Førli 2001.
Methods | Randomised clinical trial (stratified for age and sex), Norway | |
Participants | 42 underweight hospitalised adults with end‐stage pulmonary disease referred to the hospital to be evaluated for lung transplantation, at nutritional risk due to low BMI Male:Female = 20:22 Mean age = 48.5 years Exclusion criteria: Unwillingness to participate and eat the prescribed diet, too sick to be able to co‐operate and leave of absence due to the possibility of eating meals outside the hospital |
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Interventions | Experimental group: Energy‐rich diet 10 MJ/day + offered extra meals(n = 20) Control group: Regular hospital diet 8.5 ‐ 9 MJ/day(n = 22) | |
Outcomes | Weight, BMI, energy intake, mortality, pulmonary function | |
Study dates | Not stated | |
Notes | We could obtain no contact information for the authors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The trial used random‐number tables. |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The trial was described as unblinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The trial was described as unblinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Above 5% dropouts and the trial did not allow proper methodology for an 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 | High risk | The trial was supported by the Research Council of Norway and the Norwegian Heart and Lung Association, as well as financial support from Pharmacia & Upjohn and Abbott Norway A/S. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |