Ballauff 1999
| Methods | Prospective cohort study | |
| Participants |
N of patients original cohort: 50; N of patients described study group: 50; N of patients study group of interest: 50; N of patients with liver function tests: 50 Tumour: various tumours; Time period diagnosis/treatment: 1980‐1991; Age at diagnosis: nm; Age at follow‐up: median 12.3 (6.7‐24.5) yr; F/M%: 36/64; BMI: nm N of patients hepatitis virus infection: 14/50 (28.0%) anti‐HCV+, HCV‐RNA+, 2/50 (4.0%) anti‐HCV+, HCV‐RNA‐ and 2/50 (4.0%) HBsAntigen+ N of patients acute liver disease: 43/50 (86.0%) elevated AST/ALT during chemotherapy; 13/50 (26.0%) elevated bilirubin and GGT during chemotherapy Follow‐up duration: median 3.6 (0.5‐11.8) yr after end of treatment; Completion of follow‐up: 100% |
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| Interventions |
N of patients chemotherapy: 50/50 (100%); Chemotherapy type: nm; Chemotherapy dose: nm 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: 50/50 (100%) |
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| Outcomes | Method of detection of hepatic late adverse effects: ALT, AST, bilirubin, GGT (frequency of testing nm) Definition of hepatic late adverse effects: ALT > normal (24 U/L), AST > normal (22 U/L), bilirubin >1.5 mg/dL (normal: 0.3 mg/dL), GGT >100 U/L (normal: 20 U/L) N of patients hepatic late adverse effects at end of follow‐up: 16/50 (32.0%) Risk factors: Chronic HBV/HCV infection: 13/16 (81.3%) with abnormal liver function tests chronic HBV/HCV infection versus 2/34 (5.9%) with normal liver function tests chronic HBV/HCV infection (P=0.001) (Univariate) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Representative study group | Low risk | Described study group consisted of more than 90% of the original cohort |
| Complete follow‐up assessment | Low risk | Outcome was assessed for more than 90% of the study group of interest |
| Blinded outcome assessor | Unclear risk | Unclear if outcome assessors were blinded to the investigated determinant |
| Adjustment important confounders | High risk | Important prognostic factors or follow‐up were not taken into account |
| Well defined study group | High risk | Type of chemotherapy was not mentioned |
| Well defined follow‐up | Low risk | Length of follow‐up was mentioned |
| Well defined outcome | High risk | Outcome definition was not objective and precise |
| Well defined risk estimation | Low risk | Chi2 was calculated |