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. 2018 Feb 13;2018(2):CD009812. doi: 10.1002/14651858.CD009812.pub2
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