Stockholm 1998.
| Methods | RCT Opaque sealed envelopes Independent (single‐blind) outcome measurement | |
| Participants | 83 patients recruited from the neurology department of a city hospital Inclusion criteria: cerebral infarct or primary intracerebral haemorrhage, 5 to 7 days post stroke, continent and able to feed, residual impairment, medically stable, intact cognition Characteristics: median age 72 (range 49 to 89) years. Median Lindmark Motor Capacity scale 127/153 (IQR 100 to 138). Trial included 86/220 (38%) of patients screened (approximately 30% of all patients) | |
| Interventions | Intervention: multidisciplinary hospital out‐reach early supported discharge team, with special interest in rehabilitation and co‐ordinated through weekly meetings. This was a therapist‐based service (no nursing input) based in the hospital stroke unit. Pre‐discharge home visit carried out with the patient. Intervention provided on a less than daily basis for 3 to 4 months after discharge. Team co‐ordinated and delivered care Control: these patients received conventional hospital care involving co‐ ordinated multidisciplinary stroke unit care in a hospital stroke unit and conventional discharge procedures | |
| Outcomes | Outcomes measured at 3, 6 and 12 months: death, place of residence, dependency (Katz ADL, BI, Frenchay Activities Index; in the current analysis dependency = BI < 20/20), subjective health status (Sickness impact profile), carer subjective health status (Sickness impact profile), patient and carer satisfaction, resource use (length of stay and service costs) Outcome assessment was repeated again at 5 years ‐ including resource use |
|
| Notes | Team felt that co‐ordinated continuity of care provided at home was the key element 1 intervention and 1 control patient lost to follow‐up | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "blocks of two or four, ... by a computerized random procedure" |
| Allocation concealment (selection bias) | Low risk | "Sealed numbered envelopes" |
| 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 | "Assessors were blinded with respect to group assignment and were not involved in randomisation" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All withdrawals explained |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported at 1 year |