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

Baldelli 1993.

Study characteristics
Methods RCT
Participants N = 23 (23F/0M)
Alzheimer’s (SDAT)
Mean MMSE 20.6 (SD 4.9)
Mean age 84.5 (SD 6.4; range 75‐94)
All resident in institution
Interventions RO group sessions (N = 13)
Treatment‐as‐usual (N = 10)
Outcomes Cognition: MMSE; Berg Orientation Scale
Mood: GDS‐30
ADL: Stewart ADL scale
Notes 60 minutes, 3 times a week for 3 months; 3‐month follow‐up data on cognitive measures
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated by email that their trials were randomised (with no detail of the methods used)
Allocation concealment (selection bias) Unclear risk Stated by email that their trials were randomised (with no detail of the methods used)
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No details of who assessors were
Incomplete outcome data (attrition bias)
All outcomes Low risk Zero attrition at 3‐month post‐treatment assessment; no attrition reported at follow‐up 3 months later
Selective reporting (reporting bias) Low risk Scores for all measures reported
Other bias ‐ training and supervision Unclear risk No details of who carried out the groups
Other bias ‐ treatment manual Unclear risk Described as 'formal ROT'