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

Evelyne Mélotte, Marion Belorgeot, Roxanne Herr, Jessica Simon, Jean-François Kaux, Steven Laureys, Leandro R D Sanz, Aude Lagier, Dominique Morsomme, Frederic Pellas, Olivia Gosseries, Evelyne Mélotte, Marion Belorgeot, Roxanne Herr, Jessica Simon, Jean-François Kaux, Steven Laureys, Leandro R D Sanz, Aude Lagier, Dominique Morsomme, Frederic Pellas, Olivia Gosseries

Abstract

Background: After a coma, patients with severe brain injury may present disorders of consciousness (DOC). A substantial proportion of these patients also suffer from severe dysphagia. Assessment of and therapy for swallowing disabilities of patients with DOC are essential because dysphagia has major functional consequences and comorbidities. Dysphagia evaluation in patients with DOC is impeded by the lack of adapted tools. The first aim of this study was to create a new tool, the SWallowing Assessment in Disorders Of Consciousness (SWADOC), and propose a validation protocol. The SWADOC was developed to help therapists assess factors related to swallowing in patients with DOC. The second aim was to investigate the relationship between patients' level of consciousness and SWADOC items and scores. Method/Design: In this multicenter prospective cohort, 104 patients with DOC will be tested three times over five consecutive days with the SWADOC. Statistical analyses will focus on the reliability and validity of the SWADOC, especially the intrarater and interrater reliability, internal consistency, measures of dispersion, and concurrent validity with the Facial Oral Tract Therapy Swallowing Assessment of Saliva (FOTT-SAS). The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorders (SECONDs) and the Coma Recovery Scale-Revised (CRS-R). Discussion: The assessment of swallowing abilities among patients with DOC is the first necessary step toward the development of a customized dysphagia care plan. A validated scoring tool will be essential for clinicians to better assess dysphagia in patients with DOC and document the evolution of their disorders. Trial Registration: NCT04706689.

Keywords: assessment; consciousness; dysphagia; severe brain injury; swallowing.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Mélotte, Belorgeot, Herr, Simon, Kaux, Laureys, Sanz, Lagier, Morsomme, Pellas and Gosseries.

Figures

Figure 1
Figure 1
Description of the SWADOC. ENT, Ear, Nose, and Throat; SWADOC, SWallowing Assessment in Disorders Of Consciousness.
Figure 2
Figure 2
SWADOC-scored (English version). DOC, disorders of consciousness; SWADOC, SWallowing Assessment in Disorders Of Consciousness.
Figure 3
Figure 3
Study protocol. Example of the assessment program for a patient. The program for each patient is organized such that the three sessions take place over 5 days in the morning or in the afternoon. The SECONDs is administered before or after the SWADOC. Examiner 2 will administer the SWADOC before or after examiner 1 in one of the three sessions. Examiner 1 will score the FOTT-SAS after one of the three sessions. SECONDs, Simplified Evaluation of CONsciousness Disorders; SWADOC, SWallowing Assessment in Disorders Of Consciousness; FOTT-SAS, Facial Oral Tract Therapy Swallowing Assessment of Saliva.

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