High Percentage of Subjects with poor quality ECGs

High Percentage of Subjects with Poor Quality ECGs Table

High Percentage of Subjects with Poor Quality ECGs

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 the number of Subjects with poor ECG readings, divide by the total number of enrolled Subjects, multiply by 100%.
Suggested Thresholds - High	>5 %
Suggested Thresholds - Medium	>3 %
Associated Metric 1	Number of Subject with min 1 poor ECG reading
Associated Metric 2	Number of enrolled Subjects