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. 2011 Feb 16;2011(2):CD007546. doi: 10.1002/14651858.CD007546.pub2

Pellfolk 2010.

Methods Cluster‐randomised controlled trial
Participants Country: Sweden
40 group dwelling units for people with dementia
All residents of the included group dwelling units
Interventions Intervention: educational intervention
Control: usual care
Outcomes Residents: physical restraint status, falls, benzodiazepine and neuroleptics' use
Staff: knowledge, attitudes (The Perceptions of Restraints Use Questionnaire (PRUQ))
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Low risk  
Allocation concealment? High risk  
No baseline imbalance between groups Unclear risk Unclear
No loss of clusters bias Low risk  
Outcome assessors blinded to treatment allocation High risk  
No recruitment bias Unclear risk Unclear
Methods of analysis adequate for cluster‐randomised trials Low risk Only for the likelihood of being restrained, not for sample size calculation, no intra‐cluster correlation coefficient was calculated.