Extended Hospital Stay compared to expectation (Complications)


Extended Hospital Stay Compared to Expectation (Complications) Table

Extended Hospital Stay Compared to Expectation (Complications)

Type of indicator Risk
Risk Category Safety
Golden KRI No
Therapeutic Area General
IF Risk-Event High number of extended hospital stays are required
DUE TO Risk Causes More than expected complications during surgery
THEN Risk Impact MAY RESULT Possible negative impact on safety and well-being of randomized Subjects; a protocol amendment leading to delays and additional cost
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 experiencing complications.
Description KRI monitors if extended number of days that randomized Subject spent in hospital exceed XXX days
Formula For randomized 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
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