Silvers 2014.

Study characteristics
Methods	RCT (pilot study). Parallel design with 2 arms. Duration: 6 months. Location: Australia.
Participants	Inclusion criteria: histologically proven new diagnosis of primary oesophageal or stomach cancer, due to undergo surgery and/or chemotherapy, aged 19 years and over. Exclusion criteria: recurrent disease or physical, cognitive, language or emotional problems that would prevent participation, treatment was planned at another health care facility. Number randomised: 21 participants (intervention group, n = 10; control group, n = 11). Attrition: 6 deaths (intervention group, n = 1; control group, n = 5). Gender split: intervention group 50% males, control group 64% males. Age: mean (SD) intervention group 72 (12) years; control group 64 (14) years. Nutritional status: mean (SD) BMI: intervention group 28 (6) kg/m2, control group 26 (5) kg/m2.
Interventions	Intervention group: participants received dietary advice plus ONS if required in the form of intensive nutritional counselling commenced immediately after diagnosis via weekly telephone call by a research dietitian (nutritional assessment and advice using a tailored, symptom‐directed treatment approach) with face‐to‐face interviews scheduled if the participant was attending the hospital; weight, nutrition‐impact symptoms and oral intake monitored and oral nutritional supplements supplied if clinically indicated. Control group: participants received no dietary advice and no ONS in the form of no planned dietetic input until participants admitted for surgery or chemotherapy leading to an anticipated delay of approximately 6 ‐ 10 weeks before initial contact with a dietitian; contact with the dietitian only if nursing or medical staff made a referral.
Outcomes	Primary outcome: health‐related QoL*. Secondary outcomes: change in weight*, and patient‐generated SGA.
Publication details	Language: English. Funding: Southern Melbourne Integrated Cancer Service (SMICS). Publication status: peer‐reviewed journal.
Notes	Additional data on weight change were obtained from the authors
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The allocation sequence was constructed using a computer random number generator. Randomisation was stratified by diagnosis (oesophageal or stomach cancer).
Allocation concealment (selection bias)	Low risk	The method of concealment was through use of opaque, consecutively numbered, sealed envelopes with the group allocation written on a piece of paper inside.
Blinding (performance bias and detection bias) Clinical outcomes	Low risk	The study was unblinded. However, this is unlikely to influence clinical outcomes.
Blinding (performance bias and detection bias) Functional outcomes	High risk	The study was unblinded. Functional outcomes could have been influenced by lack of blinding.
Blinding (performance bias and detection bias) Nutritional outcomes	High risk	The study was unblinded. Nutritional outcomes could have been influenced by lack of blinding.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not blinded 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	Judged to be unclear, as low risk for clinical outcomes and high risk for nutritional outcomes.
Incomplete outcome data (attrition bias) All outcomes	High risk	Missing outcome data unbalanced in numbers across intervention groups; 5 (45%) deaths in control group, 1(10%) death in intervention group.
Selective reporting (reporting bias)	Unclear risk	No study protocol identified, thus unable to judge whether all planned outcomes were reported.
Other bias	Unclear risk	Participants in the intervention group tended to be older and have a higher BMI.