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.
Balance problems are caused by multiple factors and often lead to falls and related fractures, bringing large socio-economic costs. The complexity of balance control mechanisms, the lack of medical expertise, and the absence of specialised equipment contribute to the delayed or incorrect diagnosis and management ofthese patients. Advances in computer science have allowed the development of computer systems that support clinical diagnosis and treatment decisions based on individualised patient data. The aim of the EMBalance decision support system (DSS) is to support doctors facing this clinical challenge, to make a definitive diagnosis and implement an effective management plan. The EMBalance study will determine the accuracy of this supportive tool when used by non-specialist doctors. This study is funded by the European Union's Seventh Framework Programme.



EMBalance is a proof-of-concept study designed as a non-commercial, international, multi-centre, single-blind, parallel-group randomised controlled trial to be carried out at four clinical sites in the United Kingdom, Germany, Greece and Belgium. The study is comprised of three stages: internal pilot, phase I (diagnosis) and stage II (management). For this purpose, 200 patients presenting with persistent dizziness (>3 months' duration) to primary care services will be randomised to either the intervention group (diagnostic assessment with the DSS) or a control group (diagnostic assessment without the DSS). Patients allocated to the intervention group will be assessed by a doctor with the support of the EMBalance DSS, while patients allocated to the control group will receive a visit as per standard practice. Ultimately, all patients' diagnoses and management plans will be certified by a consultant in neuro-otology.



EMBalance is the first trial to test the accuracy of a DSS in both the diagnosis of and the management plan for vestibular disorders across the healthcare systems of four different countries. The EMBalance study is the result of a combined effort of engineers and physicians to develop an accurate tool to support non-specialist doctors, with no risk for the patient. This trial will provide reliable information about the benefits of implementing DSSs in primary care while supporting the feasibility of testing the EMBalance algorithms in further research.



ClinicalTrials.gov NCT02704819 . Registered 29 February 2016.
Neuro-otology Department, National Hospital for Neurology and Neurosurgery, Queen Square, London, WC1N 3BG, UK. l.rammazzo@ucl.ac.uk.|UCL Ear Institute, University College London, 332 Gray's Inn Road, London, WC1X 8EE, UK. l.rammazzo@ucl.ac.uk.
Laura
0000-0003-3220-2013
L
Rammazzo
First Department of Otolaryngology-Head and Neck Surgery, 'Hippokrateio' General Hospital, University of Athens, Vassilissis Sophias Avenue 114, 115 27, Athens, Greece.
Dimitris
D
Kikidis
UCL Ear Institute, University College London, 332 Gray's Inn Road, London, WC1X 8EE, UK.
Amal
A
Anwer
Neuro-otology Department, National Hospital for Neurology and Neurosurgery, Queen Square, London, WC1N 3BG, UK.|UCL Ear Institute, University College London, 332 Gray's Inn Road, London, WC1X 8EE, UK.
Nora
N
Macdonald
First Department of Otolaryngology-Head and Neck Surgery, 'Hippokrateio' General Hospital, University of Athens, Vassilissis Sophias Avenue 114, 115 27, Athens, Greece.
Efthymios
E
Kyrodimos
Department of Neurology, University of Freiburg, Hugstetter Straße 55, 79106, Freiburg, Germany.
Christoph
C
Maurer
Research Centre for Equilibrium and Aerospace (AUREA), Antwerp University, Wilrijkstraat 10 Route 71, B904, Edegem, 2650, Antwerp, Belgium.
Floris
F
Wuyts
Neuro-otology Department, National Hospital for Neurology and Neurosurgery, Queen Square, London, WC1N 3BG, UK.|UCL Ear Institute, University College London, 332 Gray's Inn Road, London, WC1X 8EE, UK.|Royal College of Physicians, 11 St. Andrews Place, Regent's Park, London, NW1 4LE, UK.
Linda
L
Luxon
First Department of Otolaryngology-Head and Neck Surgery, 'Hippokrateio' General Hospital, University of Athens, Vassilissis Sophias Avenue 114, 115 27, Athens, Greece.
Athanasios
A
Bibas
Neuro-otology Department, National Hospital for Neurology and Neurosurgery, Queen Square, London, WC1N 3BG, UK. d.bamiou@ucl.ac.uk.|UCL Ear Institute, University College London, 332 Gray's Inn Road, London, WC1X 8EE, UK. d.bamiou@ucl.ac.uk.
Doris-Eva
DE
Bamiou
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000066491:Clinical Decision-Making; D002985:Clinical Protocols; D003661:Decision Support Techniques; D019033:Delivery of Health Care, Integrated; D004244:Dizziness / Q000175:diagnosis* / Q000503:physiopathology / Q000628:therapy*; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010348:Patient Care Team; D010865:Pilot Projects; D004856:Postural Balance; D011237:Predictive Value of Tests; D011320:Primary Health Care; D000075082:Proof of Concept Study; D015203:Reproducibility of Results; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D014717:Vertigo / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D015837:Vestibular Diseases / Q000175:diagnosis* / Q000503:physiopathology / Q000628:therapy*; D055815:Young Adult
Decision support system; Dizziness; Feasibility study; Randomised controlled trial; Vertigo; Vestibular disease