title: What proportions of focal liver lesions detected by unenhanced ultrasound are inconclusive?
abstract: In August 2012, the National Institute for Health and Care Excellence produced positive diagnostics guidance on the ultrasound contrast agent SonoVue®, but recommended further research involving an estimation of the proportion of unenhanced ultrasound scans reporting, but not characterising, focal liver lesions, particularly in cirrhotic livers. Patient records from the Radiology Information System of an acute hospital trust were progressively filtered based on categorical fields and keywords in the free text reports, to obtain ultrasound records including the liver that were appropriate for manual analysis. In total, 21,731 records referred from general practice or out-patient clinics were analysed. Patients described as having cirrhosis were analysed as a subgroup. After automatic exclusion of records considered likely to be negative, 5812 records were manually read and categorised as focal liver lesion inconclusive, benign or malignant. In the general practice cohort of 9175 records, 746 reported the presence of one or more focal liver lesions, with 18.4% (95% CI 15.7% to 21.3%) of these records mentioning an inconclusive focal liver lesion. In the out-patient cohort of 12,556 records, 1437 reported one or more focal liver lesions, and 29.4% (95% CI 26.9% to 32.0%) of these were inconclusive. Cirrhosis was reported in 10.8% of the out-patient scans that also reported a focal liver lesion, and 47.4% (95% CI 39.3% to 55.6%) of these scans had an inconclusive focal liver lesion, compared with 27.3% (95% CI 24.9% to 29.8%) that were inconclusive in non-cirrhotic livers (odds ratio 2.4; 95% CI 1.7 to 3.4). This retrospective study indicates that unenhanced ultrasound scans, in which a focal liver lesion is detected, are frequently inconclusive, with the probability of an inconclusive scan being greater in out-patient than general practice referrals. Inconclusive focal liver lesions were also reported in greater proportions of cirrhotic than non-cirrhotic livers. The results of this research will inform future updates of National Institute for Health and Care Excellence diagnostics guidance.
authors.affiliation: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Iain
authors.initials: I
authors.lastname: Willits
authors.affiliation: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Julie
authors.initials: J
authors.lastname: Burn
authors.affiliation: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Cole
authors.affiliation: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Tim
authors.initials: T
authors.lastname: Hoare
authors.affiliation: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Sims
keywords: Liver; National Institute for Health and Care Excellence; SonoVue®; cirrhosis; inconclusive; ultrasound