Orsulic‐Jeras 2000.

Methods	Non‐randomised trial Duration of follow‐up: 9 months
Participants	Country: USA Participants were recruited from 1 dementia special care unit of the Menorah Park Center for Senior Living, an Orthodox Jewish facility with over 350 long‐term care beds. No inclusion or exclusion criteria reported Number of participants completing the study: n = 25 (intervention group n = 13, control group n = 12). Age (mean ± SD) years: 88 ± 6 Gender, female: 92% Cognitive status, MMSE (mean ± SD): 11 ± 6 Care dependency: not reported
Interventions	Intervention: Montessori‐based activities (group or individual activities) Control: usual care (regular activities)
Outcomes	Agitation (CMAI), depression (CSD) (9 months' follow‐up); engagement (MRI‐ES), affect (ARS) (6 months' follow‐up)
Funding	Not mentioned
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Non‐randomised trial; "Thirteen residents were assigned to the treatment condition and 12 to the control condition. Participants were matched across groups according to their scores on the MMSE, along with their performances on the Myers Menorah Park/Montessori Assessment System (MMP/MAS) and the reading subtest of the Wide Range Achievement Test (WRAT3)."
Allocation concealment (selection bias)	High risk	Not applicable (not an RCT)
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Individual activity sessions "were run by either a trained volunteer, a research assistant, or the activities therapist on the unit." The 2 types of group activities were run "one day by a volunteer and one day by the activities therapist on the unit" and "led by either a trained volunteer or by the activities therapist on the unit" respectively. Comment: the control group received no additional activities and so it seems not possible to blind the personnel or the participants.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"Research staff interviewed nursing assistants on the special care unit at pretest and at final posttest for approximately 20 minutes for all measures"; comment: nursing assistants were not blinded to group allocation.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	"Forty‐four residents from the dementia SCU were initially recruited. During the course of this 9‐month study, 19 participants dropped out of the study, either because of death (n = 3), transfer to another unit within the facility (n = 12), or excessive absence (n = 4). Thus, 25 participants (23 women and 2 men) completed the study." No information about the group allocation for the participants lost to follow‐up were reported.
Selective reporting (reporting bias)	Unclear risk	No trial registration and no study protocol is available.
Other bias	Unclear risk	No primary outcome defined (multiple testing).