Testad 2005.

Study characteristics
Methods	Study design: cluster‐randomised controlled trial (not registered, no study protocol published) Intervention period: 6 months Duration of follow‐up: 6 months (follow‐up data were assessed after the intervention period) Study period: not reported
Participants	Country: Norway Setting: four public nursing and residential homes in Stavanger. Additional information from the study authors: nursing homes were representative of all Norwegian nursing homes in terms of size and organisation. Participants/clusters: Inclusion criteria: all residents with a dementia diagnosis determined by the Clinical Dementia Rating Scale (CDR) were included. Number of participants randomised: 151; intervention group 55 (2 clusters), control group 96 (2 clusters) Number of participants lost to follow‐up: intervention group 0; control group 9 (reason death (n = 7) or moved to another facility (n = 2)); no clusters were lost to follow‐up. Number of participants completed the study: 142; intervention group 55 (2 clusters); control group 87 (2 clusters) Baseline characteristics: Age (mean ± SD), years: intervention group 84.9 ± 5.6; control group 84.0 ± 6.3 Gender, female: intervention group 67%; control group 72% Cognitive status (Clinical Dementia Rating Scale; mean ± SD): intervention group 2.0 ± 1.0; control group 2.2 ± 0.9 Care dependency: not assessed
Interventions	Intervention: educational intervention plus guidance Control: usual care
Outcomes	Both outcomes were defined as primary outcomes by the authors. Physical restraints status Agitation (Brief Agitation Rating Scale, BARS)
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)	Low risk	"The nursing homes were randomly assigned to the treatment intervention or control condition, two in each group, after stratification for size." "The two groups were similar with respect to age, CDR and gender distribution and proportion of subjects using medication for physical disease." Information provided by the study authors: sealed envelopes were used.
Allocation concealment (selection bias)	High risk	Not concealed
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	"Data were collected immediately before and after the intervention period by a trained rater who was blind to the study hypothesis and to treatment allocation."
Incomplete outcome data (attrition bias) All outcomes	Low risk	"All patients in the intervention group and 87 in the control group (nine had died or moved to another facility) were assessed at follow‐up." It is unlikely that the higher attrition rate in the control group was associated with the intervention, so we judged risk of bias to be low.
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'.