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. 2021 Dec 21;2021(12):CD002008. doi: 10.1002/14651858.CD002008.pub5

Ravasco 2005b.

Study characteristics
Methods RCT.
Parallel design with 3 arms.
Duration: 42 days intervention plus 3 months follow‐up.
Location: Portugal.
Participants Inclusion criteria: adults receiving radiotherapy for head and neck cancer.
Exclusion criteria: renal disease or diabetes.
Number randomised: 75 participants (intervention group 1, n = 25; intervention group 2, n = 25; control group, n = 25). Attrition: no participants lost to follow‐up.
Gender split: 60 males, 15 females.
Age: mean (range) 60 years (36 ‐ 79 years).
Nutritional status: at baseline 45/75 participants were 'malnourished' (identified by PG‐SGA); intervention group 1, n = 16 ; intervention group 2, n = 14; control group, n = 15).
Interventions Intervention (intervention group 1): participants received dietary advice in the form of individualised dietary counselling to achieve calculated energy and protein requirements.
Intervention (intervention group 2): particpants received ONS in the form of 2x 200 mL cans of nutritional supplement.
Control group: participants received no dietary advice in the form ad libitum food intake.
Outcomes Survival*, weight*, energy intake*, nutritional status (PG‐SGA), symptom‐induced morbidity, QoL.
Publication details Language: English.
Funding: Nucleo Regional do Sul da Liga Portuguesa contra o Cancro‐Terry Fox Foundationn.
Publication status: peer‐reviewed journal.
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 Low risk Blinding not described but assessment of mortality unlikely to be influenced by lack of blinding.
Blinding (performance bias and detection bias)
Functional outcomes Unclear risk Not stated and likely that some outcomes might be influenced by lack of blinding.
Blinding (performance bias and detection bias)
Nutritional outcomes Unclear risk Not stated and likely that some outcomes might be influenced by lack of blinding.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not described and likely that researchers and participants were aware of group allocation as this was a nutritional intervention. It is possible that assessment of some outcomes was influenced by lack of blinding.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No blinding described and likely that lack of blinding might influence assessment of some outcomes.
Incomplete outcome data (attrition bias)
All outcomes Low risk No participants lost to follow‐up. Author confirmed that no deaths occurred in the 3‐month study.
Selective reporting (reporting bias) Unclear risk No protocol identified. All specified outcomes reported in text and figures but not in a format or sufficient detail to make them usable for meta‐analysis. Much of the data reported as medians (IQR). Additional data on mean change (SD) for weight, energy intake and QoL obtained from author.
Other bias Unclear risk Baseline variables not given, not sure if groups similar at baseline.