Development and Validation of the SWADOC Tool

Study Overview
=================
Brief Summary
-----------------
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) and the Coma Recovery Scale-Revised (CRS-R) 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.

Official Title
-----------------
The Development and Validation of the SWADOC Tool: A Study Protocol for a Multicentric Prospective Cohort Study

Conditions
-----------------
Swallowing Disorders, Dysphagia, Disorders of Consciousness, Assessment Tool, Speech Therapy

Intervention / Treatment
-----------------
* Behavioral: SWADOC tool
* Behavioral: FOTT-SAS


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Unresponsive wakefulness syndrome patients (UWS)<br>The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R). | Behavioral: SWADOC tool<br>* The tool explores some oral and pharyngeal components of swallowing as well as a range of prerequisite and related components of swallowing in DOC patients. It is composed of an average of 50 qualitative items and a subsection named SWADOC-scored comprising 8 quantitative items.<br>Behavioral: FOTT-SAS<br>* Facial Oral Tract Therapy Swallowing Assessment of Saliva : the results of the SWADOC-scored in one of the sessions will be compared to the FOTT Swallowing Assessment of Saliva (FOTT-SAS) (27). The test is based on 7 questions under which if items 1-4 are answered Yes and items 5-7 are answered No, oral intake should be initiated. The FOTT-SAS includes items that can be scored based on the administration of the SWADOC tool. In that respect, no additional administration will be required<br>|
| Minimally conscious patients MINUS (MCS-)<br>The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R). | Behavioral: SWADOC tool<br>* The tool explores some oral and pharyngeal components of swallowing as well as a range of prerequisite and related components of swallowing in DOC patients. It is composed of an average of 50 qualitative items and a subsection named SWADOC-scored comprising 8 quantitative items.<br>Behavioral: FOTT-SAS<br>* Facial Oral Tract Therapy Swallowing Assessment of Saliva : the results of the SWADOC-scored in one of the sessions will be compared to the FOTT Swallowing Assessment of Saliva (FOTT-SAS) (27). The test is based on 7 questions under which if items 1-4 are answered Yes and items 5-7 are answered No, oral intake should be initiated. The FOTT-SAS includes items that can be scored based on the administration of the SWADOC tool. In that respect, no additional administration will be required<br>|
| Minimally conscious patients PLUS<br>The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R). | Behavioral: SWADOC tool<br>* The tool explores some oral and pharyngeal components of swallowing as well as a range of prerequisite and related components of swallowing in DOC patients. It is composed of an average of 50 qualitative items and a subsection named SWADOC-scored comprising 8 quantitative items.<br>Behavioral: FOTT-SAS<br>* Facial Oral Tract Therapy Swallowing Assessment of Saliva : the results of the SWADOC-scored in one of the sessions will be compared to the FOTT Swallowing Assessment of Saliva (FOTT-SAS) (27). The test is based on 7 questions under which if items 1-4 are answered Yes and items 5-7 are answered No, oral intake should be initiated. The FOTT-SAS includes items that can be scored based on the administration of the SWADOC tool. In that respect, no additional administration will be required<br>|
| Patients emerging from the minimally conscious state (EMCS)<br>The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorder (SECONDs) and the Coma Recovery Scale-Revised (CRS-R). | Behavioral: SWADOC tool<br>* The tool explores some oral and pharyngeal components of swallowing as well as a range of prerequisite and related components of swallowing in DOC patients. It is composed of an average of 50 qualitative items and a subsection named SWADOC-scored comprising 8 quantitative items.<br>Behavioral: FOTT-SAS<br>* Facial Oral Tract Therapy Swallowing Assessment of Saliva : the results of the SWADOC-scored in one of the sessions will be compared to the FOTT Swallowing Assessment of Saliva (FOTT-SAS) (27). The test is based on 7 questions under which if items 1-4 are answered Yes and items 5-7 are answered No, oral intake should be initiated. The FOTT-SAS includes items that can be scored based on the administration of the SWADOC tool. In that respect, no additional administration will be required<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the SWADOC-scored during three sessions (Examiner 1) - Intra-reliability | The SWallowing Assessment in Disorders Of Consciousness (SWADOC) tool is composed of an average of 50 qualitative and quantitative items. The subsection SWADOC-scored includes the 8 quantitative items. Four items are linked to the oral phase and four to the pharyngeal phase. For each quantitative item, patient's abilities are rated on a four-level severity scale ranging from 0 to 3. These levels correspond to item scores that can be added together to calculate 3 performance scores: the oral phase sub-score (sum of the 4 oral item scores - minimum of 0, maximum of 12), the pharyngeal phase sub-score (sum of the 4 pharyngeal item scores - minimum of 0, maximum of 12) and the total swallowing score (sum of the 8 item scores - minimum of 0, maximum of 24). The better the score is, the better the swallowing is. | 15-25 minutes (3 times in 5 business days) | 
| SECONDs | The Simplified Evaluation of CONsciousness Disorders (SECONDs): it features a shorter administration time (median of 7 minutes) and required only a mirror as material. It consists of 8 items: observation and reporting spontaneous behaviors, response to command, communication, visual pursuit and fixation, pain localization, oriented behaviors and arousal. The SECONDs provides a total score directly reflecting one diagnosis (0 = coma, 1 = UWS, 2-5 = MCS-, 6-7 = MCS+, 8 = EMCS). The better the score is, the better the consciousness level is. | 7 minutes (immediately before or after the SWADOC tool in each of the three sessions) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SWADOC-scored by Examiner 2 (inter-reliability) | The SWallowing Assessment in Disorders Of Consciousness (SWADOC) tool is composed of an average of 50 qualitative and quantitative items. The subsection SWADOC-scored includes the 8 quantitative items. Four items are linked to the oral phase and four to the pharyngeal phase. For each quantitative item, patient's abilities are rated on a four-level severity scale ranging from 0 to 3. These levels correspond to item scores that can be added together to calculate 3 performance scores: the oral phase sub-score (sum of the 4 oral item scores - minimum of 0, maximum of 12), the pharyngeal phase sub-score (sum of the 4 pharyngeal item scores - minimum of 0, maximum of 12) and the total swallowing score (sum of the 8 item scores - minimum of 0, maximum of 24). The better the score is, the better the swallowing is. | 15-25 minutes - immediately before or after one of the three sessions | 
| FOTT-SAS (Examiner 1) | FOTT-SAS (Facial Oral Tract Therapy Swallowing Assessment of Saliva) The FOTT-SAS is a reliable assessment for detecting aspiration risk in patients with acquired brain injury. The test is based on 7 questions under which if items 1-4 are answered Yes and items 5-7 are answered No, oral intake should be initiated (the better the score is, the better the swallowing is, minimum of 0, maximum of 7). The observations made during the assessment will permit to score the FOTT-SAS and verify the concurrent validity of the SWADOC tool. | Immediately after one of the three sessions | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
swallowing, dysphagia, disorders of consciousness, severe brain injury