Chotsampancharoen 2009
| Methods | Prospective cohort study | |
| Participants |
N of patients original cohort: 205a; N of patients described study group: 133; N of patients study group of interest: 133; N of patients with liver function tests: nm Tumour: ALL, AML, CML; Time period diagnosis/treatment: 1990‐2005; Age at diagnosis: nm (age at HSCT: mean 9.1 ± 5.6 (0.6‐21.4) yr); Age at follow‐up: nm; F/M%: 46/54; BMI: nm N of patients hepatitis virus infection: nm N of patients acute liver disease: nm Follow‐up duration: mean 5.6 ± 3.5 (1‐15) yr after HSCT; Completion of follow‐up: unclear |
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| Interventions |
N of patients chemotherapy: nm; Chemotherapy type: nm; Chemotherapy dose: nm N of patients radiotherapy involving the liver: 127/133 (95.5%); Radiotherapy field: TBI; Radiotherapy dose: 8‐14.4 Gya N of patients hepatectomy: nm N of patients BMT: 133/133 (100%) N of patients blood transfusion: 133/133 (100%) |
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| Outcomes | Method of detection of hepatic late adverse effects: ALT, total bilirubin (frequency of testing nm) Definition of hepatic late adverse effects: nm N of patients hepatic late adverse effects at end of follow‐up: nm Risk factors: High serum ferritin (iron overload): serum ferritin was positively correlated with ALT (r=0.17) and total bilirubin (r=0.21) (P<0.001) (Univariate) |
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| Notes | a Reported in Leung 2007 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Representative study group | High risk | Described study group consisted of less than 90% of the original cohort and was no random sample of the original cohort with respect to cancer treatment |
| Complete follow‐up assessment | Unclear risk | Unclear if outcome was assessed for more than 60% 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 | Number of patients with hepatitis virus infection was not 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 |
| Well defined risk estimation | Low risk | Chi2 was calculated |