Moloney 1983.
Study characteristics | ||
Methods | RCT. Parallel design with 2 treatment arms. Duration: unclear, intervention given for 3 weeks, survival reported to 1 year; outcomes reported at different time points. Location: Ireland. |
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Participants |
Inclusion criteria: consecutive adults with cancer (various sites) undergoing radiotherapy. Exclusion criteria: clinically poor and considered unethical to withhold adjunctive feeding. Number randomised: 84 participants (intervention group, n = 42; control group, n = 42). Attrition: no information. Gender split: 50 males and 34 females. Age: mean intervention group 63 years; control group 55 years. Nutritional status: no information given. |
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Interventions |
Intervention: participants received dietary advice plus ONS if required in the form of dietary counselling and supplements. Control: participants received no dietary advice and no ONS in the form of no advice. |
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Outcomes | Survival*, energy intake*, macronutrient and micronutrient intake. | |
Publication details |
Language: English. Funding: not declared. Publication status: peer‐reviewed journal. |
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Notes | Data for survival given at 9 months for dietary advice and supplement group and at 11 months for no advice group. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but method not stated. |
Allocation concealment (selection bias) | Unclear risk | Method not stated. |
Blinding (performance bias and detection bias) Clinical outcomes | Low risk | The study was assumed to be unblinded. However, this is unlikely to influence clinical outcomes. |
Blinding (performance bias and detection bias) Functional outcomes | Unclear risk | Not measured. |
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 because low risk for clinical outcomes and high risk for functional and nutritional outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information on attrition. |
Selective reporting (reporting bias) | Unclear risk | No study protocol identified, thus unable to judge whether all planned outcomes were reported. Mortality data obtained from the paper. Data on change in energy intake is expressed as mean (SD) at baseline and end of intervention, therefore change scores were calculated and SDs imputed. No response received from author. |
Other bias | Unclear risk | Baseline variables given, treatment group were older. |