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

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%)