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AI-assisted Diagnosis, Triage and Assessment of Hearing Loss and Tinnitus

2026年5月7日 更新者:Royal Cornwall Hospitals Trust

Artificial Intelligence for the Automated Diagnosis, Triage, and Assessment of Patients With Hearing Loss and Tinnitus: A Pilot Comparative Study With Clinical Evaluation by Otolaryngologists

Hearing loss affects approximately 11 million people in the UK, while tinnitus impacts around 7 million. Both conditions can significantly reduce quality of life and are linked to poorer mental health and employment challenges. Each year, tinnitus alone accounts for more than one million GP appointments, and patients referred to hospital ear, nose and throat (ENT) services often face long delays, sometimes exceeding a year, before their first assessment.

To address this demand, the Royal Cornwall Hospitals NHS Trust has developed a virtual ENT clinic. Patients undergo a validated hearing test in person and complete online questionnaires. Clinicians then review these data to determine next steps, which may include discharge with advice, referral for imaging, or a face-to-face consultation. Initial trials demonstrated that the majority of patients could be managed virtually, substantially reducing waiting times. However, clinicians must still review every case, limiting capacity for patients who require direct care.

This project builds on the virtual clinic by introducing artificial intelligence (AI) to support the assessment process. Using explainable AI methods, the system will be trained to replicate clinician-level decision-making while providing transparent reasoning for its recommendations. The study will evaluate how closely AI-generated outcomes align with clinician assessments, with all cases continuing to receive a clinician's final review. Clinicians will not be aware of the recommendations produced by the AI tool, but the study aims to measure how concordant AI recommendations are with clinician assessments.

If the AI tool's clinical recommendations closely align with clinician recommendations (the gold standard for care), the AI tool could be introduced as a clinical recommendation assistant tool, streamlining the triage and management of hearing loss and tinnitus, enabling clinicians to focus on complex cases, accelerating access to care, and improving efficiency.

調査の概要

詳細な説明

BACKGROUND

Hearing loss affects approximately 11 million people in the UK, while tinnitus impacts around 7 million.1,2 Both conditions can significantly reduce quality of life and are linked to poorer mental health and employment challenges.3 Each year, tinnitus alone accounts for more than one million GP appointments, and patients referred to hospital ear, nose and throat (ENT) services often face long delays, sometimes exceeding a year, before their first assessment.4 This was exacerbated even further following the coronavirus (COVID-19) pandemic.5

To address this demand, the Royal Cornwall Hospitals NHS Trust has developed a virtual ENT clinic to manage patients with hearing loss and/or non-pulsatile tinnitus. Patients undergo a validated hearing test in person and complete online questionnaires. Clinicians then review these data to determine next steps, which may include discharge with advice, referral for imaging, or a face-to-face consultation. Inclusion criteria for the virtual clinic for hearing loss and non-pulsatile tinnitus were: ≥16 years of age; subjective bilateral hearing loss and/or tinnitus that did not fulfil the criteria for direct referral to audiology (they would see patients ≥50 years of age); subjective asymmetrical sensorineural hearing loss; and subjective unilateral non-pulsatile tinnitus. Exclusion criteria for the virtual clinic for hearing loss and non-pulsatile tinnitus were: cognitive, motor or visual impairment that may preclude use of an iPad®; patients who had been referred back to ENT having previously been fully medically assessed (redirected to audiology or hearing therapy where appropriate); and symptoms that required a face-to-face appointment (conductive hearing loss, pulsatile tinnitus, vertigo or dizziness, pain, discharge, infections, abnormal ear examination, and history of ear disease, surgery or ear injury).6

Published results demonstrated that most patients could be managed virtually, substantially reducing waiting times.6 However, clinicians must still review every case, limiting capacity for patients who require direct care. This project builds on the virtual clinic by introducing artificial intelligence (AI) to support the assessment process, as a clinical decision support system (CDSS). Using explainable AI methods, the system is trained to replicate clinician-level decision-making while providing transparent reasoning for its recommendations. This retrospective and prospective observational feasibility pilot study aims to evaluate how closely AI-generated outcomes align with clinician assessments, with all cases continuing to receive a clinician's final review. Clinicians will be blind to the recommendations produced by the AI tool, but the study aims to measure how concordant AI recommendations are with clinician assessments.

