Evaluating the validity, reliability and clinical utility of the Music therapy Sensory Instrument for Cognition, Consciousness and Awareness (MuSICCA): protocol of a validation study

Abstract

Introduction: A growing number of children and young people are surviving severe acquired brain injuries due to advances in healthcare. However, many fail to emerge from coma and continue to live with disorders of consciousness (DOC). Diagnostic, clinical and ethical challenges are prominent in this group. Misdiagnosis can have severe consequences for children and their families, including inadequate care, insufficient access to rehabilitation and stimulation, reduced accessibility to services and inappropriately limited opportunities for participation. The proposed project will develop and validate a diagnostic measure that supports detailed goal-planning-the Music therapy Sensory Instrument for Cognition, Consciousness and Awareness (MuSICCA).

Methods and analysis: Face validity will be assessed using a short questionnaire and the MuSICCA will be amended if face validity is insufficient. Once face validity is sufficient, 80 participants with suspected DOC will be recruited from multiple sites around the UK, USA and Ireland.Validity will be assessed using external reference standards (Coma Recovery Scale-Revised, Coma Near-Coma Scale and Nociception Coma Scale). Intra-rater reliability will be established using repeated ratings of video recordings from the assessment sessions. Inter-rater reliability will be assessed through video ratings by a second blinded assessor. In addition to these analyses, the clinical utility of the MuSICCA will be evaluated using a questionnaire to be completed by clinicians and relatives of the participants following the completion of the MuSICCA assessment.

Ethics and dissemination: Ethical approval has been obtained for this study from the Research Ethics Committee and Health Research Authority of the National Health Service of the UK (ID: 167534). Results will be presented at national and international conferences, published in scientific journals and disseminated to participant representatives, clinicians, educators and care providers.

Trial registration details: This study was registered at ClinicalTrials.gov Protocol Registration and Results System on 7^th August 2019 (ID: NCT04050995); Pre-results.

Keywords: developmental neurology & neurodisability; neurological injury; paediatric neurology; paediatric palliative care; rehabilitation medicine.

Figure 1

Flow diagram of study design. A1_L1 represents data from assessor A1 conducting the first live assessment; A1_L2 represents data from assessor A1 conducting a further live assessment (randomly selected from sessions 2, 3 or 4); A1_V represents assessor A1 conducting video analysis of his/her own session after 4 to 6 weeks; A2_V represents assessor A2 conducting video analysis of a MuSICCA session that was conducted by assessor A1. CRS-R, Coma Recovery Scale-Revised; DOC, disorders of consciousness;MuSICCA, Music therapy Sensory Instrument for Cognition, Consciousnessand Awareness; NCS-R, Nociception Coma Scale-Revised.