Validity of a New Stroke Dysphagia Screening Tool

Specific Aims:

1. To show that the dysphagia screening tool achieves greater than 90% positive and
negative predictive values relative to the gold standard for dysphagia defined in this
study as the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) as performed by
speech-language pathologists.

2. To show that the risk of aspiration pneumonia is less than 10% during hospitalization
in patients undergoing the dysphagia screening tool.

3. To show that the dysphagia screening tool is applicable across the spectrum of stroke
severity, as defined by the NIH stroke scale score.

4. To assess specific components and combinations of components of the dysphagia screening
tool with respect to positive and negative predictive values.

5. To show that the dysphagia screening tool has excellent inter-rater reliability and can
be performed in under 5 minutes.

Methods: The investigators will recruit 18 patients with a clinical diagnosis of acute
ischemic stroke. Patients with a clinical diagnosis of stroke will initially be screened
with the dysphagia screening tool within 24 hours of last known well admission by two
separate evaluators performed no more than 2 hours apart. The first evaluator will be either
a nurse (e.g. emergency medicine nurse) or physician (e.g. neurology resident) certified in
use of the screen. The second evaluator will be the nurse research coordinator for the
study. The first screen is part of routine clinical care and will be used to determine the
patient's eating status (NPO or full diet). Timing between evaluations will be recorded.
Patients will include those with an NIHSS of 8-16 inclusive. Patients with primary
intracerebral hemorrhage and those who are unable to read the consent form due to language
barrier (not aphasia) will be excluded from this study. Consent for aphasic patients will be
obtained from an authorized representative. Lesion side (right, left), lesion location
(hemispheric, brainstem, cerebellar), and TOAST classification (a validated method of stroke
mechanism classification) will be recorded. The results of patients who are initially
enrolled in the study but later excluded because of brain imaging findings will be recorded.
Patients who are studied by FEES within 6 hours of the first bedside screen by ASHA
certified speech-language pathologists will be included. Time from screening to FEES
examination will be recorded. A patient studied more than 6 hours after the first bedside
screen will be excluded. Patients who passed the initial screen but later failed FEES
examination will be made NPO because of the potential implications for clinical outcome.
Patients who fail the initial screen but who later pass the FEES examination wil be released
from NPO status. Results of brain imaging will also be recorded. Patients with negative
brain imaging will also be included because diagnostic imaging with CT may not be sensitive
in the first 24 hours and MRI may not be available within hours of arrival. Patients
included in the study will also be followed during their hospitalization for clinical
evidence of aspiration pneumonia up to 7 days. A 90-day phone call will be made to determine
the patient's level of function according to the modified Rankin scale, a standard outcome
tool for stroke. Patients whose final diagnosis is not stroke will be excluded from
analysis.

Statistical analysis:

Inter-rater reliability between bedside screeners will be calculated. Results of the screen
performed by the last bedside screener will be compared to findings on FEES. Sensitivity,
specificity, positive predictive value, and negative predictive value scores will be
calculated using 2 by 2 table analysis. Likelihood ratios will be calculated. Aspiration
pneumonia rates will be described with descriptive statistics.

Inclusion Criteria:

- Clinical diagnosis of ischemic stroke

- Age 18 years or older

- NIHSS 8-16

- Within 24 hours of last known well

Exclusion Criteria:

- Diagnosis of intracerebral hemorrhage, TIA, or other non-ischemic stroke diagnosis

- Patient or authorized representative unable to read consent form