| High Percentage of Image interpretation issues (Differences) (kri) |
|
| Type of indicator |
Risk |
| Risk Category |
data collection procedures |
| Golden KRI |
NO |
| Therapeutic Area |
General |
| IF Risk-Event |
the interpretations of different image raters differ significantly |
| DUE TO Risk Causes |
the usage of different image reading approaches |
| THEN Risk Impact MAY RESULT |
a difficulty in deriving solid conclusions |
| 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 |
Optimize the accuracy and reliability of image interpretations, ensuring high-quality diagnoses and effective Subject management. |
| Description |
Monitors the occurrence of discrepancies or issues in the interpretation of medical images, ensuring accurate diagnoses and effective Subject care. |
| Formula |
Divide a number of images with different interpretations by a number of available images, multiply by 100%. |
| Suggested Thresholds - High |
>10 %. |
| Suggested Thresholds - Medium |
>5 % |
| Associated Metric 1 |
Number of enrolled Subjects |
| Associated Metric 2 |
Number of available images |
| Associated Metric 3 |
Number of images with different interpretations |
