Evaluation Tools and Outcome Measures used to assess Dysphagia in adults with Disorders of Consciousness secondary to Acquired Brain Injury: A Scoping Review protocol

1 Title Evaluation Tools and Outcome Measures used to assess dysphagia in adults with Disorders of consciousness secondary to Acquired brain injury: A Scoping Review protocol. Scoping review question: “What tools (validated or non-validated) and what outcome measures are used by speech and language therapists during dysphagia screening and assessment in adults with DoC associated with ABI?” 2 Introduction Disorders of consciousness (DoC) are a wide range of conditions whereby patients don't have the ability to interact with the environment(Young, 2012). To be conscious, arousal and awareness must be present and interact with each other, when one of these systems is disrupted, consciousness is impaired (Gosseries et al., 2011). DoC can result from Acquired Brain Injury (ABI) (Young, 2012): a damage to the brain that occurs after birth, not related to congenital disorders, developmental disabilities, or progressive conditions (Eskildsen et al., 2019). Dysphagia is frequent in this population (Mackay et al., 1999) and some components of swallowing impairments are particularly related to consciousness (Bremare et al., 2016; Mélotte et al., 2021). The existence of cognitive and behavioural disabilities in this population has a significant impact on the evaluation (Terré & Mearin, 2007). Therefore, the importance of having an overview of the formal and informal assessment outcome measures and tools used to evaluate deglutition disorders in this population. A preliminary search for existing scoping reviews and systematic reviews on the topic has been conducted in November 2021 in JBI Evidence Synthesis, Cochrane Database of Systematic Reviews, PubMed and Prospero. The aim of the project is to outline and categorize the existing evidence regarding the informal and formal assessment tools and outcome measures useful for speech and language therapists’ management of dysphagia with specific emphasis both in screening and in clinical swallow evaluation in patients with DoC secondary to ABI. The comprehensive overview of the literature may offer useful support for speech and language therapists (SLT) since it would provide an insight of the availability of the tools and measures to choose from when assessing dysphagia in DoC patients after ABI. Additionally, this scoping review may also lay the foundations for a future systematic review to identify the methodological quality of the psychometric properties of the tools and outcome measures identified and to select the most appropriate ones to include in a core outcome set. 3 Eligibility criteria Inclusion criteria - Population Patients with DoC arising from moderate, severe or very severe acquired damage of the brain. Papers should include DOC and patients with moderate, severe or very severe ABI. In the scenario where consciousness is not explicitly mentioned, scales to assess cognitive and behavioural patterns in patients emerging from a coma (e.g. Rancho Los Amigos Level of Cognitive Functioning Scale) or a description of the level of consciousness (LoC) of the patients has to be present. If information about the LoC is missing, the full text will be examined. Patients with tracheostomy are included in the study since it is frequently a necessary procedure in the ICU, especially in patients with TBI (Robba et al., 2020). Excluding patients requiring tracheostomy would dismiss severe/very severe ABI patients limiting the number of eligible papers and foremost the population of interest. However, it is recognised that some features of the dysphagia in the patients may be caused by the presence of the tracheostomy(Skoretz et al., 2020). Exclusion criteria - Population Patients with mild ABI (Glasgow Coma Scale 13-15, post-traumatic amnesia <1 hour and loss of consciousness <15 minutes) Inclusion Criteria - Concept Any instrumental and non-instrumental assessment measure or assessment tool to evaluate dysphagia must be mentioned. Exclusion criteria - Concept Holistic scales evaluating neurobehavioral measures that contain dysphagia as a collateral item will not be included in the study. Context There is no restriction on setting (i.e., hospital settings, post-acute care and in the community acute care, primary health care or the community) and language in order to avoid the exclusion of relevant studies, and therefore overcome recruitment bias. Types of evidence sources In accordance with “PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation” (Tricco et al., 2018), no restrictions are imposed on study design or quality. Research designs such as primary research studies, systematic reviews, meta-analyses, guidelines, experimental designs, single case studies and retrospective reviews will be included. 