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Table 2 Outcome measures

From: Functional stroke outcomes after mobile stroke unit deployment – the revised protocol for the Berlin Prehospital Or Usual Delivery of acute stroke care (B_PROUD) part 2 study

Primary outcome measure:

1.

Primary outcome: assessment of functional outcome over the entire range of the mRS

2.

Co-primary outcome: assessment of functional outcome including the following range of outcomes: mRS 0–3 if available, mRS 4–5 or (if mRS is missing) living in institution (information according registration office at 4 months after stroke), and death

Secondary outcome measures:

1.

Thrombolysis rate

2.

Endovascular thrombectomy rate

3.

Onset-to-treatment time

4.

Onset-to-reperfusion time (for endovascular thrombectomy, Charité centers only)

5.

Alarm-to-imaging time

6.

Alarm-to-treatment time

7.

Imaging-to-treatment time

8.

Cost effectiveness (additional costs due to implementation and running of STEMO, duration of hospital stay regarding acute treatment and rehabilitation, hospital related costs, costs of long-term care, and combination of above mentioned)

9.

Quality of life (EQ-5D)

10.

Shift analyses for mRS ≤ 1 at 3 months in patients ≤80 years of age living at home without disability and mRS ≤ 2 at 3 months in patients > 80 years of age living at home with help or living in an institution

11.

Secondary ICH after thrombolysis or thrombectomy

12.

Symptomatic secondary ICH according to the discharge letter

13.

In-hospital mortality

14.

Death rate over time (Kaplan-Meier plot)

15.

Discharge status (including in-hospital mortality among patients not included in the primary study population, especially patients with ICH)

16.

Functional outcome among patients with ICH

17.

Rate of emergency medical service deliveries to specialized facilities (patients with large vessel occlusion to endovascular thrombectomy capable facility, patients with ICH to neurosurgery department)

  1. EQ-5D EuroQol Group 5 dimensions, ICD-10 International Statistical Classification of Diseases and Related Health Problems 10th revision, ICH intracerebral hemorrhage, mRS modified Rankin Scale, MSU Mobile Stroke Unit, TIA transient ischemic attack