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Table 3 Reporting of CONSORT flow diagram items for cluster trials (n = 16)

From: Reporting of participant flow diagrams in published reports of randomized trials

 

Reported *

Cluster level

Patient level ≠

Not applicable

Enrolment

    

Assessed for eligibility (overall)

12 (75%)

8/12

4/12

 

Excluded (overall)

11 (69%)

7/11

4/11

1/11

   Not meeting inclusion criteria

8 (50%)

2/8

5/8

1/8

   Declined to participate

11 (69%)

3/11

2/11

6/11

   Other reasons

10 (63%)

4/10

3/10

4/10

Randomized (overall)

15 (94%)

13/15

4/15

 

Allocation

    

Allocated to intervention (per group)

15 (94%)

14/15

8/15

 

Received allocated intervention (per group)

14 (88%)

8/14

14/14

 

Did not receive allocated intervention (per group)

14 (88%)

6/14

10/14

 

   Reported reasons did not receive intervention

12 (75%)

4/12

9/12

 

Follow up

    

Lost to follow up (per group)

13 (81%)

6/13

12/13

 

   Reported reasons lost to follow up

11 (69%)

3/11

9/11

 

Discontinued intervention (per group)

10 (63%)

2/10

3/10

6/10

   Reported reasons discontinued intervention

10 (63%)

1/10

3/10

6/10

Analysis

    

Included in main analysis (per group)

15 (94%)

9/15

14/15

 

Excluded from main analysis (per group)

12 (75%)

2/12

7/12

4/12

   Reported reasons excluded

12 (75%)

1/12

7/12

4/12

  1. * Directly reported or could be inferred from the flow diagram.
  2. ≠Patient level: 10 flow diagrams reported the total number of participants, 2 reported the median and range, 1 reported the mean and total number of participants, 1 reported the mean and standard deviation, 1 reported the average and range and 1 reported the median, range and total number of participants. Some flow diagrams reported both the number of clusters per item and the number of participants.