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. 2021 Dec 21;2021(12):CD002008. doi: 10.1002/14651858.CD002008.pub5

Ollenschlager 1992.

Study characteristics
Methods RCT.
Parallel design with 2 treatment arms.
Duration: mean of 25.5 weeks.
Location: Germany.
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.
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.
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.
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.