Gariballa 1998.
Methods | Randomised clinical trial, UK | |
Participants | 42 hospitalised adults admitted with an acute stroke and did not have problems with swallowing. The participants had to be conscious the 1st week after the stroke, and they had to show evidence of undernutrition measured with midarm circumference ˜1 SD below the
mean, and triceps skinfold thickness. Partipants were at nutritional risk due to stroke. Male:Female = 21:21 Mean age = 78 years Exclusion criteria: cerebral and subarachnoid haemorrhage, active gastrointestinal disease, gastric surgery, biochemical evidence of hepatic or renal impairment, uncontrolled heart failure, diagnosed malignancy, sepsis, or persistent swallowing difficulty |
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Interventions | Experimental group: Daily oral food supplement for 4 weeks in addition to hospital food(n = 21) The nutritional support consisted of > 400 mL of Fortisip containing 600 kcal and 20 g protein. Control group: Received only hospital food for 4 weeks(n = 21) |
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Outcomes | Energy and protein intakes during the intervention period, change in nutritional status, disability, infective complications, length of stay, and mortality | |
Study dates | Not stated | |
Notes | We contacted the authors on 19th August 2015 by email: s.gariballa@uaeu.ac.ae . 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 block‐randomised, but it was unclear how the sequence was generated. |
Allocation concealment (selection bias) | Low risk | Randomisation blocks were kept separately by the dietitian, and allocation to the treatment group was done by telephone. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Nurses and participants were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Single‐blinded study, with the outcome assessors blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Above 5% dropouts according to weight, and the trial did not allow proper methodology for intention‐to‐treat analysis. |
Selective reporting (reporting bias) | Low risk | All‐cause mortality and serious adverse events were reported. A protocol was not found. |
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. |