Table 2.
Study outcomes by intention-to-treat analysis
| Intervention group | Control group | Difference between groups (95% CI) | P value | Number needed to screen (95% CI) | |
| Primary outcome | |||||
| Proportion of patients with high fibrosis scores who were referred for hepatology care or further fibrosis assessment within 1 year | 55/165 (33.3%) | 4/131 (3.1%) | 30.2% (22.2% to 38.0%) | <0.001 | 4 (3 to 5) |
| Secondary outcomes | |||||
| Proportion of patients in the entire cohort who were referred for hepatology care or further fibrosis assessment within 1 year* | 57/533 (10.7%) | 6/528 (1.1%) | 9.6% (6.9% to 12.5%) | <0.001 | 11 (9 to 15) |
| Proportion of patients with low fibrosis scores who were referred for hepatology care within 1 year | 1/368 (0.3%) | 2/397 (0.5%) | −0.2% (−1.8% to 1.3%) | >0.999 | – |
| Liver stiffness measurement≥10 kPa† | 11/56 (19.6%) | 1/5 (20.0%) | −0.4% (−51.3% to 22.7%) | >0.999 | – |
| Liver stiffness measurement≥15 kPa† | 6/56 (10.7%) | 0/5 (0%) | 10.7% (−43.4% to 22.6%) | >0.999 | – |
| Hepatic decompensation within 1 year‡ | 1/533 (0.2%) | 0/528 (0%) | 0.2% (−0.7% to 1.2%) | >0.999 | 533 (181 to ∞) |
| Proportion of patients confirmed to have advanced liver disease within 1 year‡ | 11/533 (2.1%) | 1/528 (0.2%) | 1.9% (0.61% to 3.5%) | 0.006 | 54 (32 to 164) |
*The numerators are different from those for the primary outcome because one patient with low fibrosis scores was referred to hepatology clinic and one patient underwent vibration controlled transient elastography directly in the intervention group, and two patients with low fibrosis scores in the control group were referred to hepatology clinic.
†Among patients who had undergone vibration controlled transient elastography examination.
‡Confirmed advanced liver disease was defined as liver stiffness measurement at or above 10 kPa by vibration controlled transient elastography, fibrosis stage 3 or 4 by liver biopsy, unequivocal radiological features of cirrhosis and/or manifestations or portal hypertension. In this study, only one patient in the intervention group developed jaundice, acute variceal haemorrhage and hepatic encephalopathy. Advanced liver disease was confirmed by vibration controlled transient elastography in all the remaining patients.