Ratner 1986
| Methods | Retrospective cohort study | |
| Participants |
N of patients original cohort: nm; N of patients described study group: 39; N of patients study group of interest: 39; N of patients with liver function tests: 39 Tumour: ALL; Time period diagnosis/treatment: 1971‐1980; Age at diagnosis: nm; Age at follow‐up: nm; F/M%: nm; BMI: nm N of patients hepatitis virus infection: 5/39 (12.8%) HBsAntigen+ of whom 3/39 (7.7%) anti‐HDV+ co‐infection N of patients acute liver disease: 50/79 (63.3%) elevated ALT during maintenance therapya Follow‐up duration: range 1.0‐8.3 yr after end of treatment; Completion of follow‐up: 100% |
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| Interventions |
N of patients chemotherapy: 39/39 (100%); Chemotherapy type: vincristine, 6‐mercaptopurine, methotrexate, asparaginase, cyclophosphamide, daunorubicin, hydroxyurea and prednisone; 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 (measured 6 monthly), liver biopsy (n=3) Definition of hepatic late adverse effects: ALT >2 times upper limit of normal (90 U/L) N of patients hepatic late adverse effects at end of follow‐up: ALT: 9/39 (23.1%); liver biopsy: 3/3 (100%) cirrhosis Risk factors: not evaluated |
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| Notes | a Data of 79 patients with ALL | |
| 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 | 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 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 |