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 |
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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 |
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Outcomes | Overall survival (definition nm) | |
Notes | Length of follow‐up for all patients maximal 18 months Age in treatment and control group nm |
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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) |