Ravasco 2005b.
Methods | Randomised controlled trial. Duration 42 days intervention plus 3 months. | |
Participants | Adults (n = 75) receiving radiotherapy for head and neck cancer, mean age 60 years (range 36 to 79 years). At baseline 45/75 participants were 'malnourished' (identified by PG‐SGA); 16 in Group 1, 14 in Group 2, 15 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 = 25) versus 2x 200 ml cans of nutritional supplement (n = 25) versus ad libitum food intake (n = 25). | |
Outcomes | Survival*, weight*, energy intake*, nutritional status (PG‐SGA), 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. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation using computer‐generated random assignments. |
Allocation concealment (selection bias) | Low risk | Concealed in numbered 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. |