Outcomes and Expected Impact

The primary outcome is the score on the mRS at 90 days (± 14 days). The mRS is the preferred disability parameter for clinical trials in stroke and has six categories from 0 up to and including 5, and describes the range of disability encountered post stroke. ‘Death’ is assigned a score of 6.

 

Secondary outcomes include: death; poor functional outcome, defined as mRS >2; disability assessed with the score on the Barthel index (BI); the score on the Montreal Cognitive Assessment (MoCA); and quality of life assessed with the EuroQol 5D-5L (EQ-5D-5L) score, all at 90 days (± 14 days).

In addition, we will assess the use of healthcare resources in the first 90 days and the occurrence of (serious) adverse events, including Clostridium difficile infections.

 

What may be the outcome for undefinedindividual patients following stroke:

 

  • 50% reduction in the risk of aspiration, infections, and fever in the acute phase of stroke.

  • 5% absolute reduction in the risk of death or long-term dependency.

  • This would lead to over 25,000 fewer elderly Europeans each year being dead or disabled as a result of a stroke.

  • Improved quality of life in survivors, because this is strongly related to functional outcomes.

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