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. 2020 May 11;2020(5):CD003689. doi: 10.1002/14651858.CD003689.pub4

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
  • Depression measured using the Nottingham Health Profile (NHP)


Secondary outcomes
  • Physical function measured using the NHP,

  • Disability measured using the BI

  • Activities of daily living measured using the Frenchay Activities Index (FAI)

  • Death

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