Forli 2001.
Methods | Randomised controlled trial. Duration 10‐18 days. | |
Participants | Adults (n = 37, 18 men and 19 women, dietary advice and supplement group, mean age 49 years (range 44 ‐ 53); and no advice group, mean age 48 years range (44 ‐ 52)) with end‐stage lung disease awaiting transplantation. All patients malnourished defined as BMI <18.7 kg/m2. 2 participants withdrew from each group. |
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Interventions | Dietary advice to take an energy‐rich diet and supplements if wanted (n = 20) versus normal hospital diet (n = 22). | |
Outcomes | Survival*, weight*, BMI, TSF*, MAMC*, MUAC*, respiratory function*. | |
Notes | Additional data and information on quality obtained from authors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Described in the paper as using random number tables. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment is not described. |
Blinding (performance bias and detection bias) Clinical outcomes | Low risk | Stated in the paper as assessed blind to intervention group. |
Blinding (performance bias and detection bias) Functional outcomes | Low risk | Stated in the paper as assessed blind to intervention group. |
Blinding (performance bias and detection bias) Nutritional outcomes | High risk | All assessments of nutritional status performed by the study dietitian who was not blinded to intervention group. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 participants withdrew from each group, the reasons for withdrawals are clearly stated. |
Selective reporting (reporting bias) | High risk | Data not reported for clinical and functional outcomes but stated as not significantly different. Data on weight reported as median change with no SD, therefore mean change (SD) obtained from author. Data on energy intake reported as median intake kj/kg therefore obtained from authors. |
Other bias | Unclear risk | Baseline variables given, but one assessment of lung function was significantly different. |