Delvecchio 2017.
| Methods | Cohort study | |
| Participants |
N of participants original cohort: nm N of participants described study group: 53 N of participants study group of interest: 53 N of participants with liver function tests: 53 N of control participants: 34 healthy subjects pair matched by age and sex Tumour: ALL Time period diagnosis/treatment: nm Age at diagnosis: mean 5.4 ± 3.8 yr (inclusion criteria: 4‐20 yr) Age at follow‐up: mean 9.7 ± 4.1 yr F/M%: 64/36 BMI: standard deviation score 0.9 ± 0.9 N of participants hepatitis virus infection: nm N of participants acute liver disease: 0 (0%) Follow‐up duration: median 28.5 months (range 3 to 102 months) since end of chemotherapy Completion of follow‐up: 100% |
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| Interventions |
N of participants chemotherapy: 53 (100%) Chemotherapy type: methotrexate, mercaptopurine, thioguanine, adriamycin, cytarabine, cyclophosphamide, daunorubicin, dexamethasone, asparaginase, prednisone, vincristine Chemotherapy dose: nm N of participants radiotherapy involving the liver: 0 (0%) Radiotherapy field: na Radiotherapy dose: na N of participants hepatectomy: 0 (0%) N of participants BMT: nm N of participants blood transfusion: nm |
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| Outcomes | Method of detection of hepatic late adverse effects: ALT, AST and γGT Definition of hepatic late adverse effects: nm N of participants hepatic late adverse effects at end of follow‐up: mean ALT participants vs controls: 23 ± 6 vs 24 ± 7 IU/mL, P = 0.781, mean AST participants vs controls: 22 ± 6 vs 20 ± 5 IU/mL, P = 0.839; mean γGT participants vs controls: 16 ± 5 vs 18 ± 6 IU/mL, P = 0.690 Risk factors: mean ALT, AST and γGT were not significantly different in participants with ultrasound‐negative vs ultrasound‐positive steatosis (fatty liver) (P > 0.05) (univariable) |
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| Notes | ||
| 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 | Low risk | Unclear if blinding of outcome assessment, but the outcome measurement was not likely to be influenced by lack of blinding |
| Adjustment important confounders | High risk | Important prognostic factors or follow‐up were not taken into account |
| Well defined study group | High risk | Number of participants with hepatitis virus infection was not mentioned |
| Well defined follow‐up | High risk | Exact follow‐up duration of the study group was not mentioned |
| Well defined outcome | High risk | Outcome definition was not objective and precise |
| Well defined risk estimation | Low risk | ANOVA tests were performed |