Locasciulli 1997b
| Methods | Prospective cohort study | |
| Participants |
N of patients original cohort: 53; N of patients described study group: 53; N of patients study group of interest: 53; N of patients with liver function tests: 53 Tumour: ALL, AML, CML, JCML, Histiocytosis X, SAA, RAEB; Time period diagnosis/treatment: 1985‐1995; Age at diagnosis: nm (age at BMT: mean 9.4 (0.9‐18.0) yra; Age at follow‐up: nm; F/M%: 34/66a; BMI: nm N of patients hepatitis virus infection: minimal 9/53 (17.0%) ant‐HCV+, HCV‐RNA+, minimal 5/53 (9.4%) anti‐HCV+, HCV‐RNA‐ and 2/53 (3.8%) HBsAntigen+ N of patients acute liver disease: 82/111 (73.9%) elevated ALT after BMTa; 4/111 (3.6%) VOD leading to multi‐organ failurea Follow‐up duration: range 1.3‐10.9 yr after BMT; Completion of follow‐up: 100% |
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| Interventions |
N of patients chemotherapy: 53/53 (100%); Chemotherapy type: cyclophosphamide, cytarabine, vincristine, etoposide, busulphan, melphalan, cyclosporine and methotrexate; Chemotherapy dose: 120 mg/kg cyclophosphamide was given as 2 daily doses of 60 mg/kg, alone, or in combination with high‐dose cytarabine 3 mg/m2 for 2 days, high‐dose vincristine 4 mg/m2 in 4 days, etoposide 60mg/kg in 1 day, busulphan 16 mg/kg as 4 daily doses and melphalan 140 mg/m2. Children with SAA were conditioned with 200 mg/kg cyclophosphamide given in divided doses on 4 days. Cyclosporine and methotrexate dose: nm N of patients radiotherapy involving the liver: nm (76/111 (68.5%))a; Radiotherapy field: TBI; Radiotherapy dose: 12 Gy N of patients hepatectomy: nm N of patients BMT: 53/53 (100%) N of patients blood transfusion: nm |
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| Outcomes | Method of detection of hepatic late adverse effects: ALT (measured 3 monthly) Definition of hepatic late adverse effects: ALT > upper limit of normal (42 IU/L) for ≥6 months N of patients hepatic late adverse effects at end of follow‐up: 28/53 (52.8%) Risk factors: not evaluated |
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| Notes | a Data of 111 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 | Low risk | Outcome definition was objective and precise |