Cooke 2010

Methods	RCT (crossover). Data collection from October 2008 to March 2009.
Participants	Country: Australia. 2 mixed‐gender long‐term care facilities, which provided low (assisted living) and high (nursing home) care. N = 47 (33 female and 14 male). Age: 3 people between 65 and 74, 13 between 75 and 84, 28 between 85 and 94 and 3 people aged 95+. Dementia diagnosis: a confirmed diagnosis of early‐ to mid‐stage dementia, OR probable dementia (i.e. a cognitive impairment level of 12 to 24 on MMSE) OR Alzheimer’s dementia according to DSM‐IV criteria. At baseline, the mean MMSE score was 16.51, representing middle‐stage dementia (SD = 6.737). Parcipants had "a documented behavioural history of agitation/aggression on nursing/medical records within the last month."
Interventions	1) Active live group music programme (30 minutes per session) and listening to pre‐recorded instrumental music (10 minutes per session) led by 2 musicians. 2) Reading group chosen as the control group activity so as to provide a comparable activity. The facilitator of the 40‐minute sessions was trained research assistant. Both the active group music programme and the control activities ran 3 mornings a week (Monday, Wednesday and Friday) for 8 weeks, and the facilitators were trained in the delivery of the sessions and in working with older people with dementia.
Outcomes	Primary outcome Agitation was measured with the Cohen‐Mansfield Agitation Inventory – Short Form (CMAI‐SF) and overall and sub scale scores are reported for a modified 14‐item short form. Timeframe: previous 2 weeks. Secondary outcome Anxiety was measured with the Rating Anxiety in Dementia Scale (RAID). Timeframe: previous 2 weeks. Quality of life was measured with Dementia Quality of Life (DQOL) using overall and sub scale scores. Depression was measured with Geriatric Depression Scale (GDS). Outcomes were measured at baseline, mid‐point (after the first 8‐week intervention arm) and post‐intervention (after the second 8‐week intervention arm).
Notes	Funding: funded by the National Health & Medical Research Council, Australia
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The randomisation process was conducted by the study’s biostatistician, who was blinded to the identity of potential participants, using a computer‐generated programme".
Allocation concealment (selection bias)	Low risk	Quote: "The randomisation process was conducted by the study’s biostatistician, who was blinded to the identity of potential participants, using a computer‐generated programme".
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	Low risk	Quote about CMAI‐SF: "Aged care staff who provided most care to the participant, but blinded to treatment groups, were asked to rate the ..." Quote about RAID: "Research assistants (RAs) blinded to the treatment groups asked participants to rate, on a scale from ‘1 = absent’ to ‘3 = severe’, how often he/she had experienced each symptom in the previous two weeks". Research assistant completed DQOL and GDS (Figure 1). Quote: "Both measures were conducted by trained RAs blinded to the treatment groups at a time most convenient for the participant (i.e. any day of the week from 9am–5pm). The RAs took the role as interviewer, taking the participants through the measures by asking them questions to elicit their response".
Incomplete outcome data (attrition bias) All outcomes	Low risk	Prior to all sessions, participants were asked if they wished to attend. This resulted in some refusals and differences in attendance levels amongst participants. Following a missing values analysis, which indicated data to be missing at random, an ITT analysis, in which all randomized participants were included (n = 47), was undertaken. Missing values in the outcome measures were imputed with multiple imputation methods.
Selective reporting (reporting bias)	High risk	Inconsistencies compared with the trial registration which was retrospectively registered in 2012. Number of registration therefore not in article. Registration points to anxiety as a secondary outcome, not a primary outcome. Moreover, quality of life and depression were not reported as secondary outcomes.
Other bias	Low risk