Chandra 1985.
Study characteristics | ||
Methods | RCT.
Duration: 4 weeks. Location: Newfoundland, Canada |
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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. |
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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. |
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Outcomes | Weight*, TSF*, biochemistry. | |
Publication details |
Language: English. Funding: not declared. Publication status: peer‐reviewed journal. |
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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. |