Ravasco 2005a.
Methods | Randomised controlled trial. Duration 42 days intervention plus 3 months. | |
Participants | Adults (n = 111, 66 men and 45 women, mean (SD) age 58 years (15)) with colorectal cancer undergoing radiotherapy. At baseline 42/111 participants were 'malnourished' (identified by PG‐SGA); 15 in Group 1, 14 in Group 2, 13 in Group 3). No participants lost to follow‐up. |
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Interventions | Individualised dietary counselling to achieve calculated energy and protein requirements (n = 37) versus 2x 200 ml cans of nutritional supplement (n = 37) versus ad libitum food intake (n = 37). | |
Outcomes | Survival*, weight*, BMI*, energy intake*, protein intake, symptom‐induced morbidity, QoL. | |
Notes | Data will be used in 2 parts of the review dietary advice versus no advice and dietary advice versus nutritional supplements. Additional data and information obtained from authors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
Allocation concealment (selection bias) | Low risk | Sequentially numbered sealed opaque envelopes. |
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 | Low risk | No participants lost to follow up. |
Selective reporting (reporting bias) | Low risk | All specified outcomes reported but in text and figures but not in a format or sufficient detail to make them usable for meta‐analysis. Additional data on mean change (SD) for weight and energy intake obtained from author. Author confirmed that no deaths occurred in the 3‐month study. |
Other bias | High risk | Baseline variables not given, not sure if groups similar at baseline. |