Forster 1996.
Study characteristics | ||
Methods | Study design: parallel design Number of arms: 2 Treatment arm: specialist nurse intervention Control arm: usual care |
|
Participants | Geographical location: UK
Setting: outpatient
Stroke criteria: all subtypes excluding cerebral haemorrhage Method of diagnosis: via clinical signs and CT (% not reported) Time since stroke: not reported Inclusion criteria: 1) over 60 years; 2) disability related to stroke Exclusion criteria: 1) multi‐infarction dementia; 2) concurrent medical condition associated with a poor prognosis; 3) lived in residential care Total number randomised in this study: 240 Number randomised to treatment group: 120 (55% men, median age 73 years, range 60 to 94 years) Number randomised to control group: 120 (51% men, median age 73 years, range 60 to 90 years) Total number included in final analysis: 208 Number included in treatment group for final analysis: 103 Number included in control group for final analysis: 105 |
|
Interventions | Treatment: specialist nurse intervention; included a counselling and enabling model, specialised in problem solving, goal setting, advice on specific issues plus information booklets Treatment duration: treatment continued for a minimum 6 visits over the first 6 months (average of 8 visits over first 6 months) Administed by: specialist G‐grade nurses experienced in assessing disability in elderly and in problem solving approaches Supervision: not reported Intervention fidelity: not reported Control: usual care, no visits Follow‐up: not reported |
|
Outcomes | Primary outcomes
Secondary outcomes
|
|
Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: "An assistant in our department who was otherwise unconnected with the study randomized the patients by 4 length random permuted blocks of 6 to the control group or the intervention group (the patients receiving visits by the specialist nurses)." pp. 1642 Comments: method of sequence generation not reported |
Allocation concealment (selection bias) | Unclear risk | Comments: method of allocation not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comments: blinding of participants and personnel not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comments: blinding of outcome assessment not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comments: per protocol analysis reported only. 33/240 participants not included in the analysis |
Selective reporting (reporting bias) | Unclear risk | Comments: no trial protocol available to compare with the publication |
Other bias | Low risk | Comments: there was no statistically significant difference between the treatment and control group in baseline demographic characteristics |