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Table 5 Summary of results for reported information about gatekeepers, research ethic committee review, timing of any participant consent, and whether participants can opt out of the intervention or data collection

From: Reporting of key methodological and ethical aspects of cluster trials in hemodialysis require improvement: a systematic review

Component

Number of trials

N total = 31 (%)

Whether a gatekeeper was identified that allowed access to each cluster

 Yes—a clearly identified individual or body

3 (10%)

 Yes—but the gatekeeper not clearly identified

2 (6%)

 No gatekeeper information provided

26 (84%)

Reporting of research ethics review

 Stated research ethics committee approval

26 (84%)

 Stated research ethics committee exempt (specify reason)

1 (3%)

 Not reported

4 (13%)

Timing of any participant consent

 Not applicable

4 (13%)

 Any consent was before randomization of clusters

7 (23%)

 Any consent was after randomization of clusters

10 (32%)

 Timing of consent was unclear and could not be deduced from the report

10 (32%)

Whether participants can opt out of the data collection

 Yes—it is clearly reported that participants could opt out of data collection

7 (23%)

 No—participants could not opt out of data collection

3 (10%)

 Not reported or Unclear if participants could opt out

21 (68%)

Presence of any vulnerable participants* in the trial

 Clearly present

6 (20%)

 Potentially present or unclear

24 (77%)

 Clearly absent or not relevant

1 (3%)