Onder 2005.

Study characteristics
Methods	RCT
Participants	N = 156 (113F/43M) Probable Alzheimer's Disease, on donepezil for at least 3 months MMSE 20.1 (SD 3.1) Age 75.8 (SD 7.1) Living at home
Interventions	Individual RO (delivered by family caregiver) + donepezil (N = 79) Donepezil only (N = 77)
Outcomes	Cognition: MMSE; ADAS‐Cog ADL: Barthel; Lawton & Brody IADL scale Behaviour problems: NPI Family caregiver outcomes: Hamilton anxiety and depression scales; Caregiver Burden Inventory; SF‐36
Notes	30 minutes, 3 times a week, for 25 weeks; plus informal contacts 2 or 3 times a day
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computerised block randomisation process
Allocation concealment (selection bias)	Unclear risk	No information regarding the independence of the randomisation process
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessments made by blind assessors
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition data reported with reasons: 9 from RO group, 10 from control group i.e. 12%. Intention‐to‐treat analysis
Selective reporting (reporting bias)	Low risk	Data for all outcome measures reported
Other bias ‐ training and supervision	Low risk	Family caregivers trained by a multidisciplinary team including physicians, psychologists and therapists. Training included a simulated therapy session.
Other bias ‐ treatment manual	Low risk	The family caregivers were also provided with a manual of instruction on the therapy and specific schedules for each session.