Bottino 2005.
Study characteristics | ||
Methods | RCT | |
Participants | N = 13 (9F/4M) 'Mildly impaired probable Alzheimer’s diagnosis' All participants taking rivastigmine 6‐12 mg/day for 2 months Mean MMSE 22.3 (SD 3.6; range 16‐28) Age 73.7 (range 62‐83) Outpatients |
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Interventions | 'cognitive rehabilitation' plus rivastigmine; carers attended a support group at same time (N = 6) Treatment‐as‐usual: rivastigmine plus 30 minute monthly consultation with doctor in relation to medication (N = 7) |
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Outcomes | Participants: Cognition: MMSE; ADAS‐Cog, plus battery of neuropsychological tests ADL (rated by carer) Carers' mood: Hamilton Anxiety and Montgomery‐Asberg Depression Rating Scales |
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Notes | 90 minutes, once a week, for 5 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised blocks design |
Allocation concealment (selection bias) | Low risk | Random allocation to either group by telephone made by an assessor blind to the patient group |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessment made by assessors blinded to group allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Zero attrition reported |
Selective reporting (reporting bias) | Low risk | Scores for all measures reported |
Other bias ‐ training and supervision | Unclear risk | No information provided on therapists |
Other bias ‐ treatment manual | Unclear risk | Some detail given of 'cognitive rehabilitation training sessions', meeting criteria for cognitive stimulation, but no mention of manual or protocol |