Gazzotti 2003.
Methods | Randomised clinical trial, Belgium | |
Participants | 80 hospitalised adults, at nutritional risk based on Mini Nutritional Assessment Male:Female = 19:61 Mean age = 80 years |
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Interventions | Experimental group: oral supplements (1.5 kcal/ml 500 kcal and 21 g protein a day in 200 ml cup)(n = 39) Control group: no intervention(n = 41) Co‐interventions: standard diet throughout the hospitalisation and after discharge for 2 months |
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Outcomes | All‐cause mortality, weight change, MNA score | |
Study dates | November 1999 to April 2000 | |
Notes | We contacted the authors on 23rd June 2015 by email: claire.gazzotti@chrcitadelle.be. We received no reply. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The trial was described as being randomised, but it was unclear how the sequence was generated. |
Allocation concealment (selection bias) | Low risk | The allocation was concealed using sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The trial was described as not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The trial was described as not blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Above 5% dropouts and the trial did not use proper methodology for intention‐to‐treat analysis. |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained, and the trial did not report all‐cause mortality or serious adverse events. |
For‐profit bias | Low 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. |