Risk of Bias in Liver Imaging Reporting and Data System Studies Using QUADAS-2

Purpose: Use a tailored version of the Quality Assessment of Diagnostic Accuracy Studies tool to evaluate risk of bias and applicability across LIRADS related publications. Method: A tailored QUADAS-2 tool was created through consensus approach to assess risk of bias and applicability across 37 LI-RADS related publications. Studies were selected from 2017 to 2022 using the assistance of experienced hospital librarians to search for studies evaluating the diagnostic accuracy of CT, MRI, or contrast-enhanced ultrasound for HCC using LI-RADS through multiple different databases. QUADAS-2 assessments were performed in duplicate and independently by 2 authors with experience using the QUADAS-2 tool. Disagreements were resolved with a third expert reviewer. Consensus QUADAS-2 assessments were tabulated for each domain. Results: Using the tailored QUADAS-2 tool, 31 of the 37 included LI-RADS studies were assessed as high risk of bias, and 9 out of 37 studies demonstrated concerns for applicability. Patient selection (21 out of 37 studies) and flow/timing (24 out of 37 studies) domains demonstrated the highest risk of bias. 6 out of 37 studies in the index domain demonstrated high risk of bias. 2 out of 37 studies showed high risk of bias in the reference standard domain. Conclusion: A significant proportion of LI-RADS research is at risk of bias with concerns for applicability. Identifying risk of bias in such research is essential to recognize limitations of a study that may affect the validity of the results. Areas for improvement in LI-RADS research include reducing selection bias, avoiding inappropriate exclusions, and decreasing verification bias.