Maurer 1988.
Methods | Method of randomisation not clear (patients randomised within each clinical group) | |
Participants | 413 children (age nm: an inclusion criterion for this study was age < 21 years; 240 males and 173 females) with rhabdomyosarcoma or undifferentiated sarcoma (clinical group III or IV; primary disease) No prior treatment Prior cardiac dysfunction nm |
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Interventions | Chemotherapy without doxorubicin (N = 208) versus chemotherapy including doxorubicin (N = 205) Cumulative doxorubicin dose nm (according to protocol 300 mg/m2); peak dose (i.e. the maximal dose received in one week) 60 mg/m2; infusion duration nm All patients received radiotherapy to the primary lesion (dose adjusted to age); in case of pulmonary metastases patients received pulmonary irradiation No surgery No cardioprotective interventions |
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Outcomes |
Overall survival (defined as time from start of treatment to death) Tumour response (complete remission defined as complete disappearance of all signs and symptoms of disease; partial remission defined as at least 50% reduction in gross disease in widest diameter) Cardiotoxicity (clinical heart failure defined as congestive heart failure). |
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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): 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 tumour response and cardiotoxicity |
Incomplete outcome data (attrition bias): overall survival | Unclear risk | It was not clear if all participants were included in the analyses |
Incomplete outcome data (attrition bias): tumour response | Low risk | Only 1% of participants were not evaluable for this outcome |
Incomplete outcome data (attrition bias): anthracycline‐induced cardiotoxicity | Unclear risk | It was not clear if all participants were included in the analyses |
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) Baseline imbalance between treatment arms related to outcome (prior cardiotoxic treatment, age, sex and/or prior cardiac dysfunction): unclear (unclear if prior cardiotoxic treatment was balanced between treatment arms; age, sex, prior cardiac dysfunction were balanced between treatment arms) Difference in length of follow‐up between treatment arms: unclear (not reported) Inappropriate influence of funders: unclear (the study was supported by US Public Health Service Grants, but no information on the influence of funders was provided) |