Telemedicine for Adults With Cochlear Implants in the United Kingdom (CHOICE): Protocol for a Prospective Interventional Multisite Study

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Abstract

Background

Cochlear implants provide hearing to approximately 750,000 people with deafness worldwide; these patients require lifelong follow-up. Care for adults with implants in the United Kingdom occurs at one of 19 centers, which may be far from the patients’ homes. In a previous randomized controlled trial, we successfully introduced person-centered care. We designed, implemented, and evaluated the following remote care pathway: a personalized web-based support tool, home hearing check, self–device adjustment, and upgrading of sound processors at home rather than in the clinic. The remote care group had a significant increase in empowerment after using the tools, and the patients and clinicians were keen to continue. We would now like to scale up these improvements as an option for >12,000 UK adults using implants; we are commissioning an independent evaluation of this intervention and rollout to establish if it achieves its aims of more empowered and confident patients; more accessible and equitable care; stable hearing; more efficient, person-centered, and scalable service; and more satisfied and engaged patients and clinicians.

Objective

This study aims to evaluate the impact and rollout of a person-centered clinical care pathway via telemedicine for adults with cochlear implants in the United Kingdom, using both outcomes and process evaluation.

Methods

This project will scale up and evaluate a person-centered long-term follow-up pathway for adults using cochlear implants through a personalized website, including a home hearing check, uploading photos of cochlear implant site, listening in noise and music practice, ordering of spares, questionnaires, and other resources. Both quantitative and qualitative analyses will be conducted, and they will be both an outcome and process evaluation.

Results

As of July 2021, the trial is closed, and all data collection is complete. The evaluation report is expected to be published in December 2021, and the research data have not yet been analyzed.

Conclusions

This project will present the results of the first scaling up of a remote care pathway for adults with cochlear implants in the United Kingdom.

Trial Registration

International Standard Randomized Controlled Trial Number ISRCTN51668922; https://www.isrctn.com/ISRCTN51668922

International Registered Report Identifier (IRRID)

DERR1-10.2196/27207

Related collections

Most cited references 42

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Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

M. Herdman, C. Gudex, S Lloyd … (2011)

Purpose This article introduces the new 5-level EQ-5D (EQ-5D-5L) health status measure. Methods EQ-5D currently measures health using three levels of severity in five dimensions. A EuroQol Group task force was established to find ways of improving the instrument’s sensitivity and reducing ceiling effects by increasing the number of severity levels. The study was performed in the United Kingdom and Spain. Severity labels for 5 levels in each dimension were identified using response scaling. Focus groups were used to investigate the face and content validity of the new versions, including hypothetical health states generated from those versions. Results Selecting labels at approximately the 25th, 50th, and 75th centiles produced two alternative 5-level versions. Focus group work showed a slight preference for the wording ‘slight-moderate-severe’ problems, with anchors of ‘no problems’ and ‘unable to do’ in the EQ-5D functional dimensions. Similar wording was used in the Pain/Discomfort and Anxiety/Depression dimensions. Hypothetical health states were well understood though participants stressed the need for the internal coherence of health states. Conclusions A 5-level version of the EQ-5D has been developed by the EuroQol Group. Further testing is required to determine whether the new version improves sensitivity and reduces ceiling effects.

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Shared Decision Making: A Model for Clinical Practice

Glyn Elwyn, Dominick Frosch, Richard Thomson … (2012)

The principles of shared decision making are well documented but there is a lack of guidance about how to accomplish the approach in routine clinical practice. Our aim here is to translate existing conceptual descriptions into a three-step model that is practical, easy to remember, and can act as a guide to skill development. Achieving shared decision making depends on building a good relationship in the clinical encounter so that information is shared and patients are supported to deliberate and express their preferences and views during the decision making process. To accomplish these tasks, we propose a model of how to do shared decision making that is based on choice, option and decision talk. The model has three steps: a) introducing choice, b) describing options, often by integrating the use of patient decision support, and c) helping patients explore preferences and make decisions. This model rests on supporting a process of deliberation, and on understanding that decisions should be influenced by exploring and respecting “what matters most” to patients as individuals, and that this exploration in turn depends on them developing informed preferences.

