Development of a Non-invasive Device for Swallow Screening in Patients at Risk of Oropharyngeal Dysphagia: Results from a Prospective Exploratory Study

Catriona M. Steele, Rajat Mukherjee, Juha M. Kortelainen, Harri Pölönen, Michael Jedwab, Susan L. Brady, Kayla Brinkman Theimer, Susan Langmore, Luis F. Riquelme, Nancy B. Swigert, Philip M. Bath, Larry B. Goldstein, Richard L. Hughes, Dana Leifer, Kennedy R. Lees, Atte Meretoja, Natalia Muehlemann

Research output: Contribution to journalArticlepeer-review

28 Scopus citations

Abstract

Oropharyngeal dysphagia is prevalent in several at-risk populations, including post-stroke patients, patients in intensive care and the elderly. Dysphagia contributes to longer hospital stays and poor outcomes, including pneumonia. Early identification of dysphagia is recommended as part of the evaluation of at-risk patients, but available bedside screening tools perform inconsistently. In this study, we developed algorithms to detect swallowing impairment using a novel accelerometer-based dysphagia detection system (DDS). A sample of 344 individuals was enrolled across seven sites in the United States. Dual-axis accelerometry signals were collected prospectively with simultaneous videofluoroscopy (VFSS) during swallows of liquid barium stimuli in thin, mildly, moderately and extremely thick consistencies. Signal processing classifiers were trained using linear discriminant analysis and 10,000 random training–test data splits. The primary objective was to develop an algorithm to detect impaired swallowing safety with thin liquids with an area under receiver operating characteristic curve (AUC) > 80% compared to the VFSS reference standard. Impaired swallowing safety was identified in 7.2% of the thin liquid boluses collected. At least one unsafe thin liquid bolus was found in 19.7% of participants, but participants did not exhibit impaired safety consistently. The DDS classifier algorithms identified participants with impaired thin liquid swallowing safety with a mean AUC of 81.5%, (sensitivity 90.4%, specificity 60.0%). Thicker consistencies were effective for reducing the frequency of penetration–aspiration. This DDS reached targeted performance goals in detecting impaired swallowing safety with thin liquids. Simultaneous measures by DDS and VFSS, as performed here, will be used for future validation studies.

Original languageEnglish
Pages (from-to)698-707
Number of pages10
JournalDysphagia
Volume34
Issue number5
DOIs
StatePublished - Oct 15 2019

Bibliographical note

Publisher Copyright:
© 2019, The Author(s).

Funding

Funding The study was sponsored by Nestec S.A., Vevey, Switzerland, through contracts negotiated through a contract research organization with participating hospitals and directly with Cytel, Massachusetts, USA; VTT Technical Research Centre of Finland, Espoo, Finland; and University Health Network, Toronto. The sponsor was responsible for site management, data collection, database management and data archiving activities. The authors would like to thank Maryam Kadjar Olesen, Head of Global Clinical Operations at Nestlé Health Science for her contributions to the study. The authors would like to thank Paula Kamman, Nancy Schurhammer and Ryan Ping from RCRI Regulatory and Clinical Research Institute, Minneapolis, MN for their contributions to oversight of data collection, database management and quality control. The authors would like to thank Liza Blumenfeld (Scripps Memorial Hospital, La Jolla, CA), Gintas Krisciunas (Boston Medical Centre, Boston, MA), Andrea Tobochnik (Bronson Healthcare, Kalamazoo, MI), Ka Lun Tam (Bloorview Research Institute, Toronto), Melanie Peladeau-Pigeon, Melanie Tapson, Talia Wolkin and Navid Zohouri-Haghian (Toronto Rehabilitation Institute—University Health Network) for their contributions to data acquisition. The authors would like to thank Carly Barbon, Vivian Chak, Amy Dhindsa, Robbyn Draimin, Natalie Muradian, Ahmed Nagy, Ashwini Namasivayam-MacDonald, Sonya Torreiter, Teresa Valenzano and Ashley Waito, (Toronto Rehabilitation Institute—University Health Network) for their contributions to videofluoroscopy rating. The authors would like to thank Jaakko Lähteenmäki, Juha Pajula and co-workers of VTT Technical Research Centre of Finland Ltd. for their contributions to data analysis and input on technical implementation considerations. The authors would like to thank Tom Chau, Helia Mohammadi, Ali Akbar-Samadani and Ka Lun Tam from the PRISM lab, Bloorview Research Institute, Toronto, for their contributions to data analysis. The authors would like to thank Munshiimran Hossain and Andrea Hita from Cytel Inc. for their contributions to data analysis. a member of a Nestlé Advisory Board for which he receives an honorarium and travel expenses. Richard L. Hughes is Professor of Neurology and participates in clinical research sponsored by the NIH and Industry. He is a member of a Nestle Advisory Board for which he receives an honorarium and travel expenses. Kennedy R. Lees is Professor of Cerebrovascular Medicine at the Institute of Cardiovascular and Medical Sciences, University of Glasgow. He is a consultant for Nestec SA. He has also received consulting fees or research funding from the American Heart Association, Applied Clinical Intelligence, Boehringer Ingelheim, EVER NeuroPharma, Hilicon, Parexel, Translation Medical Academy, University Newcastle (Australia), European Union, IQVIA, National Institutes of Health (USA), Novartis, and Su-novion. Dana Leifer is Associate Professor of Neurology and an NIH StrokeNet Principal Investigator. He is a member of a Nestlé Advisory Board for which he receives an honorarium. Atte Meretoja has consulted for Nestec SA and Phagenesis Ltd. He is a member of a Nestlé Advisory Board for which he receives an honorarium and travel expenses. Luis F. Riquelme is a member of the board of directors for the International Dysphagia Diet Standardisation Initiative. Catriona M. Steele has served on Nestlé expert panels for which she has received honoraria and travel expenses. She is an NIH-funded principal investigator and a member of the board of directors for the International Dysphagia Diet Standardisation Initiative. Nancy B. Swigert is a paid consultant for Nestlé and serves on the Medical Advisory Board of the National Foundation on Swallowing Disorders. Natalia Muehlemann and Michael Jedwab are full-time employees of Nestlé Health Science, Nestec SA. Juha M. Kortelainen and Harri Pölönen are employees of VTT Technical Research Centre of Finland Ltd. Rajat Mukherjee is an employee of Cytel Inc. Susan L. Brady, Kayla Brinkman Theimer and Susan Langmore declare no conflicts of interest.

FundersFunder number
Applied Clinical Intelligence
IQVIA Inc.
Ka Lun Tam
Maryam Kadjar Olesen
Melanie Peladeau-Pigeon
Melanie Tapson
Nestec S.A.
Prism Computational Sciences, Inc.
RCRI
Scripps Memorial Hospital
Talia Wolkin and Navid Zohouri-Haghian
National Institutes of Health (NIH)
American the American Heart Association
Novartis
Boehringer-Ingelheim
University Health Network
Bloorview Research Institute
European Commission
Teknologian Tutkimuskeskus VTT

    Keywords

    • Deglutition
    • Deglutition disorders
    • Devices
    • Dysphagia
    • Screening
    • Swallowing

    ASJC Scopus subject areas

    • Otorhinolaryngology
    • Gastroenterology
    • Speech and Hearing

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