MacFie 2000.
Methods | Randomised clinical trial, UK | |
Participants | 52 hospitalised adults undergoing elective major gastrointestinal surgery, at nutritional risk due to major gastrointestinal surgery Male:Female = 20:32 Mean age = 65 years Exclusion criteria: dementia, major concurrent metabolic problems, such as uncontrolled diabetes, advanced liver disease, or uraemia, and those requiring emergency surgery |
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Interventions | Experimental group: Oral Dietary Supplements for at least 7 days Oral dietary supplements were available in 200‐mL cartons (Fortisip, Nutricia Ltd., Towbridge, Wiltshire, UK), in a variety of flavours providing 1.5 kcal, 0.05 g protein, and 0.18 g carbohydrate per mL. A fruit‐flavored supplement (Fortijuice, Nutricia Ltd.) was available as an alternative, providing 1.25 kcal, 0.025 g protein, and 0.285 g carbohydrate per mL. Participants were instructed to drink the supplements in addition to and not in place of their normal diet and were encouraged to take a minimum of 2 cartons daily. They were advised to drink only the volume of supplement they felt able to tolerate. (n = 27) Control group: No intervention(n = 25) Co‐interventions: Normal diet |
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Outcomes | Nutritional status, voluntary food intake, weight loss, serum albumin, morbidity and mortality, anxiety and depression, postoperative activity levels, hand‐grip strenght, midarm circumference, triceps skinfold thickness and BMI | |
Study dates | Not stated | |
Notes | We include only the inpatient part of the trial. We contacted the author on 30th June 2015 by email: johnmacfie@aol.com. We received information on financial support and randomisation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was done by a random‐number sequence. |
Allocation concealment (selection bias) | Low risk | Sealed envelopes were used. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Described as unblinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Described as unblinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The amount of dropouts was unclear. |
Selective reporting (reporting bias) | Low risk | No protocol published, but the trial reported all‐cause mortality and serious adverse events. |
For‐profit bias | Low risk | No financial support. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |