Ovesen 1993.
Methods | Randomised controlled trial. Duration 5 months. | |
Participants | Adults (n = 137, 75% men and 25% women age range for groups combined 22 ‐ 80 years) receiving chemotherapy for small‐cell‐lung cancer, ovarian cancer or breast cancer. 30 deaths: 20 in the dietary advice group and 10 in the no advice group. 50% of patients malnourished at study entry defined as >5% weight loss in the previous 3 months. 19 withdrawals: 9 in the dietary advice group and 10 in the no advice group. |
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Interventions | Dietary instruction given twice monthly to exceed the Nordic recommended allowances using supplements if indicated (n = 74) versus no dietary advice (n = 63). | |
Outcomes | Survival*, weight*, TSF*, MAMC*, MUAC*, energy intake*, QoL, tumour response. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence generation was reported as using a table of random numbers. |
Allocation concealment (selection bias) | Low risk | Allocation concealment was reported as using sealed opaque envelopes. |
Blinding (performance bias and detection bias) Clinical outcomes | Unclear risk | Not stated. |
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 | Unclear risk | 30 deaths: 20 in the dietary advice group and 10 in the no advice group. 19 withdrawals: 9 in the dietary advice group and 10 in the no advice group. No reasons given. |
Selective reporting (reporting bias) | Low risk | All specified outcomes reported at baseline and monthly to five months after the intervention. The data on mortality at interim time‐points is unclear and it has not been possible to clarify with authors, therefore only data from baseline to 5 months have been used in meta‐analysis. |
Other bias | Low risk | Baseline variables given, groups similar at baseline. |