Wilson 2001.
Methods | Randomised controlled trial. Duration 9 months (6 month treatment and 3 months follow‐up). | |
Participants | Adults (n = 32, dietary advice and supplement group 39% men, 61% women, mean (SD) age 64 years (10 years); and dietary advice group 14% men and 86 % women, mean (SD) age 58 years (8.6 years)) with hypoalbuminaemia (serum albumin 3.5 ‐ 3.7 g/dL) receiving hemodialysis. An additional group is included with severe hypoalbuminaemia (serum albumin 2.5 to 3.4 g/dL who received intervention according to current practice. 5 participants were not included in the analysis but details of the group allocation is unclear. |
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Interventions | Dietary counselling to increase energy and protein intakes and 1‐2 cans of supplement (250 calories per serving) (n = 16) versus dietary counselling to increase energy and protein intake (n = 16). | |
Outcomes | Time to nutritional repletion, number of days spent in hospital*. | |
Notes | No usable data from this study. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but method not stated. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) Clinical outcomes | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) Functional outcomes | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) Nutritional outcomes | Unclear risk | Not stated. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 5 participants were not included in the analysis but details of the group allocation is unclear therefore risk of bias. |
Selective reporting (reporting bias) | High risk | The methods section of the paper states that height, weight and weight history and serum albumin are collected at baseline, The results section reports % achieving nutritional repletion defined by improvement in serum albumin and length of hospital stay but no data on weight change. No response received from authors. |
Other bias | High risk | Baseline variables given, the dietary counselling and supplement group were significantly older than the dietary group, therefore risk of bias. |