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. 2023 Jan 31;2023(1):CD005562. doi: 10.1002/14651858.CD005562.pub3

Carbone 2021.

Study characteristics
Methods RCT
Participants N = 225 (149F/76M)
'Major neurocognitive disorder' DSM‐V mild‐to‐moderate range (no information regarding medication)
Mean MMSE 20.1 (SD 4.0)
Age 83.6 (SD 8.1; range 50‐99)
16 residential homes and day‐centres
Interventions Cognitive stimulation groups (N = 123)
Usual treatment group sessions (N = 102)
Outcomes Cognition: ADAS‐Cog; MMSE
Language: Narrative Language Test
Quality of life: QoL‐AD (self‐report)
Mood: Cornell Scale for Depression in Dementia
ADL: Disability Assessment for Dementia (DAD)
Behaviour problems: NPI
Notes 45 minutes, twice a week, for 7 weeks; 3‐month follow‐up
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Covariate adaptive randomization was used at each participating centre".
Allocation concealment (selection bias) Unclear risk No information provided as to who carried out the randomisation or the process used for concealment of allocation
Blinding of outcome assessment (detection bias)
All outcomes Low risk "Conducted by trained psychologists who did not participate in the treatment program, and they had no information on participants’ group allocation".
Incomplete outcome data (attrition bias)
All outcomes Low risk Low attrition at post‐treatment; reasons given for those dropping out; data sought for all participants irrespective of compliance
Selective reporting (reporting bias) Low risk All outcomes reported
Other bias ‐ training and supervision Low risk One‐day training for at least one facilitator of each group, plus experience of dementia care and group facilitation skills
Other bias ‐ treatment manual Low risk Italian version of 'Making a difference' manual used (Spector 2006)