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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Percentage of diagnosis agreement
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Non-specialist doctor +DSS
Patients allocated to +DSS group will receive the following intervention:
- V1: appointment with a non-specialist doctor with the support of the DSS
- V2: appointment with an overseeing expert
- V3: DSS Customised Vestibular Physiotherapy
- V4: follow-up visit with the overseeing expert
干预措施: Decision Support System (DSS) (Other)
Non-specialist doctor +DSS
Patients allocated to +DSS group will receive the following intervention:
- V1: appointment with a non-specialist doctor with the support of the DSS
- V2: appointment with an overseeing expert
- V3: DSS Customised Vestibular Physiotherapy
- V4: follow-up visit with the overseeing expert
干预措施: Specialist Audiovestibular Consultation (Other)
Non-specialist doctor +DSS
Patients allocated to +DSS group will receive the following intervention:
- V1: appointment with a non-specialist doctor with the support of the DSS
- V2: appointment with an overseeing expert
- V3: DSS Customised Vestibular Physiotherapy
- V4: follow-up visit with the overseeing expert
干预措施: DSS Customised Vestibular Physiotherapy (Other)
Non-specialist doctor +DSS
Patients allocated to +DSS group will receive the following intervention:
- V1: appointment with a non-specialist doctor with the support of the DSS
- V2: appointment with an overseeing expert
- V3: DSS Customised Vestibular Physiotherapy
- V4: follow-up visit with the overseeing expert
干预措施: Follow-up (Other)
Non-specialist doctor -DSS
Patients allocated to -DSS group will receive the following intervention:
- V1: appointment with a non-specialist doctor without the support of the DSS
- V2: appointment with an overseeing expert
- V3: Standard Physiotherapy Practice
- V4: follow-up visit with the overseeing expert
干预措施: Specialist Audiovestibular Consultation (Other)
Non-specialist doctor -DSS
Patients allocated to -DSS group will receive the following intervention:
- V1: appointment with a non-specialist doctor without the support of the DSS
- V2: appointment with an overseeing expert
- V3: Standard Physiotherapy Practice
- V4: follow-up visit with the overseeing expert
干预措施: Standard Physiotherapy Practice (Other)
Non-specialist doctor -DSS
Patients allocated to -DSS group will receive the following intervention:
- V1: appointment with a non-specialist doctor without the support of the DSS
- V2: appointment with an overseeing expert
- V3: Standard Physiotherapy Practice
- V4: follow-up visit with the overseeing expert
干预措施: Follow-up (Other)
结局指标
主要结局
Percentage of diagnosis agreement
时间窗: 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.
Percentage of management plan agreement
时间窗: 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.
次要结局
- Number of referrals to secondary care needed(Through study completion, an average of 8 months)
- Severity of symptoms (Visual Analogue Scale from 1-10 (VAS))(Change from baseline at 3 months (follow-up))
- Overall improvement according to overseeing expert (Better, stable, worse)(Change from baseline at 3 months (follow-up))
- Difficulties regarding dizziness (Dizziness Handicap Inventory questionnaire (DHI))(Change from baseline at 3 months (follow-up))
- Name of investigations required for an accurate diagnosis(Through study completion, an average of 8 months)
- Overall improvement according to the patient (Better, stable, worse)(Change from baseline at 3 months (follow-up))
- Quality of life (EQ-5D-3L Questionnaire)(Change from baseline at 3 months (follow-up))
- Number of initial diagnoses changed after investigations proposed(Through study completion, an average of 8 months)
- Number of patients not enrolled and/or withdrawn from the trial(Through study completion, an average of 8 months)
- Reason for exclusion to the trial(Through study completion, an average of 8 months)