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Is Open Access

When and how should multiple imputation be used for handling missing data in randomised clinical trials – a practical guide with flowcharts

Janus Jakobsen, Christian Gluud, Jørn Wetterslev … (2017)

Background Missing data may seriously compromise inferences from randomised clinical trials, especially if missing data are not handled appropriately. The potential bias due to missing data depends on the mechanism causing the data to be missing, and the analytical methods applied to amend the missingness. Therefore, the analysis of trial data with missing values requires careful planning and attention. Methods The authors had several meetings and discussions considering optimal ways of handling missing data to minimise the bias potential. We also searched PubMed (key words: missing data; randomi*; statistical analysis) and reference lists of known studies for papers (theoretical papers; empirical studies; simulation studies; etc.) on how to deal with missing data when analysing randomised clinical trials. Results Handling missing data is an important, yet difficult and complex task when analysing results of randomised clinical trials. We consider how to optimise the handling of missing data during the planning stage of a randomised clinical trial and recommend analytical approaches which may prevent bias caused by unavoidable missing data. We consider the strengths and limitations of using of best-worst and worst-best sensitivity analyses, multiple imputation, and full information maximum likelihood. We also present practical flowcharts on how to deal with missing data and an overview of the steps that always need to be considered during the analysis stage of a trial. Conclusions We present a practical guide and flowcharts describing when and how multiple imputation should be used to handle missing data in randomised clinical. Electronic supplementary material The online version of this article (10.1186/s12874-017-0442-1) contains supplementary material, which is available to authorized users.

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Author and article information

Contributors

Helen Cullington:

ORCID: https://orcid.org/0000-0002-5093-2020

University of Southampton Auditory Implant ServiceUniversity of SouthamptonSouthampton, SO17 1BJUnited Kingdom44 2380593522h.cullington@soton.ac.uk

Journal

Journal ID (nlm-ta): JMIR Res Protoc

Journal ID (iso-abbrev): JMIR Res Protoc

Journal ID (publisher-id): ResProt

Title: JMIR Research Protocols

Publisher: JMIR Publications (Toronto, Canada )

ISSN (Electronic): 1929-0748

Publication date Collection: April 2022

Publication date (Electronic): 13 April 2022

Volume: 11

Issue: 4

Electronic Location Identifier: e27207

Affiliations

[1 ] University of Southampton Auditory Implant Service University of Southampton Southampton United Kingdom

[2 ] Nottingham Hearing Biomedical Research Unit National Institute for Health Research Nottingham United Kingdom

[3 ] Wessex Academic Health Science Network Southampton United Kingdom

[4 ] Northumbria University Newcastle upon Tyne United Kingdom

[5 ] Centre for Clinical and Community Applications of Health Psychology University of Southampton Southampton United Kingdom

[6 ] School of Electronics and Computer Science University of Southampton Southampton United Kingdom

[7 ] School of Health Sciences University of Southampton Southampton United Kingdom

Author notes

Corresponding Author: Helen Cullington h.cullington@ 123456soton.ac.uk

Author information

Helen Cullington https://orcid.org/0000-0002-5093-2020

Padraig Kitterick https://orcid.org/0000-0001-8383-5318

Philippa Darnton https://orcid.org/0000-0002-1443-2344

Tracy Finch https://orcid.org/0000-0001-8647-735X

Kate Greenwell https://orcid.org/0000-0002-3662-1488

Carol Riggs https://orcid.org/0000-0002-4562-9836

Mark Weal https://orcid.org/0000-0001-6251-8786

Dawn-Marie Walker https://orcid.org/0000-0001-8801-8093

Andrew Sibley https://orcid.org/0000-0002-2503-5432

Article

Publisher ID: v11i4e27207

DOI: 10.2196/27207

PMC ID: 9047741

PubMed ID: 35416780

SO-VID: 2ca0a208-2b7a-4338-8567-7d6aefdef4b1

Copyright © ©Helen Cullington, Padraig Kitterick, Philippa Darnton, Tracy Finch, Kate Greenwell, Carol Riggs, Mark Weal, Dawn-Marie Walker, Andrew Sibley. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.04.2022.

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

History

Date received : 18 January 2021

Date revision requested : 17 May 2021

Date revision received : 26 July 2021

Date accepted : 31 December 2021

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Telemedicine for Adults With Cochlear Implants in the United Kingdom (CHOICE): Protocol for a Prospective Interventional Multisite Study

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Abstract

Background

Objective

Methods

Results

Conclusions

Trial Registration

International Registered Report Identifier (IRRID)

Related collections

JMIR: Research Protocols

Most cited references 42

Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

Shared Decision Making: A Model for Clinical Practice

When and how should multiple imputation be used for handling missing data in randomised clinical trials – a practical guide with flowcharts

Author and article information

Contributors

Journal

Affiliations

Author notes

Author information

Article

History

Categories

Comments

Comment on this article

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Cited by 2

Most referenced authors 345