If the AI tool's clinical recommendations closely align with clinician recommendations (the gold standard for care), the AI tool could be introduced as a clinical recommendation assistant tool, streamlining the triage and management of hearing loss and tinnitus, enabling clinicians to focus on complex cases, accelerating access to care, and improving efficiency.

RATIONALE

The primary rationale for the study is to assess the concordance between AI-generated and clinician-generated outcomes within a real-world virtual hearing loss and tinnitus clinic environment. Demonstrating strong alignment would support the future integration of AI-assisted clinical decision support systems into routine clinical workflows, with the potential to improve service capacity, reduce waiting times, and allow clinicians to focus on more complex cases requiring direct specialist expertise.

In parallel with this work, the research team is undertaking a systematic review examining the use of artificial intelligence in the diagnosis, triage, and management of patients with hearing loss and tinnitus within otolaryngology settings. Although this review has not yet reached the stage of full-text screening, preliminary scoping suggests that, to date, there are no published studies directly evaluating an AI tool used to diagnose, triage, and manage hearing loss and tinnitus patients within an ENT outpatient pathway overseen by otolaryngologists. While the use of AI as a clinical decision support tool is a recognised and growing field, there remains a notable evidence gap in its application to this specific clinical context.

The study design ensures patient safety and ethical integrity by maintaining full clinician oversight for all cases. During this evaluation phase, the AI system will function solely as a research tool and will not influence clinical decision-making, i.e. a shadow implementation. This phased, comparative approach enables a rigorous assessment of feasibility, safety, and acceptability before any consideration of broader clinical implementation.

Ultimately, the findings will help determine whether AI-assisted clinical triage could offer a sustainable and scalable response to rising demand in hearing loss and tinnitus services, enhancing patient access, efficiency, and satisfaction while maintaining the highest standards of clinical care.

THEORETICAL FRAMEWORK

This study is grounded in the intersection of clinical decision-making theory, artificial intelligence (AI) in healthcare, and health systems efficiency models. Its theoretical foundation integrates concepts from evidence-based medicine, human-AI collaboration, and service redesign in healthcare delivery.

  1. Clinical Decision-Making and Diagnostic Reasoning

    Clinical decision-making in otolaryngology involves interpreting complex data from hearing tests, patient histories, and symptom questionnaires to generate diagnostic and management recommendations. According to dual-process theory, clinicians use both analytical (systematic reasoning based on evidence) and non-analytical (pattern recognition and intuition) approaches.7 These cognitive processes underpin expert clinical judgement but are also limited by human variability, cognitive load, and time constraints-particularly in high-demand services within the NHS.

    By modelling clinician decision-making algorithmically, AI systems can emulate these cognitive processes, providing structured, data-driven, explainable recommendations that complement human expertise. This study therefore builds on clinical reasoning theory, assessing whether AI can achieve concordance with clinician judgement within a controlled, supervised framework.

  2. Artificial Intelligence and Explainability in Medicine

    The study applies explainable AI (XAI) principles, which emphasise transparency, interpretability, and accountability in algorithmic decision-making. Traditional "black box" AI models have raised ethical concerns about opacity and trust in clinical contexts. Explainable AI provides interpretable outputs that allow researchers and clinicians to understand why an AI system reached a particular decision, supporting both clinical safety and regulatory compliance.

    This theoretical stance draws on socio-technical systems theory, which views AI not as a replacement for clinicians but as part of an "intervention ensemble approach".8 Within this framework, AI serves as a clinical decision support tool designed to augment human expertise, reduce administrative burden, and enhance diagnostic efficiency, while clinicians retain final authority over all patient care decisions.

