Chapman 2004.
Study characteristics | ||
Methods | RCT | |
Participants | N = 54 (29F/25M) Probable AD, on stable dose of donepezil for at least 3 months Mean MMSE 20.87 (SD 3.55, range 12‐28) Age 76.4 (SD 7.9; range 54‐91) Living at home initially |
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Interventions | Cognitive stimulation + donepezil Donepezil only |
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Outcomes | Cognition: MMSE; ADAS‐Cog ADL: Texas Functional Living Scale Behavioural problems: NPI ‐ Irritability and Apathy Quality of Life: QoL‐AD Global functioning: CBIC Verbalisation: Composite discourse score Carer distress ‐ derived from the NPI 10‐month follow‐up data available |
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Notes | 90 minutes, once a week, for 8 weeks | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Remote telephone randomisation, using a SAS procedure |
Allocation concealment (selection bias) | Low risk | Independent randomisation procedure |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All raters underwent extensive training; assessors blinded to group allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis used. 24% attrition rate at end of study |
Selective reporting (reporting bias) | Low risk | Data on all measures reported |
Other bias ‐ training and supervision | Low risk | Programme led by trained speech therapist, assisted by three Master’s level speech language pathology students, who underwent a 2‐hr training session before beginning treatment of each group and were provided with written reference materials. Weekly meetings were held in order to ensure the programme was implemented as designed. |
Other bias ‐ treatment manual | Low risk | No indication of a manual, but a clear structure to follow was evident. |