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

Nesbit 1990.

Methods Method of randomisation not clear (patients were randomised on a 2 to 3 patient basis to intervention and control group)
Participants 94 children (age nm; 56 boys and 38 girls) with non‐metastatic Ewing's sarcoma of the bone (primary disease)
No prior treatment
Prior cardiac dysfunction nm
Interventions Chemotherapy without doxorubicin (N = 37) versus chemotherapy including doxorubicin (N = 57)
Cumulative doxorubicin dose nm (according to protocol maximal 420 mg/m2); peak dose (i.e. the maximal dose received in one week) 60 mg/m2; infusion duration nm
Radiotherapy to primary lesion (dose adjusted to age)
Part of the patients underwent surgical resection of the lesion: 3 in the intervention group and 19 in the control group
No cardioprotective interventions
Outcomes Overall survival (defined as time from start of treatment to death)
Event‐free survival (defined as time from start of treatment to first evidence of local recurrence or metastatic disease; patients dying before evidence of relapse were counted as failures)
Cardiotoxicity (clinical heart failure defined as death of irreversible cardiac failure)
Notes Length of follow‐up nm
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
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 cardiotoxicity
Incomplete outcome data (attrition bias): overall survival Low risk All patients were included in the analyses
Incomplete outcome data (attrition bias): event‐free survival Low risk All patients were included in the analyses
Incomplete outcome data (attrition bias): anthracycline‐induced cardiotoxicity Unclear risk It was unclear if outcome data were available for all patients
Selective reporting (reporting bias) Low risk There was no protocol mentioned in the manuscript (and we did not search for it), but 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 and methods of the study)
Baseline imbalance between treatment arms related to outcome (prior cardiotoxic treatment, age, sex and/or prior cardiac dysfunction): unclear (unclear if age and prior cardiac dysfunction were balanced between treatment arms; no prior cardiotoxic treatment; sex distribution was rather similar in both treatment arms)
Difference in length of follow‐up between treatment arms: unclear (not reported)
Inappropriate influence of funders: unclear (the study was supported by a Public Health Service Grant awarded by the National Cancer Institute, department of Health and Human Services, but no information on the influence of funders was provided)