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.
Descripción general del estudio
Estado
Descripción detallada
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)
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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:
Otros nombres:
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.
Otros nombres:
All patients will be reviewed after three months follow-up by the overseeing expert.
|
|
Comparador activo: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of diagnosis agreement
Periodo de tiempo: 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
|
|
Percentage of management plan agreement
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Number of initial diagnoses changed after investigations proposed
Periodo de tiempo: Through study completion, an average of 8 months
|
Through study completion, an average of 8 months
|
|
Number of referrals to secondary care needed
Periodo de tiempo: Through study completion, an average of 8 months
|
Through study completion, an average of 8 months
|
|
Name of investigations required for an accurate diagnosis
Periodo de tiempo: Through study completion, an average of 8 months
|
Through study completion, an average of 8 months
|
|
Overall improvement according to the patient (Better, stable, worse)
Periodo de tiempo: Change from baseline at 3 months (follow-up)
|
Change from baseline at 3 months (follow-up)
|
|
Overall improvement according to overseeing expert (Better, stable, worse)
Periodo de tiempo: 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))
Periodo de tiempo: Change from baseline at 3 months (follow-up)
|
Change from baseline at 3 months (follow-up)
|
|
Difficulties regarding dizziness (Dizziness Handicap Inventory questionnaire (DHI))
Periodo de tiempo: Change from baseline at 3 months (follow-up)
|
Change from baseline at 3 months (follow-up)
|
|
Quality of life (EQ-5D-3L Questionnaire)
Periodo de tiempo: 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
Periodo de tiempo: Through study completion, an average of 8 months
|
Through study completion, an average of 8 months
|
|
Reason for exclusion to the trial
Periodo de tiempo: Through study completion, an average of 8 months
|
Through study completion, an average of 8 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Doris-Eva Bamiou, MD MSc FRCP PhD, University College, London
- Director de estudio: Linda M Luxon, CBE BSc FRCP FRCPE, Royal College of Physicians
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13/0336
- 610454 (Otro número de subvención/financiamiento: EU Seventh Framework Programme)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Decision Support System (DSS)
-
DascenaNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Baystate Health; Cape... y otros colaboradoresReclutamientoSepticemia | Shock séptico | Sepsis severaEstados Unidos
-
University of California, San FranciscoTerminadoHipertensión | Insuficiencia Renal CrónicaEstados Unidos