Paddick 2017.
Study characteristics | ||
Methods | Stepped wedge design | |
Participants | N = 34 (29F/5M) Dementia according to DSM‐IV criteria None receiving AChEI medication Mean Clinical Dementia Rating 1.65 (range 1‐2) Median age 80 (IQR 76.5‐85.3) Community |
|
Interventions | Cognitive stimulation groups (N = 16) Wait‐list controls (N = 18) |
|
Outcomes | Cognition: ADAS‐Cog Quality of life: World Health Organization Quality of Life assessment (WHOQOL) Mood: Hospital Anxiety & Depression Scales ADL: World Health Organization Disability Assessment Schedule (WHODAS 2.0) Behaviour problems: NPI Caregiver outcomes: WHOQOL; Zarit Burden Inventory; Hospital Anxiety & Depression Scales; NPI Caregiver distress |
|
Notes | 45 minutes, twice a week, for 7 weeks Relevant comparison was at assessment 8 weeks after baseline, where those who received cognition stimulation could be compared with the wait‐list controls, who had received treatment‐as‐usual. Only ADAS‐Cog data were available for this comparison. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Cluster‐randomised. Simple randomisation with random number generator |
Allocation concealment (selection bias) | Low risk | Randomisation carried out by independent statistician, blinded to participant allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blind to group allocation and did not deliver the CST sessions; participants reminded not to disclose |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat protocol ‐ no attrition in relation to comparison of immediate and delayed start groups |
Selective reporting (reporting bias) | High risk | Although all outcome measures were reported for the comparison of interest (between immediate and delayed start CST groups), only data on ADAS‐Cog provided |
Other bias ‐ training and supervision | Low risk | Facilitators received training on CST in the UK and had been involved in the adaptation and pilot of adapted CST for Sub‐Saharan Africa. |
Other bias ‐ treatment manual | Low risk | Published manual ‐ adapted from CST manual |