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

Dennis 2005.

Methods Multicentric parallel randomised controlled trial
Setting: multicentric study involving many countries, mainly UK
Sample size: 1000 patients based on 85% power to detected and absolute risk difference for death or poor outcome of 9%. Type one error: 0.05
Participants 321 patients: 144 male, 177 female; mean age 76 (10); dysphagic stroke patients
Inclusion criteria: recent stroke (within 7 days before admission), first‐ever or recurrent, if the responsible clinician was uncertain of the best feeding (PEG or NGT)
Exclusion criteria: patients with subarachnoid haemorrhage        
Interventions PEG (n = 162)
NGT (n = 159)
Outcomes
  1. Mortality or poor outcome

  2. Overall survival

  3. Utility score (EUROQoL)

  4. Quality of life (EUROQoL)

  5. Length of hospital stay

  6. Adverse events in hospital stay

  7. Pneumonia

  8. Causes of death

  9. Treatment effect

  10. Number of tubes inserted

  11. Reasons for stopping feeding

  12. Vital status

  13. Functional ability (Modified Rankin scale)

  14. Clinicians' satisfaction about enteral feeding

  15. Time in enteral nutrition

Notes Follow‐up: six months
Outcomes 3, 10 and 13 were not suitable for analysis
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated, stratified by country, age, gender, and predicted probability of poor outcome (by minimisation)
Allocation concealment (selection bias) Low risk The randomisation systems were housed on a secure server with access permitted, via a password. Participating centres were issued with codes in order for them to access the randomisation services (three separate numerical codes).
Blinding of participants and personnel (performance bias) 
 All outcomes High risk According to the authors, "the randomising clinician, the clinical team, and the patients were not unaware to treatment allocation— doing so would have been impossible".
Blinding of outcome assessment (detection bias) 
 All outcomes High risk According to the authors, "the randomising clinician, the clinical team, and the patients were not unaware to treatment allocation— doing so would have been impossible". However, 6 month of follow‐up was carried out for the following variables: patients’ vital status, functionalability with themodified Rankin score (MRS), 19 place of residence, method of feeding, and quality of life with the EUROQoL. For these variables, the authors referred that "follow‐up was masked to treatment allocation (except where patients or carers inadvertently unmasked an interviewer at follow‐up; such occurrences were unusual but their frequency was not systematically recorded)".
Because of these divergences the study was considered as of high risk of bias.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Flow of patients was clearly reported
Selective reporting (reporting bias) Low risk Relevant outcomes were analysed
Other bias Low risk None suspected