Manguso 2005.
Methods | Randomised controlled cross‐over trial. Total duration of trial 6 months, only results from the first 3 months will be considered. | |
Participants | Adults (n = 90, mean age 60 years (IQR 9), 52 males, 38 females) admitted to a specialist unit for the management of liver cirrhosis. Nutritional status not categorised. 3 withdrawals, but number of deaths not reported. |
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Interventions | Controlled diet consisting of specific prescription for macronutrients and calcium (n = 45) versus spontaneous diet (n = 45). | |
Outcomes | weight*, MAMC*, TSF*, energy intake*, Childs Score, biochemistry profile | |
Notes | Weight may be inappropriate in analysis due to possible presence of ascites. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence. |
Allocation concealment (selection bias) | Low risk | Sequentially numbered opaque sealed envelopes. |
Blinding (performance bias and detection bias) Clinical outcomes | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) Functional outcomes | High risk | None measured. |
Blinding (performance bias and detection bias) Nutritional outcomes | Low risk | Information from author, the assessor was blinded to intervention group. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Information from author: no deaths occurred in the study. 1 patient withdrew from the dietary advice group and 2 from the no intervention group. |
Selective reporting (reporting bias) | Low risk | Results on all specified outcome measures reported but as mean (SD) at baseline and end of intervention. Mean change (SD) for weight, energy intake, TSF and MAMC and additional information obtained from authors. |
Other bias | Low risk | Baseline characteristics comparable between groups. |