4 Search strategy The research string consists in a branch related to consciousness and brain injuries and a second one related to dysphagia. The consciousness branch has entry terms related to behavioural scales (e.g Rancho Los Amigos Level of Cognitive Functioning Scale) to capture studies that reported assessment scales for DoC, but that did not specify DoC in the title/abstract. The combination of the terms of the branch dealing with consciousness, behavioural scales, and brain injuries should strike a balance between the strategy itself and its potential limitation. To limit the possibility of excluding relevant studies the search of the reference list of relevant articles is carried out. If further information on certain papers is needed the authors will be contacted to request the data. If there will not be an answer, the paper will be excluded. Following the suggestion of the Subject Librarian, the following electronic bibliographic databases are considered: MEDLINE (PubMed); EMBASE (Ovid); CINAHL (EBSCO); Web of Science. Grey literature will be included. The grey literature research was developed following the approach proposed in “Grey Matters: a practical tool for searching health-related grey literature” (Canadian Agency for Drugs and Technologies in Health, 2015) . 5 Source of evidence selection The study selection phase will consist of the elimination of duplicates, screening of title, abstracts, and full text according to the eligibility criteria, using Covidence systematic review online software, Veritas Health Innovation, Melbourne, Australia. The criteria will be tested on a sample of 25 abstracts before the review process to ensure that they were sufficiently robust in capturing relevant studies and excluding non-eligible studies. The team will start screening when 75% agreement is achieved. Two reviewers will conduct the process independently (Levac et al., 2010), ruling in or out according to inclusion and exclusion criteria. The third reviewer will handle the disagreements (3rd independent rater). PRISMA guidelines extensions for ScR will be used throughout the progression of the study (Tricco et al., 2018). 6 Data extraction The data extraction sheet contains author/year, publication date, country of origin, demographic data, study design, objective/s of the paper, setting, cause of ABI, type of ABI (moderate or severe), level of consciousness/scale used to assess consciousness, the dysphagia assessment tools/measures used (Levac et al., 2010; Peters et al., 2015). The charting form will be developed by the first author. To improve reliability, the first and second author will then meet to ensure common understanding of the form. The first and second author will collect the data and update the data charting form in an iterative process (Levac et al., 2010). The sheet will be modified to allow essential information to be charted. The data extraction sheet will be blindly and independently piloted on five studies by the first and second author to assess inter-rater reliability. Disagreements will be settled through discussion with the supervisor. 7 Analysis of the evidence The analysis will include quantitative descriptive numerical summaries analysis of data: frequency counts of concepts, populations, characteristics, as well as qualitative descriptive analysis (Aromataris & Munn, 2020) to identify themes from published research. The results will be reported considering the meaning of the findings concerning the overall research purpose (Levac et al., 2010) to outline and categorize the existing evidence regarding the dysphagia assessment used by SLTs with specific emphasis in patients with DoC secondary to ABI. 8 Presentation of the results The results will be presented both in tabular form and in a descriptive format. The tables and charts will include distribution of sources of evidence by year, countries of origin, research methods. The results were classified under main conceptual categories such as: “level of consciousness of the population”, “type of assessment” (screening, bedside swallow evaluation, instrumental), "type of ABI", “presence of tracheostomy”. The analyses and presentation of the results will be independently carried out by the first author. Bibliography Aromataris, E., & Munn, Z. (2020). JBI Manual for Evidence Synthesis. https://synt.hesismanual.jbi.global. https://doi.org/10.46658/JBIMES-20-01 Bremare, A., Rapin, A., Veber, B., Beuret Blanquart, F., & Verin, E. (2016). Swallowing disorders in severe brain injury in the arousal phase [Conference Abstract]. Dysphagia, 31(2), 283. https://doi.org/10.1007/s00455-016-9698-6 Eskildsen, S. J., Jakobsen, D., Riberholt, C. G., Poulsen, I., & Curtis, D. J. (2019). Protocol for a scoping review study to identify and map treatments for dysphagia following moderate to severe acquired brain injury. BMJ Open, 9(7), e029061. https://doi.org/10.1136/bmjopen-2019-029061 Gosseries, O., Vanhaudenhuyse, A., Bruno, M.-A., Demertzi, A., Schnakers, C., Boly, M. M., Maudoux, A., Moonen, G., & Laureys, S. (2011). Disorders of Consciousness: Coma, Vegetative and Minimally Conscious States. In (pp. 29-55). Springer Berlin

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