Aricò 1994
| Methods | Cohort study | |
| Participants |
N of patients original cohort: 102; N of patients described study group: 102; N of patients study group of interest: 102; N of patients with liver function tests: 102 Tumour: ALL; Time period diagnosis/treatment: 1977‐1992; Age at diagnosis: nm; Age at follow‐up: median 10.5 (2.5‐21.1) yr; F/M%: 45/55; BMI: nm N of patients hepatitis virus infection: 23/102 (22.5%) anti‐HCV+, HCV‐RNA+ and 7/102 (6.8%) anti‐HCV+, HCV‐RNA‐ N of patients acute liver disease: nm Follow‐up duration: median 2.8 (0.1‐12.5) yr after end of treatment; Completion of follow‐up: 100% |
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| Interventions |
N of patients chemotherapy: 102/102 (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: 101/102 (99.0%) |
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| Outcomes | Method of detection of hepatic late adverse effects: ALT (frequency of testing nm) Definition of hepatic late adverse effects: ALT > upper limit of normal (35 IU/mL) N of patients hepatic late adverse effects at end of follow‐up: 22/102 (21.6%) of whom 5/102 (4.9%) had mild‐to‐moderate increase, 16/102 (15.7%) moderate increase and 1/102 (1.0%) severe increase (>3.5 times upper limit of normal (35 IU/mL)) Risk factors: Chronic HCV infection: 16/23 (69.6%) with chronic HCV infection elevated ALT versus 6/79 (7.6%) without chronic HCV infection elevated ALT (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 | Low risk | Outcome definition was objective and precise |
| Well defined risk estimation | Low risk | Chi2 was calculated |