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Table 3 The quality of reporting of trialsi in accordance with CONSORT criteria [14,15] [13]

From: A systematic review of complex system interventions designed to increase recovery from depression in primary care

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
  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)
  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
  1. i A = Katon 1996, B = Mann, 1998, C = Katon 1999, D = Katzelnick, 2000, E = Simon 2000, F = Wells, 2000 (and Wells 1999), G = Smith 02 (and Smith 00, 01, Rost 00 and 01), H = Rost 2002 (and Rost 00), I = Datto 03, 2002, J = Finley 03, K = Capoccia 04 (and Boudreau 02), L = Dietrich 04a (and Dietrich 04b, and web appendices).
  2. ii *For publications to be considered as reporting information in accordance with CONSORT criteria, publications had to provide an explicit statement or clear and unambiguous information outlining details relevant to that CONSORT criteria. As many CONSORT items can be broken down into multiple components, each publication was only considered to have met CONSORT criteria if all components were adequately addressed.
  3. *If a publication referenced another article that included the required information (such as when there were multiple publications about a single trial), this article was also used in judging CONSORT criteria where indicated.
  4. iii For studies A, G, H, I, K, L, this item was either Not Applicable (because they did not report additional analyse or subgroup analyses), or was too difficult to judge as they described statistical methods but did not clearly specify the outcomes they were used for (B, C, D, E).
  5. iv When coding this item, the number analysed for primary outcome was difficult to judge as most articles reported multiple (primary) outcomes.
  6. v For simplicity, items 16 and 17 were coded as they relate to recovery data only.