Aveiro 2016.

Methods	Prospective, randomised, open‐label, blinded‐endpoint trial
Participants	Inclusion criteria: acute stroke patients (World Health Organization definition of stroke), aged 25 to 85 years, FIM no more than 100 who were admitted to the stroke unit with an initial and who gave informed consent Exclusion criteria: SAH, comorbidity, severe aphasia interfering seriously with the stroke rehabilitation, psychological and psychiatric problems or other severe illness interfering seriously with the stroke rehabilitation Actual recruitment: Mean age 67 years (range 35 to 84) Men 101 (53%) Baseline FIM 70 (range 24 to 100) On average 190/571 (33%) of screened acute stroke patients were eligible
Interventions	The main goal of this study was to adapt an 'early home‐supported discharge (EHSD)' service model to the conditions of Portugal, and then to evaluate the impact of this service Intervention: the intervention started in the stroke unit. The team co‐ordinator at the hospital identified potential patients for the study. After obtaining the informed consent, the patient would be randomised and the case manager contacted to schedule a visit to the patient. Community‐based multidisciplinary team comprising physiotherapist, occupational therapist, gerontologist (case manager), and psychologist ‐ all staff with previous experience in stroke care but no specialised training in stroke rehabilitation stroke care. Team co‐ordinate and deliver care. Team are co‐ordinated via weekly multidisciplinary meetings. The EHSD intervention started in the stroke unit, where the patient and informal caregiver were met by their assigned EHSD case manager. The assigned case manager was 1 of 2 gerontologists who were included to help negotiate the fragmented nature of the Portuguese health and social care systems. Input from the EHSD team of therapists (2 physiotherapists, 2 occupational therapists, and a psychologist) was selected according to the needs of a particular patient. For patients discharged to their homes, the intervention continued directly after discharge to provide a seamless transfer from the hospital to home (individual rehabilitation plan, provision of aids and modifications, providing information and tailored training to the patient and family). Rehabilitation was focused on daily activities valued by the patient. Caregivers were trained and made aware of the ability of the patient and were encouraged to follow their progress. The EHSD team worked with patients to provide approximately 8 home‐based training sessions for a maximum of 1 month. For patients discharged to an inpatient rehabilitation setting, contact with the EHSD team was reinitiated when discharge home was planned. For those patients discharged home while waiting for a place in a rehabilitation unit, the team provided rehabilitation at home to prevent loss of rehabilitation capability Control: patients in the usual care group were contacted in the stroke unit, introduced to the study, and assigned a case manager. They began their rehabilitation as part of standard care in the stroke unit and then accessed the standard rehabilitation available in the region following discharge They received information about services available in the community, but no further specific input was provided
Outcomes	The primary outcome of the study was independence in physical and cognitive activities as assessed by FIM at 2 and 6 months after randomisation. They proposed that a patient with 3 points in each variable (total score of less than 60) would require inpatient rehabilitation.This threshold value was used to further analyse the data. As it was not set a priori and there was no literature on which to base the decision, results were handled with care Secondary outcome measures included: the Frenchay Activity Index (FAI),the World Health Organization WHOQOLBREF quality of life assessment (WHOQOLBREF), Short Form‐6D, BI, and MMSE. Outcome measures were collected at the patients homes by the case managers. Length of stay at the stroke unit and the convalescence units was obtained from the clinical records
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Prospective, randomised, open label, blinded‐endpoint trial"
Allocation concealment (selection bias)	Low risk	"Allocation of patients to each group was done by taking one folded sheet of paper from a prefilled opaque envelope containing folded sheets of paper with either the letter H or the letter C written inside. This was done by a staff member not involved in the trial."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not explicitly stated but not possible to blind participants and personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"Outcome measures were collected at the patients homes by the case managers."
Incomplete outcome data (attrition bias) All outcomes	High risk	36 (19%) lost to follow‐up (19 EHSD, 17 controls)
Selective reporting (reporting bias)	Low risk	All key patient outcomes reported. Recording of rehabilitation activities less complete.