Development and Validation of the SWADOC Tool
Development and Validation of the SWADOC Tool
Background: After a period of coma, patients with severe brain injury may present disorders
 of consciousness (DOC). A wide proportion of these patients also suffer from severe
 dysphagia. Assessment and therapy of swallowing disabilities of DOC patients are essential
 because dysphagia has major functional consequences and comorbidities. Dysphagia evaluation
 in patients with DOC is hampered by the lack of adapted tools. The first aim of the study was
 to develop a new tool, the SWallowing Assessment in Disorders Of Consciousness (SWADOC), and
 propose a validation protocol. The SWADOC tool has been developed to help therapists to
 apprehend components related to swallowing in patients with DOC. The second aim is to
 appreciate the relationship between patients' level of consciousness and SWADOC items and
 scores.

 Method/design: In this multicentric prospective cohort, 104 patients with DOC will be tested
 three times during two consecutive days with the SWADOC tool. Statistical analyses will focus
 on the reliability and validity of the SWADOC tool, especially the intra and inter-rater
 reliability, internal consistency, measures of dispersion and concurrent validity with the
 FOTT Swallowing Assessment of Saliva (FOTT-SAS). The level of consciousness will be assessed
 with the Simplified Evaluation of CONsciousness Disorders (SECONDs).

 Discussion: The assessment of swallowing abilities among patients with DOC is the first
 necessary step towards the development of an individualized dysphagia care plan. A validated
 scoring tool will be essential for clinicians to better apprehend dysphagia in DOC patients
 and to document the evolution of their disorders.
Inclusion Criteria :

 -  Age above 18-year-old

 -  Perfect knowledge of French language before the injury

 -  Previous event of coma phase caused by a severe acquired brain injury

 -  Medical stability (absence of mechanical ventilation and sedation, no acute medical
 pathology such as infection or respiratory distress)

 -  No neurological or otorhinolaryngological disease which can impact swallowing prior to
 the brain injury

 -  Minimum of 28 days since the acquired brain injury at inclusion

 -  Diagnosis of UWS, MCS-, MCS+ or EMCS based on the CRS-R or SECONDs

 -  Informed consent from legal representative of the patient

 -  Affiliated patient or beneficiary of a health insurance plan (for French participants
 only).