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) |
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Notes | Length of follow‐up nm No funding documented |
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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) |