Proof of Concept Study of EMBalance Decision Support System to Evaluate Balance Disorders (EMBalance)
A Decision Support System Incorporating a Validated Patient-specific, Multi-scale Balance Hyper Model Towards Early Diagnostic Evaluation and Efficient Management Plan Formulation of Balance Disorders (EMBalance)
Balance is crucial for an individual's mobility and independence. Human balance is achieved and maintained by a complex set of sensorimotor systems that include sensory input from vision, proprioception and the vestibular system (motion, equilibrium, spatial orientation). This information is then integrated by the brain. This complexity leads to undiagnosed or mistreated patients with balance disorders for long period which can affect their daily activities.
The EMBalance project is a research project funded by the European Union, involving 10 universities across Europe. Its aim is to create a Decision Support System (DSS) to support doctors in diagnosing and treating balance disorders. It will be available to primary and secondary care doctors of different specialties, levels of training and in different parts of the country.
The DSS will:
- Be used by primary and secondary health care professionals
- Assist the doctor on the evaluation and management of dizzy patients
- Predict how the balance disorder may progress
- Reduce patient waiting time and the onward referrals
- Ensure patients receive prompt and efficient treatment plans
The EMBalance randomised clinical trial (RCT) is a proof-of-concept, multicentre, single-blind, and parallel group study, conducted in Belgium, Germany, Greece and United Kingdom. At present, the question that this study aims to answer is whether the algorithms developed for the EMBalance Platform will yield meaningful information and how these algorithms and platform can be improved, performing an offline comparison of the classical diagnostic approach and the outcome of the EMBalance platform, without any consequence for the patient.
Patients who present with balance related symptoms at primary care will be randomised to either intervention group (non-specialist doctor +DSS) or control group (non-specialist doctor -DSS). An overseeing expert will then confirm the diagnosis and management decisions made by the non-specialist doctors in order to determine whether the use of the DSS can help them in a more precise assessment.
調査の概要
状態
詳細な説明
Balance is crucial for an individual's mobility and independence. Dizziness and imbalance symptoms are one of the most common reasons for visits to a doctor and affect up to 30-40% of the population by 60 years of age. The healthcare service provision to address vestibular pathology remains inadequate and is regarded as low priority. The complexity of balance control mechanisms, the lack of medical expertise, and the absence of specialised equipment can be contributory factors to the mismanagement of patients suffering balance disorders. However, the mean number for patient visits to their Health Care providers required to establish a correct diagnosis and start appropriate treatment, both in the US and the UK, is 4.5. The overall socio-economic impact of balance disorders on the affected individual, patient's families as well as the burden on society and the health services is considerable.
Advances in computer science and artificial intelligence have allowed the development of computer systems that support clinical diagnosis or therapeutic and treatment decisions based on individualised patient data. However, a review of existing Decision Support Systems used in Medicine demonstrated there are not many successful integrated software systems or standalone tools that address the early diagnosis and effective management of balance disorders.
All this said, the EMBalance DSS has been developed as a supplementary and supportive tool for non-expert physicians faced with the challenge of addressing vestibular disorders.
The current study will assess the effectiveness of the EMBalance Decision Support System (DSS) for diagnosis and management of balance disorders in a feasibility/proof of concept study. Patients who present with balance related symptoms (specifically vertigo or dizziness exacerbated by head movements) in primary care, will be seen by a non-specialist doctor either with or without the support of the DSS, on a ratio 1:1.
Non-specialist doctors in each participating country are defined as follow:
- UK: General Practitioners
- Germany: Neurology residents
- Belgium & Greece: ENT residents
Overseeing experts in each participating country are defined as follow:
- UK: Consultant in audiovestibular medicine (AVM)
- Germany: Neurologist
- Belgium & Greece: ENT specialist with >10 years expertise in AVM/Neuro-otology
It is anticipated 100 participants will be recruited to each of the two treatment groups, giving a total of 200 participants across Europe. Each participating site in Greece, Belgium, Germany and United Kingdom will recruit 50 patients. Allocation will be performed based on randomisation tables that are produced in advance for each centre.
Statistical data analysis will be performed by the National and Kapodistrian University of Athens. The statistical analysis has been developed by the National and Kapodistrian University of Athens and reviewed by the Institute of Communication and Computer Science (Greece).
