Van Haitsma 2015.

Study characteristics
Methods	Study design: randomised controlled trial (not registered) Duration of follow‐up: 3 weeks Study period: not reported
Participants	Country: USA Setting: eight units of a large nonprofit nursing home, Pennsylvania Participants Inclusion criteria: all willing residents living in the nursing unit at baseline Exclusion criteria: residents living in the nursing unit for less than 1 month, actively psychotic residents or residents receiving end‐of‐life care Number of participants randomised: n = 195; intervention group n = 49, active control n = 49, usual care control n = 97 Number of participants lost to follow‐up: intervention group n = 5 (3 refused intervention, 1 died, 1 hospitalised), active control n = 6 (1 refused intervention, 5 hospitalised), usual care control n = 4 (2 refused intervention, 1 died, 1 hospitalised) Number of participants completed the study: n = 180; intervention group n = 44, active control n = 43, usual care control n = 93 Baseline characteristics Age (mean (range)) years: 88.7 (64 to 105); (mean ± SD) intervention group 87.66 ± 8.37, active control 88.71 ± 6.13, usual care control 89.21 ± 6.87 Gender, female: 82.2% Cognitive status, MMSE (mean ± SD): intervention group 7.4 ± 7.13, active control 10.35 ± 7.95, usual care control 9.02 ± 7.64 Care dependency, MDS ADL (mean ± SD): intervention group 25.05 ± 12.52, active control 27.41 ± 10.49, usual care control 25.99 ± 11.18
Interventions	Intervention: Individualized Positive Psychosocial Intervention (IPPI) Active control: standardised 1‐to‐1 activities Control: usual care
Outcomes	No primary outcome defined. Behaviour (verbal and nonverbal) Affect (positive affect: pleasure, alertness; negative affect: sadness, anger, anxiety)
Funding	Alzheimer’s Association Tacrine Fund (Pilot Research Grant TRG‐95‐006) and the Pennsylvania Department of Health (4100054858)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Drawing sealed ward‐numbers (unpublished information).
Allocation concealment (selection bias)	High risk	No information reported, group allocation was not concealed (unpublished information from the study author).
Blinding of participants and personnel (performance bias) All outcomes	High risk	"Having each unit provide only one of the two experimental conditions mitigated the possibility of cross‐contamination because staff members were blinded to the condition of their unit." On each unit, one group of residents received one type of activity programme (intervention or active control) and another group of participants received usual care; blinding of personnel refers only to the type of activity programme (intervention or active control). Since nursing staff was aware whether a participant received an activity programme or usual care there is a risk of contamination. We judged risk of performance bias to be high.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"Before data collection began, RA training included studying the coding manual, observing senior researchers code resident behavior, discussing coding decisions, and practicing coding with a mentor. Within 2 months, all trainees showed adequate reliability (75% agreement or better) and could code interventions independently. Each week, the research team analysed reliability." Outcomes were assessed by trained research assistants using a technical device (event recorder). No information about blinding was reported. We have insufficient information to permit judgement of ‘low risk’ or ‘high risk'.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Participants lost to follow‐up: n = 15; intervention group: n = 5 (n = 3 refused, n = 1 died, n = 1 hospitalised), active control group: n = 6 (n = 1 refused, n = 0 died, n = 5 hospitalised), usual care group: n = 4 (n = 2 refused, n = 1 died, n = 1 hospitalised).
Selective reporting (reporting bias)	Unclear risk	Not registered, no study protocol available.
Other bias	Low risk	‐