  3. Health Systems Efficiency, Virtual Care, and National AI Strategy

This study is grounded in the framework of health service efficiency and equitable access to care. Virtual clinics have already proven effective in reducing waiting times and improving access for patients with hearing loss and tinnitus.6 However, efficiency remains constrained by the requirement for clinicians to personally review every case in detail. Integrating AI-assisted triage models offers a mechanism to streamline this process, supporting clinicians by automating routine assessments while preserving human oversight. This approach aligns with lean healthcare principles, which emphasise reducing non-value-adding steps and directing clinical expertise toward complex or high-risk cases.9

The study also aligns with national healthcare policy promoting digital transformation. The UK Government's "Fit for the Future: 10-Year Health Plan for England" identifies AI and data-driven technologies as central to improving NHS capacity, efficiency, and patient experience through innovation and smarter service delivery.10 In parallel, NHS England's Artificial Intelligence Information Governance Guidance outlines the ethical and governance standards for deploying AI in clinical settings-framing AI as a decision-support tool that complements rather than replaces clinician judgement, ensuring accountability, transparency, and patient trust.11

The integration of AI in this study therefore reflects not only a local initiative to enhance virtual care, but also a broader policy-aligned commitment to digital innovation within the NHS. This framework is informed by the Technology Acceptance Model (TAM), which suggests that successful adoption of new technologies depends on perceived usefulness, ease of integration, and professional trust.12 By evaluating the concordance between AI-generated and clinician-generated outcomes-and later, patient satisfaction-the study contributes empirical evidence on the acceptability, feasibility, and safety of AI-assisted clinical workflows within the NHS.

This study is a prospective and retrospective observational mixed-methods service evaluation study, with elements of a diagnostic accuracy and implementation evaluation framework.

研究の種類

観察的

入学 (推定)

1500

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Neil C Tan, MEd PhD FRCS(ORL-HNS)
  • 電話番号:+441872 253404
  • メール:neil.tan@nhs.net

研究連絡先のバックアップ

  • 名前:Christian JW Grimes, BMBS MRCS (ENT) PGCert ClinEd
  • 電話番号:+447970780502
  • メール:christian.grimes@nhs.net

研究場所

    • Cornwall
      • Truro、Cornwall、イギリス、TR1 1LJ
        • Treliske Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

The study population comprises adult patients managed through the virtual hearing loss and tinnitus clinic, in the Ear, Nose and Throat Department at the Royal Cornwall Hospitals Trust. Patients included are seen in the virtual clinic during the study period, as well as clinical staff involved in reviewing and making decisions within the service. Patient data are analysed observationally, and a subset of patients and clinicians may be invited to provide questionnaire or interview data to explore experiences of the AI-assisted clinic. Patients will comprise of those living in the county of Cornwall and considered under the care of the Royal Cornwall Hospitals Trust.

説明

Inclusion Criteria:

  • Patients assessed in the RCHT virtual hearing loss and tinnitus clinic.
  • Presenting symptoms of hearing loss and/or tinnitus.
  • Ability to provide informed consent to participate in the study.

Exclusion Criteria:

