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. 2017 May 19;2017(5):CD011598. doi: 10.1002/14651858.CD011598.pub2

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
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
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.