Using "Reader Disagreement Index" as a tool for monitoring impact on read quality due to reader fatigue in central reviewers

Purpose: Fatigue may lead to high medical errors by the radiologists. Fatigue is often described as feelings of weakness, lack of energy, and a desire to rest, and is associated with impairments in the ability to function. Visual fatigue has importance in medical imaging as errors (false-negatives) are relatively common. Blinded Independent Central Review (BICR) is a well-used method employed in many oncology registration trials. Ongoing monitoring of radiologist "reviewer" performance is both good clinical trial practice and a requirement by regulatory authorities. We use Reader Disagreement Index (RDI) as a potential tool to identify reader fatigue and compare reader fatigue in reviewers performing single versus multiple type of study. Methods: A retrospective analysis of reviewers' RDI in four different clinical trials were performed. Fourteen reviewers' performance was analyzed with data for 3750 subjects having a total of 15105 timepoints across all clinical trials. These individual trial reviews were conducted by 14 board-certified radiologist reviewers using several established imaging assessment trial criteria. The objective of the study was to establish RDI as an effective tool to analyze if it could be a good surrogate marker for quality impacted by reader fatigue. Results: The results indicate the RDI can be used as a tool to track reader quality which in turn may be able to predict reader fatigue. In the random pool of readers and studies analyzed, we did not notice any major trend or impact on read quality given that these trials were anyway actively monitored for read volume distribution and quality. Conclusions: Fatigue may lead to high medical errors by the radiologists. RDI can be used as a good surrogate for read quality to monitor reader fatigue. Based on the results, it can be said that it is better to undertake more cases in a single study than undertake less number of cases in different types of studies to prevent reader fatigue.