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. 2021 Dec 21;2021(12):CD002008. doi: 10.1002/14651858.CD002008.pub5

Chandra 1985.

Study characteristics
Methods RCT.
Duration: 4 weeks.
Location: Newfoundland, Canada
Participants Inclusion criteria: elderly men with clinical and biochemical parameters suggesting malnutrition.
Exclusion criteria: not specified.
Number randomised: 30 participants (intervention group n = 15, control group n = 15).
Gender split: all male
Age: range 70 ‐ 84 years.
Nutritional status: not reported.
Interventions Intervention: participants received dietary advice and ONS in the form of dietary advice and supplements.
Control: participants received no dietary advice and no ONS in the form of no intervention.
Outcomes Weight*, TSF*, biochemistry.
Publication details Language: English.
Funding: not declared.
Publication status: peer‐reviewed journal.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details.
Allocation concealment (selection bias) Unclear risk No details.
Blinding (performance bias and detection bias)
Clinical outcomes Low risk It is not stated whether the trial was blinded or not, but the nature of the intervention suggest that the trial was unblinded.
However, this is unlikely to influence biochemistry outcomes.
Blinding (performance bias and detection bias)
Functional outcomes High risk It is not stated whether the trial was blinded or not. Functional outcomes could have been influenced by lack of blinding.
Blinding (performance bias and detection bias)
Nutritional outcomes High risk It is not stated whether the trial was blinded or not. Nutritional outcomes could have been influenced by lack of blinding.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not described and likely that researchers and participants were aware of group allocation as this was a nutritional intervention. It is possible that assessment of some outcomes was influenced by lack of blinding.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judged to be unclear because low risk for clinical outcomes and high risk for functional and nutritional outcomes.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No information on attrition.
Selective reporting (reporting bias) High risk No study protocol identified. Not all outcome data reported. Data presented on change in weight and TSF and pre‐albumin for the intervention group only. No data extracted and no response to request for data from the author.
Other bias Unclear risk Baseline characteristics not stated.