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. |