Testad 2010.

Study characteristics
Methods	Study design: cluster‐randomised controlled trial (not registered, no study protocol published) Intervention period: 6 months Duration of follow‐up: 12 months (follow‐up data were assessed 6 months after the intervention period) Study period: 2003 to 2004
Participants	Country: Norway Setting: four nursing homes, region Rogaland; all seven nursing homes in the region were invited and four agreed to participate (two small facilities (17 and 21 residents) and two larger facilities (81 and 92 residents)). Participants/clusters: Inclusion criteria: all residents with dementia, defined as a Functional Assessment Staging (FAST) score ≥ 4, were included. Number of participants randomised: 211; intervention group 113 (2 clusters), control group 98 (2 clusters) Number of participants lost to follow‐up: intervention group 69 (47 due to death, 22 transferred); control group 52 (37 due to death, 15 transferred); no clusters were lost to follow‐up Number of participants completed the study: 90; intervention group 44; control group 46 Baseline characteristics: Age (mean ± SD), years: intervention group 86.0 ± 9; control group 86.0 ± 11.25 Gender, female: intervention group 74.5%; control group 73% Cognitive status (Functional Assessment Staging (median (interquartile range): intervention group 6 (1); control group 6 (3.25)) Care dependency: not assessed
Interventions	Intervention: educational intervention plus guidance Control: usual care
Outcomes	Physical restraint status (interactional and structural restraints) Agitation (Cohen‐Mansfield Agitation Inventory)
Notes	Funding: Norwegian Research Council Cluster effect was not incorporated in the analysis (risk of unit‐of‐analysis error).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"(...) we randomly assigned subjects on home level. One small and one larger home were randomly allocated to either intervention or control condition (...)." No further information reported or given by the study authors on request. There were statistically significant differences between the study groups at baseline (proportion of participants with physical restraints, challenging behaviour, proportion of participants with antipsychotics). However, these differences may have been occurred by chance, since the number of clusters per group was small.
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinding of personnel was not possible due to the nature of the study. Clusters were allocated to the study groups and there was no evidence for an increased risk of contamination of clusters in the control group. No information about blinding of the participants was reported, but the intervention was delivered to the nursing staff. We judged the risk for a performance bias to be low.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"(...) rater‐blinded randomised‐controlled trial (...)"; "(...) blinded assessment procedure (...)".
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Attrition rates were comparable between the study groups, but the attrition rate was approximately 43%. Reasons for attrition were reported.
Selective reporting (reporting bias)	Unclear risk	Not registered; no published study protocol available. We had insufficient information to permit judgement of ‘low risk’ or ‘high risk'.