Dr. David Newman-Toker and the Brain Injury Outcomes (BIOS) coordinating center at Johns Hopkins University are happy to announce that The National Institute on Deafness and Other Communication Disorders (NIDCD), one of the National Institutes of Health (NIH), has awarded funding for the AVERT clinical trial (FAIN U01DC013778). AVERT (Acute Video-oculography for vertigo in Emergency rooms for Rapid Triage) is a randomized controlled trial evaluating the algorithmic application of a diagnostic medical device (video-oculography or VOG) in the triage of patients presenting to hospital emergency departments with vertigo and dizziness.
The study is expected to randomize 226 patients across 3 U.S.-based clinical sites. The study has been deemed a non-significant risk device trial by the U.S. FDA as it involves a new (investigational) application of this device. VOG devices are currently FDA-approved for measuring eye movements in the assessment of vestibular conditions; they have not been used extensively in the emergency department setting prior to this trial. The study is currently under review by the Institutional Review Boards at the participating sites and is expected to start enrolling next year.
The lead investigator for this trial is David E. Newman-Toker, MD, PhD. He is Associate Professor of Neurology and Otolaryngology, with joint appointments in Ophthalmology, Health Sciences Informatics, and Emergency Medicine at the Johns Hopkins University School of Medicine, as well as Epidemiology and Health Policy & Management at the Bloomberg School of Public Health. Dr. Newman-Toker holds degrees from Yale University (B.S. Molecular Biophysics & Biochemistry 1991), the University of Pennsylvania, School of Medicine (M.D.1995), and the Johns Hopkins Bloomberg School of Public Health (Ph.D. Clinical Investigation 2007). He completed internship and Neurology residency at Harvard University (Massachusetts General Hospital 1999) followed by fellowships in Neuro- ophthalmology at Harvard University (Simmons Lessell, Massachusetts Eye & Ear Infirmary, 2000) and Neuro- otology at the Johns Hopkins University School of Medicine (David Zee, Johns Hopkins Hospital 2002). He joined the Department of Neurology at the Johns Hopkins University School of Medicine as faculty in 2002.
Dr. Newman-Toker's clinical interest is in diagnosis of acute disorders affecting the vestibular system and particularly in the diagnosis of acute vertigo and dizziness. His research focus is on errors in diagnosis, decision modeling, and designing clinical algorithms and decision support systems to reduce misdiagnosis in frontline healthcare settings. He has been the Principal Investigator for several federal and non-federal research grants focused on diagnosis and misdiagnosis of dizziness and other neurologic symptoms in the emergency department. Research methods employed by his group include prospective cross-sectional, observational cohort, surveys, and systematic literature reviews.
The researchers hypothesize that VOG-guided rapid triage will help accurately, safely, and efficiently differentiate peripheral from central vestibular disorders in ED patients presenting acute vertigo or dizziness, and that doing so has the potential to improve post-treatment clinical outcomes for these patients.
- Aim 1 – Compare accuracy of diagnosis and initial management for VOG-guided vs. standard ED care
- Aim 2 – Compare costs of diagnosis and initial management for VOG-guided vs. standard ED care
- Aim 3 – Compare clinical outcomes in those correctly vs. incorrectly diagnosed in standard care arm
- This study is about an innovative diagnostic approach, not about the VOG device. The AVERT trial is focused on testing the hypothesis that smart technology and diagnosis by protocol can improve care for vestibular patients, increasing diagnostic accuracy, reducing costs of testing, and eliminating morbidity from misdiagnosis.The VOG device itself is only one component of study intervention. The more important component of the intervention is the decision support algorithm (based on eye movement decision rules) intended to assist ED physicians in making important diagnostic decisions. The solution we propose to enable accurate, frontline vestibular diagnosis is an open-source, non-proprietary decision tool based on heuristic logic. It will be made freely available for anyone in the world to use. This algorithm could be used even without the device if clinicians eventually learned to confidently interpret the results of bedside eye exams without quantitation.
- This study is not about VOG device development or FDA approval. The AVERT trial is designed to test improvements in the process and delivery of diagnostic care in the ED, and their downstream effects on clinical outcomes endpoints, not for regulatory approval. The VOG is in routine clinical use around the world in subspecialty clinics for vestibular diagnosis. We are studying the use of an FDA-approved diagnostic device for a novel patient population (mixed, acute central and peripheral disorders), in a novel location, by a novel set of providers, and in a novel way (at the time of the symptoms, not two weeks later). AVERT is designed to change clinical care processes, thereby reducing diagnostic error and saving lives.