Table 2.
Primary and secondary outcomes of DigiSep-trial
| Outcomes | Data source | Timepoint/frame |
|---|---|---|
| Primary outcomes | ||
| DOOR/RADAR score | eCRF | 28 days |
| Secondary outcomes | ||
| Long term mortality | Statutory health insurance data, eCRF | 90, 180 days |
|
Degree of organ dysfunction/failure: • Duration of mechanical ventilation • Length of time until shock resolution • Ongoing RRT-dependency |
eCRF | 28, 90, 180 days |
| Hospital length of stay | Statutory health insurance data, eCRF | 28, 90, 180 days |
| Cumulative need for anti-infective drugs | Statutory health insurance data, eCRF | 28, 90, 180 days |
| Beginning of a targeted anti-infective treatment regimen | eCRF | 28 days |
| Resource utilization (outpatient and inpatient) | Statutory health insurance data | 28, 90, 180 days |
| Duration and costs of incapacity to work | Statutory health insurance data | 28, 90, 180 days |
| Direct medical costs (outpatient and inpatient) | Statutory health insurance data | 28, 90, 180 days |
| Quality-of-life (QoL) | VR-36 questionnaire | 0, 90, 180 days |
Abbreviations: RRT renal replacement therapy; QoL quality of life; eCRF electronic case report from; DOOR/RADAR score Desirability of Outcome Ranking/Response Adjusted for Duration of Antibiotic Risk score