High Percentage of Subjects with poor quality ECGs

High Percentage of Subjects with poor quality ECGs (kri)
Type of indicator Performance
Risk Category technology
Golden KRI NO
Therapeutic Area General
IF Risk-Event a high rate of ECGs contains suspicious or poor quality data
DUE TO Risk Causes misplacement of leads
THEN Risk Impact MAY RESULT the non-usability of the data for any analysis and a lack of Subject safety
Risk Indicator High Percentage of Subjects with poor quality ECGs
Metric Percent of Subjects with poor quality ECGs
Unit %
What level should be measured Study, Country, Site
Purpose Ensure the reliability and accuracy of ECG data in clinical trials or healthcare settings, supporting effective diagnosis, monitoring of cardiovascular health, and informed decision-making.
Description KRI monitors the occurrence of poor quality electrocardiograms (ECGs) in Subjects within clinical trials or healthcare settings, ensuring the reliability and accuracy of cardiac data for effective diagnosis and patient care.
Formula Calculate a number of Subjects with poor ECG readings, devide by a total number of enrolled Subjects, multipy by 100%.
Suggested Thresholds - High >5 %
Suggested Thresholds - Medium >3 %
Associated Metric 1 Number of ECG readings
Associated Metric 2 Number of poor ECG readings
Associated Metric 3 Number of enrolled Subjects
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