Testad 2016.

Study characteristics
Methods	Study design: cluster‐randomised controlled trial (NCT01715506, retrospectively registered) Intervention period: 7 months Duration of follow‐up: 7 months (follow‐up data were assessed after the intervention period) Study duration: January 2011 and May 2013
Participants	Country: Norway Setting: 24 care homes within the Western Norway Regional Health Authority. The Western Norway Regional Health Authority consists of three counties and four health trusts, with a total of 83 care homes. All homes in the geographical area were invited to participate following a list in randomised order. Recruitment continued until six care homes were included from each of the four health trusts. Participants/clusters: Inclusion criteria: all residents with dementia Number of participants randomised: 274; intervention group 118 (12 clusters), control group 156 (12 clusters) Number of participants lost to follow‐up: intervention group 35 (3 due to death, 32 for unknown reasons); control group 45 (all for unknown reasons); no information whether any cluster was lost to follow‐up Number of participants completed the study: 197; intervention group 83; control group 114 (we found some differences between the text and the flow chart, and we used the numbers from the text, which were identical with the numbers provided in the results tables) Baseline characteristics: Age (mean ± SD), years: intervention group 88.2 ± 8.2; control group 85.2 ± 8.2 Gender, female: intervention group 72.9%; control group 71.8% Cognitive status (Clinical Dementia Rating Scale, sum of boxes mean ± SD): intervention group 12.2 ± 4.8; control group 12.6 ± 4.2 Care dependency (Physical Self‐Maintain Scale, mean ± SD): intervention group 18.2 ± 5,3; control group 16.4 ± 5.2
Interventions	Intervention: "Trust Before Restraint"‐Programme Control: usual care
Outcomes	Primary: use of restraint Secondary: agitation, use of psychotropic drugs
Notes	Funding: Norwegian Research Council "The effect of clustering was taken into account and adjusted for [when] if the ICC had a value greater than 5%." ICC was lower than 5% and the analysis was not adjusted for clustering (risk of unit‐of‐analysis error).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Care homes were randomized after recruitment to a 7‐month educational intervention or treatment as usual." Method not mentioned There were statistically significant differences between the study groups at baseline (ADL score, challenging behaviour, NPI sum score) and some differences in the prevalence of physical restraint use indicating inadequate randomisation and/or allocation concealment. We had insufficient information to permit judgement of ‘high risk'.
Allocation concealment (selection bias)	Unclear risk	No information reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Treatment allocation was revealed to the facilitating teams by the principal investigator, when baseline was completed." 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	"All data in the 24 care homes were collected within 1 week by research assistants blind to the study."
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No cluster was lost to follow‐up; attrition rate differed slightly between the study groups (30% in the intervention group and 26% in the control group) and no reasons for attrition were reported.
Selective reporting (reporting bias)	Unclear risk	Retrospectively registered; no published study protocol available. We had insufficient information to permit judgement of ‘low risk’ or ‘high risk'.

BARS = Brief Agitation Rating Scale; CDR = Clinical Dementia Rating Scale; FAST = Functional Assessment Staging; ICC = intracluster correlation coefficient; MMSE = Mini‐Mental State Examination; PR = physical restraints; SD = standard deviation