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 |
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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 |
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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) |
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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) | 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) |