BJH-SDS Validation of the German Translation

German Translation and Validation of the Barnes-Jewish-Hospital Stroke Dysphagia Screen (BJH-SDS)

The first object of the study is the validation of a translation of the Barnes-Jewish Hospital Stroke Dysphagia Screen with determination of sensitivity, specificity, interrater reliability (especially between different professional groups) and criterion validity.

If the German translation proves to be suitable, it will also be validated on general neurological patients, i.e. patients on a neurological ward without a stroke.

Study Overview

• Status: Recruiting
• Conditions: Dysphagia; Stroke, Acute
• Intervention / Treatment: Diagnostic test: BJH-SDS Screenint Test; Diagnostic test: Flexible Endoscopic Evaluation of Swallowing

Detailed Description

Stroke is now the second most common cause of death worldwide. Dysphagia is described as a direct consequence of cerebral infarction in at least 50% of stroke patients in the acute phase [2]. It often leads to aspiration pneumonia, which is the most important secondary complication in stroke unit. Within one year after a stroke, around 20% of dysphagia patients die as a result of aspiration pneumonia . In addition, dysphagia causes numerous other secondary complications (malnutrition, exsiccosis) and associated high costs for the healthcare system.

Numerous screening procedures have been developed in recent years. These are mostly based on a swallowing test with water after testing various input requirements. There are also multi-consistency tests that include liquids as well as pulpy and solid consistencies. The sensitivity of the tests is usually at least 85% with moderate specificity, which is due to the inability to detect silent aspiration by non-instrumental diagnostics. In addition, the implementation of the screening procedures is usually only evaluated by the professional group of speech therapists.

One of these screening procedures is the Barnes-Jewish-Hospital Stroke Dysphagia Screen (BJH-SDS). In our opinion, this test is very well suited as a screening procedure, as it has good sensitivity (94%) and specificity (64%), is validated for all professional groups and takes little time. In brief, it includes an assessment of sufficient consciousness (Glasgow Coma Scale over 13 points), a check for facial paresis, soft palate paresis and tongue paresis followed by a water swallow test with 90 ml of water if the previous points are assessed as normal. The water swallow test checks for signs of aspiration (throat clearing, coughing or a change in voice quality) However, the BJH-SDS is not yet available in German. The aim of this research project is therefore to translate the BJH-SDS into German (BJH-SDS-G) and validate it as the gold standard using flexible endoscopic swallowing examination (FEES) and then use it routinely in our clinics. This will be followed by validation in general neurological patients (without stroke) so that the BJH-SDS can also be used reliably in this patient population.

• Study Type: Observational
• Enrollment (Estimated): 570

Contacts and Locations

• Study Contact: Name: Tobias Braun, PD MD; Phone Number: +49 6441793517; Email: tobias.braun@neuro.med.uni-giessen.de

Study Locations

• Germany
  • Hessen
    • Giesen, Hessen, Germany, 35392
      • Recruiting
      • University Hospital Giessen and Marburg, Campus Giessen
      • Contact: Tobias Braun, MD; Phone Number: +4964198559233; Email: tobias.braun@neuro.med.uni-giessen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

• Acute ischemic stroke Patients
• General patient popluation
• Non-neurologic ICU patients

Description

Inclusion Criteria:

• All stroke patients in the neurology department of the Lahn-Dill Clinic in Wetzlar and the stroke unit of the Bürgerhospital in Friedberg and the neurologic ICU of the University Hospital in Giessen are to be screened with the BJH-SDS-G after appropriate information has been provided.

Exclusion Criteria:

• Exclusion criteria are a lack of informed consent, contraindications to an FEES examination, a history of stroke, pre-existing dysphagia or a disease that may be associated with dysphagia (e.g. ENT tumors, Parkinson's disease, neuromuscular diseases).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute stroke patients; All patients of the participating clinics who have a suspected diagnosis of stroke	Diagnostic test: BJH-SDS Screenint Test; The test includes the assessment of a sufficient level of consciousness (Glasgow Coma Scale over 13 points), a check for facial paresis, soft palate paresis and tongue paresis followed by a water swallow test with 90 ml of water if the previous points are assessed as normal. The water swallow test checks for signs of aspiration (throat clearing, coughing or a change in voice quality); Diagnostic test: Flexible Endoscopic Evaluation of Swallowing; The FEES evaluates anatomical changes, functional disorders of the visible structures (e.g. recurrent paresis), saliva management, penetration and aspiration of food boluses in order to draw conclusions about the underlying pathomechanism of dysphagia. It is an established standard diagnostic procedure for stroke patients and, in addition to the diagnosis of dysphagia, also enables pathomechanism-guided therapy by speech therapists; Other Names: FEES
Non-neurologic ICU patients; All patients of the participating clinics who are being treated in intensive care due to a non-neurological disease	Diagnostic test: BJH-SDS Screenint Test; The test includes the assessment of a sufficient level of consciousness (Glasgow Coma Scale over 13 points), a check for facial paresis, soft palate paresis and tongue paresis followed by a water swallow test with 90 ml of water if the previous points are assessed as normal. The water swallow test checks for signs of aspiration (throat clearing, coughing or a change in voice quality); Diagnostic test: Flexible Endoscopic Evaluation of Swallowing; The FEES evaluates anatomical changes, functional disorders of the visible structures (e.g. recurrent paresis), saliva management, penetration and aspiration of food boluses in order to draw conclusions about the underlying pathomechanism of dysphagia. It is an established standard diagnostic procedure for stroke patients and, in addition to the diagnosis of dysphagia, also enables pathomechanism-guided therapy by speech therapists; Other Names: FEES
Non-neurologic patientes; All patients of the participating clinics who are being treated due to a non-neurological disease	Diagnostic test: BJH-SDS Screenint Test; The test includes the assessment of a sufficient level of consciousness (Glasgow Coma Scale over 13 points), a check for facial paresis, soft palate paresis and tongue paresis followed by a water swallow test with 90 ml of water if the previous points are assessed as normal. The water swallow test checks for signs of aspiration (throat clearing, coughing or a change in voice quality); Diagnostic test: Flexible Endoscopic Evaluation of Swallowing; The FEES evaluates anatomical changes, functional disorders of the visible structures (e.g. recurrent paresis), saliva management, penetration and aspiration of food boluses in order to draw conclusions about the underlying pathomechanism of dysphagia. It is an established standard diagnostic procedure for stroke patients and, in addition to the diagnosis of dysphagia, also enables pathomechanism-guided therapy by speech therapists; Other Names: FEES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penetration-Aspiration Score	Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome	Immediately after the intervention
Barthel-Index	Barthel-Index; minimal value 0, maximum value 100; lower values mean worse outcome	Immediately before the intervention
MRS	Modified Rankin Scale; minimal value 0, maximum value 6; higher values mean worse score	Immediately before the intervention

Collaborators and Investigators

• Sponsor: University of Giessen
• Investigators: Study Director: Tobias Braun, PD MD, University of Gießen; Principal Investigator: Samra Hamzic, Dr., University of Gießen

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Dysphagia; FEES; Swallowing disorders; Swallow screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Stroke; Deglutition Disorders
• Other Study ID Numbers: BJH-G

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No