Patient-and Caregiver-Centered Outcomes in Survivors of Severe Stroke with Respiratory Failure at 6 Months: A Substudy of the SETPOINT2 Trial

Authors

• Matthew N. Jaffa, Division of Neurocritical Care, Department of Neurology, Ayer Neuroscience Institute, Hartford Hospital, Hartford, CT, USA. Matthew.jaffa@hhchealth.org.
• David B. Seder, Department of Critical Care Services, Maine Medical Center, Portland, ME, USA.
• Susanne Muehlschlegel, Division of Neurosciences Critical Care, Departments of Neurology, Anesthesiology & Critical Care Medicine, and Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
• Jan Meis, Institute of Medical Biometry, University of Heidelberg, Heidelberg, Germany.

Document Type

Article

Publication Date

7-20-2026

Institution/Department

Critical Care Medicine

Journal Title

Neurocritical care

Abstract

BACKGROUND/OBJECTIVE: The multicenter trial SETPOINT2 comparing early versus delayed tracheostomy in severe stroke was conducted in Germany and the USA. A pre-specified aim was to assess 6-month patient- and caregiver-reported outcomes to better inform clinical decision-making in the acute phase of care, irrespective of tracheostomy timing. METHODS: Patients had acute ischemic, hemorrhagic, or subarachnoid hemorrhage (SAH) strokes, respiratory failure, and a predicted necessity for tracheostomy (SETscore > 10). Outcome measures assessed by telephone interview 6 months after hospital admission included the modified Rankin scale (mRS), EuroQol 5D-5L (EQ-5D-5L), EuroQol Visual Analog Scale, Burden Scale for Family Caregivers short form (BSFC-s), and questions related to satisfaction with the treatment results. RESULTS: Of 366 patients with available data at 6 months, 118 (32%) died, 82 (22%) achieved mRS 5 (severe disability), 86 (23%) mRS 4 (moderate disability), and 80 (22%) mRS 0-3 (partial to full independence). Survivors reported markedly reduced health status with median EQ-5D-5L Index of 0.3 (IQR 0.1, 0.7) and EQ-VAS of 40 (IQR 20, 70). Caregivers reported scores describing moderate burden, although 45% scored severe to very severe burden (mean ± SD 15.0 ± 6.9). Most caregivers (121/174, 70%) and survivors (44/45, 97.8%) were satisfied with the results of treatment, and 134/174 (77%) caregivers and 40/45 (88.9%) survivors would again consent to the treatment they received. Factors associated with higher EQ-5D-5L included female sex, SAH diagnosis, treatment in Germany (vs. the USA), and absence of elevated intracranial pressure. CONCLUSIONS: For most patients 6 months after severe stroke with respiratory failure and neurocritical care treatment, physical disability and caregiver burden are profound. Nonetheless, most caregivers and nearly all survivors who were able to respond reported satisfaction with treatment and results of critical care including tracheostomy.

Recommended Citation

Jaffa, Matthew N.; Seder, David B.; Muehlschlegel, Susanne; and Meis, Jan, "Patient-and Caregiver-Centered Outcomes in Survivors of Severe Stroke with Respiratory Failure at 6 Months: A Substudy of the SETPOINT2 Trial" (2026). MaineHealth Maine Medical Center. 4603.
https://knowledgeconnection.mainehealth.org/mmc/4603