Jagt 2009
| Methods | Retrospective cohort study | |
| Participants |
N of patients original cohort: nm; N of patients described study group: 91; N of patients study group of interest: 91; N of patients with liver function tests: 64 Tumour: Wilms' tumour; Time period diagnosis/treatment: 1986‐2006; Age at diagnosis: range 0.2‐10.9 yra; Age at follow‐up: nm; F/M%: 40/60a; BMI: nm N of patients hepatitis virus infection: nm N of patients acute liver disease: minimal 13/64 (20.3%) VOD Follow‐up duration: nm (≥5 yr after end of treatment); Completion of follow‐up: 70.3% |
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| Interventions |
N of patients chemotherapy: 64/64 (100%); Chemotherapy type: vincristine, actinomycin, epirubicin and doxorubicin; Chemotherapy dose: weekly 1.5 mg/kg vincristine, 4 courses 15 μg/kg actinomycin on 3 subsequent days, or 2 courses 15 μg/kg actinomycin on 3 subsequent days, or 2 courses 45 μg/kg actinomycin once every 2 weeks, and 2 courses 50 mg/m2 epirubicin or doxorubicin N of patients radiotherapy involving the liver: nm; Radiotherapy field: nm; Radiotherapy dose: nm N of patients hepatectomy: nm N of patients BMT: nm N of patients blood transfusion: nm |
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| Outcomes | Method of detection of hepatic late adverse effects: ALT, AST, GGT, ALP (frequency of testing nm) Definition of hepatic late adverse effects: any value higher than age‐dependent upper limit of normal N of patients hepatic late adverse effects at end of follow‐up: 33/64 (51.6%) Risk factors: not evaluated |
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| Notes | a Data of 91 patients in the described study group | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Representative study group | Unclear risk | Unclear if described study group consisted of more than 90% of the original cohort or if it was a random sample with respect to cancer treatment |
| Complete follow‐up assessment | Low risk | Outcome was assessed for more than 60% of the study group of interest |
| Blinded outcome assessor | Unclear risk | Unclear if outcome assessors were blinded to the investigated determinant |
| Well defined study group | High risk | Number of patients with hepatitis virus infection was not mentioned |
| Well defined follow‐up | High risk | Length of follow‐up was not mentioned |
| Well defined outcome | Low risk | Outcome definition was objective and precise |