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 |
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Interventions | Intervention: educational intervention Control: usual care |
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Outcomes | Residents: physical restraint status, falls, benzodiazepine and neuroleptics' use Staff: knowledge, attitudes (The Perceptions of Restraints Use Questionnaire (PRUQ)) |
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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. |