Ollenschlager 1992.
Study characteristics | ||
Methods | RCT. Parallel design with 2 treatment arms. Duration: mean of 25.5 weeks. Location: Germany. |
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Participants |
Inclusion criteria: adults undergoing chemotherapy for acute leukaemia who had undesired weight loss > 5% or weight 90% < IBW. Exclusion criteria: metabolic diseases, renal or liver insufficiency, the need for artificial nutrition. Number randomised: 29 participants (intervention group, n = 15; control group, n = 16). Attrition: 2 deaths in the intervention group. Gender split: not possible to work out from the information provided. Age: aged 17 ‐ 59 years. Nutritional status: not possible to work out from the information provided. |
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Interventions |
Intervention: participants received dietary advice in the form of daily dietary instruction and modification of diet. Control: participants received no dietary advice in the form of ad libitum intake. |
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Outcomes | Weight*, survival*, number of complete remissions and days temperature >38.5 C, nutrient intake (intervention gp only) *, subjective well‐being (intervention gp only). | |
Publication details |
Language: English. Funding: none declared. Publication status: peer‐reviewed journal. |
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Notes | Data given for mean study period. Data on nutrient intake and subjective well‐being only collected for intervention group so not used. Additional data and information obtained from authors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, method not stated. |
Allocation concealment (selection bias) | Unclear risk | Method not stated. |
Blinding (performance bias and detection bias) Clinical outcomes | Low risk | Blinding not described but assessment of mortality unlikely to be influenced by lack of blinding. |
Blinding (performance bias and detection bias) Functional outcomes | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) Nutritional outcomes | Unclear risk | Not stated. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not described 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 | No blinding described and likely that lack of blinding might influence assessment of some outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Fully described with reasons. (2/15 deaths in the dietary advice group, 0/16 deaths in the routine care group; 2 participants in the dietary advice group excluded from the analysis because only 1 weight obtained in week 1). |
Selective reporting (reporting bias) | High risk | No protocol identified. Data given for mean study period. Data on nutrient intake and subjective well‐being only collected for intervention group so not used. Data on weight change presented as % of ideal body weight, mean change (SD) not available from authors and so not included in the review. Additional data on mortality and information on some outcomes obtained from authors. |
Other bias | Low risk | Baseline variables given, groups similar at baseline. |