Locasciulli 1985
| Methods | Prospective cohort study | |
| Participants |
N of patients original cohort: nm; N of patients described study group: 89 with abnormal liver function during chemotherapy; N of patients study group of interest: 89; N of patients with liver function tests: 48 Tumour: ALL, ANLL; Time period diagnosis/treatment: 1979; Age at diagnosis: mean 4.8 (0.3‐14.0) yra; Age at follow‐up: nm; F/M%: 46/54a; BMI: nm N of patients hepatitis virus infection: 23/48 (47.9%) HBsAntigen+ N of patients acute liver disease: 48/48 (100%) elevated ALT during chemotherapy Follow‐up duration: mean 2.8 (0.5‐4.1) yr after end of treatment; Completion of follow‐up: 53.9% |
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| Interventions |
N of patients chemotherapy: 48/48 (100%); Chemotherapy type: vincristine, prednisone, 6‐mercaptopurine, methotrexate, L‐asparaginase, cytosine arabinoside, 6‐thioguanine, doxorubicin, cyclophosphamide, BCNU, daunorubicin; 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: nm |
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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 >3 times upper limit of normal (60 IU/L) for ≥6 months N of patients hepatic late adverse effects at end of follow‐up: 33/48 (68.8%) Risk factors: not evaluated |
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| Notes | a Data of 164 patients with ALL/ANLL | |
| 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 | High risk | Outcome was assessed for less 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 | Low risk | Type of chemotherapy 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 |