Cohen‐Mansfield 2007.

Study characteristics
Methods	Study design: cluster‐randomised controlled trial (not registered) Duration of follow‐up: 10 consecutive days Study period: not reported
Participants	Country: USA Setting: 12 clusters from 11 suburban nursing home facilities Participants/clusters Inclusion criteria: all residents of the participating clusters with a diagnosis of dementia, who lived in the facility for more than 3 weeks and exhibited agitation several times per day Exclusion criteria: residents with a diagnosis of bipolar disorder or schizophrenia and residents who manifested aggressive behaviours Number of participants randomised: n = 230; intervention group n = 125, control group n = 105 Number of participants lost to follow‐up: intervention group n = 36 (2 bipolar, 10 deceased, 1 no dementia, 11 no agitation, 1 discharged, 1 administrator refused to allow participation, 3 illness, 2 comfort care, 5 logistic reasons), control group n = 27 (1 bipolar, 8 deceased, 9 no agitation, 3 discharged, 3 hospitalisation, 3 logistic reasons) Number of participants completing the study: n = 167; intervention group n = 89, control group n = 78 Baseline characteristics Age (mean ± SD), years: intervention group 88.0 ± 6.4, control group 85.0 ± 8.6 Gender, female: intervention group 84%, control group 76% Cognitive status, MMSE (mean ± SD): intervention group 7.26 ± 6.0, control group 6.88 ± 6.5 Care dependency, ADL performance (from MDS, 0 (independent) to 4 (total dependence)) (mean ± SD): intervention group 2.49 ± 1.01, control group 2.42 ± 1.03
Interventions	Intervention: activity programme based on the Treatment Routes for Exploring Agitation (TREA) framework Control: presentation for nursing staff describing the syndromes of agitation, their aetiologies, and possible non‐pharmacologic interventions
Outcomes	Primary: agitation (ABMI) Secondary: affect (pleasure, interest, anger, anxiety, sadness)
Funding	National Institutes of Health; USA
Notes	Cluster effect was not incorporated in the analysis (risk unit‐of‐analysis error)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	"To limit contamination of the interventions’ effectiveness, buildings were assigned either control or intervention status (rather than having both within each building). We were unable at times to assign buildings randomly to either intervention or control groups because the administrators of two facilities insisted on making the decision as a condition of participation. Other facilities without such stipulations were randomly assigned to the treatment or control group while balancing the number of facilities in each group." No method of sequence generation was reported.
Allocation concealment (selection bias)	Unclear risk	No methods for allocation concealment was reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information about blinding of personnel and participants reported, but blinding seems not possible. The intervention was delivered at cluster level. We have insufficient information to permit judgement of ‘low risk’ or ‘high risk'.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"Another measure of reliability examined the possible effect of the nonblindness of the observations. For this measure, 10 study participants were videotaped, and inter‐rater reliability was obtained from a research assistant who was blinded both to the background characteristics of the observed residents and to the raters themselves. The average agreement between observed agitation recorded from videotape and direct observations of agitated behaviors was 95%". We have insufficient information to permit judgement of ‘low risk’ or ‘high risk'.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Participants lost to follow‐up: intervention group: "1 excluded due to illness during intervention", control group: "2 excluded due to hospitalisation after baseline assessment".
Selective reporting (reporting bias)	Unclear risk	Not registered, no study protocol available.
Other bias	Low risk	‐