The Development and Validation of the SWADOC: A Study Protocol for a Multicenter Prospective Cohort Study

Area of Science:

• Neurology
• Rehabilitation Medicine
• Speech-Language Pathology

Background:

• Patients with severe brain injury and disorders of consciousness (DOC) frequently experience severe dysphagia.
• Accurate dysphagia evaluation in DOC patients is challenging due to a lack of specialized assessment tools.
• Dysphagia significantly impacts functional outcomes and comorbidities in this population.

Purpose of the Study:

• To develop and propose a validation protocol for a novel tool, the SWallowing Assessment in Disorders Of Consciousness (SWADOC), for assessing swallowing in DOC patients.
• To investigate the correlation between patients' level of consciousness and SWADOC scores.
• To provide clinicians with a reliable instrument for dysphagia assessment and monitoring in DOC.

Main Methods:

• A multicenter prospective cohort study involving 104 patients with DOC.
• Repeated assessments using the SWADOC over five consecutive days.
• Statistical analyses for reliability (intrarater, interrater) and validity (internal consistency, concurrent validity with FOTT-SAS).
• Consciousness levels assessed using the Simplified Evaluation of CONsciousness Disorders (SECONDs) and Coma Recovery Scale-Revised (CRS-R).

Main Results:

• The study aims to establish the reliability and validity of the SWADOC tool.
• Concurrent validity will be assessed against the established FOTT-SAS.
• The relationship between SWADOC scores and consciousness assessment scales (SECONDs, CRS-R) will be analyzed.

Conclusions:

• The SWADOC tool has the potential to significantly improve dysphagia assessment in patients with DOC.
• A validated tool is crucial for developing tailored dysphagia care plans and tracking patient progress.
• This research addresses a critical gap in the clinical management of swallowing disorders in DOC.