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. 2021 Oct 18;22:714. doi: 10.1186/s13063-021-05667-x

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