Lovik 1996.
Methods | Randomised controlled trial. Duration 6 weeks. | |
Participants | Adults (n = 52, men and women, age range 34 ‐ 86 years) who had received radiotherapy for cancers of head and neck. Nutritional status at study entry unclear, 10% reported weight loss and BMI ranged from 18 ‐ 37kg/m2. 3 deaths (group not reported). |
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Interventions | Intensive dietary instruction from a dietitian including advice to use nutritional supplements if required (n = 28) versus a standard information sheet providing information on all aspects of treatment and including advice to eat a nutritious diet (n = 24). | |
Outcomes | Body weight*, BMI*, TSF*, MAMC*, MUAC, energy intake*, survival*, serum chemistry, albumin and transferrin. | |
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 | Details from author, sequence generation using a random number list. |
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 | 3 deaths all in the intervention arm. |
Selective reporting (reporting bias) | Low risk | All specified outcomes reported. Data on change in weight extracted from the paper, but clarification needed for mortality data. Data on TSF, MAMC presented as number of patients with values below 85% of the normal limit and so not included. Data on energy intake is expressed according to expected intake therefore not usable. |
Other bias | Low risk | Baseline variables given, groups similar at baseline. |