Cross-cultural Adaptation and Multicenter Validation of the Italian Versions of the Brief Evaluation of Receptive Aphasia (BERA) and SWallowing Assessment in Disorders of Consciousness (SWADOC)

Official title

Adattamento Trans-culturale e Validazione Multicentrica Della Versione Italiana Delle Scale Brief Evaluation of Receptive Aphasia (BERA) e SWallowing Assessment in Disorders of Consciousness (SWADOC)

Overview

Patients with severe acquired brain injury may evolve from coma into prolonged disorders of consciousness. In these patients, residual language comprehension and swallowing abilities are difficult to evaluate because standard assessments often depend on verbal or motor responses. The Brief Evaluation of Receptive Aphasia (BERA) assesses receptive language abilities through visual/eye-movement responses, whereas the SWallowing Assessment in Disorders of Consciousness (SWADOC) assesses oral and pharyngeal components of swallowing in patients with disorders of consciousness. This national multicenter observational study aims to perform the Italian cross-cultural adaptation and validation of BERA and SWADOC. Consecutive adult inpatients with severe acquired brain injury and disorders of consciousness will be recruited from four Italian centers. SWADOC will be administered to 57 patients, and BERA will be administered to a nested subgroup of 22 patients who meet additional criteria. Inter-rater reliability, test-retest reliability over 24 hours, and convergent validity with Coma Recovery Scale-Revised scores will be analyzed.

Detailed description

This study is part of the Horizon MSCA DoC-Box project, which aims to develop a multimodal toolbox to support fast and reliable diagnosis of disorders of consciousness. The study includes two consecutive phases. In Phase 1, the original French versions of BERA and SWADOC will be translated into Italian by two expert translators. The translated versions will be synthesized, back-translated into the original language by two independent blinded translators, compared, discussed, and revised by researchers and experts according to international guidelines for translation and cultural adaptation. In Phase 2, the Italian versions will be evaluated in a multicenter observational validation study involving three Fondazione Don Carlo Gnocchi centers (Sant'Angelo dei Lombardi, Florence, Milan) and the IRCCS Istituto Neurologico Carlo Besta in Milan. After diagnostic confirmation based on repeated CRS-R assessments, Examiner A will administer the SECONDs to assess the level of consciousness. On the same day, Examiner B will administer the Italian BERA and/or SWADOC, while Examiner C will independently score the scales to assess inter-rater agreement. After approximately 24 hours, Examiner A will repeat the SECONDs, and either Examiner B or Examiner C will repeat BERA and/or SWADOC to assess test-retest reliability. Demographic and clinical variables, level of consciousness, total scores, and subscale scores will be entered in a centralized pseudonymized REDCap database and analyzed in aggregate form.

Interventions

• Diagnostic test Italian SWallowing Assessment in Disorders of Consciousness (SWADOC)
  Structured clinical assessment of oral and pharyngeal swallowing components in patients with disorders of consciousness. The Italian version will be administered and scored by trained examiners to evaluate inter-rater and test-retest reliability.
• Diagnostic test Italian Brief Evaluation of Receptive Aphasia (BERA)
  Brief clinical assessment of receptive language abilities, including phonology, semantics, and morphosyntax. Responses are based on visual/eye-movement behavior, allowing assessment of patients unable to communicate verbally or through reliable motor responses. It will be administered to the nested subgroup meeting BERA-specific criteria.

Primary outcome measures

• Inter-rater reliability of the Italian Swallowing Assessment in Disorders of Consciousness total score [Time frame: Day 1, during the first assessment session]
• Test-retest reliability of the Italian Swallowing Assessment in Disorders of Consciousness total score [Time frame: Baseline and approximately 24 hours later]
• Inter-rater reliability of the Italian Brief Evaluation of Receptive Aphasia total score [Time frame: Day 1, during the first assessment session]
• Test-retest reliability of the Italian Brief Evaluation of Receptive Aphasia total score [Time frame: Baseline and approximately 24 hours later]

Secondary outcome measures (2)

• Convergent validity of the Italian Swallowing Assessment in Disorders of Consciousness total score with the Coma Recovery Scale-Revised total score [Time frame: Baseline/Day 1]
• Convergent validity of the Italian Brief Evaluation of Receptive Aphasia total score with the Coma Recovery Scale-Revised total score [Time frame: Baseline/Day 1]

Eligibility criteria

Inclusion criteria

• Age >= 18 years.
• Native Italian speaker.
• Diagnosis of severe acquired brain injury.
• At least 28 days since the acute event.
• For SWADOC validation: stable clinical diagnosis of disorder of consciousness, including UWS, MCS, or EMCS, assessed with the Coma Recovery Scale-Revised repeated at least five times over two weeks.
• For BERA validation: stable clinical diagnosis of MCS or EMCS assessed with the Coma Recovery Scale-Revised repeated at least five times over two weeks.
• For BERA validation: presence of visual fixation and/or visual pursuit assessed with the Coma Recovery Scale-Revised.
• No remote history of neurological, neurodegenerative, or psychiatric disease; for SWADOC validation, no remote history of otorhinolaryngological disease.
• Written informed consent provided by the primary caregiver/legal representative according to local regulations.

Exclusion criteria

• Occurrence of a second cerebral event between enrollment and data collection.
• Unstable general clinical condition preventing assessment, including but not limited to need for ventilatory support, severe infection, or status epilepticus.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 4 centers

• Polo Specialistico Riabilitativo Fondazione Don Gnocchi — Sant'Angelo dei Lombardi
• IRCCS Fondazione Don Carlo Gnocchi — Florence
• IRCCS Istituto Neurologico Carlo Besta — Milan
• IRCCS SM Nascente Fondazione Don Carlo Gnocchi — Milan

Identifiers

NCT: NCT07711119 · BERA-SWADOC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