  • Individuals under 18 years of age.
  • Patients unable to provide informed consent.
  • Patients without sufficient English proficiency where translation services cannot be arranged.
  • Cases where data quality is insufficient for analysis.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Phase 1 - Patients undergoing the standard virtual hearing loss and tinnitus clinic
Phase 1 consists of a retrospective and prospective observational evaluation of consecutive adult patients managed through the virtual hearing loss and tinnitus clinic at the Royal Cornwall Hospitals Trust, between August 2025 and August 2026. No additional interventions.
An explainable AI-based clinical decision support tool within an existing virtual hearing loss and tinnitus clinic. The tool provides non-binding triage and investigation recommendations based on routinely collected patient data, with all final clinical decisions remaining the responsibility of the clinician and no change to standard care pathways
Phase 2 - Patients undergoing the AI-assisted virtual hearing loss and tinnitus clinic
Phase 2 consists of a prospective observational evaluation of consecutive adult patients managed through the AI-assisted virtual hearing loss and tinnitus clinic at the Royal Cornwall Hospitals Trust, between August 2026 and August 2027. The AI-assisted clinic is the intervention.
An explainable AI-based clinical decision support tool within an existing virtual hearing loss and tinnitus clinic. The tool provides non-binding triage and investigation recommendations based on routinely collected patient data, with all final clinical decisions remaining the responsibility of the clinician and no change to standard care pathways
Phase 2 - Staff involved in providing an AI-assisted virtual hearing loss and tinnitus clinic
Staff involved in running the artificial intelligence-assisted virtual hearing loss and tinnitus clinic at the Royal Cornwall Hospitals Trust from August 2026 to August 2027. They include doctors, healthcare assistants, administrative staff and nurses. The AI-assisted clinic is the intervention.
An explainable AI-based clinical decision support tool within an existing virtual hearing loss and tinnitus clinic. The tool provides non-binding triage and investigation recommendations based on routinely collected patient data, with all final clinical decisions remaining the responsibility of the clinician and no change to standard care pathways

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
MRI internal auditory meatus (IAM) referral recommendation
時間枠:March 2026 - August 2026

Agreement between the clinical outcomes generated by the AI clinical decision support system and the clinician-derived "gold standard" outcomes within the virtual hearing loss and tinnitus clinic. Agreement will be evaluated for:

MRI internal auditory meatus (IAM) referral recommendation (binary outcome: yes/no). Agreement will be quantified using sensitivity and specificity with 95% confidence intervals, derived from contingency tables and one-vs-rest analyses for categorical outcomes, as specified in the statistical analysis plan.

March 2026 - August 2026
Clinical triage outcome
時間枠:March 2026 - August 2026

Agreement between the clinical outcomes generated by the AI clinical decision support system and the clinician-derived "gold standard" outcomes within the virtual hearing loss and tinnitus clinic. Agreement will be evaluated for: Clinical triage outcome (categorical outcome: refer to face-to-face ENT clinic, refer to audiology, refer to audiology plus hearing therapy, or discharge).

Agreement will be quantified using sensitivity and specificity with 95% confidence intervals, derived from contingency tables and one-vs-rest analyses for categorical outcomes, as specified in the statistical analysis plan.

March 2026 - August 2026

二次結果の測定

結果測定
メジャーの説明
時間枠
Patient experience and satisfaction with the AI-assisted virtual hearing loss and tinnitus clinic
時間枠:August 2026 - August 2027

Patient experience and satisfaction with the AI-assisted virtual hearing loss and tinnitus clinic, assessed using structured satisfaction questionnaires administered by telephone. Outcomes will include:

Quantitative measures (e.g. Likert-scale ratings of confidence, satisfaction, and acceptability), and

Qualitative data from open-ended responses and semi-structured interviews, analysed using a directed content analysis informed by the NASSS framework.

August 2026 - August 2027
Staff experience, usability, and acceptability of the AI-assisted clinical decision support system
時間枠:August 2026 - August 2027
Staff experience, usability, and acceptability of the AI-assisted clinical decision support system, explored through qualitative interviews with clinicians and relevant stakeholders involved in delivering or implementing the virtual clinic pathway.
August 2026 - August 2027

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年5月30日

一次修了 (推定)

2026年8月13日

研究の完了 (推定)

2027年8月31日

試験登録日

最初に提出

2026年5月7日

QC基準を満たした最初の提出物

2026年5月7日

最初の投稿 (実際)

2026年5月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月14日

QC基準を満たした最後の更新が送信されました

2026年5月7日

最終確認日

2026年5月1日

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