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. 2015 May 22;2015(5):CD008096. doi: 10.1002/14651858.CD008096.pub4

Bath 1997.

Methods Single‐centre parallel randomised controlled trial
Setting: 1 hospital in UK
Sample size: not reported
Participants Nineteen patients (8 male, 11 female); mean age: 77 years (11)
Baseline disease: 13 Ischaemic stroke, six haemorrhagic stroke
Inclusion criteria: stroke within two weeks of stroke onset
Exclusion criteria: oro‐gastrointestinal disease concurrent severe illness, coagulopathy, pre‐morbid dependency, severe dementia, psychiatric illness
Interventions PEG: details not available
NGT: details not available
Outcomes Primary outcomes
  1. Resumption of safe feeding at 12 weeks

  2. Weight loss < 5% at 6 weeks

  3. Discharge by 6 weeks


Secondary outcomes
  1. Impairment

  2. Disability

  3. Handicap

  4. Quality of life

  5. Tube failures

  6. Chest infection

  7. Oropharyngeal delay time at 4 weeks

Notes Follow‐up: three months
Risks of bias was judged from a systematic review previously published by the author (Bath 2009) and by email contact with the author
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated by minimisation
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not possible for this type of intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not explicitly stated to be blinded by the study investigators
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Intention‐to‐treat analysis
Selective reporting (reporting bias) Low risk Relevant outcomes were analysed
Other bias High risk Unpublished study