Item |
Evans et a. 1997 |
Testad et al. 2005 |
Huizing et al. 2009 a+b |
Pellfolk et al. 2010 |
Testad et al. 2010 |
METHOD |
|
|
|
|
|
Allocation sequence adequately generated |
Yes* |
Yes* |
Yes* |
Yes* |
Unclear* |
Allocation adequately concealed |
No* |
No* |
Yes* |
No |
Unclear* |
No evidence for cluster imbalance |
No |
Yes |
Yes |
Yes |
No |
Clusters lost to follow‐up |
0/3 |
0/4 |
1/15 |
0/40 |
0/4 |
Participants identified before randomisation |
Yes |
No* |
Yes |
No* |
No* |
If no: no evidence for biased selection of participants |
‐‐‐ |
Unclear |
‐‐‐ |
Unclear |
Unclear |
PARTICIPANTS |
|
|
|
|
|
Inclusion/ exclusion criteria for participants clearly defined |
Yes* |
Yes* |
Yes* |
Yes* |
Yes |
Inclusion/ exclusion criteria for clusters clearly defined |
Unclear* |
Yes* |
Yes* |
Yes* |
Yes* |
Sample size calculation |
Yes* |
No* |
No* |
Yes |
Yes* |
Adequate sample size calculation using methods for cluster randomisation |
No* |
No* |
No* |
No* |
No* |
No relevant differences between groups after randomisation |
No |
Yes |
Yes |
Unclear |
No |
Loss to follow‐up less 5% of participants |
Unclear |
Yes |
No |
Unclear |
No |
Were incomplete data adequately explained |
Yes* |
Yes* |
Yes |
No* |
Yes |
INTERVENTIONS |
|
|
|
|
|
41. All groups treated equally, except of intervention or control |
Yes |
Yes |
Yes |
Yes |
Yes |
OUTCOMES |
|
|
|
|
|
Primary outcome clearly stated? |
Yes |
Yes |
Yes |
Yes |
Yes |
Method of primary outcome assessment adequate |
Yes |
Yes |
Yes |
Yes |
Yes |
Outcome assessors blinded to group allocation |
Yes |
Yes |
Yes |
No |
Yes |
Data collection started immediately after randomisation |
No* |
Unclear* |
No* |
No* |
Yes* |
RESULTS |
|
|
|
|
|
Intention to treat analysis |
Yes |
Yes |
Yes |
Yes |
No* |
Complete reporting of outcome (as scheduled) |
Yes |
Yes |
Yes |
Yes |
Yes |
Methods of analysis adequate for cluster‐randomised trials |
No |
No |
No |
Yes (partial)* |
No* |
Coefficient of intra‐cluster correlation reported |
No |
No |
No |
No* |
No* |
MISCELLANEOUS |
|
|
|
|
|
No evidence for interpretation bias |
Yes |
Yes |
Yes |
Yes |
Yes |
Conflicts of interest mentioned |
No |
No |
No |
No |
Yes |
Requests to authors required |
Yes |
Yes |
Yes |
Yes |
Yes |
* Items marked with an asterisk have been answered by the study authors following personal request. |