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. 2017 May 2;2017(5):CD003477. doi: 10.1002/14651858.CD003477.pub3
Methods RCT (parallel).
Exact duration of total study or start and end dates are not reported, but therapy was provided over a period of 4 months.
Participants Country: the Netherlands.
N = 94 residents of 6 nursing homes of which 77 were included in the analyses.
70% (n = 54) were female; mean age was 82.16 (SD 6.87)
Participants had any type of dementia according to DSM‐IV criteria, Cohen‐Mansfield Agitation Inventory (CMAI) score of > 44.
Interventions 1) Mixed active‐receptive group music therapy, which involved listening to live music, interacting with the therapist and playing simple instruments. A maximum of 34 sessions of 40 minutes each were held, twice weekly, over a period of 4 months.
2) General recreational activities such as handwork, playing shuffleboard, cooking, and puzzle games. Sessions lasted 40 minutes, similarly twice weekly over 4 months.
Outcomes 1) Agitation assessed with the CMAI modified through dichotomising of items resulting in a total score range of 0 to 29. Presence and absence of behaviour was presumably measured by direct observation or with very short time frames (because it was assessed 1 hour before the session, 1 hour after the session, 2 hours after the session and 4 hours after the session).
2) Neuropsychiatric symptoms (behaviour overall, NPI).
Notes Funding: ZonMW (the Netherlands Organisation for Health Research and Development), the Dutch Alzheimer Foundation (Alzheimer Nederland) and the Triodos Foundation.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk “To ensure randomised allocation, sealed envelopes were used, with at least two persons present to ensure appropriate randomisation".
Allocation concealment (selection bias) Unclear risk Only sealing is described; it remains unclear whether envelopes were sequentially numbered and opaque.
Blinding of participants and personnel (performance bias) All outcomes High risk Not possible to blind the convener and participants.
Blinding of outcome assessment (detection bias) All outcomes High risk Quote: "Some of the nurse caregivers who rated the modified CMAI scores were at occasion responsible for taking the residents to either the activity or music therapy room. Complete blinding for some of the nurse caregivers could therefore not be guaranteed.”
Incomplete outcome data (attrition bias) All outcomes Unclear risk The explanation of missing data was not clear. There were 7 missing cases in the baseline data in the general activities group, and 4 of the participants died out of 47 allocated. It is not clear if baseline data were missing because participants died before the baseline assessment.
Selective reporting (reporting bias) Unclear risk The study protocol is not available.
Other bias Low risk