Copenhagen 2009.
| Methods | RCT External list generated and managed by external person, blocks of 10 Opaque sealed envelopes |
|
| Participants | 100 patients recruited from stroke unit of 1 university hospital, 1 to 3 days post stroke Inclusion criteria: mRS 0 to 3 pre‐stroke, living at home Median age 81 (range 33 to 98) years, median BI 69 (0 to 100), median SSS 45 (11 to 58) |
|
| Interventions | Hospital out‐reach multidisciplinary team, based within stroke unit. Co‐ordinated and delivered low intensity (1 to 3 times per week) home based rehabilitation for a period of 1 month. All staff were skilled in stroke care and co‐ordinated via weekly multidisciplinary meetings Control: conventional discharge planning from combined acute/rehabilitation stroke unit and conventional after discharge care |
|
| Outcomes | At 90 days: dependency (mRS, BI, MAS, COPM), cognition (CT‐50), quality of life (EQ‐5D) At 150 days: mortality, use of municipal services, hospital contacts, cost, carer satisfaction |
|
| Notes | The published report excluded some mild stroke patients that were included in the original unpublished report | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "In blocks of each ten patients" "Sealed envelopes containing a card with the word 'intervention' or 'control'" made by a research centre in the Capital Region of Denmark (Research Centre for Prevention and Health, Department of Planning Health and Quality) |
| Allocation concealment (selection bias) | Low risk | "Consecutively numbered and sealed envelopes containing a card with the word 'intervention' or 'control'" |
| 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 | High risk | "Blinded investigators were not used in the trial and all tests were performed by members of the multidisciplinary team". |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 7 patients in the intervention group and 3 control patients 'dropped out' prior to discharge and were not included in the final analysis |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes appear to have been reported (unpublished) |