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

Park 1992.

Methods Parallel randomised controlled trial
Setting: three teaching hospitals in Glasgow
Sample size: 40 patients was selected to detect a two‐sided difference between the success of gastrostomy feeding at 90% and NGT feeding at 40% with a power of 0.9 and significance of 0.05
Participants 40 patients with neurological dysphagia, 22 male, 18 female; mean age: PEG 56, NGT 65
Inclusion criteria: longstanding (4 weeks or more) dysphagia due to neurological disease; stable medical condition with likely survival of at least one month; ability to communicate verbally or in writing; and presence of a normal gastrointestinal tract
Exclusion criteria: dementia; mechanical lesions causing obstruction of the oesophagus or stomach; active intra‐abdominal inflammation including inflammatory bowel disease or pancreatitis; history of partial gastrectomy, reflux oesophagitis, or intestinal obstruction; and presence of ascites, notable hepatomegaly, severe obesity, coagulopathy, untreated aspiration pneumonia, and major systemic disease including malignancy and respiratory, liver, or renal failure
Interventions PEG (n = 20) Bard 20Fr silicone tube, technique by Ponsky ‐ Gauderer
NGT (n = 20) fine bore Abbott Flexitube, polyurethane, 850 mm length,1.5 mm internal diameter
Outcomes
  1. Mortality

  2. Duration of feeding (days)

  3. Treatment failure

  4. Adverse events

  5. Pneumonia

  6. Nutritional status (weight, albumin, mean difference weight, mid‐arm muscle circumference, triceps skin fold thickness)

  7. Received/prescribed feed

Notes Outcome six was not considered for analysis because only one patient completed the follow‐up
Outcome seven was not considered clinically relevant by itself, unless it causes failure or affects nutritional status (anthropometric parameters)
Follow‐up: 28 days
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers (Epistat Statistical Package)
Allocation concealment (selection bias) Low risk Sealed envelopes
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 by the study investigators
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 High risk There was 95% (19/20) of dropouts in the NGT group due to failures in the treatment and death