)a |
Some | 0 (0.0)a | 0 (0.0) | 0 (0.0)a | 0 (0.0) | 0 (0.0)a | 0 (0.0) | 0 (0.0)a |
P-values provided for baseline comparisons | 5 (71.4) | 3 (75.0) | 2 (66.7) | 3 (75.0) | 2 (66.7) | 3 (60.0) | 2 (100.0) |
Clustering accounted for in the calculation of the p-values | |||||||
Yes | 1 (20.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 0 (0.0) |
Unclear | 1 (20.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 0 (0.0) |