Quality and ethical assurance are supervised by the Trial Steering Committee (TSC) and Trial Management Group (TMG)
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Be capable of understanding the information provided
- Absence of dementia/uncontrolled psychiatric disorder
- Vertigo or chronic dizziness exacerbated by head movements (<12 months)
- Sub-acute presentation of dizziness (up to 3 months) without presenting to emergency services
Exclusion Criteria:
- Subjects with learning disability or dementia
- Patients with uncontrolled psychiatric disorders
- Pregnant and breastfeeding women
- Patients' incapable or unwilling to give informed consent.
- Patients with acute vestibular disorders (present at Accident and Emergency).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Non-specialist doctor +DSS
Patients allocated to +DSS group will receive the following intervention:
|
The EMBalance DSS is a program which summarises and structures clinical information. The structuring of medical information is based on algorithms that have been developed and are employed via the DSS platform. The non-specialist doctors who use the DSS will be asked to exercise their clinical judgement in order to come up with a diagnosis or management plan. The DSS use has the following characteristics:
他の名前：
After the initial appointment with the non-specialist doctor, all patients will be invited to attend a specialist neuro-otology clinic where they will be seen by an overseeing expert in order to undergo a "Gold Standard" diagnostic process, and determine the management plan appropriate to the diagnosis, which will be compared to the management plan previously advised by the non-specialist doctor.
The overseeing expert will review investigations carried out, results assessed by the non-specialist doctor.
Customised vestibular exercise programme suggested by the DSS. Such exercises are based on the eye, head, and postural exercises that provoke a patient's symptoms.
他の名前：
All patients will be reviewed after three months follow-up by the overseeing expert.
|
|
アクティブコンパレータ：Non-specialist doctor -DSS
Patients allocated to -DSS group will receive the following intervention:
|
After the initial appointment with the non-specialist doctor, all patients will be invited to attend a specialist neuro-otology clinic where they will be seen by an overseeing expert in order to undergo a "Gold Standard" diagnostic process, and determine the management plan appropriate to the diagnosis, which will be compared to the management plan previously advised by the non-specialist doctor.
The overseeing expert will review investigations carried out, results assessed by the non-specialist doctor.
All patients will be reviewed after three months follow-up by the overseeing expert.
Patient will be referred to a local physiotherapy service by his/her non-specialist doctor within 18 weeks from referral.
Standard vestibular rehabilitation practice consists of a customised exercise programme, this is service dependent and tailored for patient's symptoms.
The rehabilitation programme might include lifestyle advice and education, sometimes accompanied by a leaflet.
他の名前：
|
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 |
|---|---|---|
|
Percentage of diagnosis agreement
時間枠：Through study completion, an average of 8 months
|
Agreement between the diagnosis established by the non-specialist doctors (using the DSS and not using DSS) and the "Gold Standard" as determined by an overseeing expert and according to current evidence based guidelines for the diagnosis/management of these disorders.
|
Through study completion, an average of 8 months
|
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Percentage of management plan agreement
時間枠：Through study completion, an average of 8 months
|
Agreement between the management plan established by the non-specialist doctors (using the DSS and not using DSS) and the "Gold Standard" as recommended by an overseeing expert and according to current evidence based guidelines for the diagnosis/management of these disorders.
