Background/Objectives: Uptake of remote cochlear implant (CI) services is feasible in clinical studies, but implementation into regular clinical practice is limited. Effective implementation requires demonstration of at least equivalent outcomes to in-person care. Use of outcome measures (e.g., specific tools such as speech tests or surveys) that are relevant and sensitive to both modes of service facilitates evidence-based provision of CI services. Following our previous study, which developed a core outcome domain set (CODS) (i.e., a set of CI outcome areas important to measure), this study aimed to (1) review current awareness and use of outcome measures implemented clinically, in-person, or remotely; and (2) provide recommendations for a pragmatic core outcome set (COS) to assess remote technologies for CI users. Methods: Expert Australian/New Zealand clinical CI professionals (n = 20) completed an online survey regarding use of, and familiarity with, pre-identified outcome measures mapping to the previously identified CODS. Respondents rated the outcomes’ usefulness, ease of use, trustworthiness, and recommendation for future use. Stakeholder workshops (clinician, n = 3, CI users n = 4) finalised recommendations. Results: Four of the six most regularly used and familiar measures were speech perception tests: BKB-A sentences, CNC words, CUNY sentences, and AB words. The long- and short-form Speech, Spatial, and Qualities of Hearing Scales (SSQ/SSQ-12) were the top-ranked patient-reported outcome measures (PROMs). These outcome measures were also perceived as the most trustworthy, easy to use, and likely to be used if recommended. Conclusions: A pragmatic COS, relevant to both remote and in-person delivery of CI services, including recommendations for measurement of service, clinician-measured and patient-reported outcomes, and how these might be developed in future, is recommended.
AimThe overall aim of this study is to develop a core set of outcome measures (COS) that we will propose to evaluate remote technologies delivered within CI services to maximise the potential benefits of this model of care, and to ensure optimal and personalised care for CI users. The COS will encompass outcome measures specific to the delivery of remote technologies in terms of both (i) patient outcomes (i.e. benefits of remote technologies for CI patients), and (ii) service delivery, ensuring the outcomes can be easily integrated into clinical care. We will use the COS development ‘roadmap’ described by Hall et al. (2015), and successfully used by Allen et al (2022) to develop a CODS for hearing aids. Core to this development is input from key stakeholders, including CI users, CI service providers, including management and clinicians, CI manufacturers, CI advocacy groups and CI researchers for the development of the COS.
Specific study aims are to:
1. Review the current evidence-base on remote technologies and associated outcome measures for CI patients/services.
2. Identify a core outcome domain set using a delphi review (development of a consensus COS) of key stakeholders.
3. Identify and agree on outcome measures to deliver the COS.
These aims will be achieved through the use of a series of scoping workshops including key stakeholders, such as CI users, hearing loss advocacy group representatives, CI service providers and CI manufacturers to identify key aspects of outcomes to inform the Delphi review.
Catherine Sucher, David Allen, Emma Laird, Isabelle Boisvert, Lize Coetzee, Rene Gifford, Helen Cullington, Padraig Kitterick, Melanie Ferguson
Disease Category: Ear, nose, & throat
Disease Name: Hearing loss
Age Range: 18
Sex: Either
Nature of Intervention: Other
- Charities
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Device manufacturers
- Families
- Patient/ support group representatives
- Researchers
- Service providers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- Delphi process
- Focus group(s)
- Systematic review
Phase 1: Synthesise the current evidence-base of outcome measures used to evaluate remote technologies used with CI patients
A systematic review will be conducted on the use of remote technologies and the associated outcome measures (patient, service) used in CI services. The review will be registered on PROSPERO.
Phase 2: To identify a core outcome domain set involving key stakeholders
To obtain a consensus on the CODS (i.e the what?), we will run two parallel electronic delphi reviews with two sets of stakeholders:
with two sets of stakeholders:
(i) CI users. These will be recruited from Australia and also countries outside Australia, to ensure that the patient voice is at the heart of the development of the COS. We will aim to recruit 50 patients through our network of CI services and advocacy groups.
(ii) Professionals: These will be recruited from the key stakeholder groups mentioned previously. We will aim to recruit 50 professionals through our network in Australia and internationally.
(iii) Phase 3: To identify and agree on outcome measures to deliver the COS
(iv) The research team will appraise the long list of outcome measures (the how?) according to the COSMIN checklist (e.g. content validity, internal consistency, dimensionality). A decision will be made whether or not to include the outcome measures for the next stage.
(v) A shorter, more rapid 2-round delphi review of the ‘short list’ of outcome measures will be sent to professionals. An online final consensus workshop will specify the final COS.