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. 2016 Mar 3;2016(3):CD005008. doi: 10.1002/14651858.CD005008.pub4

Shapira 1990.

Study characteristics
Methods Randomisations were performed according to the last digit of the national identification number
Participants 62 women (age nm) with stage III or stage IV breast cancer (N = 36) or ovarian cancer (N = 26) treated with doxorubicin, cyclophosphamide, and either 5‐FU (breast cancer) or cisplatin (ovarian cancer). No prior anthracycline therapy; prior cardiac radiotherapy possible for 1 woman in the short infusion group and 3 women in the prolonged infusion group; no prior cardiac dysfunction
Interventions Doxorubicin (peak dose 50 mg/m2) every 3 weeks with either short infusion (15 to 20 minutes) (N = 31; mean cumulative dose 410 mg/m2; range 200 to 550 mg/m2) or prolonged infusion (6 hours) (N = 31; mean cumulative dose 428 mg/m2; range 250 to 600 mg/m2)
Outcomes Heart failure (i.e. clinical heart failure defined as symptoms of congestive heart failure; subclinical heart failure defined as a fall in LVEF of more than 20% as measured by gated pool radionuclide angiography and defined as the mean fall in LVEF)
Adverse effects other than cardiac damage (according to SWOG criteria)
Notes Length of follow‐up nm
No funding documented
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Randomisations were performed according to the last digit of the national identification number
Allocation concealment (selection bias) High risk Randomisations were performed according to the last digit of the national identification number
Blinding of participants and personnel (performance bias) Unclear risk No information on blinding of participants and personnel was provided, although due to the nature of the interventions, this was most likely not the case
Blinding of outcome assessment (detection bias): clinical heart failure Unclear risk No information on blinding of outcome assessors was provided for clinical heart failure
Blinding of outcome assessment (detection bias): subclinical heart failure (dichotomous and/or continuous) Unclear risk No information on blinding of outcome assessors was provided for subclinical heart failure
Blinding of outcome assessment (detection bias): adverse effects other than cardiac damage Unclear risk No information on blinding of outcome assessors was provided for adverse effects other than cardiac damage
Incomplete outcome data (attrition bias): clinical heart failure Low risk Almost all women (93.5%) were included in the analysis of clinical heart failure
Incomplete outcome data (attrition bias): subclinical heart failure (dichotomous and/or continuous) Low risk Almost all women (93.5%) were included in the analysis of subclinical heart failure
Incomplete outcome data (attrition bias): adverse effects other than cardiac damage Low risk Almost all women (93.5%) were included in the analysis of adverse effects other than cardiac damage
Selective reporting (reporting bias) High risk There was no reference to a protocol provided in the manuscript (and we did not search for it), but not all expected outcomes were reported in a useful manner
Other bias Unclear risk Baseline imbalance between treatment arms related to outcome (prior cardiotoxic treatment, age, sex, and/or prior cardiac dysfunction): unclear (unclear if age and prior cardiotoxic treatment were balanced between treatment groups; the other items were balanced between treatment groups)
Difference in length of follow‐up between treatment arms: unclear (not reported)