Extended Hospital Stay compared to expectation (Complications)

Extended Hospital Stay compared to expectation (Complications) (kri)
Type of indicator Risk
Risk Category safety
Golden KRI NO
Therapeutic Area General
IF Risk-Event an extended hospital stay is required
DUE TO Risk Causes complication during surgery
THEN Risk Impact MAY RESULT a protocol amendment or the need for additional budget
Risk Indicator Extended Hospital Stay compared to expectation (Complications)
Metric Delta between average actual number of days spent in hospital due to complications and number of expected days in hospital
Unit Days
What level should be measured Study, Country, Site
Purpose Ensure efficient Subject management and minimize deviations from the expected duration of hospital stays for Subjects receiving IMPs and experinced complications.
Description KRI monitors the occurrence of significant deviations in the duration of hospital stays for Subjects receiving investigational medical products (IMPs) in clinical trials or healthcare settings due to complications, ensuring efficient Subject management and adherence to study timelines.
Formula For enrolled Subjects who experienced complications calculate delta between actual and planned days spent in hospital (if delta is negative (spent less than planned) then 0). Calculate average.
Suggested Thresholds - High >5 Days
Suggested Thresholds - Medium >3 Days
Associated Metric 1 Number of days in Hospital
Associated Metric 2 Number of enrolled Subjects
Do you like the KRI description? Thanks for the feedback There was a problem submitting your feedback. Please try again later.