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

Vlaming 2001.

Methods Randomised clinical trial, UK
Participants 549 hospitalised adults who were admitted acutely under the care of general medical, surgical or orthopaedic teams and were 'thin’ (5% ‐ 10% weight loss or BMI 18 ‐ 22), at nutritional risk due to anthropometrics
Male:Female = 314:235
Mean age = 66.5 years
Exclusion criteria: Planned admissions to medical or orthopaedic wards or to wards other than those 15 taking part in the trial, younger than 18, suffering mental illness, if water‐soluble vitamin supplementation was part of their standard treatment, if their admission would clearly be for 2 days or less, or if they had previously taken part in the trial.
For the secondary randomisation to sip‐feed supplements, undernourished participants were excluded if; Their BMI was < 18 or if the unintentional weight loss exceeded 10%, to allow routine supplementation, were receiving therapeutic diets, e.g. insulin‐dependent diabetes, unable to swallow liquids, or if randomisation was considered clinically unacceptable.
In practice, participants unable to communicate effectively and stroke victims could not be included because of consent issues. Weight loss, height and weight could not be documented in all participants.
 Under these circumstances the trial dietitians used their overall assessment of the participant and their discretion as to whether to randomise participants in the sip‐feed study.
Interventions Experimental group: 400 ml of a complete sip‐feed supplement (Ensure Plus, Abbott Laboratories Ltd) from the 2nd day (n = 275)
 Control group: 400 ml of a placebo drink (n = 274)
Outcomes Length of hospital stay, mortality
Study dates Not stated
Notes We contacted the authors on 8th February 2016 by email: j.powell_tuck@qmul.ac.uk. We received no reply.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk The envelopes used to conceal the randomisation code were sealed but not described as opaque.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk It was unclear if the treatment providers were properly blinded: "The enteral feeds tasted different from each other and EnsurePlus was familiar to the ward nurses. The control feed, which tasted medicinal, was described as an alternative trial feed and we avoided discussion of which feed was ‘under test’. Nurses were not discouraged from assuming that it was the new, unfamiliar feed that was primarily under trial.".
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias) 
 All outcomes High risk There was more than 5% of participants without complete data. "Of 275 patients who received supplemental active sipfeed 97 had BMI data and 99 weight loss data and 54 had both."
"274 patients received the placebo sip‐supplement of whom 101 had BMI data and 76 weight loss data and 44 both, and 133 had either one or other."
The pattern of incomplete data could be described as being different in the 2 groups.
Selective reporting (reporting bias) Unclear risk There was no protocol and the trial did not report serious adverse events.
For‐profit bias High risk The trial received funds from the industry: "We are grateful also to Abbott Laboratories Ltd (especially Dr Stephen Coles, Dr Jackie Edington and Ms J Boorman) who supplied the sip feeds and placebo drinks and provided supplementary financial".
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias.