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Public Health
Protocol
Clinical validation of a public health policy-making platform for hearing loss (EVOTION): protocol for a big data study
  1. Giorgos Dritsakis1,2,
  2. Dimitris Kikidis3,
  3. Nina Koloutsou4,
  4. Louisa Murdin4,
  5. Athanasios Bibas3,
  6. Katherine Ploumidou5,
  7. Ariane Laplante-Lévesque6,
  8. Niels Henrik Pontoppidan6,
  9. Doris-Eva Bamiou1,2,7
  1. 1 Ear Institute, University College London, London, UK
  2. 2 Royal National Throat Nose & Ear Hospital, London, UK
  3. 3 1st Department of Otolaryngology, National and Kapodistrian University of Athens, Hippocrateion Hospital, Athens, Greece
  4. 4 Guy’s and St Thomas’ NHS Foundation Trust, London, UK
  5. 5 Athens Medical Center, Athens, Greece
  6. 6 Eriksholm Research Centre, Elsinore, Denmark
  7. 7 NIHR University College London Hospitals Biomedical Research Centre, London, UK
  1. Correspondence to Professor Doris-Eva Bamiou; d.bamiou{at}ucl.ac.uk

Abstract

Introduction The holistic management of hearing loss (HL) requires an understanding of factors that predict hearing aid (HA) use and benefit beyond the acoustics of listening environments. Although several predictors have been identified, no study has explored the role of audiological, cognitive, behavioural and physiological data nor has any study collected real-time HA data. This study will collect ‘big data’, including retrospective HA logging data, prospective clinical data and real-time data via smart HAs, a mobile application and biosensors. The main objective is to enable the validation of the EVOTION platform as a public health policy-making tool for HL.

Methods and analysis This will be a big data international multicentre study consisting of retrospective and prospective data collection. Existing data from approximately 35 000 HA users will be extracted from clinical repositories in the UK and Denmark. For the prospective data collection, 1260 HA candidates will be recruited across four clinics in the UK and Greece. Participants will complete a battery of audiological and other assessments (measures of patient-reported HA benefit, mood, cognition, quality of life). Patients will be offered smart HAs and a mobile phone application and a subset will also be given wearable biosensors, to enable the collection of dynamic real-life HA usage data. Big data analytics will be used to detect correlations between contextualised HA usage and effectiveness, and different factors and comorbidities affecting HL, with a view to informing public health decision-making.

Ethics and dissemination Ethical approval was received from the London South East Research Ethics Committee (17/LO/0789), the Hippokrateion Hospital Ethics Committee (1847) and the Athens Medical Center’s Ethics Committee (KM140670). Results will be disseminated through national and international events in Greece and the UK, scientific journals, newsletters, magazines and social media. Target audiences include HA users, clinicians, policy-makers and the general public.

Trial registration number NCT03316287; Pre-results.

  • hearing loss
  • hearing aids
  • public health
  • big data

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-020978

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    Footnotes

    • Twitter #h2020evotion

    • Contributors DK, D-EB, NK, LM, AB, NHP and GD made substantial contributions to the conception and design of the work throughout the grant preparation or ethics application process and approved the final manuscript. GD and D-EB led the work and took overall responsibility of the manuscript. GD, D-EB, NK and LM were responsible for the parts of the protocol specific to the UK study. DK, AB and KP were responsible for the parts specific to the Greek study. NHP and AL-L were responsible for the parts of the protocol specific to the HAs.

    • Funding This project has received funding fromthe European Commission’s Horizon 2020 research and innovation programme under grant agreement no. 727521.

    • Competing interests Oticon A/S, which manufactures the HAs used in this study, is an EVOTION project partner but not the sponsor. The EVOTION HA is a research-only extension based on the Oticon Opn HA made specifically for this project.

    • Patient consent Not required.

    • Ethics approval Ethical approval was received from the London South East Research Ethics Committee (17/LO/0789), the Hippokrateion Hospital Ethics Committee (1847) and the Athens Medical Center Ethics Committee (KM140670).

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.