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. 2018 Jul 23;2018(7):CD003477. doi: 10.1002/14651858.CD003477.pub4

Lin 2011.

Methods RCT (parallel)
Data collection between August 2008 and January 2009
Participants Country: Taiwan
3 nursing home facilities
Of 104 included people with dementia (52 per group), 100 participants (experimental group: 49 participants; control group: 51) were included in analyses (53% women in total group; experimental group: 53.06% women; control group: 52.94%)
Mean age: overall: 82 (range 65–97, SD 6.80) years; experimental group: 81.46 years; control group: 82.15 years
Diagnosis of dementia: participants had been diagnosed by a physician as having dementia, using the DSM‐IV‐TR.
Interventions Experimental group: mixed active‐receptive music group intervention modified of the protocol developed by Clair and Bernstein (Clair 1990), 12 sessions of 30 minutes in 6 weeks; provided by a music therapist.
Control group: continued to engage in their normal daily activities.
Outcomes Physically non‐aggressive behaviours, physically aggressive behaviours, verbally non‐aggressive behaviours and verbally aggressive behaviours were measured with C‐CMAI. The instrument rates a person's agitated behaviour and its frequency over the previous 2 weeks. The C‐CMAI includes 29 items, each rated on a 7‐point scale (1–7) ranging from never (1 point) to several times an hour (7 points), with a total score of 29 (minimum) to 203 (maximum). CMAI frequency referred to the previous 2 weeks.
Depression measured with the C‐CSDD.
Cognition was measured with the C‐MMSE.
These outcomes were measured by another member of the research team in the experimental and control groups at baseline (1 week before start intervention), immediately after 6th and 12th sessions, and at 1 month after cessation of the intervention.
Cortisol levels were used as a biomarker for depression and were measured at baseline, immediately after 6th and 12th sessions.
Notes Funding: no information provided.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "subjects consisted of a total of 104 elderly persons who were randomly assigned to the experimental (n = 52) and control group (n = 52) by permuted block randomization." (p 671, Lin 2011) and "permuted block randomisation computer‐based program" (p 672, Lin 2011).
Quote: "Using permuted‐block randomisation, a separate researcher randomized participants into the experimental or usual‐care control group within each nursing home. We determined blocked randomization with a block size of 26 using the Research Randomizer computer program, which generates a list of random numbers to be used for allocating participants to the two groups. We generated the allocation sequence with the Research Randomizer program prior to the recruitment of participants and …" (Chu 2014, see under Lin 2011).
Allocation concealment (selection bias) Low risk Quote: "participants and ……(continued) concealed the results in sequentially numbered and sealed opaque envelopes, which we opened when participant were ready for allocation. After four randomization series, we assigned the 104 participants to the experimental or control condition in a blinded manner" (Chu 2014, see under Lin 2011).
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 Unclear risk Unclear who reported the C‐CMAI.
However, Chu 2014 (see under Lin 2011) described that the C‐CSDD and MSSE were reported by another member of the research team.
Quote: "Another member of the research team administered the study instruments 1 week before the start of the intervention (Time 1), immediately following the 6th (Time 2) and 12th (Time 3) sessions of the intervention, and 1 month after the final intervention session (Time 4) and collected salivary cortisol samples at Times 1–3. The same person administered the instruments each time" (Chu 2014, see under Lin 2011).
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Few cases lost to follow‐up, and only 1 in the experimental group was not interested.
Selective reporting (reporting bias) Unclear risk No protocol available
Other bias Low risk