High Percentage of Image interpretation issues (Differences)

High Percentage of Image Interpretation Issues (Differences)
Type of indicator Risk
Risk Category Data Collection Procedures
Golden KRI NO
Therapeutic Area Oncology
IF Risk-Event The interpretations of medical images by different raters differ significantly
DUE TO Risk Causes Use of different image reading methodologies or interpretation approaches
THEN Risk Impact MAY RESULT Difficulty in deriving reliable conclusions and potential inconsistency in study outcomes
Risk Indicator High Percentage of Image Interpretation Issues (Differences)
Metric Percent of Images Rated Differently Between Raters
Unit %
What level should be measured Study, Country, Site, Subject
Purpose Enhance the accuracy and reliability of image interpretation to ensure high-quality diagnostic assessments and consistent subject management.
Description This KRI monitors discrepancies in medical image interpretation between raters, helping identify variability that could affect data quality, diagnostic accuracy, or study outcomes.
Formula (Number of Images with Different Interpretations) / (Number of Available Images) × 100.
Suggested Thresholds - High 10%
Suggested Thresholds - Medium 5%
Associated Metric 1 Number of Available Images
Associated Metric 2 Number of Images with Different Interpretations
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