Frisk 1998
| Methods | Retrospective and prospective cohort study | |
| Participants |
N of patients original cohort: 40; N of patients described study group: 40; N of patients study group of interest: 40; N of patients with liver function tests: 40 Tumour: ALL, AML, NHL, HL (n=30), non‐malignant disease (n=10); Time period diagnosis/treatment: From 1985 onwards; Age at diagnosis: nm (age at BMT: median 7.6 (0.5‐18.2) yra; Age at follow‐up: nm; F/M%: 39/61a; BMI: nm N of patients hepatitis virus infection: 1/40 (2.5%) anti‐HCV+, HCV‐RNA+ N of patients acute liver disease: 52/64 (81.3%) elevated aminotransferases and/or bilirubin early after BMTa; 3/64 (4.7%) VODa; 4/64 (6.3%) acute GVHDa Follow‐up duration: median 5.0 (1.0‐10.0) yr after BMT; Completion of follow‐up: 100% |
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| Interventions |
N of patients chemotherapy: minimal 33/40 (82.5%); Chemotherapy type: prednisone, teniposide, daunorubicin, vincristine, cyclophosphamide, busulphan, BCNU, etoposide, cytarabine, cyclosporin and methotrexate; Chemotherapy dose: nm N of patients radiotherapy involving the liver: 20/40 (50.0%); Radiotherapy field: TBI; Radiotherapy dose: 7.5 Gy N of patients hepatectomy: nm N of patients BMT: 40/40 (100%) N of patients blood transfusion: minimal 1/40 (2.5%) |
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| Outcomes | Method of detection of hepatic late adverse effects: ALT, AST, ALP, bilirubin, PTT (measured annually 1 yr after BMT) Definition of hepatic late adverse effects: nm N of patients hepatic late adverse effects at end of follow‐up: 6/40 (15.0%) Risk factors: not evaluated |
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| Notes | a Data of 64 patients with BMT | |
| 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 |
| Well defined study group | Low risk | Type of chemotherapy, location of radiotherapy and number of patients with hepatitis virus infection were 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 |