Bergen 2014.

Methods	RCT comparing two different ESD models with treatment as usual
Participants	Patients admitted to the stroke unit (Department of Neurology, Haukeland University Hospital, Bergen) who were living at home in the Municipality of Bergen prior to having a stroke, had a stroke within the previous 7 days, and were admitted to the stroke unit within the previous 5 days. NIHSS score of 2 to 26 of a 13 items Norwegian version (range 0 to 34). Patients with NIHSS score < 2 were included if the mRS score was > 1. The patients had to be awake and able to agree to participation in the study by signing an informed consent, either themselves or by their relatives At recruitment (2008 to 2011) characteristics were: Average 72 years (range 27 to 98), 169 (55%) men, baseline BI 95 (SD 40), baseline NIHSS 3 (SD 4) On average 306/1736 (18%) of screened patients were included
Interventions	Patients in 2 of the 3 study arms were treated according to the ESD concept. They were followed‐up by a designated multi‐disciplinary ambulatory team consisting of a nurse, a physiotherapist, and an occupational therapist from soon after admission to the stroke unit until shortly after discharge to home. This team originated from the rehabilitation department and served as a co‐ordinating link between the patient, relatives, hospital personnel, and the personnel in primary health care. The team was particularly important in the discharge process and co‐operated closely with the municipal health care in the planning and implementation of further treatment after discharge. The two ESD arms differed by the location of treatment: ESD 1 group received their treatment in a community day unit; whereas ESD 2 group patients stayed in their homes with home visits from the community health team Patients in the third study arm constituted a control group and were treated as usual without any intervention from the study, except outpatient appointments for testing. Treatment 'as usual' mainly comprised institutional stay if necessary and/or physiotherapy as needed in the municipality (0 to 2 hours per week). Patients in all 3 study arms received language therapy as needed, regardless of allocated arm The patients in the two ESD arms were discharged to their homes as soon as possible. Patients in need of a longer in‐patient treatment period than offered by the stroke unit were discharged to a municipal institution or rehabilitation department for a period before going home. All patients in the ESD arms were offered rehabilitative treatment by a multi‐disciplinary community health team, consisting of a nurse, a physiotherapist, and an occupational therapist The scheduled treatment period was 5 weeks and maximally 4 hours per day 5 days a week, but many patients did not comply with this
Outcomes	The primary study outcome was mRS at 6 months Secondary outcomes included mRS at 3 months, NIHSS, Barthel ADL Index, and patient satisfaction (5‐point Likert scale with 1 best) at 3 and 6 months
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Participants were randomised according to a computer generated block randomisation list (six patients in each block; two for each study arm) and consecutively assigned to their groups in the same order as they were included into the study"
Allocation concealment (selection bias)	Low risk	"The randomisation list was kept by a study coordinator and was not known to any persons in the stroke unit"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not explicitly stated but probably not possible to blind participants and personnel
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"The testers were blinded for study arm and the patients were instructed not to reveal this information"
Incomplete outcome data (attrition bias) All outcomes	High risk	77/306 (25%) were not retested at 6 months (22 Day Unit; 22 Home group; 33 control)
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes appear to have been reported