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%) |