| Methods |
Design: three group parallel trial
Purpose: examine the effect of cognitive training program for patients with dementia |
| Participants |
Patients: out‐patients with possible or confirmed diagnosis of Alzheimer's disease
Baseline comparability: yes |
| Interventions |
Placebo: passive cognitive stimulation where patients did not engage in training activities
Untreated: no training
Experimental: active cognitive stimulation
where patients did engage in training activities
(Co‐intervention: NS) |
| Outcomes |
Cognitive functioning (Mattis dementia rating scale)
Behavioural functioning (Memory and behaviour problems checklist, part A) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/cognitive training program) |
| Blinding?
Outcome assessor |
Low risk |
'... research assistants who, with rare exception, were blinded to the condition to which the family had been assigned' |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
Low risk |
N = 53 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
