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

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.

Behavioral Assessment of Patients with Disorders of Consciousness

“…The Nociception Coma Scale, and the revised version, were specifically developed to assess pain perception in patients with VS/UWS and MCS. 46 Additional scales that complement the CRS-R but focus specifically on language assessment 47 and swallowing 48 have also been recently developed. Alternate CRS-R scoring criteria have been proposed to improve the utility of the total score for differentiating VS/UWS from MCS 49,50 and a new measure the Brain-Injury Outcome Measure (BI-FOM), 51 , which expands the floor and ceiling of the Functional Independence Measure instrument (FIM TM ), 52 incorporates multiple CRS-R subscales.…”

Behavioral Assessment of Patients with Disorders of Consciousness

“…The Nociception Coma Scale and its revised version were specifically developed to assess pain perception in patients with VS/UWS and MCS. 46 Additional scales that complement the CRS-R but focus specifically on language assessment 47 and swallowing 48 have also been recently developed. Alternate CRS-R scoring criteria have been proposed to improve the utility of the total score for differentiating VS/UWS from MCS, 49 50 and a new measure, the Brain Injury Functional Outcome Measure, 51 which expands the floor and ceiling of the Functional Independence Measure instrument (FIM), 52 incorporates multiple CRS-R subscales.…”

Neurogenic Dysphagia and Nutrition in Disorder of Consciousness: An Overview with Practical Advices on an “Old” but Still Actual Clinical Problem

“…One of the widely used approaches in neurorehabilitation is the Facial Oral Tract Therapy (F.O.T.T. R ), a structured issue to evaluate and treat patients with disturbances in swallowing and eating, oral hygiene, nonverbal communication, and speech articulation caused by neurological diseases [58][59][60]. The tool includes the use of compensatory strategies, such as postural adaptations, sensory stimulation, manipulations of volume, consistence and viscosity of food.…”

“…The conventional treatment of dysphagia consists of exercises to increase oropharyngeal muscles strength as well as compensation strategies (including positioning, posture change and dietary modification to promote swallowing physiology and increase sensory input through thermal-tactile stimulation) [62]. However, as the aforementioned outcomes could be reached at different times by the different patients, personalized treatment has to be considered [58][59][60]. UWS patients with complete dysphagia and enteral feeding, as well as MCS patients with severe dysphagia or mixed feeding (enteral and oral), should be treated with peri-buccal and oral sensitivity stimulation by thermal-tactile-vibratory, passive neuromotor treatment and/or active orofacial structures (massage, praxis), stimulation of the swallowing reflex, exercises to restore the costo-diaphragmatic breathing with particular attention to the stimulation of cough and apnea mechanism, and management of oral secretions to facilitate the recovery of swallowing function (remedy methods) [61].…”