|
Through study completion, an average of 8 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Number of initial diagnoses changed after investigations proposed
時間枠：Through study completion, an average of 8 months
|
Through study completion, an average of 8 months
|
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Number of referrals to secondary care needed
時間枠：Through study completion, an average of 8 months
|
Through study completion, an average of 8 months
|
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Name of investigations required for an accurate diagnosis
時間枠：Through study completion, an average of 8 months
|
Through study completion, an average of 8 months
|
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Overall improvement according to the patient (Better, stable, worse)
時間枠：Change from baseline at 3 months (follow-up)
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Change from baseline at 3 months (follow-up)
|
|
Overall improvement according to overseeing expert (Better, stable, worse)
時間枠：Change from baseline at 3 months (follow-up)
|
Change from baseline at 3 months (follow-up)
|
|
Severity of symptoms (Visual Analogue Scale from 1-10 (VAS))
時間枠：Change from baseline at 3 months (follow-up)
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Change from baseline at 3 months (follow-up)
|
|
Difficulties regarding dizziness (Dizziness Handicap Inventory questionnaire (DHI))
時間枠：Change from baseline at 3 months (follow-up)
|
Change from baseline at 3 months (follow-up)
|
|
Quality of life (EQ-5D-3L Questionnaire)
時間枠：Change from baseline at 3 months (follow-up)
|
Change from baseline at 3 months (follow-up)
|
|
Number of patients not enrolled and/or withdrawn from the trial
時間枠：Through study completion, an average of 8 months
|
Through study completion, an average of 8 months
|
|
Reason for exclusion to the trial
時間枠：Through study completion, an average of 8 months
|
Through study completion, an average of 8 months
|
協力者と研究者
協力者
捜査官
- 主任研究者：Doris-Eva Bamiou, MD MSc FRCP PhD、University College, London
- スタディディレクター：Linda M Luxon, CBE BSc FRCP FRCPE、Royal College of Physicians
出版物と役立つリンク
一般刊行物
- Neuhauser HK, Radtke A, von Brevern M, Lezius F, Feldmann M, Lempert T. Burden of dizziness and vertigo in the community. Arch Intern Med. 2008 Oct 27;168(19):2118-24. doi: 10.1001/archinte.168.19.2118. Erratum In: Arch Intern Med. 2009 Jan 12;169(1):89.
- Garg AX, Adhikari NK, McDonald H, Rosas-Arellano MP, Devereaux PJ, Beyene J, Sam J, Haynes RB. Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review. JAMA. 2005 Mar 9;293(10):1223-38. doi: 10.1001/jama.293.10.1223.
- Colledge NR, Wilson JA, Macintyre CC, MacLennan WJ. The prevalence and characteristics of dizziness in an elderly community. Age Ageing. 1994 Mar;23(2):117-20. doi: 10.1093/ageing/23.2.117.
- Royal College of Physicians, Hearing and Balance Disorders, Report of a working party (2007) Available at: https://www.rcplondon.ac.uk/sites/default/files/documents/hearing-and-balance-disorders.pdf. [Accessed 29 September 2008]
- Pavlou M, Davies RA, Bronstein AM. The assessment of increased sensitivity to visual stimuli in patients with chronic dizziness. J Vestib Res. 2006;16(4-5):223-31.
- Scuffham P, Chaplin S, Legood R. Incidence and costs of unintentional falls in older people in the United Kingdom. J Epidemiol Community Health. 2003 Sep;57(9):740-4. doi: 10.1136/jech.57.9.740.
- Keen, P. & Morton, M. S. (1978). Decision Support Systems: An Organizational Perspective, Addison-Wesley
- Eom, S. & Kim, E. A survey of decision support system applications. Journal of the Operational Research Society. 2006, 57(15): 1264-1278
- Bamiou DE, Kikidis D, Bibas T, Koohi N, Macdonald N, Maurer C, Wuyts FL, Ihtijarevic B, Celis L, Mucci V, Maes L, Van Rompaey V, Van de Heyning P, Nazareth I, Exarchos TP, Fotiadis D, Koutsouris D, Luxon LM. Diagnostic accuracy and usability of the EMBalance decision support system for vestibular disorders in primary care: proof of concept randomised controlled study results. J Neurol. 2022 May;269(5):2584-2598. doi: 10.1007/s00415-021-10829-7. Epub 2021 Oct 20.
- Rammazzo L, Kikidis D, Anwer A, Macdonald N, Kyrodimos E, Maurer C, Wuyts F, Luxon L, Bibas A, Bamiou DE. EMBalance - validation of a decision support system in the early diagnostic evaluation and management plan formulation of balance disorders in primary care: study protocol of a feasibility randomised controlled trial. Trials. 2016 Sep 5;17(1):435. doi: 10.1186/s13063-016-1568-x.
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Decision Support System (DSS)の臨床試験
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University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)募集
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Columbia UniversityNational Institute of Nursing Research (NINR); Brigham and Women's Hospital完了
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Wuerzburg University HospitalCharite University, Berlin, Germany; Goethe University; RWTH Aachen University; Technical University... と他の協力者募集