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

Middelstädt 2016.

Study characteristics
Methods RCT
Participants N = 71 (60F/11M)
Mild‐to‐moderate dementia according to ICD‐10 criteria
Mean MMSE 16.9 (SD 4.5; range 10‐24)
Age 86.4 (SD 4.5; range 74‐102)
Nursing homes
Interventions Cognitive stimulation groups 'NEUROvitalis senseful' (N = 36)
Treatment‐as‐usual control group (N = 35)
Outcomes Cognition: ADAS‐Cog
Quality of Life: QoL‐AD (self‐report and proxy)
ADL: ADCS‐ADL
Behaviour problems: NPI‐NH
Six‐week follow‐up data provided
Notes 60 minutes, twice a week for 8 weeks
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Used computer generated random numbers
Allocation concealment (selection bias) Unclear risk "The randomization process was then realized by a member of the research group who was blinded to the participants". Not clear how independent this process was?
Blinding of outcome assessment (detection bias)
All outcomes Low risk Assessors for ADAS‐Cog and QoL‐AD blind to group assignment and not involved in any other part of the study. Group secrecy emphasised
Incomplete outcome data (attrition bias)
All outcomes Low risk Details of attrition provided and followed ITT principle (also per protocol analysis)
Selective reporting (reporting bias) Low risk All outcome measures mentioned in methods were reported.
Other bias ‐ training and supervision Unclear risk Facilitator was researcher experienced in conducting non‐pharmacological interventions, but no details of training or supervision
Other bias ‐ treatment manual Low risk "Every session was described in detail in a manual, including advice for instructions."