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 |
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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 |
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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 |
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Outcomes |
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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 |
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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 |