Sposto 2001.
Methods | Method of randomisation not clear (patients were stratified according to histology (large cell versus non‐large cell) and principal disease site (abdomen versus other) | |
Participants | 284 patients (age nm: an inclusion criterion for this study was age < 21 years; 197 males and 87 females) with non‐lymphoblastic Non‐Hodgkin lymphoma (stage I to IV; nm if primary disease or relapse) Prior treatment nm Prior cardiac dysfunction nm |
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Interventions | Chemotherapy without daunorubicin (N = 139) versus chemotherapy including daunorubicin (N = 145) Cumulative daunorubicin dose nm (according to protocol 350 mg/m2); peak dose (i.e. the maximal dose received in one week) 50 mg/m2; infusion duration nm Craniospinal radiotherapy if CNS disease at diagnosis, parameningeal disease, or isolated CNS relapse (dose depending on reason to give radiotherapy) No surgery No cardioprotective interventions |
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Outcomes | Event‐free survival (defined as the minimal time from study entry to failure to induce remission, disease progression, disease relapse, the occurrence of secondary malignant disease or death from any cause; isolated CNS relapses as first event for which treatment was specified in the protocol are not counted as events in this definition although subsequent CNS relapses or persistent CNS disease were counted as events) | |
Notes | Length of follow‐up nm Exact age in treatment and control group nm, but it was balanced between treatment groups |
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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): outcomes other than overall survival | Unclear risk | No information on blinding of outcome assessors was provided for event‐free survival |
Incomplete outcome data (attrition bias): event‐free survival | Unclear risk | Unclear if 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 (age and sex were balanced between treatment arms; for prior cardiotoxic treatment and prior cardiac dysfunction this was unclear) Difference in length of follow‐up between treatment arms: unclear (not reported) Inappropriate influence of funders: unclear (the study was supported by the Division of Cancer Treatment, National Cancer Institution, National Institutes of Health and the Department of Health and Human Services, but no information on the influence of funders was provided) |