Item |
Cohen‐Mansfield 2007 |
Cohen‐Mansfield 2012a |
Kolanowski 2011 |
Richards 2005 |
Van Haitsma 2015 |
Wenborn 2013 |
Allocation sequence adequately generated |
No |
Yes |
Yes |
Unclear |
Yes* |
Yes* |
Allocation adequately concealed |
Unclear |
Unclear |
Yes |
Unclear |
No* |
Yes* |
Participants identified before randomisation |
Unclear |
Unclear |
Yes |
Yes |
Yes |
Yes |
If no: no evidence for biased selection of participants |
‐ |
‐ |
‐ |
‐ |
‐ |
‐ |
Inclusion/exclusion criteria for participants clearly defined |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Inclusion/exclusion criteria for clusters clearly defined |
No |
No |
n. a. |
n. a. |
n. a. |
Yes* |
Adequate sample size calculation |
No |
Unclear |
Yes |
Yes |
No |
Yes |
Absence of relevant differences between groups after randomisation |
Yes |
Yes |
Unclear |
Unclear |
Yes |
Yes |
Loss to follow‐up less 5% of participants |
Yes |
Yes |
Yes |
No |
No |
No |
Were incomplete data adequately explained |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
All groups treated equally, except of intervention or control |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Primary outcome clearly stated? |
Yes |
Yes |
No |
No |
No |
Yes* |
Participants blinded to group allocation |
Unclear |
Yes |
Yes |
Unclear |
Yes* |
Unclear |
Personnel blinded to group allocation |
No |
No |
Yes |
Unclear |
No |
Yes |
Outcome assessors blinded to group allocation |
No |
No |
Yes |
No |
No |
Yes |
Data collection started immediately after randomisation |
Unclear |
Unclear |
Yes* |
Unclear |
Varied* |
Unclear |
Intention to treat analysis |
Unclear |
Yes |
Yes |
Yes |
Yes* |
Yes |
Complete reporting of outcome (as scheduled) |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Methods of analysis adequate for cluster‐randomised trials |
No |
No |
n. a. |
n. a. |
n. a. |
Yes |
Conflicts of interest mentioned |
No |
Yes |
Yes |
Yes |
No |
Yes |
* Items marked with an asterisk have been answered by the study authors after personal request |