Macia 1991.
Methods | Randomised controlled trial. Duration of follow up not reported. | |
Participants | Adults (n = 92, age and sex not reported) receiving radiotherapy for cancers of head and neck, breast and abdominopelvic area. Nutritional status of participants unclear. Numbers of withdrawals and deaths not reported. |
|
Interventions | Dietary instructions on appropriate alimentation during radiotherapy given verbally and in writing (n = 30) versus ad lib food intake and no dietary instruction (n = 62). | |
Outcomes | Weight*, TSF*, MAUC*, MAMC*, BMI*, total protein, albumin, transferrin, total lymphocyte count, iron, cholesterol, triglycerides, clinical observations, overall food* intake. | |
Notes | Dietary advice given by doctors from nutrition and dietetic unit. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Used coin toss to randomise participants. |
Allocation concealment (selection bias) | Unclear risk | No details. |
Blinding (performance bias and detection bias) Clinical outcomes | Low risk | Paper states that clinical variables were assessed by doctors unaware of group allocation. |
Blinding (performance bias and detection bias) Functional outcomes | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) Nutritional outcomes | Unclear risk | Not stated. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Numbers of withdrawals and deaths not reported. |
Selective reporting (reporting bias) | Unclear risk | All outcomes reported but as mean change at baseline and end of follow‐up according to site of tumour therefore change scores were calculated and SDs imputed. No response received from author to requests for data. |
Other bias | High risk | Baseline variables not given, not sure if groups similar at baseline. |