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

McCarthy 1999.

Study characteristics
Methods RCT.
Parallel design with 2 arms.
Duration: 4 weeks.
Location: single centre in the USA.
Participants Inclusion criteria: adults beginning a first course of curative radiotherapy for stage 1 or 2 cancer.
Exclusion criteria: head and neck cancer.
Number randomised: 40 participants (intervention group, n = 19; control group, n = 18). Attrition: 32 completed the 4‐week data collection period, 8 participants dropped out, 6 in the intervention group and 2 in the control group.
Gender split: 23 males, 9 females.
Age: mean (SD) intervention group 59.6 (9.6) years; control group 55.6 (14) years.
Nutritional status: unclear.
Interventions Intervention: participants received dietary advice and ONS in the form of weekly nutritional counselling to maintain recommended dietary intake of calories and protein plus 8 oz of 1.0 kcal/mL nutritional supplement.
Control: participants received dietary advice alone in the form of weekly nutritional counselling.
Outcomes Energy intake*.
Publication details Language: English.
Funding: Mead Johnson and Abbott provided some of the nutritional supplements.
Publication status: peer‐reviewed journal.
Notes Data obtained from authors.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Coin toss used to randomise participants.
Allocation concealment (selection bias) Low risk Not reported but unlikely to have been influenced.
Blinding (performance bias and detection bias)
Clinical outcomes Unclear risk None measured.
Blinding (performance bias and detection bias)
Functional outcomes Unclear risk None measured.
Blinding (performance bias and detection bias)
Nutritional outcomes High risk Paper states that assessments were made by the nurse and dietitian that implemented the intervention. Outcomes may have been influenced by knowing groups assignment.
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 High risk Paper states that assessments were made by the nurse and dietitian that implemented the intervention. Outcomes may have been influenced by knowing groups assignment.
Incomplete outcome data (attrition bias)
All outcomes High risk 8 participants lost to follow‐up, 6 of 20 (30%) in the experimental group (disliked the supplements) and 2 of 20 (10%) in the control group. These 8 were not analysed.
Selective reporting (reporting bias) Unclear risk No study protocol identified, thus unable to judge whether all planned outcomes were reported. Outcomes reported are presented in a figure and so not in a format usable for meta‐analysis. Mean change (SD) in energy intake obtained from authors.
Other bias Unclear risk Baseline variables given, the supplement group weighed less and received less radiotherapy.