Arnold 1989.
Methods | Randomised controlled trial. Duration 6 months. Intervention to 10 weeks and follow‐up to 6 months for some outcomes. | |
Participants | Adults (n = 50: 29 men and 21 women aged 34 ‐ 88 years) living at home, planned to receive radiotherapy for cancers of head and neck. Mean weight in treatment and comparison groups was 1 ‐ 2 kg below usual weight at study entry. 3 deaths in the dietary counselling and supplement group. |
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Interventions | Intensive dietary counselling (n = 27) versus intensive dietary counselling and the prescription of nutritional supplements to provide an additional 960 ‐ 1080 kcal/day (n = 23). | |
Outcomes | Survival*, number having a complete response to therapy, radiation side‐effects, tumour status, body weight*, serum albumin, transferrin and change in dietary energy*, protein intake. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but no details of method. |
Allocation concealment (selection bias) | Unclear risk | No details of method of allocation concealment. |
Blinding (performance bias and detection bias) Clinical outcomes | Unclear risk | Not discussed. |
Blinding (performance bias and detection bias) Functional outcomes | Unclear risk | Not discussed. |
Blinding (performance bias and detection bias) Nutritional outcomes | Unclear risk | Not discussed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals. 3 deaths in the dietary counselling and supplement group. |
Selective reporting (reporting bias) | Unclear risk | All outcomes reported. Data on mortality obtained from the paper. Data on weight change obtained by extrapolation from Figure 3. Energy intake data presented in a figure with no standard deviations or standard error, therefore risk of bias. No response received from author to request for data. |
Other bias | Low risk | Baseline variables stated, groups similar at baseline. |