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

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
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
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).
Notes Length of follow‐up nm
Exact age in treatment and control group nm, but it was balanced between treatment groups
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)