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. 2014 Sep 4;2014(9):CD006647. doi: 10.1002/14651858.CD006647.pub4

Van der Does 1975.

Methods Method of randomisation not clear
Participants 42 children (age nm: an inclusion criterion for this study was age between 1 and 14 years; sex nm) with acute lymphocytic leukaemia (stage nm; primary disease)
No prior treatment
Prior cardiac dysfunction unclear
Interventions Chemotherapy without daunorubicin (N = 22) versus chemotherapy including daunorubicin (N = 20)
Cumulative daunorubicin dose nm (according to protocol maximal 300 mg/m2); peak dose (i.e. the maximal dose received in one week) 30 mg/m2; infusion duration nm
No radiotherapy or surgery
No cardioprotective interventions
Outcomes Overall survival (definition nm)
Notes Length of follow‐up for all patients maximal 18 months
Age in treatment and control group nm
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk It was stated that this was a randomised study, but no further information on the methods of randomisation was provided
Allocation concealment (selection bias) Unclear risk It was stated that this was a randomised study, but no further information on the methods of randomisation was provided
Blinding of participants and personnel (performance bias) Unclear risk No information on blinding of participants and personnel was provided
Blinding of outcome assessment (detection bias): overall survival Low risk No information on blinding of outcome assessors was provided, but since this is not applicable for overall survival we judged this as a low risk of bias
Incomplete outcome data (attrition bias): overall survival Low risk All patients were included in the analyses
Selective reporting (reporting bias) High risk There was no protocol mentioned in the manuscript (and we did not search for it), but not all expected outcomes were reported
Other bias Unclear risk Block randomisation in unblinded trials: unclear (see information provided at earlier associated risk of bias items)
Baseline imbalance between treatment arms related to outcome (prior cardiotoxic treatment, age, sex and/or prior cardiac dysfunction): unclear (unclear if age, sex and prior cardiac dysfunction were balanced between treatment arms; no prior cardiotoxic treatment)
Difference in length of follow‐up between treatment arms: unclear (not reported)
Inappropriate influence of funders: unclear (the study was supported by Ministerie van Volksgezondheid en Milieuhygiëne, but no information on the influence of funders was provided)