Extended Hospital Stay compared to expectation (Complications)
| Type of indicator | Risk |
|---|---|
| Risk Category | Safety |
| Golden KRI | NO |
| Therapeutic Area | General |
| IF Risk-Event | Subjects require extended hospital stays. |
| DUE TO Risk Causes | Unexpected or more severe complications during or after surgery. |
| THEN Risk Impact MAY RESULT | Potential negative impact on subject safety and well-being, possible need for protocol amendments, study delays, and increased study costs. |
| Risk Indicator | Extended Hospital Stay Compared to Expectation (Complications) |
| Metric | Difference between actual and expected number of days subjects spent in hospital due to complications. |
| Unit | Days |
| What level should be measured | Study, Country, Site |
| Purpose | Ensure effective subject management and monitor whether hospitalization durations align with expectations for subjects who experienced complications after treatment or surgery. |
| Description | This KRI tracks the average difference between the actual and expected number of hospital days for randomized subjects who experienced complications. It triggers an alert if the average exceeds acceptable limits, indicating potential safety or procedural issues. |
| Formula | For each randomized subject who experienced complications, calculate the difference between the actual and planned number of hospital days: Delta (Days) = Actual Days in Hospital − Expected Days in Hospital If Delta is negative (spent fewer days than expected), set Delta = 0. Then calculate the average Delta across all affected subjects. |
| Suggested Thresholds - High | 5 days |
| Suggested Thresholds - Medium | 3 days |
| Associated Metric 1 | Actual Number of Days Spent in Hospital |
| Associated Metric 2 | Expected Number of Days Spent in Hospital |