Arias 2008.
| Methods | Randomised clinical trial, Uruguay | |
| Participants | 667 hospitalised adults admitted to the medical ward, at nutritional risk due to being malnourished or severely malnourished according the Subjective Global Assessment criteria Male:Female = 337:200 (excluding dropped‐out participants) Exclusion criteria: diabetic, decompensated hepatitis with encephalitis, altered consciousness, difficulty understanding instructions or handicap, where the family was unwilling to co‐operate |
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| Interventions | Experimental group: oral nutrition support with 1 cal/ml (54.5% carbohydrates, 31.5% lipid, 14% protein), 700 ml maximum (n = 333) Control group: no intervention (n = 334) Co‐interventions: treatment as usual |
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| Outcomes | Development of infections, pressure ulcers, length of hospital stay, mortality and weight | |
| Study dates | May 2005 to September 2006 | |
| Notes | We contacted the authors by email: sylviaarias@montevideo.com.uy. We received a reply and received information on sequence generation, allocation concealment and weight data. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | The 'code' was made by folding papers with either a T or a C, not performed by an independent person. |
| Allocation concealment (selection bias) | Unclear risk | The papers were folded and put into a dark bag. It is unclear if the allocation was concealed properly. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | The trial was not blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | The trial was not blinded. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 130 participants dropped out, without the trial using proper methods to deal with the dropouts. |
| Selective reporting (reporting bias) | Low risk | All‐cause mortality and complications were reported. |
| For‐profit bias | Unclear risk | It was unclear how the trial was funded. |
| Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |