Tefft 1970
| Methods | Retrospective cohort study | |
| Participants |
N of patients original cohort: nm; N of patients described study group: 99; N of patients study group of interest: 99; N of patients with liver function tests: 88 Tumour: Wilms' tumour, neuroblastoma, hepatoma; Time period diagnosis/treatment: nm; Age at diagnosis: 14% <1 yr, 56% 1‐4 yr, 30% >5 yra; Age at follow‐up: nm; F/M%: 55/45a; BMI: nm N of patients hepatitis virus infection: nm N of patients acute liver disease: 31/51 (60.8%) abnormal liver function within 6 months following radiotherapy Follow‐up duration: mean 3.9 (0.5‐13.3) yr after end of treatment; Completion of follow‐up: 88.9% |
|
| Interventions |
N of patients chemotherapy: 88/88 (100%); Chemotherapy type: vincristine, actinomycin D and 5‐fluorouracil; Chemotherapy dose: nm N of patients radiotherapy involving the liver: 88/88 (100%); Radiotherapy field: right lobe (n=36), left lobe (n=35), entire liver (n=13), remaining liver after resection (n=4); Radiotherapy dose: <25 Gy (n=21), 25‐35 Gy (n=47), >35 Gy (n=20) N of patients hepatectomy: 4/88 (4.5%) N of patients BMT: nm N of patients blood transfusion: nm |
|
| Outcomes | Method of detection of hepatic late adverse effects: AST and other unspecified liver function tests (frequency of testing nm) Definition of hepatic late adverse effects: Abnormal liver function tests N of patients hepatic late adverse effects at end of follow‐up: 51/88 (58.0%) Risk factors: site of radiotherapy: 25/36 (96.4%) with right lobe irradiation abnormal liver function tests versus 16/35 (45.7%) with left lobe irradiation abnormal liver function tests versus 6/13 (46.2%) with whole liver irradiation abnormal liver function tests versus 4/4 (100%) with remaining liver irradiation abnormal liver function tests (ns); radiotherapy dose: 11/21 (52.4%) with <25 Gy abnormal liver function tests versus 27/47 (57.4%) with 25‐35 Gy abnormal liver function tests versus 12/20 (60.0%) with >35 Gy abnormal liver function tests (ns) (Univariate) |
|
| Notes | a Data of 115 patients | |
| 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 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 |