Bresters 2008
| Methods | Retrospective cohort study | |
| Participants |
N of patients original cohort: 290; N of patients described study group: 216; N of patients study group of interest: 216; N of patients with liver function tests: 216 Tumour: ALL, AML, CML, JMML, MDS, lymphoma (n=129), benign haematological disease (n=54), immunological disease (n=22), other inborn errors (n=11); Time period diagnosis/treatment: 1980‐2002; Age at diagnosis: nm (age at HSCT: median 7.6 (0.1‐18.4) yr); Age at follow‐up: nm; F/M%: 40/60; BMI: nm N of patients hepatitis virus infection: 3/139 (2.1%) anti‐HCV+ and 0/183 (0.0%) HBsAntigen+ N of patients acute liver disease: 14/216 (6.5%) VOD and 5/216 (2.3%) acute GVHD Follow‐up duration: 2 yr after HSCT, plus or minus 6 months; Completion of follow‐up: 100% |
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| Interventions |
N of patients chemotherapy: 211/216 (97.7%); Chemotherapy type: cyclophosphamide (n=121), cyclophosphamide with busulphan (n=69), other unspecified (n=21); Chemotherapy dose: nm N of patients radiotherapy involving the liver: 132/216 (61.1%); Radiotherapy field: TBI/TAI; Radiotherapy dose: nm N of patients hepatectomy: nm N of patients BMT: 216/216 (100%) N of patients blood transfusion: nm |
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| Outcomes | Method of detection of hepatic late adverse effects: ALT, AST (frequency of testing nm) Definition of hepatic late adverse effects: ALT and/or AST > upper limit of normal (mean plus 2 standard deviations as determined in a normal Dutch population) N of patients hepatic late adverse effects at end of follow‐up: 53/216 (24.5%) of whom 17/216 (7.9%) had ALT/AST ≥2 times upper limit of normal. In 12/13 (92.3%) patients with ALT/AST ≥2 times upper limit of normal persisting abnormal liver enzymes 3 years after HSCT. Risk factors: Older age at HSCT: median age 9.9 yr in patients with elevated ALT/AST versus 7.2 yr in patients with normal ALT/AST (P=0.027); diagnosis of benign haematological disease (OR, 2.59; 95% CI, 1.32‐5.05) (P=0.005); gender, donor type (matched sibling donor, other), stem cell source (bone marrow, autologous peripheral blood, cord blood), conditioning regimen (cyclophosphamide with TBI/TAI, cyclophosphamide with busulphan, other) and early post‐transplant morbidity (viral reactivation after HSCT, VOD, acute GVHD) (ns) (Univariate) |
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| Notes | ||
| 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 | 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 |
| Adjustment important confounders | High risk | Important prognostic factors or follow‐up were not taken into account |
| 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 |
| Well defined risk estimation | Low risk | Odds ratio, mean difference and Chi2 were calculated |