Eden 1991.
Methods | Method of randomisation not clear | |
Participants | 630 children (age nm: an inclusion criterion for this study was age between 0 and 14 years; 337 boys and 293 girls) with acute lymphoblastic leukaemia (stage nm; nm if primary disease or relapse) Prior treatment nm Prior cardiac dysfunction nm |
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Interventions | Chemotherapy without daunorubicin (N = 308) versus chemotherapy including daunorubicin (N = 322) Cumulative daunorubicin dose nm (according to protocol 90 mg/m2); peak dose (i.e. the maximal dose received in one week) 90 mg/m2; infusion duration nm. Patients received cranial irradiation No surgery No cardioprotective interventions |
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Outcomes |
Overall survival (definition nm) Event‐free survival (defined as time to relapse or death; patients who died without going into remission were counted as having an event on day 1) Tumour response (definition nm; we assumed that the number of total remitters provided in the article was the number of complete remissions) |
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Notes | Length of follow‐up nm 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) | High risk | Clinicians were "bound to record therapy given" and were thus not blinded to treatment. No information on blinding of participants 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 |
Blinding of outcome assessment (detection bias): outcomes other than overall survival | Unclear risk | No information on blinding of outcome assessors was provided for event‐free survival and tumour response |
Incomplete outcome data (attrition bias): overall survival | Low risk | It was stated that all patients were included in the analyses |
Incomplete outcome data (attrition bias): event‐free survival | Low risk | It was stated that all patients were included in the analyses |
Incomplete outcome data (attrition bias): tumour response | Low risk | It was stated that 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 (for all four items it was unclear if balanced between treatment arms) Difference in length of follow‐up between treatment arms: unclear (not reported) Inappropriate influence of funders: unclear (no information provided) |